The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery
- Conditions
- Lumbar Spinal Stenosis
- Interventions
- Device: Baxano iO-Flex® System
- Registration Number
- NCT01067014
- Lead Sponsor
- Baxano Surgical, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description iO-Flex Baxano iO-Flex® System -
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (18)
Buffalo Spine Surgery
🇺🇸Lockport, New York, United States
McCune-Brooks Regional Hospital
🇺🇸Joplin, Missouri, United States
Triangle Orthopaedic Associates
🇺🇸Chapel Hill, North Carolina, United States
Tuckahoe Orthopaedic Associates
🇺🇸Richmond, Virginia, United States
Olympia Medical Center
🇺🇸Los Angeles, California, United States
Suburban Orthopedics
🇺🇸Bartlett, Illinois, United States
Rothman Institute
🇺🇸Bensalem, Pennsylvania, United States
Spine Midwest, Inc.
🇺🇸Jefferson City, Missouri, United States
Neurospine Solutions, PC
🇺🇸Bristol, Tennessee, United States
Carolina Neurosurgery & Spine Center
🇺🇸Greenwood, South Carolina, United States
Moses Cone Hospital
🇺🇸Greensboro, North Carolina, United States
Caldwell Memorial Hospital
🇺🇸Lenoir, North Carolina, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Watsonville Community Hospital
🇺🇸Watsonville, California, United States
Resurgens Orthopaedics
🇺🇸Cumming, Georgia, United States
Spine Works Institute
🇺🇸North Richland Hills, Texas, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
Easton Hospital
🇺🇸Easton, Pennsylvania, United States