Spine Fusion Instrumented With BMP-2 vs Uninstrumented With Infuse BMP-2 Alone
The goal of spinal fusion is to relieve pain and/or increase stability in painful or unstable spine joints. A patient may or may not receive rods and screws with the use of bone graft materials to facilitate bone growth and a fusion thus preventing movement of the bones of the spine.
In this research study, bone graft substitute material called Bone Morphogenetic Protein-2 known as BMP-2 Infuse will be used. No hip bone will be used. The surgical procedure will consist of BMP-2 Infuse with or without the use of rods and screws.
|Degenerative Lumbar Disc Disease Spondylolisthesis Spinal Stenosis||Procedure: Device used in surgery with or without instrumentation|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Clinical Investigation of Posterolateral Lumbosacral Spinal Fusions With BMP-2 and Titanium Pedicle Screw Instrumentation Versus BMP-2 Alone.|
- To evaluate bone fusion; [ Time Frame: 3mon., 6mon., 12mon., 24mon ]
- Radiology tests; CT spine 24mon. [ Time Frame: 3mon., 6mon., 12mon., 24mon ]
- Clinical neurological evaluations; patient questionnaires [ Time Frame: 3mon., 6mon., 12mon., 24mon ]
- Hospital and surgical data [ Time Frame: hospitalization; ]
- Adverse events [ Time Frame: hospitalization, clinic visits, unscheduled visits ]
|Study Start Date:||November 2006|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Device
Device used in surgery with or without instrumentation
Procedure: Device used in surgery with or without instrumentation
Infuse Bone Graft BMP-2, Large Kit will be used in all surgeries. Spine surgeries will be either instrumented or uninstrumented.
In this study we will be using BMP-2 Infuse instead of the iliac crest bone graft for the spinal fusion. The BMP-2 Infuse has been researched in the only completed clinical trial for spinal fusions. It has demonstrated equivalence to the iliac crest bone graft with regard to both fusion rate and clinical outcome.
Currently, the acceptable standard of care for spinal fusion surgery requires instrumented or non-instrumented procedure with the use of bone graft materials, to facilitate bone growth, and a fusion, thus eliminating movement between the inciting vertebrae.
In this study, the surgical procedure will be BMP-2 Infuse with instrumentation or BMP-2 Infuse alone.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00405600
|Canada, Nova Scotia|
|Capital Health Health Authority, QEII Health Sciences Centre, Halifax Infirmary site,|
|Halifax, Nova Scotia, Canada, B3H-3A7|
|Principal Investigator:||Dr. David Alexander, M.D.||Capital Health District Authority, Centre for Clinical Research, Queen Elizabeth II, Health Sciences Centre, 1278 Tower Rd.,Halifax, Nova Scotia, B3H-9Z9, Canada|