Clinical Trial: A Pivotal Study of rhBMP-2/ACS/INTER FIX™ Device for Posterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the INTER FIX™ Device for Posterior Lumbar Interbody Fusion in Patients With

Brief Summary: The purpose of this clinical trial is to assess the safety and effectiveness of the rhBMP-2/ACS/INTER FIX™ device as compared to the autograft/INTER FIX™ device in patients with symptomatic degenerative disease.

Detailed Summary:
Sponsor: Medtronic Spinal and Biologics

Current Primary Outcome:

  • Fusion [ Time Frame: 24 month ]

    Fusion is defined as:

    1. Evidence of bridging trabeculae.
    2. No evidence of motion as defined by: a. No more than 3mm difference in translation on the lateral flexion/extension radiographs as determined by superimposing the two views, one upon the other. b. Less than 5° difference in angular motion between flexion and extension as seen on lateral flexion/extension radiographs.
    3. No evidence of radiolucency surrounding greater than 50% of either device.
  • Pain/Disability Status [ Time Frame: 24 month ]
    The self-administered Oswestry Low Back Pain Disability Questionnaire will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score >= 15
  • Neurological Status [ Time Frame: 24 month ]
    Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hip (Donor Site) Pain [ Time Frame: 24 month ]
  • Disc Height Measurement [ Time Frame: 24 month ]
  • General Health Status (SF-36) [ Time Frame: 24 month ]
  • Pain Status (back pain, leg pain) [ Time Frame: 24 month ]
  • Patient Satisfaction [ Time Frame: 24 month ]
  • Patient Global Perceived Effect [ Time Frame: 24 month ]


Original Secondary Outcome: Same as current

Information By: Medtronic Spinal and Biologics

Dates:
Date Received: December 12, 2011
Date Started: March 1999
Date Completion:
Last Updated: August 1, 2013
Last Verified: December 2011