Clinical Trial: A Pilot Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic 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 Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic
Brief Summary: The purpose of this pilot clinical trial is to evaluate the device design as a method of facilitating spinal fusion.
Detailed Summary:
Sponsor: Medtronic Spinal and Biologics
Current Primary Outcome:
- Severity and Rate of Implant-Associated Adverse Events [ Time Frame: 24 month ]
- Rate of Implant Revision, Removal and Supplemental Fixation Procedures [ Time Frame: 24 month ]
- Incidence of Permanent Adverse Events [ Time Frame: 24 month ]
- Fusion [ Time Frame: 24 month ]
Fusion is defined as:
- Bone observed connecting with the vertebral bodies above and below either through the implants; lateral to or between the implants; or anterior/posterior to the implants.
- Angulation < 5°.
- Translation < 3mm.
- Absence of radiolucent lines around more than 50% of either implant.
- Disc Height Measurement [ Time Frame: 24 month ]Disc height will be measured postoperative and compared to the preoperative measurement. Maintenance or improvement in disc height will be determined a success.
- Pain/Disability Status [ Time Frame: 24 month ]The self-administered Oswestry Low Back Pain Disability Questionnaire will be used. Success 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 stat
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Nature and Frequency of Adverse Events Not Associated with the Implants [ Time Frame: 24 month ]
- Rate of Reoperation Procedures [ Time Frame: 24 month ]
- Hip (Donor Site) Pain Status [ Time Frame: 24 month ]
- Patient Satisfaction/Quality of Life Status (SF-36) [ Time Frame: 24 month ]
- Pain Status (Numerical Rating Scale) [ Time Frame: 24 month ]
- Overall Success [ Time Frame: 24 months ]
A patient will be considered an overall success if all of the following conditions are met:
- fusion
- disc height maintenance or improvement
- pain/disability (Oswestry) improvement
- maintenance or improvement in neurological status
- no permanent adverse event
- no additional surgical procedure classified as a "failure."
Original Secondary Outcome: Same as current
Information By: Medtronic Spinal and Biologics
Dates:
Date Received: December 12, 2011
Date Started: April 1998
Date Completion:
Last Updated: August 1, 2013
Last Verified: December 2011