Surgical Technique Guide

Introduction Surgical Technique Pre-Operative Planning OR and Instrument Set-up Preparation for Kyphoplasty Surgical Procedure Follow Up care

 Kyphoplasty is a minimally invasive procedure designed to stabilize and reduce pain from pathological vertebral compression fractures. Pathological vertebral compression fractures can be caused by osteoporosis, a malignancy in the underlying bone, or more rarely a benign blood vessel tumour in the vertebra known as a vertebral haemangioma. The traditional conservative treatment for pathological vertebral compression fractures, including bed rest and analgesics, has been unsatisfactory for many patients who are left with chronic pain, immobility and deformity. In the management of osteoporotic vertebral compression fractures, the use of open reduction and internal fixation has a limited place. The fixation of the osteoporotic spine is usually inadequate to correct the deformity occurring as a result of crush fractures. Open surgical techniques have also had little success.

-. Bad posture -. Disease or damage -. Osteoporosis -. Scheuermanns disease -. Potts disease -. Spinal tumors

Stabilize and reduce pain from pathological vertebral compression fr actures by by balloon and filling the space in the vertebrae body with bone cement.

Painful thoracic or lumbar vertebral body compression fracture due to osteopenia arising from primary or secondary osteoporo sis or due to multiple myeloma. The residual vertebral body height as seen on X-rays is at least 8 mm at the posterior edge and the surgery is technically feasi ble. Documented history of symptomatic fracture for no more than 8 weeks.

Tenderness on physical exam at the spinous process of the in volved level. MRI showing marrow edema at the fracture site OR, recent serial X-rays demonstrating acute (< 8 weeks) loss of height. If an MRI is contraindicated use a CT plus bone scan to deter mine osteopenia.

Vertebral body fracture caused by high velocity injury. Vertebral body fracture with widened pedicles. End plate is depressed lower than the pedicle. Vertebral body burst fracture with retropulsion of fragments. Vertebral body fractures involving all 3 spinal columns. Vertebral body fracture due to solid tumors. Disabling back pain secondary to causes other than acute fracture. Patient is on anticoagulation therapy, which can not be discontinu ed. Bleeding disorder. Systemic or local infection. Documented history of symptomatic fracture(s) for greater than 8 weeks. Patient is under 40 years of age. Pregnancy

Notify the O.R. that you will need the SPASY kyphoplasty to ols and a C-arm and a compatible surgical table. You should a lso request that the operating suite be kept cold during the pro cedure. The T8 to L5 vertebrae can usually be visualized in the OR wit h a C-arm. Levels above T7 may be harder to see without a h igh resolution C-arm. If there is no high-resolution C-arm avai lable, you may wish to use a bi-plane fluoroscope in the X-ray suite. Do not perform this procedure if you can not visual ize the pedicles or other relevant spinal anatomy with you r C-arm.

If using a spinal frame, ensure that it is radiolucent. Choose your approach based on your experience, patient status, and the width of the pedicles, which should be at least 5 mm wide on an MRI to accommodate the Kyphon I ntroducer Tools. The following approaches are guidelines:
Approach Transpedicular Extrapedicular Posterolateral

The preferred approach is transpedicular unless the pedicles are too narrow
Level T10-L5 T5-T12 L2-L4

For the posterolateral approach start from the side with the better quality bone, if that can be determined. Select the appropriate SPASY Balloon Catheter size for each level on which you will be operating. The balloons are labeled according to their length and accessory t ool size. Choose the balloon size by measuring the mid-height length of the vertebral body in an oblique X-ray view. Select a balloon whose deflated length is one half the v ertebral body oblique mid-height length. Thoracic fractures typically require two size 10. Lumbar fractures typically require two size 15 for the transpedicular approach and one size 20 for the posterolateral approach. Select the appropriate bone cement filler, ensure that it is radiopaque and refrigerate a minimum of 12 hours if it is necessary to ensure appropriate consistency.

Or Set-up

One suggested operating room setup is shown below. A slave monitor should be positioned opposite the main monitor if the surgeon plans to switch sides during the procedure.

Patient Positioning

Place patient in prone position on a radiolucent table. Place rolls under the ch est, hips and shoulders. Place pillows under the l ower legs and pad the e lbows. Use the C-arm to locate the fractured vertebral b ody.

Medications Preoperative antibiotics may be administered immediately prior to surgery. If using local anesthesia, inject into the soft tissue and subperiosteally down to each pedicle using a C-arm to visualize the placement. Additional anesthetic may be injected during the procedure

Note: Patients with kyphosis (without COPD) may experience less postop erative pain if a low abdominal pad is used.

This device is designed and intended for one-time use only. Pri or to using the Inflatable SPASY Balloon Catheter in surgery, it must be properly prepared according to the instructions. SPASY Kyphoplasty System.

Kit Composition
Part No.
SWMP SWM10/15/20 SWMVP SWM-1 SWM-21 SWM-22 SWM-3 SWM-4

Description
Balloon Expander Balloon Catheter Bone Marrow Needle Guide Wire Cannula Expender Bone Drill Bone Filler

EA/Box
2 ea 2 ea 1 ea 2 ea 2 ea 2 ea 1 ea 6 ea

Balloon Catheter
Part No.
SWM10 SWM15 SWM20

Length(mm)
10 15 20

Maximum Dia()
14 17 19

Maximum Length(mm)
16 22 34

Maximum Volume(cc)
4 4 6

Open the Inflation Syring e package and remove the cap.

Turn the 3-ways stopcock to the right way to open as the picture shows below.

1. Fill the syringe of Balloon Expander with contrast medium of about 20cc. Generally, set up the zero scale of i nflation cylinder to 10cc. 2. Point the inflation syringe toward the ceiling, squeeze the handle and push the air out of the inflation syringe barrel to the 60cc syringe.

3. After filling the contrast medium into Syringe, connect Balloon expander with Balloon catheter.

4. Prepare the equipment and medication for local or general anesthesia.

1. Use a pedicular en face view of the vertebrae t o begin insertion of the needle. The pedicle im age will be at its widest and brightest in this vi ew. To achieve this view, position the C-arm te n to twenty degrees lateral to a true A/P view. 2. Using A-P and lateral images insert the needle into the upper 1/3 of the pedicle. Aim the needle inferiorly toward the middle of the vertebral body. Push or gently tap the needle creating a cortical window at the posterior cortex. Continue insertion 3-4 mm past the posterior wall of the vertebral body. Always use radiographic guidance to monitor tool placement. 3. Find the approaching point of pedicle with wire pin and mark the point with a pen.

4. Puncture up to 1/3 of verte bral body passing through the pedicle with Bone marrow needle.

5. Pull out the needle from the Bone marrow needle.

6. Push the guide wire into the Bone marrow needle up to 3/4 of vertebral body.

7. Remove the Bone marrow needle except for the guide wire

8. Through the guide wire, push the Cannula and Expander from the starting point of vertebral body to 1/4.

9. Remain the Cannula only an d remove the Guide wire and Expande r.

10. Ream with bone drill to the en d of callous bone of vertebral body through the Ca nnula. 11. Remove the bone drill and reciprocate the bone cement fil ler several times through the Cannula. (For smooth balloon insertion and prevention of the balloon b ursting by sharp bone)

12. Slightly inflate the balloon at suitable position in vertebral body, after insertion.

13. Remove the wire

14. Pressurize the balloon to the appropriate level of reduction. (Maximum 200 PSI)

Additional Explanation

Instruments Inserted Through a half inch incision, small instruments are placed into the fractured vertebral body to create a working channel.

Additional Explanation

Cavity Created Inserted the balloon catheter

The balloon is carefully inflated, creating a cavity inside the vertebral body.

15. Remove the Balloon from the VB after reduction

Balloon Deflated The balloon is deflated, leaving a cavity in the vertebral body.

Balloon is removed, leaving a cavity

16. Prepare the Bone cement. (Each balloon covers 4~5cc of bone cement) 17. Inject the 1.5 cc of cement with each bone cement filler and pusher. (Each filler covers 1.5cc of bone cement , one balloon needs 3 bone filler regularly.) 18. Close up at the end of the filler with pusher to prevent solid cement before insertion to balloo n. Caution Unless inject bone cement with balloon within 6 minutes or it will be solid.

19. Fill the balloon with bone cement 20. Close up at the end of Cannula(up to 1/ 3 of vertebral body) with bone fillier until the cement completely be solid. During t his time, roll the Cannula once or twice. 31. Remove the filler after the cement be solid. Guess the cement whether solid or not by check the heat of cement

Additional Explanation

Cavity filled with bone cement

Take routine post-operative X-rays in the Recovery Room to d ocument bone void filler placement in the vertebral body. Use external orthosis as necessary. Patients typically remain one day in the hospital. Walking is encouraged. No lifting is permitted for six weeks. P atients are followed in the office according to standard practice at one week and return again in 10 to 14 days for suture remo val. On completion of a one-month follow-up visit, patients are returned to the referring physician for usual medical care or as required. Note: Some patients may experience anterior thigh pain. This usually resolves in four to six weeks. If the pain does not resolve, consider radiculopathy or myelopathy.