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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Musculoskeletal Clinical Regulatory Advisers (MCRA)
Information provided by (Responsible Party):
Paradigm Spine
ClinicalTrials.gov Identifier:
NCT00534235
First received: September 20, 2007
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Spinal Stenosis
Procedure: Decompression
Device: Posterolateral Fusion and Implantation of Pedicle Screws
Device: Implantation of coflex Interlaminar Technology
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Post-Approval Study to Investigate The Long Term (5-Year) Survivorship of Coflex Compared to Control Fusion Study Patients

Resource links provided by NLM:


Further study details as provided by Paradigm Spine:

Primary Outcome Measures:
  • Improvement of ODI [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.

  • No reoperations, revisions, removals, or supplemental fixation [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Assessment of reoperations, revisions, removals, or supplemental fixation associated with either coflex or control group

  • No major device related complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Assessment of major device-related complications, including but not limited to permanent new or increasing sensory or motor deficit at 5 years;

  • Epidural injections [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Assessment of lumbar epidural injections


Secondary Outcome Measures:
  • Zurich Claudication Questionnaire (ZCQ) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.

  • Quality of Life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Assessment of the patient's Quality of Life as measured by SF-12

  • VAS Leg Pain [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Improvement of the Visual Analog Scale (VAS) for leg pain(on the 100 mm scale) compared to control group

  • VAS Back Pain [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Improvement of the Visual Analog Scale (VAS) for low back pain(on the 100 mm scale) compared to control group

  • Radiographic Assessment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Radiographic Assessment of coflex and control group including range of motion, radiolucency, deveice displacement, spinous process fractures, heterotopic ossification


Enrollment: 384
Study Start Date: October 2012
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Accepts Healthy Volunteers:   No
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided by Paradigm Spine

Additional 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
Study First Received: September 20, 2007
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014