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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00534235
Recruitment Status : Completed
First Posted : September 24, 2007
Results First Posted : February 27, 2019
Last Update Posted : February 6, 2020
Sponsor:
Collaborator:
Musculoskeletal Clinical Regulatory Advisers
Information provided by (Responsible Party):
Paradigm Spine

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

Condition or disease Intervention/treatment Phase
Spinal Stenosis Procedure: Decompression Device: Posterolateral Fusion and Implantation of Pedicle Screws Device: Implantation of coflex Interlaminar Technology Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Post-Approval Study to Investigate The Long Term (5-Year) Survivorship of Coflex Compared to Control Fusion Study Patients
Study Start Date : October 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Active Comparator: Posterolateral Fusion w/Pedicle Screws
Control: Posterolateral fusion and implantation of pedicle screws after decompression
Procedure: Decompression
Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain

Device: Posterolateral Fusion and Implantation of Pedicle Screws
Active Comparator: coflex Interlaminar Technolgy
Investigative: Implantation of coflex Interlaminar Technology after decompression
Procedure: Decompression
Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain

Device: Implantation of coflex Interlaminar Technology



Primary Outcome Measures :
  1. Number of Subjects With Improvement of at Least 15 Points in 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 (scale 0-100 with a higher score representing increased disability).

  2. Number of Subjects With no Reoperations, Revisions, Removals, or Supplemental Fixation [ Time Frame: 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).

  3. Number of Subjects With no Major Device Related Complications [ Time Frame: 5 years ]
    Assessment of major device-related complications at 5 years

  4. Number of Subjects With no Epidural Injection(s) [ Time Frame: 5 years ]
    Assessment of lumbar epidural injections

  5. Number of Subjects With no Persistent New or Increasing Sensory or Motor Deficit [ Time Frame: 5 years ]
    No persistent new or increasing sensory or motor deficit

  6. Number of Subjects With no Persistent New or Increasing Sensory Deficit [ Time Frame: 5 years ]
    No persistent new or increasing sensory deficit

  7. Number of Subjects With no Persistent New or Increasing Motor Deficit [ Time Frame: 5 years ]
    No persistent new or increasing motor deficit

  8. Number of Subjects With no Reoperations or Epidural (Up to Day 1825) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Number of Subjects With a Decrease in Zurich Claudication Questionnaire (ZCQ) Symptom Severity of at Least 0.5 Points [ Time Frame: 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.

  2. Number of Subjects With Decrease in Zurich Claudication Questionnaire (ZCQ) Physical Function of at Least 0.5 Points [ Time Frame: 5 years ]
    ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.

  3. Number of Subjects With Maintenance or Improvement in SF-12 Physical Function Component [ Time Frame: 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.

  4. Number of Subjects With Maintenance or Improvement in SF-12 Mental Health Component [ Time Frame: 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.

  5. Number of Subjects With a Decrease in VAS Back Pain of at Least 20mm [ Time Frame: 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.

  6. Number of Subjects With Decrease VAS Worse Leg Pain of at Least 20mm [ Time Frame: 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.

  7. Mean Oswestry Disability Index (ODI) Score [ Time Frame: 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.

  8. Mean Visual Analog Scale Back Pain Score [ Time Frame: 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.

  9. Mean Visual Analog Scale Leg (Worse) Pain Score [ Time Frame: 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.

  10. Mean Visual Analog Scale (VAS) Leg (Right) Pain Score [ Time Frame: 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.

  11. Mean Visual Analog Scale (VAS) Leg (Left) Pain Score [ Time Frame: 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.

  12. Number of Subjects With a Decrease in VAS Right Leg Pain of at Least 20mm [ Time Frame: 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.

  13. Number of Subjects With a Decrease in VAS Left Leg Pain of at Least 20mm [ Time Frame: 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.

  14. Mean Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score [ Time Frame: 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.

  15. Mean Zurich Claudication Questionnaire (ZCQ) Physical Function Score [ Time Frame: 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.

  16. Mean Short Form-12 Physical Component Score [ Time Frame: 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.

  17. Mean Short Form-12 Mental Component Score [ Time Frame: 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.

  18. Patient Survey: Satisfaction [ Time Frame: 5 years ]
    Subjects who responded "Very Satisfied" or "Somewhat Satisfied".

  19. Patient Survey: Recommendation of Treatment [ Time Frame: 5 years ]
    Subjects who responded "Definitely Yes" or "Probably Yes"

  20. Pain Management: Class II Narcotics Usage by Device Group [ Time Frame: 5 years ]
    Number of subjects using Class II narcotics

  21. Pain Management: NSAIDs/ASA/Acetaminophen Usage by Device Group [ Time Frame: 5 years ]
    Number of subjects using NSAIDs/ASA/Acetaminophen


Other Outcome Measures:
  1. Mean Rotation (F to E) in Degrees - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the index level(s) in both treatment groups at 5 years.

  2. Rotation (F to E) in Degrees - Below Level of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the level below the implant in both treatment groups at 5 years.

  3. Rotation (F to E) in Degrees - Above Level of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the average measure of rotation (flexion to extension) at the level above the implant in both treatment groups at 5 years.

  4. Translation (mm) - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the average measure of translation at the index level(s) in both treatment groups at 5 years.

  5. Translation (mm) - Below Level of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the average measure of translation at the level below the implant in both treatment groups at 5 years.

  6. Translation (mm) - Above Level of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the average measure of translation at the level above the implant in both treatment groups at 5 years.

  7. Anterior Disc Height (mm) - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the average measure of anterior disc height at the index level(s) in both treatment groups at 5 years.

  8. Posterior Disc Height (mm) - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the average measure of posterior disc height at the index level(s) in both treatment groups at 5 years.

  9. Translation (F to E) in Percent (%) - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the percentage of translation at the index level(s) in both treatment groups at 5 years.

  10. Translation (F to E) in Percent (%) - Below Level of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the percentage of translation at the level below the implant in both treatment groups at 5 years.

  11. Translation (F to E) in Percent (%) - Above Level of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the percentage of translation at the level above the implant in both treatment groups at 5 years.

  12. Average Disc Height (mm) - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the average measure of disc height at the index level(s) in both treatment groups at 5 years.

  13. Change From Pre-Op Anterior Disc Height (mm) - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the average change from baseline for anterior disc height at the index level(s) in both treatment groups at 5 years.

  14. Change From Pre-Op Posterior Disc Height (mm) - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the average change from baseline for posterior disc height at the index level(s) in both treatment groups at 5 years.

  15. Change From Pre-Op Average Disc Height (mm) - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the average change from baseline for disc height at the index level(s) in both treatment groups at 5 years.

  16. Change From Post-Op Anterior Disc Height (mm) - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the average change from immediate post-op for anterior disc height at the index level(s) in both treatment groups at 5 years.

  17. Change From Post-Op Posterior Disc Height (mm) - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the average change from immediate post-op for posterior disc height at the index level(s) in both treatment groups at 5 years.

  18. Change From Post-Op Average Disc Height (mm) - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the average change from immediate post-op for disc height at the index level(s) in both treatment groups at 5 years.

  19. Disc Angle in Degrees - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the mean disc angle at the index level(s) in both treatment groups at 5 years.

  20. Change From Pre-Op Disc Angle in Degrees - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the mean change in disc angle from baseline at the index level(s) in both treatment groups at 5 years.

  21. Change From Post-Op Disc Angle in Degrees - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the mean change in disc angle from immediate post-op at the index level(s) in both treatment groups at 5 years.

  22. Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the measure of spondylolisthesis at the index level(s) in both treatment groups at 5 years.

  23. Change From Post-Op Spondylolisthesis (%) - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the measure of the percentage of spondylolisthesis at the index level(s) in both treatment groups at 5 years.

  24. Change From Pre-Op Spondylolisthesis (mm) - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the mean change in measure of spondylolisthesis at the index level(s) in both treatment groups at 5 years.

  25. Change From Post-Op Spondylolisthesis (mm) - At Level(s) of Implant [ Time Frame: 5 years ]
    As determined by independent radiographic lab, this is the mean change in measure of spondylolisthesis from immediate post-op at the index level(s) in both treatment groups at 5 years.

  26. Foraminal Height (X-ray) (mm) - At Level(s) of Implant [ Time Frame: 5 years ]
    This is the mean foraminal height via x-ray at the index level(s) in both treatment groups at 5 years.

  27. Change From Pre-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant [ Time Frame: 5 years ]
    This is the mean change in foraminal height via x-ray from baseline at the index level(s) in both treatment groups at 5 years.

  28. Change From Post-Op Foraminal Height (X-ray) (mm) - At Level(s) of Implant [ Time Frame: 5 years ]
    This is the mean change in foraminal height via x-ray from immediate post-op at the index level(s) in both treatment groups at 5 years.

  29. Bony Bridging [ Time Frame: 5 years ]
    Bridging through the posterolateral gutters, between the facet joints, between transverse processes, and/or between facet joint and transverse process will all be considered acceptable forms of bridging bone.

  30. Heterotopic Ossification [ Time Frame: 5 years ]
    Assessment applicable to coflex arm only. The assessment applies to bony formations that occur in and around the implant.

  31. Fusion Status [ Time Frame: 5 years ]
    The assessment is an analysis of three component factors: Bridging Bone, Angular Motion and Translational Motion.

  32. Interface Remodeling - At Level(s) of Implant [ Time Frame: 5 years ]
    Per level; Assessment applicable to coflex arm only. This is an assessment of the bone-implant interface.

  33. Device Condition (Coflex Arm) [ Time Frame: 5 years ]
    Per level; Assessment only applicable to coflex group. Device Condition in the investigational subjects was graded as: Intact, Deformed, Fractured, Migrated, or Dislodged.

  34. Device Condition (Fusion Control) [ Time Frame: 5 years ]
    Per level; This assessment is applicable to the fusion arm only. Device Condition in the control subjects will be graded as: Intact, Loose Screws, or Failed Hardware.

  35. Device Mobility [ Time Frame: 5 years ]
    Per level; Assessment is applicable to coflex arm only. Device Mobility is an expected occurrence in some subjects and represents the amount of the of lift-off of the implant from the inferior spinous process.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paradigm Spine
ClinicalTrials.gov Identifier: NCT00534235    
Other Study ID Numbers: PS-001
First Posted: September 24, 2007    Key Record Dates
Results First Posted: February 27, 2019
Last Update Posted: February 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases