Condition of Approval Study
Condition: Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Intervention: X-STOP PEEK
Intervention description: Placement of X-STOP PEEK in up to two levels in the lumbar spine for patients diagnosed with moderately symptomatic lumbar spinal stenosis in accordance with current labeling instructions for use.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 176.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Lumbar Spinal Stenosis; X-STOP Spacer; Interspinous process decompression; Neurogenic Intermittent Claudication

Summary:

      This prospective, multicenter longitudinal five-year study of X-STOP PEEK usage in LSS
      patients is designed to supplement pre-market safety and effectiveness data with information
      on longer-term device performance in a population of patients with moderately impaired
      physical function at preoperative baseline (i.e., an "indicated" population) who elect to
      undergo X STOP PEEK surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. has a baseline score >2.0 in the Physical Function (PF) domain of the Zurich
             Claudication Questionnaire

          2. is 50 years old or older

          3. has leg/buttock/groin pain with or without back pain NOTE: Leg/buttock/groin pain must
             be completely relieved when flexed such as when sitting in a chair. If back pain is
             also present, it must be partially relieved when flexed.

          4. can sit for 50 minutes without pain

          5. can walk 50 feet or more

          6. has a confirmed diagnosis of neurogenic intermittent claudication secondary to lumbar
             spinal stenosis, with X-Ray, MRI and/or CT evidence of thickened ligamentum flavum,
             narrowed lateral recess and/or central canal narrowing

          7. has completed at least six months of conservative care therapy which may include but
             is not limited to physical therapy, bracing, systemic or injected medications

          8. has signed a patient informed consent document

          9. is physically and mentally willing and able or has a caregiver who can comply with the
             postoperative and routinely scheduled clinical and radiographic evaluations

         10. lives in the immediate area and has no plans to relocate to another geographic area
             before completion of the study or lives outside the immediate area and will comply
             with the scheduled postoperative visits with a prearranged and designated physician

        Exclusion Criteria:

          1. has a baseline score less than or equal to 2.0 in the Physical Function (PF) domain of
             the Zurich Claudication Questionnaire

          2. cannot sit for 50 minutes

          3. cannot walk more than 50 feet

          4. has unremitting pain in any spinal position

          5. has axial back pain only without leg/buttock/groin pain

          6. has a fixed motor deficit

          7. has cauda equina syndrome defined as neural compression causing neurogenic bowel
             (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction

          8. has severe symptomatic lumbar spinal stenosis at more than two levels

          9. has significant instability of the lumbar spine, e.g., isthmic spondylolisthesis or
             degenerative spondylolisthesis greater than grade 1 (on a scale of 1 to 4)

         10. has an ankylosed segment at the affected level(s);

         11. has significant scoliosis (Cobb angle is greater than 25 degrees)

         12. has an acute fracture of the spinous process or pars interarticularis

         13. has sustained pathologic fractures of the vertebrae or multiple fractures of the
             vertebrae and /or hips

         14. has severe osteoporosis of the spine or hip, defined as bone mineral density (BMD) in
             the spine or hip more than 2.5 SD below the mean of adult normals in the presence of
             one or more fragility fractures

         15. has Paget's disease at the involved segment(s) or metastasis to the vertebrae

         16. has had any surgery of the lumbar spine

         17. has significant peripheral neuropathy demonstrated by nerve conduction velocity tests

         18. has acute denervation secondary to radiculopathy, as shown by EMG

         19. has significant peripheral vascular disease characterized by diminished dorsalis pedus
             or tibial pulses

         20. has extreme obesity as defined by a Body Mass Index (BMI) greater than 40 kg/m2

         21. has an active systemic infection or infection localized to the site of implantation

         22. has an active systemic disease such as AIDS, HIV, hepatitis, etc.

         23. has a medical condition that may interfere with postoperative management and
             follow-up, or may result in patient death prior to study completion (e.g., Alzheimer's
             disease, unstable cardiac disease, active malignancy)

         24. has a recent history of narcotic abuse (i.e., within last 3 years)

         25. has a known allergy to titanium,titanium alloy, or polyetheretherketone

         26. is immunologically suppressed, or has received or is receiving steroids at any dose
             daily for more than one month within the last 12 months

         27. is currently involved in a study of another investigational product that may affect
             the outcome of this study

         28. is pregnant or planning to become pregnant during the study period

         29. cannot undergo MRI or tolerate closed MRI scanning.