Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression

Exclusion Criteria

• •1. Back pain only
• •2. Diagnosis of moderate to severe peripheral neuropathy such as diabetic or idiopathic peripheral neuropathy, by EMG/NCS or a Neurologist.
• •3. History of pathologic fractures of the vertebrae
• •4. Primary disc pathology; planned or incidental discectomies will NOT be excluded as long as surgeon believes the disc pathology is not the primary reason for the surgical intervention.
• •5. Subjects for whom removal of the midline structures is planned, likely or is the result of an intraoperative decision; every attempt should be made to spare the supraspinous, interspinous and facet capsular ligaments.
• •6. Significant instability of the lumbar spine as defined by ≥ 4mm translational motion between standing lateral view flexion and extension radiographs
• •7. Prior surgery of the lumbar spine
• •8. Spondylolisthesis greater than grade 1 (on a scale of 1 to 4)
• •9. Spondylolysis (pars fracture) at any level in the lumbar spine
• •10. Degenerative lumbar scoliosis with a Cobb angle of ≥ 25°
• •11. Vascular claudication in the lower extremities
• •12. Cauda equina syndrome
• •13. Evidence of active (systemic or local) infection at time of surgery
• •14. Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease
• •15. Tumor in the spine or a malignant tumor except for basal cell carcinoma.
• •16. Prisoner or transient
• •17. Any significant psychological disturbance past or present, psychotic or neurotic that could impair the consent process or ability to complete subject self-report questionnaires
• •18. Involved in pending litigation of the spine or worker's compensation related to the back
• •19. Inability to communicate clearly in the English language
• •20. Morbid obesity (BMI \> 40)
• •21. Pregnant, nursing, or planning on becoming pregnant.
• •22. History of narcotic abuse
• •23. Current involvement in another drug or device clinical trial
• •24. Uncontrolled diabetes
• •25. Irreversible coagulopathy or bleeding disorder (patients on anticoagulant therapy may participate. Investigators should follow routine practices for perioperative discontinuation and reinitiation of anticoagulants.)
• •26. Plans to relocate in the next 2 years
• •27. Subject unwilling to undergo a blood transfusion, if necessary