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

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ClinicalTrials.gov Identifier: NCT00534235
Recruitment Status : Completed
First Posted : September 24, 2007
Last Update Posted : February 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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
Spinal Stenosis Procedure: Decompression Device: Posterolateral Fusion and Implantation of Pedicle Screws Device: Implantation of coflex Interlaminar Technology

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 396 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
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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;

  4. Epidural injections [ Time Frame: 5 years ]
    Assessment of lumbar epidural injections


Secondary Outcome Measures :
  1. 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.

  2. Quality of Life [ Time Frame: 5 years ]
    Assessment of the patient's Quality of Life as measured by SF-12

  3. 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

  4. 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

  5. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Accepts Healthy Volunteers:   No
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paradigm Spine
ClinicalTrials.gov Identifier: NCT00534235     History of Changes
Other Study ID Numbers: PS-001
First Posted: September 24, 2007    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases