This trial is active, not recruiting.

Condition lumbar spinal stenosis
Treatment baxano io-flex® system
Sponsor Baxano Surgical, Inc.
Start date February 2010
End date December 2014
Trial size 75 participants
Trial identifier NCT01067014, CP-1318


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
baxano io-flex® system
Decompressive lumbar surgery using Baxano iO-Flex® System

Primary Outcomes

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
time frame: 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%
time frame: 6 months
Re-operation at the treatment level(s) at one year post-procedure
time frame: 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
time frame: Hospital discharge

Secondary Outcomes

Changes in Visual Analog Scale scores compared to baseline
time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Changes in Zurich Claudication Questionnaire scores compared to baseline
time frame: 6 weeks, 3, 6, 12, and 24 months
Changes in Oswestry Disability Index scores compared to baseline
time frame: 6 weeks, 3, 6, 12, and 24 months
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
time frame: 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
time frame: Through 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Baxano Surgical, Inc..