Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis
- Conditions
- Spinal Stenosis
- Interventions
- Procedure: DecompressionDevice: Posterolateral Fusion and Implantation of Pedicle ScrewsDevice: Implantation of coflex Interlaminar Technology
- Registration Number
- NCT00534235
- Lead Sponsor
- Paradigm Spine
- Brief Summary
Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 322
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Posterolateral Fusion w/Pedicle Screws Posterolateral Fusion and Implantation of Pedicle Screws Control: Posterolateral fusion and implantation of pedicle screws after decompression Posterolateral Fusion w/Pedicle Screws Decompression Control: Posterolateral fusion and implantation of pedicle screws after decompression coflex Interlaminar Technolgy Decompression Investigative: Implantation of coflex Interlaminar Technology after decompression coflex Interlaminar Technolgy Implantation of coflex Interlaminar Technology Investigative: Implantation of coflex Interlaminar Technology after decompression
- Primary Outcome Measures
Name Time Method Number of Subjects With Improvement of at Least 15 Points in ODI 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 (scale 0-100 with a higher score representing increased disability).
Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation 5 years Assessment of secondary surgical interventions, i.e., reoperations, revisions, removals, or supplemental fixation associated with either coflex or control group. Refer to FDA guidance for complete definitions (https://www.fda.gov/RegulatoryInformation/Guidances/ucm072263.htm).
Number of Subjects With no Persistent New or Increasing Sensory Deficit 5 years No persistent new or increasing sensory deficit
Number of Subjects With no Major Device Related Complications 5 years Assessment of major device-related complications at 5 years
Number of Subjects With no Epidural Injection(s) 5 years Assessment of lumbar epidural injections
Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit 5 years No persistent new or increasing sensory or motor deficit
Number of Subjects With no Reoperations or Epidural (Up to Day 1825) 5 years No reoperations, revisions, removals or supplemental fixation and no epidural injection at any lumbar level up to and including the Month 60 visit.
Number of Subjects With no Persistent New or Increasing Motor Deficit 5 years No persistent new or increasing motor deficit
- Secondary Outcome Measures
Name Time Method Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points 5 years ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.
Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points 5 years ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component 5 years Assessment of the patient's Quality of Life as measured by SF-12. Scores range from 0 to 100, where a zero score indicates the lowest level of health. Success was defined as subjects who maintained or improved from their SF-12 score at baseline.
Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component 5 years Assessment of the patient's Quality of Life as measured by SF-12. Scores range from 0 to 100, where a zero score indicates the lowest level of health. Success was defined as subjects who maintained or improved from their SF-12 score at baseline.
Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm 5 years Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.
Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm 5 years Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.
Mean Oswestry Disability Index (ODI) Score 5 years Assessment of disability from low back pain as measured by ODI (Oswestry Disability Index) mean score in each treatment group at 5 years. On a scale of 0-100, a higher score represents increased disability.
Mean Visual Analog Scale Back Pain Score 5 years Assessment of Back Pain as measured by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.
Mean Visual Analog Scale Leg (Worse) Pain Score 5 years Assessment of Worse Leg Pain by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.
Mean Visual Analog Scale (VAS) Leg (Right) Pain Score 5 years Assessment of Right Leg Pain by VAS mean score in each treatment group at 5 years. On a scale of 0-100mm, a higher score represents worse pain.
Mean Visual Analog Scale (VAS) Leg (Left) Pain Score 5 years Assessment of Left Leg Pain by VAS mean score in both treatment groups at 5 years. On a scale of 0-100mm, a higher score represents worse pain.
Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score 5 years Assessment of symptom severity by ZCQ mean score in both treatment groups at 5 years. ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.
Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm 5 years Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.
Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm 5 years Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group. On a scale of 0 to 100, 0 indicates no pain and 100 indicates worst pain imaginable.
Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score 5 years Assessment of physical function by ZCQ mean score in both groups at 5 years. ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. Scores range from 1-5 with a higher score indicating worsening disability.
Mean Short Form-12 Physical Component Score 5 years Assessment of the patient's Quality of Life as measured by SF-12 mean score in both treatment groups at 5 years. Scores range from 0 to 100, where a zero score indicates the lowest level of health.
Mean Short Form-12 Mental Component Score 5 years Assessment of the patient's Quality of Life as measured by SF-12 mean score in both treatment groups at 5 years. Scores range from 0 to 100, where a zero score indicates the lowest level of health.
Patient Survey: Satisfaction 5 years Subjects who responded "Very Satisfied" or "Somewhat Satisfied".
Patient Survey: Recommendation of Treatment 5 years Subjects who responded "Definitely Yes" or "Probably Yes"
Pain Management: Class II Narcotics Usage by Device Group 5 years Number of subjects using Class II narcotics
Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group 5 years Number of subjects using NSAIDs/ASA/Acetaminophen