Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis
This study has been completed.
Musculoskeletal Clinical Regulatory Advisers
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First received: September 20, 2007
Last updated: February 2, 2017
Last verified: February 2017
Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis
Device: Posterolateral Fusion and Implantation of Pedicle Screws
Device: Implantation of coflex Interlaminar Technology
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Post-Approval Study to Investigate The Long Term (5-Year) Survivorship of Coflex Compared to Control Fusion Study Patients|
Resource links provided by NLM:
Further study details as provided by Paradigm Spine:
Primary Outcome Measures:
- Improvement of ODI [ Time Frame: 5 years ]The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI) in both treatment groups at 5 years. It will be assessed if the improvement in ODI since the pre surgery status in the coflex™ group is better than the improvement in the control group.
- No reoperations, revisions, removals, or supplemental fixation [ Time Frame: 5 years ]Assessment of reoperations, revisions, removals, or supplemental fixation associated with either coflex or control group
- No major device related complications [ Time Frame: 5 years ]Assessment of major device-related complications, including but not limited to permanent new or increasing sensory or motor deficit at 5 years;
- Epidural injections [ Time Frame: 5 years ]Assessment of lumbar epidural injections
Secondary Outcome Measures:
- Zurich Claudication Questionnaire (ZCQ) [ Time Frame: 5 years ]ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
- Quality of Life [ Time Frame: 5 years ]Assessment of the patient's Quality of Life as measured by SF-12
- VAS Leg Pain [ Time Frame: 5 years ]Improvement of the Visual Analog Scale (VAS) for leg pain(on the 100 mm scale) compared to control group
- VAS Back Pain [ Time Frame: 5 years ]Improvement of the Visual Analog Scale (VAS) for low back pain(on the 100 mm scale) compared to control group
- Radiographic Assessment [ Time Frame: 5 years ]Radiographic Assessment of coflex and control group including range of motion, radiolucency, deveice displacement, spinous process fractures, heterotopic ossification
|Study Start Date:||October 2012|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Posterolateral Fusion w/Pedicle Screws
Control: Posterolateral fusion and implantation of pedicle screws after decompression
Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient painDevice: Posterolateral Fusion and Implantation of Pedicle Screws
Active Comparator: coflex Interlaminar Technolgy
Investigative: Implantation of coflex Interlaminar Technology after decompression
Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient painDevice: Implantation of coflex Interlaminar Technology
The primary objective of this post-approval study is to examine the long-term survivorship of the coflex®. The coflex® Interlaminar Technology is an interlaminar stabilization device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).
Contacts and Locations
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