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:
- Evidence of bridging trabeculae.
- 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.
- 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