Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis

Study Overview
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Brief Summary
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Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis

Detailed Description
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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).

Official Title
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Post-Approval Study to Investigate The Long Term (5-Year) Survivorship of Coflex Compared to Control Fusion Study Patients

Conditions
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Spinal Stenosis

Intervention / Treatment
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* Procedure: Decompression
* Device: Posterolateral Fusion and Implantation of Pedicle Screws
* Device: Implantation of coflex Interlaminar Technology


Participation Criteria
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Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Posterolateral Fusion w/Pedicle Screws<br>Control: Posterolateral fusion and implantation of pedicle screws after decompression | Procedure: Decompression<br>* Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain<br>Device: Posterolateral Fusion and Implantation of Pedicle Screws<br> <br> |
| Active Comparator: coflex Interlaminar Technolgy<br>Investigative: Implantation of coflex Interlaminar Technology after decompression | Procedure: Decompression<br>* Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain<br>Device: Implantation of coflex Interlaminar Technology<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 5 years | 
| Number of Subjects With no Major Device Related Complications | Assessment of major device-related complications at 5 years | 5 years | 
| Number of Subjects With no Epidural Injection(s) | Assessment of lumbar epidural injections | 5 years | 
| Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit | No persistent new or increasing sensory or motor deficit | 5 years | 
| Number of Subjects With no Persistent New or Increasing Sensory Deficit | No persistent new or increasing sensory deficit | 5 years | 
| Number of Subjects With no Persistent New or Increasing Motor Deficit | No persistent new or increasing motor deficit | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 5 years | 
| Patient Survey: Satisfaction | Subjects who responded Very Satisfied or Somewhat Satisfied. | 5 years | 
| Patient Survey: Recommendation of Treatment | Subjects who responded Definitely Yes or Probably Yes | 5 years | 
| Pain Management: Class II Narcotics Usage by Device Group | Number of subjects using Class II narcotics | 5 years | 
| Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group | Number of subjects using NSAIDs/ASA/Acetaminophen | 5 years |