Decompression and interlaminar stabilization with the coflex device - A motion preserving alternative to fusion for lumbar spinal stenosis.
Lumbar spinal stenosis is a narrowing of the spinal canal that occurs in the lower part of the spine (lumbar region). For decades, the surgical options for patients with lumbar spinal stenosis were limited to either decompression or decompression with spinal fusion. In 2012, the FDA approved the coflex® Interlaminar Stabilization® device , a small U-shaped titanium implant that provides spinal stability without the invasiveness and loss of mobility associated with spinal fusion.
Indication
The coflex device is not for everyone. The coflex Interlaminar Technology is an interlaminar stabilization device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).
Procedure
The goal of spinal stenosis surgery is to take away bone or neural elements that are impinging on the nerves that are trying to extend to the rest of your body (called a decompression). After the surgeon performs a direct decompression that removes bone, facet, ligament and/or disc segments from the narrowed spinal canal, your spine can become unstable. The coflex device is then inserted directly following a decompression procedure to help keep your spine stable while maintaining normal height and motion in your spine.
The unique design of the coflex® device maintains stability in the spine after direct surgical decompression while preserving more natural movement in the treated area.
Post-operative Instructions
Immediately following surgery
When you wake from recovery, you may be encouraged to get up and walk nearly immediately, taking into consideration your overall health at the time of surgery. Since there is no fusion, and therefore no healing bone to wait for, you’ll most likely be able to do this right after your procedure. You’ll notice that your pain has been significantly relieved, and your spine should feel stable and strong. Most patients do need to wait several days following the surgery for the incision wound to heal.
Weeks and months following surgery
In the weeks and months following surgery, your recovery depends on a number of factors, including the degree of your stenosis and the extent of the decompression that was performed. Most patients are able to return to normal activity, and even expanded activity such as golf, cycling, gardening and other activities, within weeks of the surgery. Some patients may require physical therapy to help with mobility and flexibility°.
Every patient is different; therefore results may vary.
Complications
As a patient, there is always potential risk in having surgery or getting a medical device. Usually these risks are rare. You should refer to the coflex Patient Labeling for a list of all potential risks and hazards that were observed during the clinical study. For patients receiving coflex, the biggest risk is continued pain. Other risks include wound healing problems (such as infection or drainage), brief numbness or tingling in your arms or legs, and spinous process fractures. Some patients had illnesses or diseases not related to their surgery, like problems with their skin, problems breathing, problems with their heart, and other muscle or bone pain or soreness. In the clinical trial, similar problems were experienced with patients who had fusion. The coflex surgery may not help relieve pain in some patients, and you may need another surgery to remove the device. It is hard to predict who will not benefit from this surgery. Although uncommon, the device could be removed if necessary.
