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
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, see Learn About Clinical Studies.

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 August 27, 2014