The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery

Study Overview
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Brief Summary
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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.

Official Title
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The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Device: Baxano iO-Flex® System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Candidates for this study must meet ALL of the following criteria: Age ≥18 years Leg/buttock pain with or without back pain Failed nonoperative medical management A minimum leg pain score of 4.0 cm on the Visual Analogue Scale (VAS) Clinical/radiographic diagnosis of LSS in the L2-L3 to L5-S1 region 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: Back pain only A diagnosis of central stenosis only More than two levels requiring decompression Fixed motor deficit Significant instability of the lumbar spine as defined by ≥ 4mm translation between standing flexion and extension lumbar spine plain film radiographs Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips Primary disc pathology and/or patients who will undergo a discectomy Prior surgery of the lumbar spine at the level(s) of planned treatment Spondylolisthesis or degenerative spondylolisthesis greater than Grade 1 (on a scale of 1 to 4) Spondylolysis (pars fracture) at any level in the lumbar spine Degenerative lumbar scoliosis with a Cobb angle greater than or equal to 25° Symptomatic vascular claudication in the lower extremities Cauda equina syndrome (neural compression causing neurogenic bowel or bladder dysfunction) Evidence of active (systemic or local) infection at time of surgery Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease Tumor in the spine or a malignant tumor except for basal cell carcinoma Prisoner or transient Recent history of known narcotic abuse Any significant psychological disturbance past or present, psychotic or neurotic, that could impair the consent process or ability to complete subject self-report questionnaires Involved in pending litigation of the spine or worker's compensation related to the back Inability to communicate clearly in the English language Morbid obesity (BMI > 40) Plans to relocate within the next 2 years Pregnant or planning to become pregnant 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. Subject unwilling to undergo blood transfusion, if necessary

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| iO-Flex<br> | Device: Baxano iO-Flex® System<br>* Decompressive lumbar surgery using Baxano iO-Flex® System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Changes in Oswestry Disability Index scores compared to baseline |  | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar spinal stenosis, Decompression, Lumbar spinal decompression, Lumbar spinal decompressive surgery