Lumbar Spinal Stenosis
Conditions
Keywords
Lumbar spinal stenosis, Decompression, Lumbar spinal decompression, Lumbar spinal decompressive surgery
Brief summary
The purpose of this study is to evaluate the clinical performance of the iO-Flex® System in reducing pain and symptom severity in patients with one or two level lumbar spinal stenosis that requires surgery.
Interventions
DEVICEBaxano iO-Flex® System
Decompressive lumbar surgery using Baxano iO-Flex® System
Sponsors
Baxano Surgical, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Candidates for this study must meet ALL of the following criteria: 1. Age ≥18 years 2. Leg/buttock pain with or without back pain 3. Failed nonoperative medical management 4. A minimum leg pain score of 4.0 cm on the Visual Analogue Scale (VAS) 5. Clinical/radiographic diagnosis of LSS in the L2-L3 to L5-S1 region 6. Able and willing to give voluntary, written informed consent to participate in this clinical study
Exclusion criteria
Candidates will be excluded from the evaluation if ANY of the following apply: 1. Back pain only 2. A diagnosis of central stenosis only 3. More than two levels requiring decompression 4. Fixed motor deficit 5. Significant instability of the lumbar spine as defined by ≥ 4mm translation between standing flexion and extension lumbar spine plain film radiographs 6. Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips 7. Primary disc pathology and/or patients who will undergo a discectomy 8. Prior surgery of the lumbar spine at the level(s) of planned treatment 9. Spondylolisthesis or degenerative spondylolisthesis greater than Grade 1 (on a scale of 1 to 4) 10. Spondylolysis (pars fracture) at any level in the lumbar spine 11. Degenerative lumbar scoliosis with a Cobb angle greater than or equal to 25° 12. Symptomatic vascular claudication in the lower extremities 13. Cauda equina syndrome (neural compression causing neurogenic bowel or bladder dysfunction) 14. Evidence of active (systemic or local) infection at time of surgery 15. Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease 16. Tumor in the spine or a malignant tumor except for basal cell carcinoma 17. Prisoner or transient 18. Recent history of known narcotic abuse 19. Any significant psychological disturbance past or present, psychotic or neurotic, that could impair the consent process or ability to complete subject self-report questionnaires 20. Involved in pending litigation of the spine or worker's compensation related to the back 21. Inability to communicate clearly in the English language 22. Morbid obesity (BMI \> 40) 23. Plans to relocate within the next 2 years 24. Pregnant or planning to become pregnant 25. Irreversible coagulopathy or bleeding disorder a. Subjects on Coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and reinitiation of anticoagulants. 26. Subject unwilling to undergo blood transfusion, if necessary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Symptom Severity domain of the Zurich Claudication Questionnaire (ZCQ) from baseline to 6 months post-procedure quantified as a percentage of subjects with an improvement of at least 0.5 points | 6 months |
| Change in Visual Analog Scale (VAS) for leg pain related to lumbar spinal stenosis at the treatment level from baseline to 6 months post-procedure quantified as a percentage of subjects with an improvement of at least 30% | 6 months |
| Re-operation at the treatment level(s) at one year post-procedure | One year |
| Acute safety outcomes will be determined by evaluating the type, frequency, severity, and relatedness of adverse events through discharge visits for all subjects | Hospital discharge |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Oswestry Disability Index scores compared to baseline | 6 weeks, 3, 6, 12, and 24 months |
| Long term safety outcomes that occur after discharge through 2 years post-procedure will be determined by evaluating adverse events involving the musculoskeletal or neurological systems | Through 2 years |
| Flexion/extension lumbar spine plain film radiographs will be collected and assessed for presence/absence of instability at baseline, 6-month, 12-month, and 24-months | 6, 12, and 24 months |
| Changes in Visual Analog Scale scores compared to baseline | 6 weeks, 3 months, 6 months, 12 months, 24 months |
| Changes in Zurich Claudication Questionnaire scores compared to baseline | 6 weeks, 3, 6, 12, and 24 months |
Countries
United States
Outcome results
None listed