Clinical Trial: A Pivotal Study of rhBMP-2/ACS/LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Symptomati
Brief Summary: This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE® Device using laparoscopic surgical technique as compared to an historical control group treated with Autogenous Bone/LT-CAGE® Device using an open surgical technique in patients with symptomatic degenerative disc disease.
Detailed Summary:
Sponsor: Medtronic Spinal and Biologics
Current Primary Outcome: Overall Success [ Time Frame: 24 month ]
A patient will be considered an overall success if all of the following conditions are met:
- fusion;
- pain/disability (Oswestry) improvement;
- maintenance or improvement in neurological status;
- no serious adverse event classified as implant associated or implant/surgical procedure associated;
- no additional surgical procedure classified as a "failure."
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Disc Height Measurement [ Time Frame: 24 month ]
- General Health Status (SF-36) [ Time Frame: 24 month ]
- Pain Status (Numerical Rating Scale) [ 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: November 1998
Date Completion:
Last Updated: August 1, 2013
Last Verified: December 2011