The X-STOP device is not appropriate for all patients with symptoms of lumbar stenosis. The following outlines what is known about who is eligible for the X-STOP procedure.
To be eligible for an X-STOP surgery, the patient must meet the following criteria:
- Have received a clinical diagnosis of lumbar spinal stenosis confirmed by an X-ray, CT or MRI scan
- Suffer from leg pain and/or buttock pain and/or groin pain (neurogenic intermittent claudication)
- May or may not have low back pain along with the leg pain
- Have moderately impaired ability to physically function with relief from symptoms experienced when bending forward at the waist
- Have completed at least six months of non-surgical treatment (such as pain medication, physical therapy, epidural injections) without satisfactory pain relief
- Be over 50 years old
- Have significant stenosis present at only one or at most two levels of the spine.
In addition, there are some patients with spinal stenosis in the lumbar spine who fit the above criteria but who nonetheless should not use the X-STOP. The device should not be used by people who have:
- Spinal anatomy that would prevent implantation of the device or cause it to be unstable in the body e.g. ankylosing spondylitis at the operative level, spinal instability such as most grades of spondylolisthesis, fracture of the spinous process or pars interarticularis or significant scoliosis curvature)
- Widespread stenotic changes in the lumbar spine
- Cauda equina syndrome which is multiple spinal nerve compression that causes bowel or bladder dysfunction
- Severe osteoporosis because the device is adjacent to bones in the spine and cannot function if they may be weakened by osteoporosis
- A blood infection or infection of the lower back where the surgery is planned
- Certain types of abnormal spinal anatomy at the operative site, including previous laminectomy
- An allergy to titanium or titanium alloy
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The above list includes what is known about who may be eligible for the procedure, but it may not be an exhaustive list as there are limited, long term randomized studies that have proven details about which types of patients/conditions will do best with this treatment.