RU2456947C1 - Method of reconstruction of vertebra body in case of compressive fractures - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to field of medicine, namely to traumatology and orthopedics, neurosurgery, and can be applied in treatment of compressive fractures of vertebra body. Essence of method lies in transcutaneous passage into body of fractured vertebra, introduction of cannula into vertebra body, through which balloon with stent is introduced, reconstruction of height of fractured vertebra body by inflating balloon, removal of balloon, further introduction of bone-substituting material into fractured vertebra body. Cannula is introduced monolaterally extrapedicularly, along ventral surface of transverse process with point of introduction in vertebra body located 0.8-1.0 cm from plane of arch pedicle base. Balloon with stent is installed on diameter of vertebra body. As bone-substituting material introduced is mixture of calcium-sulfate and calcium-phosphate cement in ratio 7:3 respectively.

EFFECT: application of claimed invention makes it possible to reduce duration of patient's state in hospital, reduce probability of development of intra- and post-operation complications, increase quality of patients' life, reduce operation cost.

5 dwg, 2 ex

Description

The invention relates to medicine, namely to traumatology and orthopedics, neurosurgery, and can be used in the treatment of spinal injuries - compression fractures of the vertebral bodies in osteoporosis.

A known method of transcutaneous strengthening of the vertebral body in osteoporotic compression fractures. Using a cannulated needle with a trocar, they transcutaneously pass through the leg of the vertebra into the body of the vertebra. The trocar is removed and cylinders are inserted through the cannulated needle, the height of the vertebral body is restored, and then polymethyl methacrylate cement (George P. Teitelbaum, MD, Samuel Shaolian, MS, Cameron G. McDougall, MD, Marc C. Preul, MD, Neil R. Crawford , PhD, and Volker KH Sonntag, MD New percutaneously inserted spinal fixation system SPINE Volume 29, Number 6, pp 703-709 2004, Lippincott Williams & Wilkins, Inc.).

The disadvantage of this method is that it cannot be used to maintain the restored height of the vertebral body, since after the balloon is deflated and before the cement is introduced, a partial loss of the restored height occurs. Polymethylmethacrylate cement is a toxic drug and is not recommended for young patients, since it remains in the body for life, does not resolve. Possible fracture of adjacent vertebrae with osteoporosis, because This cement has a high modulus of elasticity.

A known method of treating fractures of the vertebral bodies (RF Patent No. 2351375, IPC A61B 17/56, publ. 2009), comprising introducing a balloon into the damaged vertebral body and restoring the height of the vertebral body by inflating it. At the same time, the zone and the direction of balloon inflation are limited in the direction opposite to compression, ensuring its expansion in the area of the damaged area. After filling the cavity with bone-substituting material, it is sealed with a contact action by ultrasonic vibrations. The zone and direction of inflation of the balloon is limited by placing it inside a rigid tube at its distal end, which is muffled, having an outlet for the balloon on the side surface. In this case, the tube is installed with an outlet directed to the compression area of the damaged vertebral body. The wall of the rigid tube opposite the outlet is a support, so that, being located on it, the balloon inflates only in one direction opposite to the support.

The disadvantage of this method is its complexity in execution, the use of ultrasonic vibrations lengthens the operation time, high invasiveness.

The closest is a method of restoration of the vertebral body during compression fractures, including a transcutaneous bipedicular passage into the body of the broken vertebra, insertion of cannulas into the vertebral body through which 2 cylinders with stents placed on them are inserted, restoration by inflating the height of the body of the broken vertebra, removing the cylinders, s subsequent injection of bone cement based on polymethyl methacrylate into the body of a broken vertebra (Robert Rotter, Heiner Martin, Sebastian Fuerderer, Michael Gabl, Cristoph Roeder, Paul Heini, Thomas Mittlmeier Vertebral body stenting: new method for vertebral augmentation versus kyphoplasty Eur Spine J (2010) 19: 916-923).

The disadvantage of this method is that after restoration of the height of the body of the broken vertebra and further removal of the balloon, before the introduction of cement, a partial loss of the restored body height may occur due to ligamentotaxis, muscle tone and elastic properties of the vertebral body. A further disadvantage of this method is its limited indications. Polymethyl methacrylate cement should not be administered to young patients. Another disadvantage of this method is the high likelihood of complications associated with the outflow of cement into the cavity of the spinal canal, fracture of the legs of the vertebral arch when a cannula passes through them.

The objective of the invention is to remedy these disadvantages, increase the effectiveness of surgical intervention, reduce the likelihood of postoperative complications by maintaining the restored height of the vertebra and ensuring the germination of bone-replacing material with its own bone.

To do this, in the method of restoring the vertebral body during compression fractures, including a transcutaneous passage into the body of the broken vertebra, introducing a cannula into the vertebral body through which a balloon with a stent placed on it is inserted, restoring the balloon to the height of the body of the broken vertebra, removing the balloon, followed by the introduction bone-substituting material into the body of a broken vertebra, it is proposed that the cannula be introduced monolaterally extrapedicularly along the ventral surface of the transverse process with the point of insertion vertebral body, spaced at 0.8-1.0 cm from the arc feet ground plane vertebra. In this case, the cannula is installed according to the diameter of the vertebral body, and a mixture of calcium sulfate and calcium phosphate cement is introduced as a bone substitute material in a ratio of 7: 3, respectively.

The fact that one cannula is inserted and then only one balloon with a stent, reduces the morbidity, the duration of the operation, the likelihood of cement flowing into the cavity of the spinal canal and its cost. The use of calcium sulfate and calcium phosphate cement, which has osteoconductive properties, allows to avoid a foreign body, since it is replaced by its own bone. The proposed ratio of the components of the mixture of cements allows you to accelerate the replacement of cement with your own bone.

Figure 1 presents a cannula mounted in the vertebral body through which a catheter with a balloon and a stent is inserted; figure 2 is the same in the sagittal plane; figure 3 - presents the expansion of the balloon with a stent with the extension of the vertebral body; figure 4 - the same in the sagittal plane, figure 5 - filling the cement cavity of the stent and the damaged vertebra.

The method is as follows.

The operation is performed in the presence of a compression fracture of the vertebral body, with the safety of the posterior elements of the vertebral column and the intact posterior wall of the vertebral body. A fracture can be pathological, against the background of osteoporosis or oncology.

For the operation you need:

- cannula;

- catheter with balloon and stent;

- osteoconductive calcium sulfate and calcium phosphate bone cement. It has a bioresorbable property, i.e. replaced by its own bone. All currently used bone cements consist of polymethylmethacrylate, a synthetic material that stays in the body for life, covered with a fibrous capsule, and has a modulus of elasticity much greater than that of the bone, which, against the background of osteoporosis, provokes a fracture of adjacent vertebrae.

Stages of the operation.

The position of the patient on the stomach. Local anesthesia.

Under X-ray control, cannula 2 is extrapedicularly monolaterally through a paramedian puncture in the skin 1 along the ventral surface of the transverse process 3 with the point of introduction of the damaged vertebra in the body, at a distance of 0.8-1.0 cm from the base of the leg of the arch 4, into the vertebral body 5. Then through A catheter 6 is inserted diametrically into the vertebral body into the cannula, at the distal end of which there is a balloon 7 with a stent. The balloon is inflated, the stent is expanded and the height of the body of the broken vertebra is restored. After deflating the balloon, the straightened stent 8 remains in the vertebral body, maintaining the restored height.

Then through the cannula into the cavity formed by the stent, osteoconductive cement 9 is introduced in a volume of 3-5 ml, depending on the filling of the stent cavity and the degree of infiltration of the cancellous bone. Osteoconductive cement is a mixture of calcium sulfate and calcium phosphate cement in a ratio of 7: 3, respectively. Commonly used are β-tricalcium phosphate cement (Chron OS Inject or Norian Drillable, Synthes, Switzerland) and calcium sulfate cement (MIIG X3, USA). When applying the proposed mixture of cements, first of all, the resorption of the calcium-sulfate component occurs, providing space for the germination of its own bone, stimulated by calcium-phosphate cement.

Example 1

Patient D.N.G., born in 1931.

Diagnosis: Compression fracture of the Th11 vertebral body against osteoporosis.

Complaints at admission: For pain in the lower thoracic spine

Anamnesis of the disease: According to the patient, she received an injury in everyday life when lifting a heavy bag (01/29/11), felt a sharp pain in the thoracic spine. For honey. I didn’t apply for help. The pains continued to bother. 02.02.11, I went to the clinic at the place of residence, where, after a clinical and radiological examination, a compression fracture of Th11 of the thoracic vertebra was revealed.

X-ray of the thoracic spine.

Conclusion (04.02.2011): Compression wedge-shaped deformation of the 11th thoracic vertebra, 1/3 decrease in body height along the front surface.

MSCT of the thoracic spine. Conclusion (02/04/2011): compression-degenerative changes in the Th1l vertebral body.

Surgery performed: Stentoplasty of the 11th thoracic vertebra. Surgery protocol: Patient position on the abdomen. Local anesthesia with 0.5% novocaine solution - 10 ml. Paravertebral incision of the skin and fascia with a scalpel injection. The cannula was carried out extrapedicularly along the ventral surface of the transverse process with the insertion point in the body of the damaged vertebra, at a distance of 1.0 cm from the base of the leg of the arch, into the vertebral body. A catheter with a balloon and a stent 4 mm in diameter was inserted through the cannula. Under x-ray control balloon inflated to 30 ATM. There was a restoration of the height of the broken vertebral body. In this case, the stent straightened to 17 mm. The above-described mixture of cements was prepared and introduced into the cavity of the stent under x-ray control; no cement leakage outside the vertebral body was found. Aseptic sticker.

After the operation, a decrease in pain is noted.

Activated 3 hours after surgery.

The next day was discharged.

3 and 6 months after the operation, CT was performed, the last revealed a replacement of osteoconductive cement with bone by 30%. The height of the vertebral body has not decreased.

Example 2

Patient Z.N.N., born in 1933.

Diagnosis: Compression fracture of the L3 vertebra. Osteoporosis.

Complaints of pain in the lumbar region.

MSCT of the lumbosacral spine (12/07/2010).

Conclusion (12/07/2010): L3 vertebral body deformity is noted, with an uneven decrease in height in the central departments to 14 mm, in the marginal to 18 mm. The back wall of the vertebral body is intact.

Densitometry revealed a decrease in bone mineral density. Surgery protocol: Patient position on the abdomen. Local anesthesia with a 0.5% solution of novocaine with a volume of 10 ml. A skin incision was made at a distance of 8 cm from the line of the spinous processes on the left. The cannula is held at an angle of 30 degrees to the horizontal plane along the ventral surface of the transverse process diametrically into the body L3 at a distance of 1 cm from the plane of the base of the arc leg. A catheter with a balloon and a stent 4 mm in diameter is passed through the cannula. Under x-ray control, balloon inflation was performed up to 26 atm. There was a restoration of the height of the broken vertebral body. In this case, the stent straightened to 15 mm. A mixture of calcium sulfate and calcium phosphate cements was prepared and introduced into the cavity of the stent under x-ray control; no cement leakage was found outside the vertebral body. Aseptic sticker. Two seams on the skin. Aseptic dressing.

The patient is activated and discharged the day after surgery.

In the CT scan after 6 months, the loss of the restored L3 body height was not detected. Osteoconductive cement is kneaded by bone by more than 50%.

According to the proposed method, 11 operations were performed: 8 operations for compression fractures against osteoporosis of the lower thoracic spine, 3 operations for fractures of the lumbar vertebral bodies. In 10 cases, a restoration of the height of the body of a broken vertebra occurred. In 1 case, the balloon was not able to inflate and the stent did not open, apparently, this is due to good bone quality and a sufficiently long period after the injury, sufficient for the formation of fibrous and bone block. After applying this technique, the time spent in the hospital has decreased. 90.9% of patients were discharged the day after surgery. When observed after 6 months, bone cement was replaced by its own bone from 30% to 70% at the time of the last observation. Loss of the restored height according to the X-ray examination was not found.

The method allows to reduce the length of the patient’s hospital stay, reduce the likelihood of intra- and postoperative complications, improve the quality of life of patients, reduce the cost of surgery.

Claims (1)

A method of restoring a vertebral body during compression fractures, including a transcutaneous passage into the body of a broken vertebra, introducing a cannula into the vertebral body through which a balloon with a stent is inserted, restoring the balloon to the height of the body of the broken vertebra, removing the balloon, followed by the introduction of bone-replacing material into the body of the broken vertebra, characterized in that the cannula is administered monolaterally extrapedicularly, along the ventral surface of the transverse process with the insertion point in the vertebral body, boiling at 0.8-1.0 cm from the arc feet ground plane, wherein the balloon with a stent mounted on the diameter of the vertebral body, and as the material is introduced kostnozameschayuschego mixture of calcium sulfate and calcium phosphate cement in a ratio of 7: 3, respectively.

Images