Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
322
Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain
Number of Subjects With Improvement of at Least 15 Points in ODI
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).
Time frame: 5 years
Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation
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).
Time frame: 5 years
Number of Subjects With no Major Device Related Complications
Assessment of major device-related complications at 5 years
Time frame: 5 years
Number of Subjects With no Epidural Injection(s)
Assessment of lumbar epidural injections
Time frame: 5 years
Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit
No persistent new or increasing sensory or motor deficit
Time frame: 5 years
Number of Subjects With no Persistent New or Increasing Sensory Deficit
No persistent new or increasing sensory deficit
Time frame: 5 years
Number of Subjects With no Persistent New or Increasing Motor Deficit
No persistent new or increasing motor deficit
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Time frame: 5 years
Number of Subjects With no Reoperations or Epidural (Up to Day 1825)
No reoperations, revisions, removals or supplemental fixation and no epidural injection at any lumbar level up to and including the Month 60 visit.
Time frame: 5 years
Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points
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.
Time frame: 5 years
Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points
ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
Time frame: 5 years
Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component
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.
Time frame: 5 years
Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component
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.
Time frame: 5 years
Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm
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.
Time frame: 5 years
Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm
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.
Time frame: 5 years
Mean Oswestry Disability Index (ODI) Score
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.
Time frame: 5 years
Mean Visual Analog Scale Back Pain Score
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.
Time frame: 5 years
Mean Visual Analog Scale Leg (Worse) Pain Score
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.
Time frame: 5 years
Mean Visual Analog Scale (VAS) Leg (Right) Pain Score
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.
Time frame: 5 years
Mean Visual Analog Scale (VAS) Leg (Left) Pain Score
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.
Time frame: 5 years
Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm
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.
Time frame: 5 years
Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm
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.
Time frame: 5 years
Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score
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.
Time frame: 5 years
Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score
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.
Time frame: 5 years
Mean Short Form-12 Physical Component Score
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.
Time frame: 5 years
Mean Short Form-12 Mental Component Score
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.
Time frame: 5 years
Patient Survey: Satisfaction
Subjects who responded "Very Satisfied" or "Somewhat Satisfied".
Time frame: 5 years
Patient Survey: Recommendation of Treatment
Subjects who responded "Definitely Yes" or "Probably Yes"
Time frame: 5 years
Pain Management: Class II Narcotics Usage by Device Group
Number of subjects using Class II narcotics
Time frame: 5 years
Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group
Number of subjects using NSAIDs/ASA/Acetaminophen
Time frame: 5 years