X-Stop

Description:

This implant is designed specifically to treat and relieve lumbar spinal stenosis. It is designed to be implanted in the lower spinal processes. By physically preventing the spinal processes from moving closer together and compressing, it treates the causes of LSS. It also offers a much less invasive, time consuming, and body tolling surgical procedure then traditional and newly developed surgeries that alter the bodies natural composition by removing and modifying the structure of the spine. The patient is able to go home the same day of the operation. No part of the spine or adjacent tissues are removed in the operation, making for a much less harmful procedure.

Materials:

Ti 6AI-4V ELI Titanium Alloy

Sizes:

6-16 mm

Surgical Procedure:

The operation begins with the patient in a right lateral decubitus position, or fetal position resting on the patient's right side. This enables proper implant sizing and permits flexion.

The patient is then given local anesthesia and mildly sedated so as to still be able to respond to commands. The surgeon then determines the correct level to instert the implant via X-ray. Then a five to eight centimeter incision is made. The surgeon then makes an insicion in the fascia without severing or damagin the sepraspinous ligament.

The musculature is then elevated from both sides of the ligament. A dilator is then inserted through the ligament to make a hole for the implant to rest. If necessary, any hypertrophied or redundant facet tissue is excised. The surgeon then determines the proper implant size with special instrumentation and then inserts the distractor to enlarge and prepare the hole in the ligament for the implant to rest.

The implant is then guided and placed in the hole, and locked into place with the universal and fixed wings. They are adjusted and tightened.

The position of the implant is then confirmed via X-Ray and then if correct, the implant is successfully in place.

Indications:

Lumbar Spinal Stenosis.

Effect:

• Relief from symptoms of lumbar spinal stenosis.
• At least ten percent less chance of additional surgery when compared to standard surgeries
• At least as effective as traditional laminectomy with much less risk.
• Significant increase in spinal canal and foraminal area:
  • Canal area increases by eighteen percent.
  • Canal diameter increases by nine percent.
  • Foraminal area increases by twenty five percent.
  • Foraminal width increases by forty one percent.
  • Sub-articular diameter increases by fifty percent.
• Significant decreases in pressure in extension:
  • Sixty three percent decrease in posterior annulus pressure.
  • Forty one percent decrease in nucleus pulposus pressure.
• Significant decreases in pressure in neutral position:
  • Thirty eight percent decrease in posterior annulus pressure.
  • Twenty percent decrease in nucleus pulposus pressure.

Studies:

In an IDE study conducted for FDA approval of the device, one hundred and twenty two patients were given the X-Stop implant, and one hundred and twelve were given traditional non-surgical treatment. The X-Stop had significantly faster effect on relief of pain, an average of 1.3 years faster. Patient satisfaction in the study was quite high, ranging from ninety percent in the first six weeks to seventy seven percent after two years. At each stage in the trial the X-Stop showed positive feedback over the traditional non-operative treatment.

Success Rates:

In a study done for the FDA nationwide on patients older then fifty, the X-stop gave eighty percent successful results after the first year follow up. It proved to be stable for over five years. It also presented much less risk then a laminectomy and more sucessful results than any non-operative treatments. While there were only four complications in the surgeries done to implant the X-Stop to date, laminectomies have many small percentage chances for varying severe complications.

Availability:

This implant is in the FDA approval process and will be reviewed in the fall/winter quarter of 2004. Update: this device is approved for use by the FDA as of 2005.

Last Updated: 12/22/2010