WO2025199572A1

WO2025199572A1 - Cerclage device and fixation methods

Info

Publication number: WO2025199572A1
Application number: PCT/AU2025/050285
Authority: WO
Inventors: Stuart Kirkham
Original assignee: Dr Stuart Kirkham Pty Ltd
Current assignee: Dr Stuart Kirkham Pty Ltd
Priority date: 2024-03-25
Filing date: 2025-03-24
Publication date: 2025-10-02
Anticipated expiration: 2026-09-25

Abstract

A cerclage device configured for fixation of at least one bone portion and/or tissue of a subject's shoulder is disclosed. The cerclage device comprises an elongate member having a medial end and a lateral end. The cerclage device is configured to be irreversibly secured relative to the at least one bone portion and/or tissue when the medial end and/or the lateral end are moved in a fastening direction. The cerclage device may be coupled with a metaphyseal component or humeral prosthesis implanted in the subject's shoulder. A method for cerclage fixation of at least one bone portion and/or tissue of a subject's shoulder using a cerclage device is also disclosed. A cerclage device and method for cerclage fixation of at least one bone portion and/or tissue of a subject's body is also disclosed. The cerclage device may be coupled with a fixation support implanted in the subject's body.

Description

CERCLAGE DEVICE AND FIXATION METHODS

[0001] This application claims priority from Australian Provisional Patent Application No. 2024900797 filed on 25 March 2024, the contents of which are to be taken as incorporated herein by this reference.

Field

[0002] The present disclosure relates to fixation of bone and/or tissue of a shoulder of a subject. It relates particularly but not exclusively to cerclage fixation of bone and/or tissue of the subject’s shoulder with an implanted humeral prosthesis.

[0003] The present disclosure also relates to fixation of bone and/or tissue of a subject’s body, such as within joints or limbs of the subject. It relates particularly but not exclusively to cerclage fixation of bone and/or tissue of the subject’s body with an implanted fixation support.

Background

[0004] The shoulder 1020 of a human subject 1000 includes a number of bones as illustrated in Figure 1. The shoulder 1020 includes a humerus bone 1100 with a humeral head 1120, a clavicle 1050, and a scapula 1040 with an acromion 1060, a coracoid process 1070 and a glenoid 1080 that is the socket portion of the shoulder joint that articulates with the humeral head 1120. The proximal humerus refers to the end of humerus 1100 having the humeral head 1120.

[0005] Proximal humeral fractures typically result in a 4-part displaced fracture as shown in Figure 2. The proximal humerus often becomes separated into one or more head fragment(s) 1130, a greater tuberosity fragment 1140, a lesser tuberosity fragment 1160 and the remaining long bone of the humerus 1100. The soft tissues of the shoulder 1020 may remain attached or be surgically re-attached to the bone fragments and humerus 1100. The supraspinatus muscle 1200 is attached by its tendon to the greater tuberosity fragment 1140. The infraspinatus muscle 1240 is also attached by its tendon to the greater tuberosity fragment 1140 (not shown, see Figures 24- 25). The subscapularis muscle 1220 is attached by its tendon to the lesser tuberosity fragment 1160 and also part of remaining long bone of the humerus 1100. [0006] Surgery may be required to repair proximal humeral fractures, such as the fracture shown in Figure 2. Proximal humeral fractures that require operative surgery have been generally treated by one of four procedures, 1) plate and screw fixation, 2) nail fixation, 3) reverse arthroplasty, or 4) hemiarthroplasty. There is still much debate amongst the world’s leading shoulder fracture experts regarding the optimal procedure, noting that each type of surgical implant is associated with a significant number of complications and negative outcomes.

[0007] As will be appreciated, one operation is preferable to several operations. Furthermore, the worst results have been seen when a first operation has failed and needs to be salvaged with one or more subsequent operations. Accordingly, selecting the optimal procedure is of the utmost importance.

[0008] Plate and screw fixation, and nail fixation both suffer from migration of the hardware, avascular necrosis, and a second or more operation rate. Nail fixation results in deeper infections and worse outcomes than plate and screw fixation. Reverse arthroplasty is the most invasive procedure and the highest cost option. It involves reversing the normal ball-and-socket structure of the shoulder to attach a prosthetic ball to the scapular bone and replace the humeral head with a prosthetic socket.

[0009] Hemiarthroplasty involves replacing the damaged humeral head with a prosthetic humeral head and often includes a stem component fixed within the humeral shaft. Hemiarthroplasty is lower cost and less invasive than reverse arthroplasty, however is often associated with loss of tuberosity fixation, which has been correlated with poor outcomes. In recent years, more and more proximal humeral fractures have been treated with reverse arthroplasty, largely because of the inadequate hardware choice available to perform a reliable hemiarthroplasty.

[0010] The challenge during and after hemiarthroplasty surgery for proximal humeral fractures has been the issue of tuberosity fixation. Tuberosities are those positions on the humeral bone where the rotator cuff tendons are attached. The greater tuberosity serves as the attachment for the supraspinatus and the infraspinatus muscles, and the lesser tuberosity serves as the attachment for the subscapularis muscle. It is now understood and well documented that tuberosity fixation is the single most important determinant of the outcome following hemiarthroplasty surgery. If the tuberosity bony fixation fails, this results in failure of the tendons of the rotator cuff muscles, and subsequently, failure of the surgery. [0011] Tuberosity fixation with most hemiarthroplasty designs on the market today only allow for fixation with the use of sutures or cerclage wires. Suture fixation of the tuberosities is relatively weak and is not strong enough to allow the patient to actively mobilise their shoulder through the full range of motion in the early weeks. There are also many reports of tuberosity failure after suture fixation of the bone fragments.

[0012] Failures and poor outcomes after hemiarthroplasty surgery are reported if there is nonunion of one or more of the tuberosities. Tuberosity failure is linked to excessive active motion while the tuberosities have not yet united or healed after surgery.

[0013] It would be desirable to provide a humeral prosthesis and fixation method that allows for improved tuberosity fixation, thereby improving the outcomes for hemiarthroplasty in treating proximal humeral fractures. As a less invasive and lower cost option, hemiarthroplasty may then become a more viable choice compared to the current use of reverse arthroplasty.

[0014] It would also be desirable to provide devices and methods that provide secure fixation of various bones and/or tissues of a subject’s body to improve outcomes and earlier healing of bone fractures and/or tissue trauma.

[0015] A reference herein to a patent document or any other matter identified as prior art, is not to be taken as an admission that the document or other matter was known or that the information it contains was part of the common general knowledge as at the priority date of any of the claims.

Summary of Disclosure

[0016] In one aspect, the present disclosure provides a cerclage device configured for fixation of at least one bone portion and/or tissue of a shoulder of a subject, the cerclage device comprising: an elongate member having a medial end and a lateral end, wherein the elongate member comprises: a leading section located at the medial end for insertion around and/or through the at least one bone portion and/or tissue; a flexible section between the medial end and the lateral end, wherein the flexible section is configured to prevent or reduce damage to the at least one bone portion and/or tissue; and a securing section; and a securing mechanism for irreversibly securing the cerclage device relative to the at least one bone portion and/or tissue when the medial end and/or the lateral end are moved in a fastening direction, wherein the securing mechanism engages with the securing section of the elongate member to prevent movement of the medial end and/or the lateral end in a direction opposite to the fastening direction.

[0017] In some embodiments, the medial end and the lateral end may be moved in the fastening direction to irreversibly secure the cerclage device. The medial end and the lateral end may be moved towards each other in the fastening direction. The medial end and the lateral end may be brought together to irreversibly secure the cerclage device. In other embodiments, only the medial end or the lateral end is moved in the fastening direction to irreversibly secure the cerclage device.

[0018] The securing mechanism may prevent movement of both the medial end and the lateral end in a direction opposite to the fastening direction. Alternatively, the securing mechanism may only prevent movement of one of the medial end or the lateral end in a direction opposite to the fastening direction. The securing mechanism may be formed of a polymeric material, such as a plastic material, and preferably, Polyether ether ketone (PEEK). Alternatively, the securing mechanism may include an outer layer comprising a polymeric material, such as PEEK.

[0019] In some embodiments, the securing section is located between the flexible section and the leading section of the elongate member. A portion of the securing mechanism may be located adjacent to the lateral end of the elongate member. The securing mechanism may be configured to receive the leading section of the elongate member when the medial end is moved in the fastening direction. The elongate member may be passed through the securing mechanism until the securing section is received within the securing mechanism and is engaged therewith.

[0020] The securing mechanism may comprise a locking portion for engaging with a plurality of interlocking portions positioned along a length of the securing section of the elongate member. The securing mechanism may be a ratchet mechanism. The plurality of interlocking portions may comprise teeth and the locking portion may comprise a head with a pawl that engages lockably with the teeth. Additionally/altematively, the plurality of interlocking portions may be a series of serrated angulated steps. The medial end of the elongate member may be received in a portion of the securing mechanism adjacent the lateral end. The medial end may include the plurality of interlocking portions which are received in a locking portion adjacent the lateral end. Alternatively, the plurality of interlocking portions may be located along a length of securing section of the elongate member between the medial and lateral ends. [0021] In other embodiments, the securing mechanism may comprise a compressible portion for permanently deforming a length of securing section of the elongate member. The compressible portion may allow for crimping of two sections of the elongate member together. The two sections may be the lateral end and the medial end. The compressible portion may be adjacent to the lateral end. Alternatively, the two sections may include the lateral end and a portion of securing section of the elongate member between the lateral and medial ends. In another embodiment, the two sections may include the medial end and a portion of securing section of the elongate member between the lateral and medial ends.

[0022] The leading section, the flexible section and the securing section of the elongate member may comprise different materials. The flexible section may be formed of a protective material which may be. The protective material may be a soft material. The protective material may comprise at least one of a group selected from mersilene, silk, dacron, an ultrabraid material or a non-braided material, or combinations thereof. The securing section may be formed of a polymeric material, such as a plastic, and preferably Polyether ether ketone (PEEK).

[0023] In some embodiments, the leading section comprises a cutting edge to perforate and/or puncture the at least one bone portion and/or tissue. The leading portion may include a metal material such as steel or titanium. The leading portion may perforate and/or puncture a tissue of the subject’s shoulder, such as a tendon or muscle of the rotator cuff, including a supraspinatus, a subscapularis or an infraspinatus tendon or muscle.

[0024] The cerclage device may be configured for fixation of the at least one bone portion and/or tissue with an implanted humeral prosthesis. The implanted humeral prosthesis may be suitable for hemiarthroplasty. The medial end and the lateral end may be couplable together around and/or through the at least one bone portion and/or tissue for fixation with the implanted humeral prosthesis.

[0025] The cerclage device may be couplable with the implanted humeral prosthesis. The implanted humeral prosthesis may comprise a metaphyseal component having a body, and the elongate member may be couplable with the body of the metaphyseal component. The medial end of the elongate member may be configured to be received through a slot on the body of the metaphyseal component. [0026] In some embodiments, the cerclage device further comprises an internal surface configured to prevent or reduce slippage during irreversible securing of the cerclage device relative to the at least one bone portion and/or tissue. The internal surface may be roughened for frictional engagement with the at least one bone portion and/or tissue. The internal surface may comprise a textured pattern and/or one or more projections for frictional engagement with the at least one bone portion and/or tissue. The textured pattern may be a zig zag shaped pattern. The projections may include prongs or spikes formed on the internal surface or part of the securing mechanism. The securing mechanism and/or the flexible section of the elongate member may comprise the internal surface of the cerclage device.

[0027] The at least one bone portion may be part of a humerus of the subject. The at least one bone portion may be part of a lesser tuberosity, a greater tuberosity or a head of the humerus. The at least one tissue may be a tendon or a muscle. The at least one tissue may comprise a supraspinatus, a subscapularis or an infraspinatus tendon or muscle of the subject’s shoulder.

[0028] In another aspect, the present disclosure provides a metaphyseal component configured for coupling with a cerclage device according to the above aspect for fixation of at least one bone portion and/or tissue of a shoulder of a subject with the metaphyseal component when implanted, wherein the metaphyseal component comprises a body having at least one location for coupling with the cerclage device.

[0029] The at least one location may be on a medial side of the metaphyseal component. Additionally/alternatively, the at least one location may be on a lateral side of the metaphyseal component. The at least one location may comprise a slot for receiving the cerclage device therethrough. In other embodiments, the body may comprise an opening, passage, aperture, slit, groove or notch to provide a fixation point for coupling of the cerclage device. The body may comprise a plurality of locations for coupling with a respective plurality of cerclage devices. The body may comprise at least two locations (e.g., slots) on the medial side of the metaphyseal component for coupling with two respective cerclage devices.

[0030] The at least one bone portion may be part of a humerus of the subject. The at least one bone portion may be part of a lesser tuberosity, a greater tuberosity or a head of the humerus. The at least one tissue may be a tendon or a muscle. The at least one tissue may comprise a supraspinatus, a subscapularis or an infraspinatus tendon or muscle of the subject’s shoulder. [0031] In another aspect, the present disclosure provides a humeral prosthesis, comprising: a metaphyseal component configured for coupling with a cerclage device according to the above aspect for fixation of at least one bone portion and/or tissue of a shoulder of a subject with the humeral prosthesis when implanted, wherein the metaphyseal component comprises a body having at least one location for coupling with the cerclage device; and a diaphyseal component comprising a stem configured for placement in a prepared shaft of a humerus of the subject.

[0032] The at least one location may be on a medial side of the metaphyseal component. Additionally/alternatively, the at least one location may be on a lateral side of the metaphyseal component. The at least one location may comprise a slot for receiving the cerclage device therethrough. In other embodiments, the body may comprise an opening, passage, aperture, slit, groove or notch to provide a fixation point for coupling of the cerclage device. The body may comprise a plurality of locations for coupling with a respective plurality of cerclage devices. The body may comprise at least two locations (e.g., slots) on the medial side of the metaphyseal component for coupling with two respective cerclage devices.

[0033] In some embodiments, the metaphyseal component and the diaphyseal component are configured for locking engagement together. The humeral prosthesis may further comprise a head component comprising a domed surface, where the head component and the metaphyseal component may be configured for locking engagement together.

[0034] The at least one bone fragment may be part of a humerus of the subject. The at least one bone fragment may be part of a lesser tuberosity, a greater tuberosity or a head of the humerus. The at least one tissue may be a tendon or a muscle. The tissue may comprise one of a supraspinatus, a subscapularis or an infraspinatus tendon or muscle of the shoulder.

[0035] In another aspect, the present disclosure provides a kit, comprising: at least one cerclage device according to the above aspect configured for fixation of at least one bone portion and/or tissue of a shoulder of a subject; and at least one metaphyseal component comprising a body having at least one location for coupling with the at least one cerclage device.

[0036] The kit may further comprise at least one cerclage tool configured to be secured to the body of the at least one metaphyseal component at the at least one location. The at least one cerclage tool may have a tubular cross-section to allow for passage of the at least one cerclage device therethrough. The at least one cerclage tool may comprise a curved end portion for ease of access in passing the at least one cerclage device.

[0037] In some embodiments, the kit further comprises at least one diaphyseal component having a component comprising a stem configured for placement in a prepared shaft of a humerus of the subject, where the at least one metaphyseal component and the at least one diaphyseal component are configured for locking engagement together.

[0038] In some embodiments, the kit further comprises at least one head component comprising a domed surface, where the at least one head component and the at least one metaphyseal component are configured for locking engagement together.

[0039] The at least one metaphyseal component may be a metaphyseal component according to the above aspect or any one of the embodiments of the above aspect.

[0040] In another aspect, the present disclosure provides a cerclage tool configured to be secured to a body of a metaphyseal component having at least one location for coupling with at least one cerclage device according to the above aspect, wherein the cerclage tool has a tubular crosssection to allow for passage of the at least one cerclage device therethrough.

[0041] In another aspect, the present disclosure provides a cerclage tool configured to be secured to a body of a metaphyseal component having at least one location for coupling with at least one cerclage device according to the above aspect, wherein the cerclage tool comprises a curved end portion for ease of access in passing the at least one cerclage device.

[0042] In another aspect, the present disclosure provides a method for cerclage fixation of at least one bone portion and/or tissue of a shoulder of a subject, the method comprising the steps of: providing a cerclage device configured for fixation of the at least one bone portion and/or tissue, the cerclage device comprising: an elongate member having a medial end and a lateral end, wherein the elongate member comprises: a leading section located at the medial end for insertion around and/or through the at least one bone portion and/or tissue; a flexible section between the medial end and the lateral end, wherein the flexible section is configured to prevent or reduce damage to the at least one bone portion and/or tissue; and a securing section; and a securing mechanism for irreversibly securing the cerclage device relative to the at least one bone portion and/or tissue; moving the medial end and/or the lateral end of the elongate member in a fastening direction; and irreversibly securing the cerclage device relative to the at least one bone portion and/or tissue for fixation by engaging the securing mechanism with the securing section of the elongate member to prevent movement of the medial end and/or the lateral end in a direction opposite to the fastening direction.

[0043] In some embodiments, the step of irreversibly securing the cerclage device comprises operating the securing mechanism to prevent movement of the medial end and/or the lateral end in a direction opposite to the fastening direction. The step of operating the securing mechanism may comprise engaging a locking portion of the cerclage device with a plurality of interlocking portions positioned along a length of the securing section of the elongate member. Alternatively, the step of operating the securing mechanism may comprise compressing a compressible portion of the cerclage device to permanently deform a length of the securing section of the elongate member. The compressing step may comprise crimping two portions of the length of the elongate member together. The method may further comprise receiving the medial end of the elongate member in part of the securing mechanism adjacent to the lateral end.

[0044] Before the step of moving the medial end and/or the lateral end in a fastening direction, the method may further comprise inserting the leading section of the elongate member around and/or through the at least one bone portion and/or tissue. The step of inserting the leading section may comprise perforating and/or puncturing the at least one bone portion and/or tissue with a cutting edge of the leading section.

[0045] Before the step of moving the medial end and/or the lateral end in a fastening direction, the method may further comprise coupling the cerclage device with an implanted humeral prosthesis. The step of coupling the cerclage device may comprise coupling the medial end of the elongate member at at least one location on a body of a metaphyseal component of the implanted humeral prosthesis. The at least one location may comprises a slot in the body, and wherein coupling the medial end may comprises receiving the medial end through the slot on the body of the metaphyseal component.

[0046] In some embodiments, the method further comprises coupling a plurality of cerclage devices at a respective plurality of locations on the body of the metaphyseal component. The step of coupling the plurality of cerclage devices may further comprise fixing, using at least one cerclage device, a portion of the lesser tuberosity of a humerus of the subject with the implanted humeral prosthesis. After cerclage fixation of the portion of the lesser tuberosity, the method may further comprise fixing, using at least one cerclage device, a portion of the greater tuberosity of the humerus of the subject with the implanted humeral prosthesis.

[0047] In another aspect, the present disclosure provides a cerclage device configured for fixation of at least one bone portion and/or tissue of a subject’s body, the cerclage device comprising: an elongate member having a medial end and a lateral end, wherein the elongate member comprises: a leading section located at the medial end for insertion around and/or through the at least one bone portion and/or tissue; a flexible section between the medial end and the lateral end, wherein the flexible section is configured to prevent or reduce damage to the at least one bone portion and/or tissue; and a securing section; and a securing mechanism for irreversibly securing the cerclage device relative to the at least one bone portion and/or tissue when the medial end and/or the lateral end are moved in a fastening direction, wherein the securing mechanism engages with the securing section of the elongate member to prevent movement of the medial end and/or the lateral end in a direction opposite to the fastening direction.

[0048] The cerclage device may be configured for fixation of at least one bone portion and/or tissue of a joint of the subject’s body, including but not limited to a shoulder joint, elbow joint, hip joint or knee joint. The cerclage device may also be configured for fixation of at least one bone portion and/or tissue of or adjacent to a long bone of the subject’s body, such as a humerus or femur. The cerclage device may also be used for fixation of other bones and/or tissues in the upper or lower extremities of the subject’s body.

[0049] The cerclage device may be configured for fixation of the at least one bone portion and/or tissue with an implanted fixation support. The medial end and the lateral end may be couplable together around and/or through the at least one bone portion and/or tissue for fixation with the implanted fixation support. The fixation support may be implanted adjacent to a bone of the subject’s body, such as a long bone including a humerus or femur. The fixation support may be fixed to the bone of the subject’s body via one or more fixation screws. The fixation support may be a fixation plate. The fixation support may support healing of fractures of one or more bones of the subject’s body.

[0050] The fixation support may include at least one opening for receiving the cerclage device. The cerclage device may pass through the at least one opening and be secured around the at least one bone portion and/or tissue for fixation with the implanted fixation support. The at least one opening may be shaped for receiving the cerclage device. The at least one opening may be circular, oval, or elliptical, for example, and have smooth edges to prevent damage to the cerclage device. The fixation support may include a plurality of openings for receiving a plurality of cerclage devices.

[0051] In another aspect, the present invention provides a method for cerclage fixation of at least one bone portion and/or tissue of a subject’s body, the method comprising the steps of: providing a cerclage device configured for fixation of the at least one bone portion and/or tissue, the cerclage device comprising: an elongate member having a medial end and a lateral end, wherein the elongate member comprises: a leading section located at the medial end for insertion around and/or through the at least one bone portion and/or tissue; a flexible section between the medial end and the lateral end, wherein the flexible section is configured to prevent or reduce damage to the at least one bone portion and/or tissue; and a securing section; and a securing mechanism for irreversibly securing the cerclage device relative to the at least one bone portion and/or tissue; moving the medial end and/or the lateral end of the elongate member in a fastening direction; and irreversibly securing the cerclage device relative to the at least one bone portion and/or tissue for fixation by engaging the securing mechanism with the securing section of the elongate member to prevent movement of the medial end and/or the lateral end in a direction opposite to the fastening direction.

[0052] The cerclage device may be configured for fixation of at least one bone portion and/or tissue of a joint of the subject’s body, including but not limited to a shoulder joint, elbow joint, hip joint or knee joint. The cerclage device may also be configured for fixation of at least one bone portion and/or tissue of or adjacent to a long bone of the subject’s body, such as a humerus or femur. The cerclage device may also be used for fixation of other bones and/or tissues in the upper or lower extremities of the subject’s body.

[0053] In some embodiments, before the step of moving the medial end and/or the lateral end in a fastening direction, the method may further comprise coupling the cerclage device with an implanted fixation support. The fixation support may be implanted adjacent to a bone of the subject’s body, such as a long bone including a humerus or femur. The fixation support may be fixed to the bone of the subject’s body via one or more fixation screws. The fixation support may be a fixation plate. The fixation support may support healing of fractures of one or more bones of the subject’s body. [0054] The step of coupling the cerclage device may comprise passing the medial end of the elongate member through at least one opening provided in the fixation support. The method may further comprise moving the medial end and/or the lateral end towards one another to secure the cerclage device around the bone portion and/or tissue of the subject’s body. The at least one opening may be shaped for receiving the cerclage device. The at least one opening may be circular, oval, or elliptical, for example, and have smooth edges to prevent damage to the cerclage device. The fixation support may include a plurality of openings for receiving a plurality of cerclage devices.

[0055] In another aspect, the present disclosure provides a cerclage device configured for fixation of at least one bone portion and/or tissue of a shoulder of a subject, the cerclage device comprising an elongate member having a medial end and a lateral end, wherein the cerclage device is configured to be irreversibly secured relative to the at least one bone portion and/or tissue when the medial end and/or the lateral end are moved in a fastening direction.

[0056] In some embodiments, the medial end and the lateral end may be moved in the fastening direction to irreversibly secure the cerclage device. The medial end and the lateral end may be moved towards each other in the fastening direction. The medial end and the lateral end may be brought together to irreversibly secure the cerclage device. In other embodiments, only the medial end or the lateral end is moved in the fastening direction to irreversibly secure the cerclage device.

[0057] In some embodiments, the cerclage device further comprises a securing mechanism that prevents movement of the medial end and/or the lateral end in a direction opposite to the fastening direction. The securing mechanism may prevent movement of both the medial end and the lateral end in a direction opposite to the fastening direction. Alternatively, the securing mechanism may only prevent movement of one of the medial end or the lateral end in a direction opposite to the fastening direction. The securing mechanism may be formed of a polymer material, such as Polyether ether ketone (PEEK). Alternatively, the securing mechanism may include an outer layer comprising a polymer material, such as PEEK.

[0058] The securing mechanism may comprise a locking portion for engaging with a plurality of interlocking portions positioned along a length of the elongate member. The securing mechanism may be a ratchet mechanism. The plurality of interlocking portions may comprise teeth and the locking portion may comprise a head with a pawl that engages lockably with the teeth. Additionally/alternatively, the plurality of interlocking portions may be a series of serrated angulated steps. The medial end of the elongate member may be received in a portion of the securing mechanism adjacent the lateral end. The medial end may include the plurality of interlocking portions which are received in a locking portion adjacent the lateral end. Alternatively, the plurality of interlocking portions may be located along a length of the elongate member between the medial and lateral ends.

[0059] In other embodiments, the securing mechanism may comprise a compressible portion for permanently deforming a length of the elongate member. The compressible portion may allow for crimping of two sections of the elongate member together. The two sections may be the lateral end and the medial end. The compressible portion may be adjacent to the lateral end Alternatively, the two sections may include the lateral end and a portion of the elongate member between the lateral and medial ends. In another embodiment, the two sections may include the medial end and a portion of the elongate member between the lateral and medial ends.

[0060] In some embodiments, the elongate member comprises a leading section located at the medial end for insertion around and/or through the at least one bone portion and/or tissue. The leading section may comprise a cutting edge to perforate and/or puncture the at least one bone portion and/or tissue. The leading portion may include a metal material such as steel or titanium. The leading portion may perforate and/or puncture a tissue of the subject’s shoulder, such as a tendon or muscle of the rotator cuff, including a supraspinatus, a subscapularis or an infraspinatus tendon or muscle.

[0061] The cerclage device may be configured for fixation of the at least one bone portion and/or tissue with an implanted humeral prosthesis. The implanted humeral prosthesis may be suitable for hemiarthroplasty. The medial end and the lateral end may be couplable together around and/or through the at least one bone portion and/or tissue for fixation with the implanted humeral prosthesis.

[0062] The cerclage device may be couplable with the implanted humeral prosthesis. The implanted humeral prosthesis may comprise a metaphyseal component having a body, and the elongate member may be couplable with the body of the metaphyseal component. The medial end of the elongate member may be configured to be received through a slot on the body of the metaphyseal component. [0063] In some embodiments, the cerclage device further comprises an internal surface configured to prevent or reduce slippage during irreversible securing of the cerclage device relative to the at least one bone portion and/or tissue. The internal surface may be roughened for frictional engagement with the at least one bone portion and/or tissue. The internal surface may comprise a textured pattern and/or one or more projections for frictional engagement with the at least one bone portion and/or tissue. The textured pattern may be a zig zag shaped pattern. The projections may include prongs or spikes formed on the internal surface or part of the securing mechanism.

[0064] The cerclage device may further comprise a flexible section between the medial end and the lateral end, where the flexible section is configured to prevent or reduce damage to the at least one bone portion and/or tissue. The flexible section may be configured to prevent or reduce damage to the at least one bone portion and/or tissue. The flexible section may be formed of a protective material. The protective material may be a soft material. The protective material may comprise at least one of a group selected from mersilene, silk, dacron, an ultrabraid material or a non-braided material, or combinations thereof.

[0065] The at least one bone portion may be part of a humerus of the subject. The at least one bone portion may be part of a lesser tuberosity, a greater tuberosity or a head of the humerus. The at least one tissue may be a tendon or a muscle. The at least one tissue may comprise a supraspinatus, a subscapularis or an infraspinatus tendon or muscle of the subject’s shoulder.

[0066] In another aspect, the present disclosure provides a metaphyseal component configured for coupling with a cerclage device for fixation of at least one bone portion and/or tissue of a shoulder of a subject with the metaphyseal component when implanted, wherein the metaphyseal component comprises a body having at least one location for coupling with the cerclage device.

[0067] The at least one location may be on a medial side of the metaphyseal component. Additionally/alternatively, the at least one location may be on a lateral side of the metaphyseal component. The at least one location may comprise a slot for receiving the cerclage device therethrough. In other embodiments, the body may comprise an opening, passage, aperture, slit, groove or notch to provide a fixation point for coupling of the cerclage device. The body may comprise a plurality of locations for coupling with a respective plurality of cerclage devices. The body may comprise at least two locations (e.g., slots) on the medial side of the metaphyseal component for coupling with two respective cerclage devices. [0068] The at least one bone portion may be part of a humerus of the subject. The at least one bone portion may be part of a lesser tuberosity, a greater tuberosity or a head of the humerus. The at least one tissue may be a tendon or a muscle. The at least one tissue may comprise a supraspinatus, a subscapularis or an infraspinatus tendon or muscle of the subject’s shoulder.

[0069] The cerclage device may be a cerclage device according to the above aspect or any one of the embodiments of the above aspect.

[0070] In another aspect, the present disclosure provides a humeral prosthesis, comprising: a metaphyseal component configured for coupling with a cerclage device for fixation of at least one bone portion and/or tissue of a shoulder of a subject with the humeral prosthesis when implanted, wherein the metaphyseal component comprises a body having at least one location for coupling with the cerclage device; and a diaphyseal component comprising a stem configured for placement in a prepared shaft of a humerus of the subject.

[0071] The at least one location may be on a medial side of the metaphyseal component. Additionally/alternatively, the at least one location may be on a lateral side of the metaphyseal component. The at least one location may comprise a slot for receiving the cerclage device therethrough. In other embodiments, the body may comprise an opening, passage, aperture, slit, groove or notch to provide a fixation point for coupling of the cerclage device. The body may comprise a plurality of locations for coupling with a respective plurality of cerclage devices. The body may comprise at least two locations (e.g., slots) on the medial side of the metaphyseal component for coupling with two respective cerclage devices.

[0072] In some embodiments, the metaphyseal component and the diaphyseal component are configured for locking engagement together. The humeral prosthesis may further comprise a head component comprising a domed surface, where the head component and the metaphyseal component may be configured for locking engagement together.

[0073] The at least one bone fragment may be part of a humerus of the subject. The at least one bone fragment may be part of a lesser tuberosity, a greater tuberosity or a head of the humerus. The at least one tissue may be a tendon or a muscle. The tissue may comprise one of a supraspinatus, a subscapularis or an infraspinatus tendon or muscle of the shoulder. [0074] The cerclage device may be a cerclage device according to the above aspect or any one of the embodiments of the above aspect.

[0075] In another aspect, the present disclosure provides a kit, comprising: at least one cerclage device configured for fixation of at least one bone portion and/or tissue of a shoulder of a subject; and at least one metaphyseal component comprising a body having at least one location for coupling with the at least one cerclage device.

[0076] The kit may further comprise at least one cerclage tool configured to be secured to the body of the at least one metaphyseal component at the at least one location. The at least one cerclage tool may have a tubular cross-section to allow for passage of the at least one cerclage device therethrough. The at least one cerclage tool may comprise a curved end portion for ease of access in passing the at least one cerclage device.

[0077] In some embodiments, the kit further comprises at least one diaphyseal component having a component comprising a stem configured for placement in a prepared shaft of a humerus of the subject, where the at least one metaphyseal component and the at least one diaphyseal component are configured for locking engagement together.

[0078] In some embodiments, the kit further comprises at least one head component comprising a domed surface, where the at least one head component and the at least one metaphyseal component are configured for locking engagement together.

[0079] The at least one cerclage device may be a cerclage device according to the above aspect or any one of the embodiments of the above aspect. The at least one metaphyseal component may be a metaphyseal component according to the above aspect or any one of the embodiments of the above aspect.

[0080] In another aspect, the present disclosure provides a method for cerclage fixation of at least one bone portion and/or tissue of a shoulder of a subject, the method comprising the steps of: providing a cerclage device configured for fixation of the at least one bone portion and/or tissue, the cerclage device comprising an elongate member having a medial end and a lateral end; moving the medial end and/or the lateral end in a fastening direction; and irreversibly securing the cerclage device relative to the at least one bone portion and/or tissue for fixation. [0081] In some embodiments, the step of irreversibly securing the cerclage device comprises operating a securing mechanism to prevent movement of the medial end and/or the lateral end in a direction opposite to the fastening direction. The step of operating a securing mechanism may comprise engaging a locking portion of the cerclage device with a plurality of interlocking portions positioned along a length of the elongate member. Alternatively, the step of operating a securing mechanism may comprise compressing a compressible portion of the cerclage device to permanently deform a length of the elongate member. The compressing step may comprise crimping two portions of the length of the elongate member together. The method may further comprise receiving the medial end of the elongate member in part of the securing mechanism adjacent to the lateral end.

[0082] Before the step of moving the medial end and/or the lateral end in a fastening direction, the method may further comprise inserting a leading section of the elongate member around and/or through the at least one bone portion and/or tissue. The step of inserting the leading section may comprise perforating and/or puncturing the at least one bone portion and/or tissue with a cutting edge of the leading section.

[0083] Before the step of moving the medial end and/or the lateral end in a fastening direction, the method may further comprise coupling the cerclage device with an implanted humeral prosthesis. The step of coupling the cerclage device may comprise coupling the medial end of the elongate member at at least one location on a body of a metaphyseal component of the implanted humeral prosthesis. The at least one location may comprises a slot in the body, and wherein coupling the medial end may comprises receiving the medial end through the slot on the body of the metaphyseal component.

[0084] In some embodiments, the step of coupling the cerclage device further comprises securing a cerclage tool to the body of the metaphyseal component at the at least one location, wherein the cerclage tool has a tubular cross-section, and passing the cerclage device through the cerclage tool to couple with the body of the metaphyseal component. The method may further comprise using the cerclage tool to pass the cerclage device around and/or through the at least one bone portion and/or tissue for fixation with the implanted humeral prosthesis.

[0085] In some embodiments, the method further comprises coupling a plurality of cerclage devices at a respective plurality of locations on the body of the metaphyseal component. The step of coupling the plurality of cerclage devices may further comprise fixing, using at least one cerclage device, a portion of the lesser tuberosity of a humerus of the subject with the implanted humeral prosthesis. After cerclage fixation of the portion of the lesser tuberosity, the method may further comprise fixing, using at least one cerclage device, a portion of the greater tuberosity of the humerus of the subject with the implanted humeral prosthesis.

[0086] The cerclage device may be a cerclage device according to the above aspect or any one of the embodiments of the above aspect.

[0087] In another aspect, the present disclosure provides a cerclage device configured for fixation of at least one bone portion and/or tissue of a subject’s body, the cerclage device comprising an elongate member having a medial end and a lateral end, wherein the cerclage device is configured to be irreversibly secured relative to the at least one bone portion and/or tissue when the medial end and/or the lateral end are moved in a fastening direction.

[0088] The cerclage device may be configured for fixation of at least one bone portion and/or tissue of a joint of the subject’s body, including but not limited to a shoulder joint, elbow joint, hip joint or knee joint. The cerclage device may also be configured for fixation of at least one bone portion and/or tissue of or adjacent to a long bone of the subject’s body, such as a humerus or femur. The cerclage device may also be used for fixation of other bones and/or tissues in the upper or lower extremities of the subject’s body.

[0089] The cerclage device may be configured for fixation of the at least one bone portion and/or tissue with an implanted fixation support. The medial end and the lateral end may be couplable together around and/or through the at least one bone portion and/or tissue for fixation with the implanted fixation support. The fixation support may be implanted adjacent to a bone of the subject’s body, such as a long bone including a humerus or femur. The fixation support may be fixed to the bone of the subject’s body via one or more fixation screws. The fixation support may be a fixation plate. The fixation support may support healing of fractures of one or more bones of the subject’s body.

[0090] The fixation support may include at least one opening for receiving the cerclage device. The cerclage device may pass through the at least one opening and be secured around the at least one bone portion and/or tissue for fixation with the implanted fixation support. The at least one opening may be shaped for receiving the cerclage device. The at least one opening may be circular, oval, or elliptical, for example, and have smooth edges to prevent damage to the cerclage device. The fixation support may include a plurality of openings for receiving a plurality of cerclage devices.

[0091] In another aspect, the present disclosure provides a method for cerclage fixation of at least one bone portion and/or tissue of the subject’s body, the method comprising the steps of providing a cerclage device configured for fixation of the at least one bone portion and/or tissue, the cerclage device comprising an elongate member having a medial end and a lateral end; moving the medial end and/or the lateral end in a fastening direction; and irreversibly securing the cerclage device relative to the at least one bone portion and/or tissue for fixation.

[0092] The cerclage device may be configured for fixation of at least one bone portion and/or tissue of a joint of the subject’s body, including but not limited to a shoulder joint, elbow joint, hip joint or knee joint. The cerclage device may also be configured for fixation of at least one bone portion and/or tissue of or adjacent to a long bone of the subject’s body, such as a humerus or femur. The cerclage device may also be used for fixation of other bones and/or tissues in the upper or lower extremities of the subject’s body.

[0093] In some embodiments, before the step of moving the medial end and/or the lateral end in a fastening direction, the method may further comprise coupling the cerclage device with an implanted fixation support. The fixation support may be implanted adjacent to a bone of the subject’s body, such as a long bone including a humerus or femur. The fixation support may be fixed to the bone of the subject’s body via one or more fixation screws. The fixation support may be a fixation plate. The fixation support may support healing of fractures of one or more bones of the subject’s body.

[0094] The step of coupling the cerclage device may comprise passing the medial end of the elongate member through at least one opening provided in the fixation support. The method may further comprise moving the medial end and/or the lateral end towards one another to secure the cerclage device around the bone portion and/or tissue of the subject’s body. The at least one opening may be shaped for receiving the cerclage device. The at least one opening may be circular, oval, or elliptical, for example, and have smooth edges to prevent damage to the cerclage device. The fixation support may include a plurality of openings for receiving a plurality of cerclage devices. Brief Description of Drawings

[0095] The present disclosure will now be described in greater detail with reference to the accompanying drawings in which like features are represented by like numerals. It is to be understood that the embodiments shown are examples only and are not to be taken as limiting the scope of the present disclosure as defined in the claims appended hereto.

[0096] Figure l is a schematic diagram illustrating the bones of a right shoulder of a human subject.

[0097] Figure 2 is a schematic diagram illustrating a typical 4-part displaced fracture of a right shoulder of a human subject, showing soft tissues attached to the bone fragments.

[0098] Figure 3 is a side view of an existing shoulder implant with a first component and a second component of the shoulder implant coupled to each other.

[0099] Figure 4 is a side view of a fastener of the existing shoulder implant of Figure 3.

[0100] Figure 5 is a side view of an inserter tool used to implant the existing shoulder implant of Figure 3.

[0101] Figure 6 is a side view of an existing shoulder implant similar to Figure 3 with the first component separated from the second component.

[0102] Figure 7 is a side view of the first component of the existing shoulder implants of Figure 3 and 6 implanted in the diaphysis of a bone.

[0103] Figure 8 is a top view of the first component of the existing shoulder implant of Figures 3 and 6 implanted in the diaphysis of a bone.

[0104] Figure 9 is a bottom view of the second component of the existing shoulder implant of Figures 3 and 6.

[0105] Figure 10 is a side view of an alternative second component to be used with the existing shoulder implant of Figures 3 and 6. [0106] Figure 11 is frontal view of a humeral prosthesis implanted in a subject’s left shoulder in an assembled state, showing a diaphyseal component implanted in a prepared humeral shaft, a metaphyseal component having one medial slot for receiving a cerclage device for fixation of bone fragments and/or tissues and being coupled with the diaphyseal component, and a head component coupled with the metaphyseal component, according to some embodiments of the disclosure.

[0107] Figure 12 is another frontal view of a humeral prosthesis being implanted in a subject’s left shoulder in a disassembled state, illustrating a tool configured to engage with the metaphyseal component for assembly and disassembly from the diaphyseal component, and the metaphyseal component having two medial slots for receiving a cerclage device for fixation of bone fragments and/or tissues, according to some embodiments of the disclosure.

[0108] Figure 13 is a perspective view of a metaphyseal component of a humeral prosthesis having a body with a cavity/cage portion and two optional laterally protruding slots for receiving a cerclage device for fixation of bone fragments and/or tissues, according to some embodiments of the disclosure.

[0109] Figure 14 is a rotated view of the metaphyseal component of Figure 13 showing two medially protruding slots for receiving a cerclage device for fixation of bone fragments and/or tissues, and an angled neck portion configured to receive a head component of a humeral prosthesis, according to some embodiments of the disclosure.

[0110] Figures 15 to 18 are schematic diagrams illustrating cerclage devices with a ratchet mechanism according to some embodiments of the disclosure, with Figures 15 and 16 showing an external surface of the cerclage device with a tapered end (Figure 15) and a double tapered pointed tip (Figure 16), and Figures 17 and 18 showing an internal surface of the cerclage device with interlocking portions to be engaged with a locking portion and having a tapered end, and showing a textured pattern and multiple prongs (Figure 18) on the internal surface to prevent or minimise slippage during securing of the cerclage device.

[0111] Figures 19 to 22 are schematic diagrams illustrating cerclage devices with a compressible portion for irreversibly deforming a portion of the medial end of the cerclage device according to some embodiments of the disclosure, with Figures 19 and 20 showing an external surface of the cerclage device with a tapered end (Figure 19) and a double tapered pointed tip (Figure 20), and Figures 21 and 22 showing an internal surface of the cerclage device and having a tapered end, and showing a roughened surface on the crimping box (Figure 22) to prevent or minimise slippage during securing of the cerclage device.

[0112] Figure 23 is a perspective view of a humeral prosthesis implanted in a prepared humeral shaft of a subject’s left shoulder and fixation of the lesser tuberosity fragment using a cerclage device with a compressible portion (similar to Figures 19 to 22) according to some embodiments of the disclosure, where the humeral shaft is transparent to show the diaphyseal component and where the cerclage device is passed through the subscapularis muscle and tendon, around the lesser tuberosity fragment and is received through a medial slot in the body of the metaphyseal component.

[0113] Figure 24 is another perspective view following on from Figure 23, where the cerclage device for the lesser tuberosity fragment is now secured, and two cerclage devices are passed through the supraspinatus and infraspinatus muscles and around the greater tuberosity fragment and received through medial slots in the body of the metaphyseal component, according to some embodiments of the disclosure.

[0114] Figure 25 is another perspective view following on from Figure 24, where the cerclage devices for the lesser and greater tuberosity fragments are now secured, and illustrating an optional suture for securing the greater tuberosity fragment and the humeral shaft for additional stability, according to some embodiments of the disclosure.

[0115] Figure 26 is a cross-sectional view through the frontal plane of a shoulder with an implanted humeral prosthesis and illustrating a cerclage tool for passing of the cerclage devices, with two cerclage devices secured and an optional additional suture between the greater tuberosity fragment and the humeral shaft, and where the humeral shaft is transparent to show the diaphyseal component, according to some embodiments of the disclosure.

[0116] Figure 27 is a top view of a shoulder with an implanted humeral prosthesis (not visible), illustrating another cerclage tool with curved portions for passing of a cerclage device, according to some embodiments of the disclosure.

[0117] Figure 28 is a top view of a shoulder with an implanted humeral prosthesis (not visible except for the head component) and illustrating passing of a cerclage device around the greater and lesser tuberosity fragments using the cerclage tool of Figure 27 to be engaged at points A, B and C, according to some embodiments of the disclosure.

[0118] Figure 29 is a schematic diagram of the cerclage tool of Figures 27 and 28 showing passages in arms of the tool (broken lines) for passage of a cerclage device in each arm in the direction indicated by the arrows, according to some embodiments of the disclosure.

[0119] Figure 30 is a flow chart illustrating steps in a method for cerclage fixation of at least one bone portion and/or tissue of a subject’s shoulder, optionally with an implanted humeral prosthesis, according to some embodiments of the disclosure.

[0120] Figure 31 is a schematic diagram of a kit including at least one cerclage device and at least one metaphyseal component, according to some embodiments of the disclosure.

[0121] Figure 32 is a frontal view showing an implanted hemiarthroplasty prosthesis in a left humerus of a subject (humeral head shown in broken lines as shape would differ following repair, e.g., 4-part proximal humerus fracture), where the humerus is transparent to show positioning of the prosthetic components, and illustrating two cerclage devices coupled with the metaphyseal component via respective slots on each of medial and lateral sides of the prosthesis, according to some embodiments of the disclosure.

[0122] Figure 33 is a frontal view showing an implanted shoulder replacement prosthesis in a left humerus of a subject (humeral head shown in broken lines as shape would differ following repair), where the humerus is transparent to show positioning of the prosthetic components and screws, and where a shaft fracture below the prosthesis is supported via a lateral fixation plate secured to the humerus proximally with cerclage devices and distally with screws, according to some embodiments of the disclosure.

[0123] Figure 34 is a frontal view showing an implanted elbow prosthesis in a left humerus of a subject (elbow joint portion of humerus shown in broken lines as shape would differ following repair), where the humerus is transparent to show positioning of the prosthesis and screws, and where a shaft fracture above the prosthesis is supported via a lateral fixation plate secured to the humerus distally with cerclage devices and proximally and distally with screws, according to some embodiments of the disclosure. [0124] Figure 35 is a frontal view showing an implanted total hip replacement prosthesis in a left femur of a subject (femoral head shown in broken lines as would not be present), where the femur is transparent to show positioning of the prosthesis components and screws, and where a shaft fracture below the prosthesis is supported via a lateral fixation plate secured to the femur proximally with cerclage devices and proximally and distally with screws, according to some embodiments of the disclosure.

[0125] Figure 36 is a frontal view showing an implanted knee prosthesis in a left femur of a subject (knee joint portion of femur shown in broken lines as would not be present), where the femur is transparent to show positioning of the prosthesis and screws, and where distal femoral fractures are supported via a lateral fixation plate secured to the femur distally with cerclage devices and proximally with screws, according to some embodiments of the disclosure.

[0126] Figure 37 is a flow chart illustrating steps in a method for cerclage fixation of at least one bone portion and/or tissue of a subject’s body, optionally with an implanted fixation support, according to some embodiments of the disclosure.

Description of Embodiments

[0127] Embodiments of the present disclosure are discussed herein by reference to the drawings which are not to scale and are intended merely to assist with explanation of the present disclosure.

[0128] The term “subject” as referred to herein may include a human or animal subject.

[0129] The term “proximal” as referred to herein means towards the trunk of the subject’s body and away from the head or extremities. In particular, “proximal” means in the direction towards the humeral head of the humeral bone, or in the direction towards the femoral head of the femoral bone.

[0130] The term “distal” as referred to herein means away from the trunk of the subject’s body and towards the head or extremities. In particular, “distal” means in the direction away from the humeral head of the humeral bone, or in the direction away from the femoral head of the femoral bone. [0131] The term “medial” as referred to herein means towards the midline or centre of the subject’s body. The term “lateral” as referred to herein means away from the midline or centre of the subject’s body.

[0132] Although the description and figures herein describe embodiments of the disclosure in the context of a left humerus and femur of a subject, and left humeral and femoral prostheses, it is to be understood that the embodiments of the disclosure could readily be applied to a right humerus and femur of a subject, and to right humeral and femoral prostheses.

[0133] The present disclosure is directed to a novel cerclage device configured for fixation of at least one bone portion and/or tissue of a subject’s shoulder. The cerclage device may be configured for fixation of the bone portion and/or tissue with an implanted humeral prosthesis. The humeral prosthesis is preferably suitable for hemiarthroplasty. The present disclosure is also directed to a novel metaphyseal component and humeral prosthesis couplable with the cerclage device, a kit and a method for fixation of at least one bone portion and/or tissue of the subject’s shoulder. Aspects of the present disclosure may allow for improved tuberosity fixation and an earlier range of motion for the patient after surgery, particularly hemiarthroplasty.

[0134] The humeral prosthesis may be a proximal humeral prosthesis for hemiarthroplasty, which is designed specifically to treat fractures of the proximal humerus. It is known as a fracture stem in the orthopaedic industry. The word fracture pertains to its intended use. It is not intended for use in the arthritis setting but rather in the fracture presentation setting. The word stem pertains to the fact that it is inserted as a cylindrically shaped object inside the medullary canal or shaft of the humerus bone in a stem-like manner. There are many fracture stems which are intended to treat proximal humerus fractures that are commercially available. However, all of the existing designs have problems that lead to inferior fixation and poor clinical outcomes for patients.

[0135] The humeral prosthesis of various embodiments of the disclosure is designed to provide an implant which results in better patient outcomes due to restoration of the anatomy and improved tuberosity fixation. It may also make a difficult operation easier by enabling the height and version/rotation of a broken bone to be assessed where the normal anatomical landmarks have been damaged, and thus provide a more user-friendly implant where the surgeon can make adjustments during surgery and therefore be more accurate in recreating the anatomy of each patient. The novel humeral prosthesis may allow for earlier movements for the patient, a better range of movement of the shoulder, lower cost as there are no glenoid components required (hemiarthroplasty compared to a reverse arthroplasty), less revisions, and a shorter surgical time.

[0136] As will be described, the humeral prosthesis of the present disclosure is the first design of any fracture stem or hemiarthroplasty prosthesis, which provides for improved tuberosity fixation by cerclage device(s) configured to be irreversibly secured relative to the bone fragments and/or tissue for fixation with the prosthesis. The humeral prosthesis may also allow for variation of the height/length intra operatively by selecting a metaphyseal component with up to a further 20 mm of additional height/length. The humeral prosthesis may also allow variation of the rotation intra operatively by measuring and readjusting the rotation (version) to obtain maximal joint stability. Improved tuberosity fixation may also be provided for by a cage for bone graft in a metaphyseal component of the humeral prosthesis. The bone graft can be autologous and/or synthetic bone substitutes, to improve healing between the tuberosities and the implant, and the cerclage device(s) for irreversibly securing relative to the bone/tissue for fixation with the implant.

[0137] The present disclosure is also directed to a novel cerclage device configured for fixation of at least one bone portion and/or tissue of a subject’s body. The present disclosure is also directed to a novel method for fixation of at least one bone portion and/or tissue of the subject’s body using the novel cerclage device. The cerclage device may be configured for fixation of at least one bone portion and/or tissue of a joint of the subject’s body, including but not limited to a shoulder joint, elbow joint, hip joint or knee joint. The cerclage device may also be configured for fixation of at least one bone portion and/or tissue within a limb of the subject’s body, including an upper or lower limb. The cerclage device may be configured for fixation of a bone portion and/or tissue of or adjacent to a long bone of the subject’s body, such as a humerus or femur. The cerclage device may also be used for fixation of other bones and/or tissues in the upper or lower limbs of the subject’s body.

[0138] The cerclage device may be configured for fixation of the bone portion and/or tissue with an implanted fixation support. The fixation support may be a fixation plate of an appropriate size and/or shape to support healing of fractures of one or more bones of the subject’s body. Aspects of the present disclosure may allow for improved bone and/or tissue fixation and an earlier range of motion for the patient after surgery to repair bone fractures and/or resolve tissue trauma, particularly with respect to joints and/or long bones of the subject. Existing Shoulder Implant

[0139] The humeral prosthesis of the present disclosure relates to an improvement of an existing shoulder implant disclosed in Australian Patent Publication No. 2017225021 Al published on 22 March 2018, the disclosure of which is incorporated herein by this reference. The features of the existing shoulder implant will be described with references to Figures 3 to 10 reproduced from Australian Patent Publication No. 2017225021 Al.

[0140] Figure 3 shows an existing shoulder implant 100 in an assembled state. The implant 100 has a longitudinal axis 10 and comprises a first component 102 and a second component 104. Figure 6 shows an existing shoulder implant 100 similar to Figure 3 with the first component 102 separated from the second component 104. The first component 102 is to be implanted within a diaphysis of the humerus and the second component 104 is to be implanted within a metaphysis of the humerus. Referring to Figure 4, the implant 100 further comprises a fastener 106 having an external thread 108.

[0141] Referring to Figure 6, the first component 102 has an elongate first component body 110 having a fluted shape. It is envisaged that the first component 102 is formed from titanium or any other suitable material known in the art. The first component body 110 has an end 112 and a first component end face 114 that defines a first component engaging profile 116. A bore 118 extends into the first component body 110 from the first component end face 114 along the longitudinal axis 10. Referring to Figure 7, the bore 118 has an internal thread 120. Referring to Figure 8, the first component end face 114 further comprises a plurality of recesses 122 displaced angularly around the bore 118. As can be seen from Figure 8, the plurality of recesses 122 are angularly displaced about the longitudinal axis 10 from adjacent recess 122 by multiples of 15°. It is also envisaged that any number of recesses 122 may be employed and that the recesses 122 may be angularly displaced from each other about the longitudinal axis 10 by other angles.

[0142] Figures 7 and 8 show the first component 102 implanted within a diaphysis of a humeral bone 12. Referring to Figure 8, the humeral bone 12 has a transepicondylar axis 14.

[0143] Referring to Figure 6, the second component 104 has a second component body 124 surrounding a cavity 126. The second body 124 is formed of a perforated material 128 such as a steel mesh. It is also envisaged that the second component body 124 can be formed of any other suitable material known in the art. Due to the perforated material 128, the cavity 126 is in communication with the exterior of the second component 104.

[0144] The second component body 124 further comprises an end 130, a second component end face 132 that defines a second component engaging profile 134, and a number of straps 136 (only one labelled for clarity of illustration). A passage 138 extends from the end 130 through the second component body 124 to the second component end face 132 along the longitudinal axis 10. Referring to Figure 9, a plurality of protrusions 140 are angularly arranged around the passage 138. As can be seen from Figure 9, the plurality of protrusions 140 are angularly displaced about the longitudinal axis 10 from adjacent protrusions 140 by multiples of 15°. It is envisaged that any number of protrusions 140 may be employed and that the protrusions 140 may be angularly displaced from each other about the longitudinal axis 10 by other angles.

[0145] Referring to Figure 6, the second component body 124 is formed of a first member 142 and a second member 144 coupled to each other. Coupling the first member 142 to the second member 144 forms the cavity 126. The first member 142 comprises holes 145 through which a strap 136 may pass. The second member 144 comprises holes 147 through a strap 136 may pass. The first member 142 may be secured to a greater tuberosity GT, and the second member 144 may be secured to a lesser tuberosity LT. It is envisaged that the first member 142 and second member 144 are formed from porous steel mesh or any other suitable material known in the art.

[0146] The second member 144 of the second component body 124 has a joint surface 148. The joint surface 148 has a projection 150 formed as a morse taper. The projection 150 has an axis 16. The axis 16 intersects the longitudinal axis 10 at an angle a of 45 degrees. The second member 144 further comprises a head component 152 that has an orifice 154. The projection 150 is configured to be received in the orifice 154 thereby coupling the head component 152 to the projection 150. The head component 152 forms a ball part of a ball and socket joint. It is envisaged that the head component 152 is formed from chrome cobalt or any other suitable material known in the art.

[0147] Figure 5 shows an inserter tool 156 used to insert the first component 102 into the diaphysis of the humeral bone 12. The inserter tool 156 has a longitudinal axis 18 and comprises an inserter thread 158, a version rod 160 and markings 162 (only one labelled for clarity of illustration). The version rod 160 is angularly movable about the longitudinal axis 18 in order to measure the anteversion or retroversion of the transepicondylar axis 14. The markings 162 assist in determining the required length of the second component 104.

[0148] Figure 10 shows an alternative second component 204. The second component 204 is similar to the second component 104 except that it does not comprise the joint surface 148, the projection 150 or the head component 152. The second member 244 of the second component body 224 has a socket 264 and a ball joint 266. The ball joint 266 comprises a hemispherical ball 268 and a baseplate 270. The base plate 270 comprises implant fixtures 272. The ball joint 266 together with the socket 264 form a ball and socket joint.

[0149] Assembly of the second component 104 will now be discussed. Referring to Figure 6, the first member 142 and the second member 144 are brought into engagement with each other such that the holes 145 of the first member 142 align with the holes 147 of the second member 144. Straps 136 are then passed through corresponding aligned holes 145 and holes 147 and tensioned thereby coupling the first member 142 to the second member 144. Bone material and/or bone substitute material is inserted into the cavity 126 either before engagement of the first member 142 with the second member 144 or before tensioning of the straps 136. It will be appreciated that the second component 204 is assembled in a similar manner to that described above.

[0150] Coupling of the first component 102 to the second component 104, 204 will now be discussed. When the first component 102 and the second component 104, 204 are aligned along the longitudinal axis 10, the first component 102 and second component 104, 204 are angularly moveable about the longitudinal axis 10 with respect to each other. The first component 102 and second component 104, 204 are moved along the longitudinal axis 10 until the first component end face 114 abuts the second component end face 132, 232 such that the first component engaging profile 116 engages with the second component engaging profile 134, 234. When the first component engaging profile 116 is engaged with the second component engaging profile 134, 234, each of the plurality of protrusions 140 are received within a respective one of the plurality of recesses 122 thereby forming a locking connection 157 (see Figure 3). It will be appreciated that the number of protrusions 140 may be less than or equal to the number of recesses 122. It will also be appreciated that the angular displacement about the longitudinal axis 10 between adjacent protrusions 140, 240 must correspond to the angular displacement about the longitudinal axis 10 between adjacent recesses 122. Although not shown in Figure 10, it is to be appreciated that the second component 204 will include corresponding protrusions to the protrusions 140 of the second component 104.

[0151] It will be appreciated that the first component 102 can be coupled to the second component 104, 204 in a number of angular positions about the longitudinal axis 10 with respect to each other. This is achieved by angularly moving the first component 102 about the longitudinal axis 10 with respect to the second component 104, 204 and abutting the first component end face 114 with the second component end face 132, 232 to engage the first component engaging profile 116 with the second component engaging profile 134, 234 such that the each of the plurality of protrusions 140 are received within a different one of the plurality of recesses 122 thereby forming the locking connection 157. Accordingly, the first component 102 can be coupled to second component 104, 204 in a number of desired angular positions about the longitudinal axis 10 with respect to each other. The angular position of the first component 102 with respect to the second component 104, 204 about the longitudinal axis 10 is referred to as the “version”. Depending on the angular position of the first component 102 with the respect to the second component 104, 204 about the longitudinal axis 10, the version may be an anteversion or a retroversion.

[0152] The locking connection 157 maintains the desired angular position of the first component 102 with respect to the second component 104, 204 about the longitudinal axis 10.

[0153] When the locking connection 157 has been formed, the bore 118 of the first component 102 aligns with the passage 138, 238 of the second component 104, 204. The fastener 106 is then inserted into the passage 138, 238 from the second end 130, 230 of the second component 104, 204. The fastener 106 engages with the passage 138, 238 and is able to move angularly about the longitudinal axis 10 within the passage 138, 238. Moving the fastener 106 angularly about the longitudinal axis 10 in a first direction 20 (see Figure 4) causes the external thread 108 of the fastener 106 to engage with the internal thread 120 of the first component 102 thereby coupling first component 102 to the second component 104, 204 and tensioning the fastener 106. Additional angular movement of the fastener 106 about the longitudinal axis 10 in the first direction 20 further tensions the fastener 106. The locking connection 157 maintains the desired angular position of the first component 102 with respect to the second component 104, 204 about the longitudinal axis 10 when tensioning the fastener 106. Accordingly, the locking connection 157 prevents the first component 102 angularly moving away from the desired angular position with respect to the second component 104, 204 about the longitudinal axis 10 when tensioning the fastener 106.

[0154] Angularly moving the fastener 106 about the longitudinal axis 10 in a direction opposite to the first direction 20 relaxes the tension of the fastener 106 thereby allowing the first component 102 to be decoupled from the second component 104, 204.

[0155] The procedure of implanting the shoulder implant 100 will now be discussed. The inserter tool 156 is coupled to the first component 102 by engaging the inserter thread 158 of the inserter tool 156 with the internal thread 120 of the bore 118.

[0156] Referring to Figure 6, the first component 102 is implanted into the diaphysis of the humeral bone 12 using the inserter tool 156. After the first component 102 has been implanted into the diaphysis of the humeral bone 12, the first component 102 is cemented in place using bone cement 174 (see Figure 7). The usual standard bone cement widely used and recommended for this has been commercially available and widely used for over 50 years and is made from methyl-methacrylate, with embedded gentamicin, an antibiotic. The version rod 160 is then angularly moved with respect to the longitudinal axis 10 until it is aligned with the transepicondylar axis 14. The alignment of the version rod 160 with the transepicondylar axis 14 determines the desired angular position of the first component 102 with respect to the second component 104 about the longitudinal axis 10. In other words, the version rod 160 determines the version required for the shoulder implant 100. The transepicondylar axis 14 is then marked on the first component 102 for reference when coupling the second component 104 to the first component 102. The surgeon may select the desired angle of version, noting that 30-50 degrees of retroversion is the most commonly selected.

[0157] The length of the humerus before the procedure determines the required length of the second component 104, 204. The required length of the second component 104, 204 is determined during the operative procedure, and after the final cementation of the first component, so that it allows for a more accurate measurement of the exact required length for the second component; such that the length of the humerus together with the shoulder implant 100 after the procedure is approximately the same length of the humerus before the procedure. While the inserter tool 156 is coupled to the first component 102, the required length of the second component 104, 204 is calculated with reference to the markings 162 on the inserter tool 156. After the required length of the second component 104, 204 and the version have been determined, the inserter tool 156 is decoupled from the first component 102.

[0158] Implanting the second component 104 will now be discussed. After the required length of the second component 104 has been determined, a corresponding first member 142 and a corresponding second member 144 are coupled to each other as discussed above. The first member 142 and the second member 144 are coupled to each other such that there is bone material and/or bone substitute material (suitable and appropriate bone substitutes are used when there is not enough local or host bone to fill a defect). Commercially available and suitable bone substitutes would include Bon Alive® putty and/or BonAlive granules® disposed in the cavity 126 of the resulting second component body 124. The bone material may be sourced from the head of the humerus that has been surgically removed during the hemiarthroplasty surgery.

[0159] The head component 152 is sized such that it corresponds to the head size of the patient’s humerus that has been removed during the hemiarthroplasty surgery and the Glenoid cavity of the patient. After the head component 152 has been sized, it is coupled to the projection 150. The head component could be made from chrome cobalt, or pyrocarbon, or ceramic.

[0160] The second component engaging profile 134 is then positioned to engage the first component engaging profile 116 at the version determined previously thereby forming the locking connection 157. After the locking connection 157 has been formed, the fastener 106 is inserted into the passage 138 and moved angularly about the longitudinal axis 10 such that the external thread 108 of the fastener 106 engages with the internal thread 120 of the bore 118 thereby coupling the first component 102 to the second component 104 and tensioning the fastener 106.

[0161] After the first component 102 has been coupled to the second component 104, the head component 152 is located adjacent the Glenoid cavity of the patient. Subsequently, the muscles and ligaments connected to the GT of the humerus of the patient before the hemiarthroplasty surgery are coupled to the first member 142. Similarly, the muscles and ligaments connected to the LT of the humerus of the patient before the hemiarthroplasty surgery are coupled to the second member 144.

[0162] The muscles and ligaments are coupled to the respective first member 142 and second member 144 by stitches (not illustrated). The stitches pass through the perforated material 128 of the first member 142 and/or second member 144 to engage respective muscles and/or ligaments thereby coupling the respective muscles and/or ligaments to the second component 104.

[0163] Implanting the second component 204 of Figure 10 (known as the reverse arthroplasty humeral metaphyseal component) will now be discussed. After the required length of the second component 204 has been determined, a corresponding first member 242 and a corresponding second member 244 are coupled to each other as discussed above and similar to coupling of the respective members of the second component 104. The coupling may be achieved through passing straps through aligned holes 245, 247 of the first and second members 242, 244. The first member 242 and the second member 244 are coupled to each other such that there is bone material and/or bone substitute material disposed in the cavity of the resulting second component body 224. The bone material may be sourced from the head of the humerus that has been surgically removed during the hemiarthroplasty surgery.

[0164] The second component engaging profile 234 is then positioned to engage the first component engaging profile 116 at the version determined previously thereby forming the locking connection (not shown but see 157 of Figure 3). After the locking connection has been formed, the fastener 106 is inserted into the passage 238 and moved angularly about the longitudinal axis 10 such that the external thread 108 of the fastener 106 engages with the internal thread 120 of the bore 118 thereby coupling the first component 102 to the second component 204 and tensioning the fastener 106.

[0165] The base plate 270 of the gl enosphere 266 is then implanted in the scapula of the patient at a predetermined position using the implant fixings 272. The hemispherical ball (glenosphere) 268 is then coupled to the base plate 270.

[0166] Subsequently, the socket 264 of the second component 204 is then coupled to the hemispherical ball 268 to form a ball and socket joint 271 (see Figure 10). After the ball and socket joint 271 has been formed, the muscles and ligaments connected to the GT of the humerus of the patient before the hemiarthroplasty surgery are coupled to the first member 242. Similarly, the muscles and ligaments connected to the LT of the humerus of the patient before the hemiarthroplasty surgery are coupled to the second member 244.

[0167] The muscles and ligaments are coupled to the respective first member 242 and second member 244 by stitches (not illustrated). The stitches pass through the perforated material of the first member 242 and/or second member 244 to engage respective muscles and/or ligaments thereby coupling the respective muscles and/or ligaments to the second component 204.

[0168] Disposing bone material and/or bone substitute material in the cavity 126 of the second component 104, 204 promotes osteoinduction and osteoconduction thereby promoting bone growth within the cavity 126. The bone growth continues towards and/or partially through the porous material 128 that forms the second component 104 such that the muscles and ligaments grafted to second component 104, 204 also form a connection with the bone material and/or bone substitute material within the cavity 126. Having the muscles and ligaments grafted to the second component 104 as well as the muscles and ligaments forming a connection with the bone material and/or bone substitute material reduces the probability of non-union between the muscles and ligaments and the second component 104. Accordingly, this improves the probability of success of the hemiarthroplasty surgery.

[0169] Although the first component 102 was described with having a plurality of recesses 122 and the second component 104, 204 was described with having a plurality of protrusions 140, 240, it will be appreciated that the first component 102 can have the plurality of protrusions 140 and the second component 104, 204 can have the plurality of recesses 122, 222.

Humeral Prosthesis

[0170] Turning to Figures 11 to 14, a humeral prosthesis is now illustrated according to some embodiments of the disclosure. The humeral prosthesis may include similar features to the existing shoulder implant described with reference to Figures 3 to 10, which will be discussed where relevant.

[0171] Figure 11 is a frontal view of a humeral prosthesis 2000 comprising a metaphyseal component 2100 configured for coupling with a cerclage device 3000 (see Figures 15 to 22) for fixation of at least one bone portion and/or tissue of a shoulder 1020 of a subject 1000 with the humeral prosthesis when implanted, according to an aspect of the disclosure. The metaphyseal component 2100 comprises a body 2120 having at least one location for coupling with the cerclage device 3000. The humeral prosthesis 2000 also comprises a diaphyseal component 2200 comprising a stem 2220 configured for placement in a prepared shaft 1180 of a humerus 1100 of the subject 1000. [0172] The humeral prosthesis 2000 of Figure 11 is shown implanted in a left shoulder 1020 of the subject 1000. In this case, the humerus 1100 has been surgically repaired as indicated by a zig-zag line 1110 separating the humeral head 1120 and remaining humeral long bone having the shaft 1180. The proximal humerus 1100 may have been fractured, such as via a 4-part displaced fracture shown in Figure 2. The surgical repair procedure in this case is a hemiarthroplasty. This involves removal of the humeral head 1120 and any bone fragments which ideally remain attached or are surgically re-attached to the corresponding tendons or muscles of the rotator cuff. The humeral prosthesis 2000 is then implanted into a hollowed shaft 1180 of the humerus 1100 and the humeral head 1120 and any bone fragments are attached over the prosthesis 2000 and fixed with sutures or ribbons, for example, to surrounding muscles and/or humeral bone 1100.

[0173] As previously discussed, current fixation methods are inadequate, often resulting in failure of fixation of the tuberosities, namely the greater tuberosity (GT) fragment 1140 and the lesser tuberosity (LT) fragment 1160 (see Figure 2), and subsequent failure of the implant and hemiarthroplasty procedure. The humeral prosthesis 2000 of the present disclosure seeks to address these problems by providing an implant which provides for improved tuberosity fixation, and also better restoration of the natural anatomy of the shoulder.

[0174] Figure 11 illustrates the components of the humeral prosthesis 2000 in an assembled state after implantation. The humeral prosthesis 2000 is modular and includes three components, a metaphyseal component 2100, a diaphyseal component 2200, and a head component 2300. While the humeral prostheses 2000 illustrated in the figures is modular, it will be appreciated that one or more of the components may be integrally formed and the implant may be monoblock. The benefits to modularity of humeral implants include that the sizes of the components and relative orientations when implanted can be customised to better restore the natural anatomy of the shoulder for a particular patient. The modularity and locking engagement of the parts is described below with reference to Figure 12.

[0175] Figure 12 illustrates the diaphyseal component 2200 implanted in a prepared shaft or diaphysis 1180 of the humerus 1100. The diaphyseal component 2200 has an elongate body with a fluted shape. The diaphyseal component can be made of titanium or other suitable metal or metal alloys of titanium or chromium, such as Ti-6AI-4V (titanium-aluminium-vanadium) and CoCrMo (cobalt-chromium-molybdenum). The diaphyseal component 2200 has a stem 2220 and an engagement portion 2260 for engaging with the metaphyseal component (see Figure 12). In this example, the stem 2220 of the diaphyseal component 2200 has been cemented into the shaft 1180 using bone cement 2240. In other embodiments, the diaphyseal component 2200 may be press-fit into the shaft 1180. However, cement fixation is preferred over press-fit due to very low revision rates for cement fixed stems and the ability to convert this modular design into a reverse arthroplasty if required.

[0176] Figure 11 also illustrates the metaphyseal component 2100 implanted in the location of the metaphysis of the humerus 1100. The humeral head 1120 and bone fragments are removed from the remaining long bone of the humerus 1100 before implantation of the humeral prosthesis 2000. An outline of the natural humeral head 1120 (prior to fracture) is illustrated in Figure 11 to demonstrate the positioning of the metaphyseal component 2100 and head component 2300 when implanted. However, it will be appreciated that the fracture parts of the humerus 1100, including bone fragments and also surrounding tissues are re-attached over the implant 2000 and so the outline of the humeral head 1120 shown in Figure 11 is not representative of the shape formed by the repaired head 1120.

[0177] The metaphyseal component 2100 has a body 2120 which includes a cavity 2040 as best shown in Figures 13 and 14. The cavity 2040 may be positioned in a proximal-most portion of the component 2100. In other embodiments, the cavity 2040 occupies most if not all of the space within the body 2120 (see e.g., the existing shoulder implant shown in Figures 3 and 6). The cavity 2040 may be formed by a plurality of openings 2130 in the body 2120. For example, the body 2120 may be formed of a perforated material, such as a mesh. The metaphyseal component may be made of titanium or steel for example. Due to the plurality of openings 2130, the cavity 2040 is in communication with an exterior to the body 2120, which when the metaphyseal component 2100 is implanted includes the surrounding bone and/or tissues of the shoulder.

[0178] The purpose of the cavity or bone cage 2040 is for placement of bone grafts or substitute material and/or fragments of the humeral head 1120 to encourage growth of the bone fragments, namely the greater and lesser tuberosity fragments 1140, 1160 onto the cavity or tuberosity cage 2040. Commercially available and suitable bone substitutes include Bon Alive® putty and/or BonAlive granules® disposed in the cavity 2040 of the metaphyseal component body 2120. The bone material/grafts may be sourced from the head of the humerus that has been surgically removed during the hemiarthroplasty surgery. For example, morsellised bone graft and/or bone substitutes may be placed into the tuberosity cage 2040, either through the perforations/openings 2130 or through a designated opening.

[0179] The bone graft/bone substitutes may also be deposited directly into the cavity 2040 in the case where the cavity 2040 is formed of two parts which are joined together during assembly.

For example, the metaphyseal component 2100 may a cavity 2040 which is formed of a two-part structure that is joined together e.g., straps or sutures which pass through perforated material of the body 2120. The metaphyseal component 2100 may have the arrangement of the existing shoulder implant 100 of Figures 3 and 6 in which the body 2120 is formed of two parts, such as a first member 142 and second member 144 of the shoulder implant 100. The first and second members 142, 144 are coupled together using straps 136 which are passed through aligned holes 145, 147 and tensioned, as shown in Figures 3 and 6. A similar arrangement is also provided in relation to the second component 204 of the existing shoulder implant 100 of Figure 10.

[0180] Figure 11 also illustrates the head component 2300 which includes a domed surface to replace the function of the humeral head 1120. Although an outline of the natural humeral head 1120 is shown in Figure 11 that surrounds the head component 2300, it is to be understood that bone of the humeral head 1120 would not be located around the head component 2300 in a surgical humeral repair. The head component 2300 may be made of chrome cobalt.

Alternatively, the head component 2300 may be made of pyrocarbon or ceramic.

[0181] Figure 12 illustrates a disassembled view of the components of the humeral prosthesis 2000 of Figure 11, with the diaphyseal component 2200 shown implanted in a prepared shaft 1180 of the humerus 1100. The diaphyseal component 2200 and the metaphyseal component 2100 are configured for locking engagement together. The metaphyseal component 2100 and the head component 2300 are also configured for locking engagement together.

[0182] The diaphyseal component 2200 has an engagement portion 2260 which is couplable with a corresponding engagement portion 2180 on the metaphyseal component 2100 (see coupled state in Figure 11). The engagement portion 2180 of the metaphyseal component 2100 may a notch, groove or slot (see in Figure 11) for receiving a corresponding protrusion or neck portion of the diaphyseal component 2200. For example, the metaphyseal component 2100 and diaphyseal component 2200 may be press-fit together, or a locking mechanism may be employed such as a screw head, e.g., a grub screw, on the diaphyseal component 2200 and corresponding threaded bore in the metaphyseal component 2100. The metaphyseal component 2100 and diaphyseal component 2200 may have a screw head and threaded bore arrangement.

[0183] In other embodiments, the locking arrangement may be similar to the existing shoulder implant of Figures 3 to 10. In that arrangement, the diaphyseal component 102 has a bore 118 configured to receive an external thread 108 of a fastener 106 that is secured within a passage 138 of the metaphyseal component 104 (see Figures 3, 4 and 6). The diaphyseal component 2200 and metaphyseal component 2100 of the present disclosure may have a similar arrangement, or it may be reversed such that the metaphyseal component 2100 has the bore 118 and the diaphyseal component 2200 is configured to receive the external thread 108 of the fastener 106.

[0184] The metaphyseal component 2100 may also be rotated relative to the diaphyseal component 2200 to provide a desired rotation and/or version of the humeral implant 2000. The metaphyseal component 2100 or the diaphyseal component 2200 may include a flat engagement surface with a plurality of protrusions that are angularly displaced about a threaded bore by multiples of around 15 degrees (not shown, see existing shoulder implant of Figures 8 and 9). It is envisaged that any number of protrusions could be used and that the protrusions may be angularly displaced by other angles. The protrusions may engage with corresponding recesses on the other of the metaphyseal component 2100 or the diaphyseal component 2200. The components 2100, 2200 may be rotated relative to one another to adjust the rotation and/or version of the humeral implant 2000. The humeral implant 2000 may have the arrangement of the metaphyseal and diaphyseal components 102, 104 of the existing shoulder implant 100 as shown in Figures 8 and 9 with the plurality of protrusions 140 and plurality of recesses 122 to form a locking connection 157.

[0185] The head component 2300 also includes an engagement portion 2340 which is couplable with a corresponding engagement portion 2190 on the metaphyseal component 2100 (see Figure 12 and also coupled state in Figure 11). The engagement portion 2190 of the metaphyseal component 2100 may be a notch, groove or slot as shown, with walls corresponding to the shape of engagement portion 2340 of the head component 2300. The engagement portion 2340 may be a protrusion which is tapered and inserts into the notch on the metaphyseal component 2100. The head component 2300 and the metaphyseal component 2100 may be press-fit together, or a locking mechanism may be employed such as a screw head on the head component 2300 and corresponding threaded bore in the metaphyseal component 2100. The relative angular between the head component 2300 and the metaphyseal component 2100 when assembled may be about 45 degrees, although other angles are contemplated to provide a variety of metaphyseal components 2100 and head components 2300 to best suit the patient’s natural anatomy.

[0186] For a reverse arthroplasty, the metaphyseal component 2100 and head component 2300 may be removed from the diaphyseal component 2200 which remains implanted in the shaft 1180. Figure 12 illustrates a tool 4200 that is configured to couple with an insertion slot or groove 2020 on the metaphyseal component 2100. The tool 4200 can then be rotated as indicated by the arrows to remove the metaphyseal component 2100, such as by unscrewing the metaphyseal component 2100 from the diaphyseal component 2200. A reverse arthroplasty component can then be attached to the engagement portion 2260 of the diaphyseal component 2200. The reverse arthroplasty component may include a prosthetic socket portion and a prosthetic ball or head component to be secured to the patient’s scapula. Thus, the humeral prosthesis 2000 may be usefully converted to a reverse arthroplasty if required for subsequent surgeries. This may be similar to the reverse arthroplasty arrangement provided by the existing shoulder implant as shown in Figure 10.

[0187] Figures 11 to 14 illustrate a metaphyseal component 2100 configured for coupling with a cerclage device 3000 (see Figures 23 to 28) for fixation of at least one bone portion and/or tissue of a shoulder 1020 of a subject 1000 with the metaphyseal component 2100 when implanted, according to an aspect of the disclosure. The metaphyseal component 2100 comprises a body 2120 having at least one location for coupling with the cerclage device 3000.

[0188] The body 2120 of the metaphyseal component 2100 of Figures 11 to 14 includes at least one location for coupling with a cerclage device 3000 (see Figures 23 to 28). In Figures 11 and 12, the at least one location is on a medial side 2140 of the metaphyseal component 2100. The at least one location comprises a medial slot 2150 for receiving the cerclage device therethrough as shown in Figure 11. Two medial slots 2150 may be included as shown in Figure 12 or any number of slots as preferred to secure one or more cerclage device(s) 3000.

[0189] In the embodiment of the metaphyseal component 2100 of Figures 13 and 14, there may be two medial slots 2150 and two lateral slots 2170. The lateral slots 2170 are optional and typically not required since the cerclage device 3000 will be passed through a medial slot and then secured around and/or through a bone/tissue on a lateral side 2160 of the metaphyseal component 2100. However, one or more lateral slots 2170 may be optionally included for addition coupling or fixation points for the cerclage device(s) 3000.

[0190] Although slots 2150, 2170 are depicted in Figures 11 to 14 and the later Figures 23 to 28, it is to be appreciated that various other mechanisms/ structures may be employed for coupling of a cerclage device 3000 with the body 2120 of the metaphyseal component 2100. In other embodiments, the body 2120 may comprise an opening, passage, aperture, slit, groove or notch, for example, to provide a fixation point for coupling with the cerclage device 3000. The one or more slots may also be recessed within the body 2120 as shown in Figure 14, or may be located on a protruding portion of the body 2120 as shown in Figure 13. Preferably, the metaphyseal component 2100 includes at least two medial slots 2150 as shown in Figures 12 and 14 for attachment of at least two cerclage devices 3000. However, a single elongated slot 2150 may be provided which is able to receive more than one cerclage device 3000 therethrough as shown in Figure 11.

[0191] Figures 13 and 14 also illustrate an alternative engagement portion 2110 of the metaphyseal component 2100 which includes an angled neck portion configured to receive a corresponding engagement portion 2340 of the head component 2300. The neck portion has an axis 2360 that is offset by around 45 degrees relative to an axis 2380 through the metaphyseal component 2100 as shown in Figure 14. The angle may be varied by providing a variety of metaphyseal components 2100 for selection by the surgeon that best matches the patient’s natural anatomy. The angle may be less than 45 degrees, and preferably about 40 degrees, about 35 degrees or about 30 degrees, or any other angle suitable for the patient’s anatomy.

Cerclage Device

[0192] Figures 15 to 22 illustrate another aspect of the disclosure which is a cerclage device 3000 configured for fixation of at least one bone portion and/or tissue of a shoulder 1020 of a subject 1000. The cerclage device 3000 comprises an elongate member 3300 having a medial end 3020 and a lateral end 3040. The cerclage device 3000 is configured to be irreversibly secured relative to the at least one bone portion and/or tissue when the medial end 3020 and/or the lateral end 3040 are moved in a fastening direction 3100 (see arrows in Figures 23 and 24).

[0193] The medial end 3020 and the lateral end 3040 may be moved in the fastening direction 3100 to irreversibly secure the cerclage device 3000. The medial end 3020 and the lateral end 3040 may be moved towards each other in the fastening direction 3100. The medial end 3020 and the lateral end 3040 may be brought together to irreversibly secure the cerclage device 3000. In other embodiments, only the medial end 3020 or the lateral end 3040 is moved in the fastening direction 3100 to irreversibly secure the cerclage device 3000.

[0194] The cerclage device 3000 of various embodiments comprises a securing mechanism that prevents movement of the medial end 3020 and/or the lateral end 3040 in a direction opposite to the fastening direction 3100 (see arrows in Figures 23 and 24). That is, the medial end 3020 and/or the lateral end 3040 may only be moved in the fastening/tightening direction 3100 for securing the cerclage device 3000. Thus, the cerclage device 3000 is irreversibly secured since the device cannot loosen once it is tightened relative to the bone fragments and/or tissue.

[0195] Figures 15 to 18 illustrate various embodiments of the cerclage device 3000 including a ratchet mechanism for irreversibly securing the cerclage device 3000 relative to the bone fragment and/or tissue. The securing mechanism comprises a locking portion 3060 for engaging with a plurality of interlocking portions 3080 (see Figures 17 and 18) positioned along a length of the elongate member 3300. The plurality of interlocking portions 3080 may comprise teeth as shown by the lines in the securing section 3240 of the elongate member 3300. In other embodiments, the interlocking portions may be a series of angulated steps in the securing section 3240. The locking portion 3060 comprises a head 3070 with a pawl 3090 that engages lockably with the teeth when the securing section 3240 of the elongate member 3300 is passed through the head 3070.

[0196] Figures 19 to 22 illustrate various embodiments of the cerclage device 3000 including a compressible portion 3120 for irreversibly deforming a length of the elongate member 3300. The compressible portion 3120 may be crimping portion or box that allows for crimping of two sections of the elongate member 3300 together. The elongate member 3300 of Figures 19 to 22 show a securing section 3240 that can be positioned within the compressible portion 3120 for crimping with part of a lateral end 3040 of the elongate member 3300.

[0197] In the embodiments of the cerclage device 3000, the medial end 3020 of the elongate member 3000 is received in a portion of the securing mechanism adjacent the lateral end 3040. The elongate member 3300 comprises a leading section 3140 located at the medial end 3020 for insertion around and/or through the at least one bone portion and/or tissue. The leading section 3140 may include a taper 3150 as shown in Figures 15, 17, 18, 19, 21 and 22 to provide guidance of the medial end 3020 through a slot 2150, 2170 on the metaphyseal component 2100 (see Figures 11 to 14). In the embodiment shown in Figures 16 and 20, the leading section 3140 includes a double taper 3160 that converges to a sharp tip. The taper ends of the leading section 3140 provide cutting edge(s) 3150, 3160 to perforate and/or puncture the at least one bone portion and/or tissue. This is particularly the case when the leading section 3140 comprises a metal material thereby providing a sharp cutting edge.

[0198] The cerclage device 3000 of Figures 15 to 22 also comprises a flexible section 3250 between the medial end 3020 and the lateral end 3040. The flexible section 3250 may also be adjacent the securing section 3240 which is received in part of the securing mechanism for irreversibly securing the cerclage device 3000. The flexible section 3250 is configured to prevent or reduce damage to the bone portion and/or tissue and preferably has a low-profile and a tape or ribbon-like structure. The flexible section 3250 is preferably as low-profile as possible to avoid irritation of the deltoid muscle in situ. The flexible section 3250 may be formed of a soft and/or malleable material. The flexible section 3250 may be formed of a protective material comprising at least one of a group selected from mersilene, silk, dacron, an ultrabraid material or a nonbraided material, or combinations thereof.

[0199] The securing section 3240 described above which engages with the securing mechanism of the embodiments of Figures 15 to 22, is illustrated positioned between the leading section 3140 and the flexible section 3250. The securing section 3240 may be formed of a polymeric material, such as a plastic, and preferably Polyether ether ketone (PEEK). The locking portion 3060 and compressible portion 3120 may also be formed of a polymeric material, such as a plastic, and preferably PEEK. In other embodiments, one or both parts of the securing mechanism may instead include an outer layer comprising a polymer material, such as PEEK. The PEEK/polymeric material section 3240 of the cerclage device 3000 should ideally be as short as possible or it will irritate the deltoid muscle in situ. Hence, a length gauge for determining an appropriate length of the cerclage device 3000 may be required to avoid this issue.

[0200] In some alternative embodiments, the PEEK section 3240 may be excluded from the elongate member 3300 (not shown). The cerclage device 3000 may comprise a securing mechanism near a lateral end 3040, a flexible section 3240 and a leading section 3140. In this embodiment, the securing mechanism may be a compressible portion for deforming at least a length of the elongate member 3300, or a locking portion for engaging with a plurality of interlocking portions on the leading section 3140 at the medial end 3020. The medial end 3020 may be received within the compressible portion or locking portion (see Figures 15 to 18 and 19 to 22) and irreversibly secured such that the medial end 3020 cannot be removed or loosened.

[0201] Figures 15, 16, 19 and 20 illustrate an external surface 3170 of the cerclage device 3000 which may be exposed to the tissues of the shoulder when the cerclage device 3000 is in situ. Figures 17, 18, 21 and 22 illustrate an internal surface 3180 of the cerclage device 3000 which contacts the bone fragments/tissue. The internal surface 3180 is configured to prevent or reduce slippage during irreversible securing of the cerclage device 3000 relative to the bone fragments/tissue.

[0202] Figures 18 and 22 illustrate embodiments which include an internal surface 3180 configured for frictional engagement with the bone fragments/tissue. In Figure 18, the internal surface 3180 may include a textured pattern 3200, such as a zig-zag pattern as shown although any pattern may be used, to roughen the surface for frictional engagement. Figure 18 also includes a number of projections 3220 on the internal surface of the locking mechanism head 3070. The projections may be short prongs or claws which provide purchase with the bone fragments/tissue. There may be six projections 3220 as shown or any number of projections to provide fixation on the bone fragments/tissue.

[0203] In Figure 22, the internal surface 3180 may include one or more projections 3260 in the form of prongs or spikes on the compressible/crimping portion 3120. There may be four projections 3260 as shown or any number of projections to provide fixation on the bone fragments/tissue. The internal surface 3180 in Figure 22 may alternatively be roughened for frictional engagement, and may include grit blasted titanium for example.

[0204] The cerclage device 3000 may be configured for fixation of at least one bone portion and/or tissue with an implanted humeral prosthesis 2000, and the cerclage device 3000 may be couplable with the implanted humeral prosthesis 2000. The humeral prosthesis 2000 may be suitable for a hemiarthroplasty. Prior to disclosing an embodiment of the fixation method, a method of implantation of the humeral prosthesis 2000 will be described. Hemiarthroplasty Method

[0205] The subject 1000 will be referred to herein as a patient in the context of implantation of a humeral prosthesis 2000 in a human shoulder. The method described herein is for hemiarthroplasty of the shoulder.

[0206] 1, Positioning. The patient is prepared for surgery. Nerve blocks are considered for analgesia. General anaesthetic may be performed under ultrasound guidance. Prophylactic antibiotics are given by IV access via the non-operative limb. Entropy monitors may be used and ECG dots for monitoring are positioned from the surgical sone. The patient is shaved if needed. The patient is positioned in the supine position with a head ring pillow. The hair and face is covered with an impervious "10-10 drepe” . Surgeons may choose to use modifications of the beach chair position, or any position that is suitable. A radiolucent shoulder support or table with an optional forearm-board will allow for intra-operative x-rays when necessary. Typically, an intra operative x-ray is not required. For the operative limb, the forearm must be draped free, e.g., with a sterile stockinette, which allows for the later rotation during final tuberosity tightening in the fixation method.

[0207] 2, Equipment. Routine x-rays are not typically necessary. However, if the surgeon prefers intra-operative x-rays then positioning on a radiolucent bed or table should also allow for C-arm entry of a CT scanner into the room. Other equipment to be used include retractors (Guelpi, Weitlander or similar), suction and diathermy. The method below also requires instruments including a Hohmanns large retractor, a reamer in the form of a drill and burr 5 mm bigger, small and large rongeurs, and small and large bristow.

[0208] 3. Preparation. Chi orhexi dine with 70% alcohol is typically used as it provides the best protection from Staphylococcus Epidermidis, Corynebacterium and Propionibacterium Acnes.

[0209] 4. Skin Incision & Approach. The Deltopectoral interval is opened, with the vein preferably preserved. Weitlander and Guelpi retractors may be used for deeper wounds. Axillary nerve and musculocutaneous nerves are considered and avoided. The use of Hohmann retractors under the deltoid is preferred to expose the greater tuberosity fragment 1140 (GT). Next, any bursal tissue or reactive tissue resulting from trauma is removed and debrided as necessary. The coracoacromial ligament can be left intact or divided depending on the surgeon’s preference. Any haematoma is evacuated. [0210] 5. Biceps tenotomy & tenodesis. In a fracture with displaced anatomy, the biceps tendon is often the best guide and reference to locating the displaced tuberosities 1140, 1160 and head fragments 1130. The Long Head of Biceps (LHB) tendon is divided as superiorly as possible, maintaining the maximum length; the LHB can be tenodesed after the implant 2000 is secured. At this step, the LHB is tagged with a vicryl suture.

[0211] 6. Tuberosity management. The greater and lesser tuberosity fragments size and shape will not be the same in every case. There are significant variations in fragment shapes and sizes. The surgeon must take time to locate these fragments and preserve them while separating them. Until insertion of the implant, it is preferable to retain as much bone attached with each tendon as possible to provide more surgical options later. The subscapularis 1220 is mobilized with the lesser tuberosity (LT) fragment 1160. The supraspinatus and infraspinatus tendons 1200, 1240 are both mobilized with the greater tuberosity (GT) fragment 1140. It is vital to take the time by the surgeon in each case to correctly identify each of these structures.

[0212] 7. Head removal. The humeral head 1120 is next removed, preferably in one piece to allow for diameter measurements. Often a Bristow or similar tool will suffice. It should be then kept sterile and used as a source of cancellous bone graft. If possible, it is preferred to remove the humeral head 1120 in one piece so that its diameter can be measured using specialized calipers. The head diameter will determine which trial head implant diameter - see below.

[0213] 8. Bone graft procurement. Any scrubbed team device can then morsellise the bone graft; small and large bone nibbiers or rongeurs are preferably used. The cancellous graft is placed in a sterile galley pot or similar and kept safe on a back-table until needed.

[0214] 9. Humeral shaft preparation. The fractured humeral shaft medullary canal 1100 is prepared with a series of gentle hand reamers of various diameters - typically 8, 9, 10, 11 and 12 mm. As much bone is removed as possible that is soft to touch or that can be easily removed with gentle hand tools. All of the cortex is left intact and some firm medullary bone is acceptable. A cement restrictor is not essential but can be used if the surgeon prefers.

[0215] 10. Trial Diaphyseal Component. The first component to insert is the cemented diaphyseal component 2200. There are three trial diameters of the diaphyseal stem, including 8, 10 and 12 mm. All are the same length. At this stage, a monoblock trial stem can be inserted with respect to recreating the humeral height/length. The stem can be inserted, with reference to the cortical fragments as reference landmarks in comparison with the top of the diaphyseal trial component. The introducer rod has 5 mm laser markings to recreate depth of the trial implant in contrast to the definitive implant. The system will allow the surgeon to misjudge the length by up to a maximum of 15 mm. It is therefore worthwhile attempting to be as accurate as possible with the first trial of implant depth and position. An inserter tool 156 with inserter thread 158 and version rod 160 as described with reference to Figure 5 may be used for implanting the diaphyseal component 2200 into the prepared shaft 1180 of the humerus 1100.

[0216] 11. Definitive Diaphyseal Component. Insert the definitive diaphyseal implant 2200 and secure with bone cement 2240. CMW2 quick drying cement can be used, although surgeons may choose any cement. The diaphyseal stem 2220 has denotation flutes which should be kept stationary until the cement is dry and hardened. The cement should be kept out of the flutes needed for the next component.

[0217] 12. Trial Metaphyseal Component for height reconstruction. Once the diaphyseal cement 2240 is dry, the metaphyseal component 2100 can be trialed onto the diaphyseal component 2200. The metaphyseal component 2100 allows the surgeon to add an additional 15 mm, or even 20 mm of height as needed to recreate the bony anatomy, which is highly desirable to mimic the natural anatomy of the patient. There are 3 length sizes available and the optimal length for the patient is chosen.

[0218] 13. Version reconstruction. The metaphyseal component 2100 also allows the surgeon to adjust and vary the version. 20 to 30 degrees of humeral head retroversion is attempted to be recreated, but there is the ability to rotate the implant and choose the version that gives best stability on the operating table.

[0219] 14. Lock components together. Once the height and version is acceptable, the diaphyseal and metaphyseal components 2200, 2100 are locked together by inserting a grub screw 2260 from the diaphyseal component 2100 into a bore 2180 of the metaphyseal component 2100 and the grub screw 2260 is tightened. The grub screw 2260 may be the external thread 108 of a fastener 106 which is inserted into a bore 118 of the diaphyseal component 2100, which engages with a corresponding internal threaded bore 138 of the metaphyseal component 104, according to the arrangement of the existing shoulder implant of Figures 3 to 10. [0220] 15. Place cancellous bone grafts. Morsellised graft is next placed into the tuberosity cages which is the cavity 2040 formed in the body 2120 of the metaphyseal component 2100. The cages allow bone graft to remain inside the cage while in the weeks after surgery the tuberosities later unite onto this graft. The specialized titanium surface will allow ongrowth of living bone. The graft allows the tuberosities to unite and to attach to the implant - the aim is to reduce post operative tuberosity complications such as resorption, non-union and displacement of bone. The graft area is lavaged e.g., using XPERIENCE wound lavage.

[0221] 16. Place head component & secure it. The head diameter has been measured earlier. There are 4 diameters available for the head component 2300, namely 39, 42, 45 and 48mm, - if in doubt, then undersize the head component 2300 and do not overstuff the joint. Each of the 4 trial heads has a correspondingly longer neck length. As the head diameter increases, the humeral neck length also increases proportionately, and the trial sizes are proportioned accordingly. Trial heads with various neck lengths are now placed on the metaphyseal component 2100. There is a choice of chrome cobalt and pyrocarbon head options - noting that some studies cite glenoid erosion after hemiarthroplasty as a potential complication. Again, do not overstuff the joint. The implant is then impacted with a morse taper and mallet.

[0222] 17. Fix tuberosities and associated tendons or muscles. The fixation method using cerclage device(s) 3000 according to the disclosure will be described in more detail below.

[0223] 18. Assess Range of Motion (ROM) and Stability. Once all prosthetic components are secured, the graft is placed and tuberosities are fixed/tightened with the cerclage device(s) 3000, a final check of ROM is performed. If the tuberosities undergo displacement, then the surgeon should consider tightening the cerclage device(s) 3000. Importantly, the cerclage devices 3000 cannot be reversed or untightened; if they are too tight then the only way to modify them is to cut them off and replace them with new ones. The surgeon should make a final note of the strength of the reconstruction at both bone and tendon tissues so that the physiotherapist can be guided on post operative safe movements.

[0224] 19. Lavage with Xperiens lavage. Additional use of lavage is recommended, using XPERIENCE wound lavage or similar. This reduces the risk of infection.

[0225] 20. Post-operative protocols. X-rays are performed in the recovery ward and reviewed before any motion commences. Early active motion using the tendons of subscapularis 1220, supraspinatus 1200 and infraspinatus 1240 is proportional to the strength achieved and noted in the steps above. The stronger the reconstruction, the safer the early motion will be and therefore allowed. This was not previously possible with suture fixation. If concerns, passive motion including IR, ER and abduction can be performed. Each week of healing changes in tissue oedema, turgor and stiffness are to be reviewed. Safe active motions include: elbow flexion, shoulder shrugs, shoulder pendulum and shoulder circular. Gradually increase ranges of allowed motion every week. X-ray again at week 6 for review and check of the tuberosity positions. If the x-ray is acceptable, then gradually increase loads. At week 12, consider a CT scan to assess union of tuberosities.

Fixation Method

[0226] The fixation method at step 17 above will now be described in more detail with reference to Figures 24 to 30, according to embodiments of the disclosure.

[0227] In another aspect, the disclosure provides as shown in the flow chart of Figure 30, a method 5000 for cerclage fixation of at least one bone portion and/or tissue of a shoulder 1020 of a subject 1000. The method 5000 comprises the step 5020 of providing a cerclage device 3000 configured for fixation of the at least one bone portion and/or tissue, the cerclage device 3000 comprising an elongate member 3300 having a medial end 3020 and a lateral end 3040. The method 5000 also comprises the step 5060 of moving the medial end 3020 and/or the lateral end 3040 in a fastening direction 3100. The method 5000 also comprises the step 5080 of irreversibly securing the cerclage device 3000 relative to the at least one bone portion and/or tissue for fixation.

[0228] Figure 30 shows an optional step 5040 of coupling the cerclage device 3000 with an implanted humeral prosthesis 2000. Following on from the implantation method described above, after step 16 once the humeral prosthesis 2000 has been implanted, a cerclage device such as cerclage device 3000 described herein may be used for fixation of the lesser and greater tuberosity fragments 1140, 1160, and their associated tendons or muscles, with the implanted humeral prosthesis 2000 at outline in step 17 above. The fixation method will now be described in detail with reference to Figures 23 to 28.

[0229] The cerclage device 3000 is couplable with the implanted humeral prosthesis 2000. The cerclage devices 3000 may be passed using short and/or long cerclage tools 4000, 4100 according to another aspect of the disclosure, as described below with reference to Figures 26 to 28. Each tuberosity fragment 1140, 1160 is attached separately to the implant 2000 using a cerclage device 3000. At least one cerclage device 3000 per tendon/tuberosity fragment is recommended.

[0230] Figure 23 is a perspective diagram illustrating a humeral prosthesis 2000 implanted in a prepared humeral shaft 1180 of a subject’s shoulder 1020. The three components, the diaphyseal component 2200, the metaphyseal component 2100 and the head component 2300, are now all inserted, and fixed in their final positions. The medial neck area of the metaphyseal component 2100 includes three slots 2150A, 2150B and 2150C for receiving a cerclage device 3000. The cerclage device with crimping portion 3120 (see Figures 19 to 22) may be used for fixation of the lesser tuberosity fragment 1160. In other embodiments (not shown), the cerclage device may have the securing mechanism shown in any of Figures 15 to 18.

[0231] 17, 1 Timming bone fragments and tissues. Before fixing the bone fragments and tissues, both the GT fragment 1140 and LT fragment 1160 are trimmed before passing the cerclage devices 3000 to ensure that they fit the shape of the body 2120 of the metaphyseal component 2100, and particularly the cavity/cage section 2040. The LT fragment 1160 preferably makes contact with the graft within the cavity or cage section 2040 of the metaphyseal component 2100.

[0232] 17,2 Passing of cerclage device for LT fragment. A medial end 3020 of a cerclage device 3000A is passed through the subscapularis muscle and tendon 1220 (e.g., using the cutting edge of the leading section 3140 at the medial end 3020 to perforate and/or puncture the tissue) and around the lesser tuberosity fragment 1160, and is received through medial slot 2150A in the body 2120 of the metaphyseal component 2100. The cerclage device 3000A may optionally be passed through both bone and tendon as desired by the surgeon to create maximal fixation. The metaphyseal cage or cavity 2040 needs to be medial enough to allow the subscapularis muscle and tendon 1220 and LT fragment 1160 to reach without tension. The medial end 3020 of the cerclage device 3000A is then passed in the fastening direction 3100 around the rear of the metaphyseal component 2100 as indicated by the broken lines. The crimping box 3120 becomes placed over the outer cortex of the LT fragment 1160.

[0233] The crimping box 3120 is roughened on an internal surface 3180 which is in contact with bone and roughened to prevent or reduce slippage during the tightening step. At minimum, one cerclage device is to be used per tuberosity fragment. However, preferably two cerclage devices are used per tuberosity fragment to create optimal fixation. The LT fragment 1160 is preferably reduced bore compared to the GT fragment 1140 as this provides an improved surgical view until the final steps of tightening both the cerclage devices. The cerclage device 3000A is not to be tightened yet.

[0234] 17,3 Passing of cerclage devices for GT fragment. Figure 24 is another perspective diagram following on from Figure 23, where the cerclage device 3000A for the lesser tuberosity fragment 1160 is now tensioned but not yet fully tightened and locked. Two cerclage devices 3000B, 3000C are passed through the supraspinatus 1200 and infraspinatus 1240 muscles and around the greater tuberosity fragment 1140 and received through medial slots 2150B and 2150C, respectively, in the body 2120 of the metaphyseal component 2100. The GT fragment 1140 will typically require two cerclage devices to neutralise the forces in rotation and abduction. The medial end 3020 of the cerclage devices 3000B, 3000C are passed in the fastening direction 3100 as indicated in Figure 24 and the securing mechanism, in this case the crimping box 3120, will be employed to secure the medial end 3020.

[0235] The cerclage device 3000A for the LT fragment 1160 is tightened and locked before the GT fragment 1140. The cerclage devices 3000B, 3000C for the GT fragment 1140 are slowly tensioned and tightened bringing the GT fragment 1140 into its final resting position over the tuberosity cage, that is the cavity 2040 of the metaphyseal component 2100, which is already full with morsellised, cancellous bone autograft. Notably, the LHB Biceps tenodesis is ideally below the cuff repairs to avoid tension. However, it can also be optionally secured to the implant if needed using a cerclage device. If the LHB tenodesis is fixed with a cerclage device, it will be tensioned last.

[0236] Importantly, the cerclage devices 3000 A, 3000B, 300C should all be passed through and/or around the relevant tendons and/or bone before tightening begins. Otherwise, if the cerclage device 3000 A for the LT fragment 1160 is tightened first, it will be more difficult to find enough space to tighten and secure the remaining cerclage devices 3000B, 3000C once the tightening commences. In order to reach around behind the humerus 1100, a short or long cerclage tool 4000, 4100 may be used which connects to the medial slots 2150 on the metaphyseal component 2100 (see Figures 26 to 28). [0237] 17,4 Assessment of fragment stability and optional additional fixation. Figure 25 is another perspective diagram following on from Figure 24, where the cerclage devices 3000 A, 3000B, 3000C for the lesser and greater tuberosity fragments 1140, 1160 are now secured and tensioned. The surgeon assesses the GT fragment’s stability and additional fixation may be provided to prevent superior migration. It may be possible to fix the GT fragment 1140 to either the implant or the bony shaft. For example, an optional suture 3280 may be used for securing the greater tuberosity fragment 1140 to the long bone of the humerus 1100 for additional stability.

[0238] Notably, the surgeon uses tactile feel and judgement to determine how tight the tuberosities should be secured. Each tuberosity should be tightened until the fragments do not displace during passive rotation of the joint. If the cerclage devices are too loose, there is a risk of tuberosity displacement. If the cerclage devices are too tight, there is risk of damage to the bone or tendon tissues. With the cerclage devices of the disclosure, there is the ability to tighten in the fastening direction 3100 as indicated in Figures 23 and 24 but not in the opposite direction to loosen the devices, which cannot be achieved with sutures.

Cerclage Fixation Tools

[0239] Figure 26 is a cross-sectional view through the frontal plane of a shoulder 1020 with an implanted humeral prosthesis 2000 and illustrating a cerclage tool 4000 for passing of the cerclage devices 3000, with two cerclage devices 3000 A and 3000B secured and an optional cerclage suture 3280 secured between the greater tuberosity fragment 1140 and the humeral long bone 1100, according to some embodiments of the disclosure. The cerclage tool 4000 is a short tool and is configured to couple with a slot 2150 on the body 2120 of the metaphyseal component 2100. The tool 4000 has a tubular passage therethrough (not shown) to allow passage of a cerclage device 3000 through the slot 2150, around and/or through the bone/tissue and then exits the tool 4000 to be irreversibly secured by the securing mechanism of the cerclage device 3000.

[0240] For passing of the cerclage device 3000 using the short cerclage tool 4000, the first step is to remove the head component 2300 of the humeral prosthesis 2000 to improve access. The short tool 4000 has a hollow bore, preferably of cylindrical shape corresponding to the cerclage device 3000, and may be curved to assist with coupling with the metaphyseal component 2100. The second step is to puncture the tendon and the connect the short tool 4000 into the metaphyseal component 2100 at the slot 2150 on the body 2120. The cerclage devices 3000A and 3000B then cannot miss the slot 2150 as they are fed through the short cerclage tool 4000. The lateral end 2040 of the cerclage devices 3000A and 3000B is then passed safely and accurately through the infraspinatus tendon and then the implant 2000.

[0241] Figure 27 is a top view of a shoulder 1020 with an implanted humeral prosthesis 2000 (not visible), illustrating a cerclage tool 4100 with curved portions 4120 for passing of a cerclage device 3000, according to some embodiments of the disclosure. An embodiment of the cerclage tool 4100 is shown in Figure 29 which includes tubular passages 4140 in the arms 4160 for passage of a cerclage device 3000 and a handle for operating the two arms 4160 in a scissor arrangement. The passages 4140 are shown in the arms 4160 of the tool 4100 in broken lines in the direction taken by the arrows. Although each arm 4160 includes a passage 4140, the tool 4100 may only include one passage 4140 in one arm 4160 in other embodiments.

[0242] In passing the cerclage device 3000, the head component 2300 is typically removed for access. In relation to the long tool 410 of Figure 27, both sides of the cerclage device 3000 are passed at once. The cerclage device 3000 is weaved through the infraspinatus 1240 before puncturing the supraspinatus 1200 (see Figure 28). The cerclage device 3000 is then passed through the implant slot 2150 on the metaphyseal component 2100, and finally through the subscapularis 1220. Before tensioning, sutures can run in a superior direction to provide for easier access and minimise tendon trauma, damage and handling.

[0243] Figure 28 is a top view of a shoulder 1020 with an implanted humeral prosthesis 2000 (not visible except for the head component) and illustrating passing of a cerclage device 3000 around the greater and lesser tuberosity fragments 1140, 1160 with the long cerclage tool 4100 of Figures 27 and 29 to be engaged at points A, B and C, according to some embodiments of the disclosure. The cerclage device 3000 is passed around the greater and lesser tuberosity fragments 1140, 1160 in the direction indicated by the arrows from A to C. In this embodiment, item 3060/3120 represents part of the securing mechanism which is located near the lateral end 3040. When the medial end 3020 is passed through the part of the securing mechanism 3060/3120, the cerclage device 3000 is tensioned and pulled tightly around the anatomy and implant 2000. Excess material from the leading section 3140 is pulled and then cut off with scissors or the like to avoid any irritation to the surrounding anatomy in situ. The PEEK section 3240 is made as short as possible to avoid irritation with the deltoid muscle in situ. [0244] It is noted that the length of the cerclage device 3000 to be employed must be measured first with a trial tape having 1 cm markings. A total length of two cerclage devices/tapes 3000 with all tuberosities provisionally clamped into position. The trial tapes are then exchanged for definitive cerclage devices 3000.

Kit

[0245] Another aspect of the disclosure relates to a kit 6000 as shown in Figure 31. The kit 6000 comprises at least one cerclage device 3000 and at least one metaphyseal component 2100. The at least one cerclage device 3000 is configured for fixation of at least one bone portion and/or tissue of a shoulder 1020 of a subject 1000. The at least one metaphyseal component 2100 comprises a body 2120 having at least one location for coupling with the at least one cerclage device 3000.

[0246] The at least one cerclage device may be the cerclage device 3000 as described in the above aspect and include any combination of features of the embodiments described and shown in Figures 15 to 22. The at least one metaphyseal component 2100 may be the metaphyseal component 2100 as described in the above aspect and include any combination of features of the embodiments described and shown in Figures 11 to 14 and 23 to 28. The kit 6000 may include a plurality of cerclage devices 3000 and metaphyseal components 2100 for selection to best match the patient’s anatomy. The kit 6000 may include at least three metaphyseal components 2100 to allow for the addition of different heights as needed to recreate the bony anatomy. The surgeon can add up to an additional 15 mm, or even up to 20 mm, of height as needed. The surgeon can choose the best length option of the metaphyseal component 2100 from the kit 6000 for the patient.

[0247] The kit 6000 may also comprise at least one cerclage tool 4000, 4100 to be secured to the body 2120 of the at least one metaphyseal component 2100 at the at least one location. The cerclage tool 4000, 4100 may have a tubular cross-section to allow for passage of the at least one cerclage device therethrough. The cerclage tool 4000, 4100 may include any combination of features described above and shown in relation to Figures 26 to 29. The cerclage tool 4100 may comprise a curved end portion 4120 for ease of access in passing the at least one cerclage device 3000 (see Figures 28 and 29). The kit 6000 may include at least two cerclage tools (such as the short tool 4100 and long tool 4200 previously described) or a single tool. [0248] The kit 6000 may also include at least one diaphyseal component 2200 comprising a stem 2220 configured for placement in a prepared shaft 1180 of a humerus 1100 of the subject 1000. The at least one metaphyseal component 2100 and the at least one diaphyseal component 2200 may be configured for locking engagement together. The diaphyseal component 2200 may include any combination of features described above and shown in relation to Figures 11, 12 and 23 to 28. The kit 6000 may include three diaphyseal components 2200 of different diameters. The diameters may be 8, 10 and 12 mm. The length of the diaphyseal components 2200 may be the same.

[0249] The kit 6000 may also include at least one head component 2300. The head component 2300 may include a domed surface 2320. The at least one head component 2300 and the at least one metaphyseal component 2100 may be configured for locking engagement together. The diaphyseal component 2200 may include any combination of features described above and shown in relation to Figures 11 and 23 to 28. The kit 6000 may include four head components 2300 for example, with different diameters to best suit the patient’s anatomy. The diameters may include 39 mm, 42 mm, 45 mm and 48 mm, for example. As the diameter increases, the length of the engagement protrusion 2340 (see Figures 11 and 12) also increases proportionally.

Additional Examples of Cerclage Fixation

[0250] In other embodiments, the present disclosure is directed to a novel cerclage device 3000 configured for fixation of at least one bone portion and/or tissue of a subject’s body 1010 (see Figures 32 to 36). The present disclosure is also directed to a novel fixation method 9000 that uses the novel cerclage device 3000 (see Figure 37). The cerclage device 3000 comprises an elongate member 3300 having a medial end 3020 and a lateral end 3040. The cerclage device 3000 is configured to be irreversibly secured relative to the at least one bone portion and/or tissue when the medial end 3020 and/or the lateral end 3040 are moved in a fastening direction 3100 (see arrows in Figures 23 and 24).

[0251] The cerclage device 3000 may have any combination of features of the embodiments shown and described with respect to Figures 15 to 22. The cerclage device 3000 may be used in methods of fixation of bone portions and/or tissues using any combination of steps of the embodiments shown and described with respect to Figures 23 to 28 and 30 and using a cerclage tool 4000, 4100 of the embodiments shown and described with respect to Figures 26 to 29. [0252] The cerclage device 3000 and method 9000 of Figures 32 to 37 may be configured for fixation of the bone portion and/or tissue within a subject’s joint, including but not limited to hip, knee, shoulder or elbow joints. The cerclage device 3000 may also be configured for fixation of at least one bone portion and/or tissue which is proximal or distal of a joint, including in shaft regions of the humerus 1100 (e.g., see Figure 33 and 34) or femur 1300 (e.g., see Figures 35 and 36), or in other bone portions and/or tissues adjacent to a joint. The cerclage device 3000 may also be used for fixation of other bones and/or tissues in the upper or lower extremities of the subject’s body 1010.

[0253] Figures 32 to 36 illustrate examples of cerclage fixation using the cerclage device 3000 and an optional fixation support 8000, according to some embodiments of the disclosure. The fixation support 8000 as illustrated may be implanted adjacent to a bone of the subject’s body 1010, such as a long bone including a humerus 1100 or femur 1300. The fixation support 8000 may support healing of fractures of one or more bones of the subject’s body 1010 including the humerus 1100 or femur 1300.

[0254] The fixation support 8000 may be a fixation plate which is laterally fixed to the bone of the subject’s body via one or more fixation screws 8200, 8300. The fixation screws may be bicortical screws 8200 and/or monocortical screws 8300 as shown. The bicortical screws 8200 may be fixed in the bone by compression or through a locking arrangement. The monocortical screws 8300 may include a locking arrangement. Any number of screws may be used with the fixation plate 8000 as illustrated in Figures 32 to 36 and with a mixture of bicortical and/or monocortical screws 8200, 8300. Furthermore, the fixation plate 8000 may not be fixed laterally to the bone but instead anteriorly, posteriorly or even medially as preferred for optimal healing of the bone fractures. The fixation support or plate 8000 may be pre-contoured with a range of sizes and/or shapes suitable for supporting healing of various fractures.

[0255] The fixation support 8000 may include at least one opening 8100 for receiving the cerclage device 3000. The cerclage device 3000 may pass through the at least one opening 8100 and be secured around the at least one bone portion and/or tissue for fixation with the implanted fixation support 8000. The at least one opening 8100 may be shaped for receiving the cerclage device 3000. The at least one opening 8100 may be circular, oval, or elliptical, for example, and have smooth edges to prevent damage to the cerclage device. The fixation support 8000 may include a plurality of openings for receiving a plurality of cerclage devices 3000. Figures 32 to 36 illustrate different examples of fixation plates 8000 with a plurality of oval openings or passages 8100 and with different lengths/shapes as preferred for optimal healing of the bone fractures. The fixation support 8000 may comprise a metal material such as titanium or steel.

[0256] Figure 32 is a frontal view showing an implanted hemiarthroplasty prosthesis 2000 in a left humerus 1100 of a subject 1000, according to some embodiments of the disclosure. The humeral head 1120 is shown in broken lines as the shape would differ following repair e.g., 4- part proximal humerus fracture as previously discussed. The humerus 1100 is transparent to show positioning of the prosthetic components including a head component 2300, metaphyseal component 2100 and diaphyseal component 2200. The hemiarthroplasty prosthesis 2000 may have any combination of features of the embodiments shown and described with respect to Figures 11 to 14. The diaphyseal component 2200 may be coated in silver or a heavy metal in order to reduce the risk of infection. The metaphyseal component 2100 may include a cavity in which bone graft may be implanted and have a mesh with apertures sized accordingly for tissue growth between the prosthesis 2000 and the repaired bone fragments.

[0257] Figure 32 also illustrates two cerclage devices 3000 coupled with the metaphyseal component 2100 via respective slots 2150, 2170 on medial and lateral sides of the metaphyseal component 2100 of the implanted prosthesis 2000. The cerclage devices 3000 may couple with the metaphyseal component and then be secured around and/or through bone portions and/or tissue for repair of the humerus fracture.

[0258] Figure 33 is a frontal view showing an implanted shoulder replacement prosthesis 7000 in a left humerus 1100 of a subject 1000, according to some embodiments of the disclosure. The humeral head 1120 is shown in broken lines as the shape would differ following repair. The humerus 1100 is transparent to show positioning of the prosthesis 7000 and screws 8200, 8300. There is a shaft fracture 1190 illustrated below the prosthesis 7000 which is supported via a lateral fixation plate 8000 secured to the humerus 1100 proximally with three cerclage devices 3000 and distally with two bicortical screws 8200 and two monocortical screws 8300.

[0259] Figure 34 is a frontal view showing an implanted elbow prosthesis 7400 in a left humerus 1100 of a subject 1000, according to some embodiments of the disclosure. The elbow portion 1170 of the humerus 1100 is shown in broken lines as the shape would differ following repair. The humerus 1100 is transparent to show positioning of the prothesis 7400 and screws 8200, 8300. There is a shaft fracture 1190 illustrated above the prosthesis 7400 which is supported via a lateral fixation plate 8000 secured to the humerus 1100 distally with three cerclage devices 3000, proximally with three bicortical screws 8200 and distally with two monocortical screws.

[0260] Figure 35 is a frontal view showing an implanted total hip replacement prosthesis 7500 in a left femur 1300 of a subject 1000, according to some embodiments of the disclosure. The femoral head 1320 is shown in broken lines as this would not be present following the repair. The femur 1300 is transparent to show positioning of the prosthesis components 7500 (head and stem) and screws 8200, 8300. There is a shaft fracture 1310 below the prosthesis 7500 which is supported via a lateral fixation plate 8000 secured to the femur 1300 proximally with four cerclage devices 3000, proximally with four monocortical screws 8300, and distally with one monocortical screw 8300 and four bicortical screws 8200.

[0261] Figure 36 is a frontal view showing an implanted knee prosthesis 7400 in a left femur 1300 of a subject 1000, according to some embodiments of the disclosure. The knee joint portion 1340 of the femur 1300 is shown in broken lines as this would not be present following the repair. The femur 1300 is transparent to show positioning of the prosthesis 7400 and screws 8200. There are two distal femoral fractures 1310 which are supported via a lateral fixation plate 8000 secured to the femur 1300 distally with three cerclage devices 3000 and proximally with five bicortical screws 8200.

[0262] The above additional examples demonstrate that the cerclage device 3000 of embodiments of the disclosure can be used for fixation where bone fractures have occurred across or near previously operated and/or repaired sections of bone of the humerus 1100 or femur 1300, including where a prosthesis component has already been implanted. The cerclage devices 3000 advantageously provide fixation of these bone and/or tissue fragments where bone screws cannot be inserted due to excessive mechanical forces and/or damage. Instead, the cerclage devices 3000 are secured across the exterior of the humeral or femoral bone and to the optional fixation plate 8000 as shown. It is to be appreciated that the cerclage devices 3000 could be used without a fixation plate or support 8000 and secured to bone and/or tissues, such as by using sutures, for additional fixation.

[0263] Figure 37 is a flow chart illustrating steps in a method 9000 for cerclage fixation of at least one bone portion and/or tissue of a subject’s body 1010, optionally with a fixation support 8000, according to some embodiments of the disclosure. The method 9000 comprises the step 9020 of providing a cerclage device 3000 configured for fixation of the at least one bone portion and/or tissue, the cerclage device 3000 comprising an elongate member 3300 having a medial end 3020 and a lateral end 3040. The method 9000 also comprises the step 9060 of moving the medial end 3020 and/or the lateral end 3040 in a fastening direction 3100. The method 9000 also comprises the step 9080 of irreversibly securing the cerclage device 3000 relative to the at least one bone portion and/or tissue for fixation.

[0264] The method 9000 as shown in Figure 37 may include the optional step 9040 of coupling the cerclage device 3000 with a fixation support 8000 before the step 9060 of moving the medial end 3020 and/or the lateral end 3040 in a fastening direction 3100. The fixation support 8000 may have any combination of features of embodiments shown and described with respect to Figures 33 to 36. The fixation support 8000 may be a fixation plate having at least one opening 8100 for receiving the cerclage device 3000, or optionally, a plurality of openings 8100 for receiving multiple cerclage devices 3000. The at least one opening 8100 may be circular, oval, or elliptical, for example, and have smooth edges to prevent damage to the cerclage device 3000.

[0265] The method 9000 may include the step of implanting the fixation support 8000 adjacent to a bone of the subject’s body 1010, such as a long bone including a humerus 1100 or femur 1300. The fixation support 8000 may be fixed to the bone 1100, 1300 of the subject’s body 1010 via one or more fixation screws 8200, 8300, such as bicortical or monocortical bone screws.

[0266] The step 9040 of coupling the cerclage device 3000 may comprise passing the medial end 3020 of the elongate member 3300 through at least one opening 8100 provided in the fixation support 8000. The method 9000 may further comprise moving the medial end 3020 and/or the lateral end 3040 towards one another to secure the cerclage device 3000 around the bone portion and/or tissue of the subject’s body 1010. The cerclage device 3000 may be secured around an exterior of a bone of a subject 1000.

[0267] The method 9000 may further include any combination of steps of the embodiments shown and described with respect to the method 6000 of Figure 30.

Advantages of Disclosure

[0268] The humeral prosthesis of embodiments of the disclosure seek to address the obstacles previously faced by surgeons that resulted in failures and hemiarthroplasty becoming less popular; notably poor tuberosity fixation, and additionally the difficulty in assessing height and version of the prosthesis and graft migration.

[0269] The humeral prosthesis of some embodiments of the disclosure may provide for unique features over existing implants including improved tuberosity fixation provided by the use of novel cerclage devices of some embodiments disclosed herein. Other advantageous features may also include modular components than monoblock to recreate the patient’s anatomy, ability to vary the height and version/rotation of the prosthesis intraoperatively which improves the margin for surgeon error/judgement, and tuberosity cages for bone graft to encourage growth of the tuberosities and implant success.

[0270] The cerclage device of some embodiments of the disclosure may provide secure fixation of various bones and/or tissues of a subject’s body to improve outcomes and earlier healing of bone fractures and/or tissue trauma. The cerclage device in some embodiments has an elongate member with three portions, a leading section, securing section and flexible section, together with a securing mechanism, which allows for secure fixation to be provided while protecting the bone and tissues. Furthermore, the cerclage device may be configured to couple with a humeral prosthesis to further enhance tuberosity fixation as described in respect of addressing problems with hemiarthroplasty.

[0271] The cerclage device may also be couplable with other fixation supports, including fixation plates for assisting with repair of different bone fractures, including in the shaft of long bones such as the humerus and femur. Advantageously, cerclage devices may be employed to secure bone portions where the bone has been previously repaired or surgically operated on, including where a prosthesis is already implanted. The cerclage devices may be secured around the exterior of the bone without further mechanical damage such as through the use of bone screws to protect the native bone and enhance healing of the fractures. Furthermore, the fixation plate may be omitted and cerclage devices solely used for fixation of bone and/or tissue in various embodiments of the disclosure which avoids any damage to the underlying bone structure.

[0272] It is to be understood that various modifications, additions and/or alternatives may be made to the parts previously described without departing from the ambit of the present disclosure as defined in the claims appended hereto. [0273] Where any or all of the terms “comprise”, “comprises”, “comprised” or “comprising” are used in this specification (including the claims) they are to be interpreted as specifying the presence of the stated features, integers, steps or components, but not precluding the presence of one or more other features, integers, steps or components or group thereof.

[0274] It is to be understood that the following claims are provided by way of example only, and are not intended to limit the scope of what may be claimed in any future application. Features may be added to or omitted from the claims at a later date so as to further define or re-define the disclosure or disclosures.

Claims

Claims:

1. A cerclage device configured for fixation of at least one bone portion and/or tissue of a shoulder of a subject, the cerclage device comprising: an elongate member having a medial end and a lateral end, wherein the elongate member comprises: a leading section located at the medial end for insertion around and/or through the at least one bone portion and/or tissue; a flexible section between the medial end and the lateral end, wherein the flexible section is configured to prevent or reduce damage to the at least one bone portion and/or tissue; and a securing section; and a securing mechanism for irreversibly securing the cerclage device relative to the at least one bone portion and/or tissue when the medial end and/or the lateral end are moved in a fastening direction, wherein the securing mechanism engages with the securing section of the elongate member to prevent movement of the medial end and/or the lateral end in a direction opposite to the fastening direction.

2. The cerclage device according to claim 1, wherein the securing section is located between the flexible section and the leading section of the elongate member.

3. The cerclage device according to claim 1 or claim 2, wherein a portion of the securing mechanism is located adjacent to the lateral end of the elongate member.

4. The cerclage device according to any one of claims 1 to 3, wherein the securing mechanism is configured to receive the leading section of the elongate member when the medial end is moved in the fastening direction.

5. The cerclage device according to any one of claims 1 to 4, wherein the securing mechanism comprises a locking portion for engaging with a plurality of interlocking portions positioned along a length of the securing portion of the elongate member.

6. The cerclage device according to claim 5, wherein the plurality of interlocking portions comprise teeth and the locking portion comprises a head with a pawl that engages lockably with the teeth.

7. The cerclage device according to any one of claims 1 to 4, wherein the securing mechanism comprises a compressible portion for permanently deforming a length of the securing portion of the elongate member.

8. The cerclage device according to claim 7, wherein the compressible portion allows for crimping of two sections of the elongate member together.

9. The cerclage device according to any one of claims 1 to 8, wherein the leading section, the flexible section and the securing section of the elongate member comprise different materials.

10. The cerclage device according to any one of claims 1 to 9, wherein the flexible section of the elongate member is formed of a protective material comprising at least one of a group selected from mersilene, silk, dacron, an ultrabraid material or a non-braided material, or combinations thereof.

11. The cerclage device according to any one of claims 1 to 10, wherein the securing section is formed of a polymeric material.

12. The cerclage device according to any one of claims 1 to 11, wherein the leading section comprises a cutting edge to perforate and/or puncture the at least one bone portion and/or tissue.

13. The cerclage device according to any one of claims 1 to 12, wherein the leading section is formed of a metal material.

14. The cerclage device according to any one of claims 1 to 13, wherein the cerclage device further comprises an internal surface configured to prevent or reduce slippage during irreversible securing of the cerclage device relative to the at least one bone portion and/or tissue.

15. The cerclage device according to claim 14, wherein the internal surface comprises a textured pattern and/or one or more projections for frictional engagement with the at least one bone portion and/or tissue.

16. The cerclage device according to claim 14 or claim 15, wherein the securing mechanism and/or the flexible section of the elongate member comprises the internal surface of the cerclage device.

17. The cerclage device according to any one of claims 1 to 16, wherein the at least one bone portion is part of a humerus of the subject, and wherein the at least one bone portion is part of a lesser tuberosity, a greater tuberosity or a head of the humerus.

18. The cerclage device according to any one of claims 1 to 17, wherein the at least one tissue is a tendon or muscle, and wherein the at least one tissue comprises a supraspinatus, a subscapularis or an infraspinatus tendon or muscle of the subject’s shoulder.

19. A metaphyseal component configured for coupling with a cerclage device according to any one of claims 1 to 18 for fixation of at least one bone portion and/or tissue of a shoulder of a subject with the metaphyseal component when implanted, wherein the metaphyseal component comprises a body having at least one location for coupling with the cerclage device.

20. The metaphyseal component according to claim 19, wherein the at least one location is on a medial side of the metaphyseal component.

21. The metaphyseal component according to claim 19 or claim 20, wherein the at least one location comprises a slot for receiving the cerclage device therethrough.

22. The metaphyseal component according to any one of claims 19 to 21, wherein the body comprises a plurality of locations for coupling with a respective plurality of cerclage devices.

23. A humeral prosthesis, comprising: a metaphyseal component configured for coupling with a cerclage device according to any one of claims 1 to 18 for fixation of at least one bone portion and/or tissue of a shoulder of a subject with the humeral prosthesis when implanted, wherein the metaphyseal component comprises a body having at least one location for coupling with the cerclage device; and a diaphyseal component comprising a stem configured for placement in a prepared shaft of a humerus of the subject.

24. The humeral prosthesis according to claim 23, wherein the at least one location is on a medial side of the metaphyseal component.

25. The humeral prosthesis according to claim 23 or claim 24, wherein the at least one location comprises a slot for receiving the cerclage device therethrough.

26. The humeral prosthesis according to any one of claims 23 to 25, wherein the body comprises a plurality of locations for coupling with a respective plurality of cerclage devices.

27. A kit, comprising: at least one cerclage device according to any one of claims 1 to 18 configured for fixation of at least one bone portion and/or tissue of a shoulder of a subject; and at least one metaphyseal component comprising a body having at least one location for coupling with the at least one cerclage device.

28. The kit according to claim 27, further comprising: at least one cerclage tool configured to be secured to the body of the at least one metaphyseal component at the at least one location.

29. The kit according to claim 28, wherein the at least one cerclage tool has a tubular crosssection to allow for passage of the at least one cerclage device therethrough.

30. The kit according to claim 28 or claim 29, wherein the at least one cerclage tool comprises a curved end portion for ease of access in passing the at least one cerclage device.

31. A cerclage tool configured to be secured to a body of a metaphyseal component having at least one location for coupling with at least one cerclage device according to any one of claims 1 to 18, wherein the cerclage tool has a tubular cross-section to allow for passage of the at least one cerclage device therethrough.

32. A cerclage tool configured to be secured to a body of a metaphyseal component having at least one location for coupling with at least one cerclage device according to any one of claims 1 to 18, wherein the cerclage tool comprises a curved end portion for ease of access in passing the at least one cerclage device.

33. A method for cerclage fixation of at least one bone portion and/or tissue of a shoulder of a subject, the method comprising the steps of: providing a cerclage device configured for fixation of the at least one bone portion and/or tissue, the cerclage device comprising: an elongate member having a medial end and a lateral end, wherein the elongate member comprises: a leading section located at the medial end for insertion around and/or through the at least one bone portion and/or tissue; a flexible section between the medial end and the lateral end, wherein the flexible section is configured to prevent or reduce damage to the at least one bone portion and/or tissue; and a securing section; and a securing mechanism for irreversibly securing the cerclage device relative to the at least one bone portion and/or tissue; moving the medial end and/or the lateral end of the elongate member in a fastening direction; and irreversibly securing the cerclage device relative to the at least one bone portion and/or tissue for fixation by engaging the securing mechanism with the securing section of the elongate member to prevent movement of the medial end and/or the lateral end in a direction opposite to the fastening direction.

34. A cerclage device configured for fixation of at least one bone portion and/or tissue of a subject’s body, the cerclage device comprising: an elongate member having a medial end and a lateral end, wherein the elongate member comprises: a leading section located at the medial end for insertion around and/or through the at least one bone portion and/or tissue; a flexible section between the medial end and the lateral end, wherein the flexible section is configured to prevent or reduce damage to the at least one bone portion and/or tissue; and a securing section; and a securing mechanism for irreversibly securing the cerclage device relative to the at least one bone portion and/or tissue when the medial end and/or the lateral end are moved in a fastening direction, wherein the securing mechanism engages with the securing section of the elongate member to prevent movement of the medial end and/or the lateral end in a direction opposite to the fastening direction.

35. A method for cerclage fixation of at least one bone portion and/or tissue of a subject’s body, the method comprising the steps of: providing a cerclage device configured for fixation of the at least one bone portion and/or tissue, the cerclage device comprising: an elongate member having a medial end and a lateral end, wherein the elongate member comprises: a leading section located at the medial end for insertion around and/or through the at least one bone portion and/or tissue; a flexible section between the medial end and the lateral end, wherein the flexible section is configured to prevent or reduce damage to the at least one bone portion and/or tissue; and a securing section; and a securing mechanism for irreversibly securing the cerclage device relative to the at least one bone portion and/or tissue; moving the medial end and/or the lateral end of the elongate member in a fastening direction; and irreversibly securing the cerclage device relative to the at least one bone portion and/or tissue for fixation by engaging the securing mechanism with the securing section of the elongate member to prevent movement of the medial end and/or the lateral end in a direction opposite to the fastening direction.