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Sponsored by: |
Capital District Health Authority, Canada |
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Information provided by: | Capital District Health Authority, Canada |
ClinicalTrials.gov Identifier: | NCT00405600 |
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 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.
Condition | Intervention |
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Degenerative Lumbar Disc Disease Spondylolisthesis Spinal Stenosis |
Device: Infuse Bone Graft BMP-2, Large Kit |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective Randomized Clinical Investigation of Posterolateral Lumbosacral Spinal Fusions With BMP-2 and Titanium Pedicle Screw Instrumentation Versus BMP-2 Alone. |
Estimated Enrollment: | 50 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
Contact: Donna Shakespeare, R.N. | 902 473-6648 | donna.shakespeare@cdha.nshealth.ca |
Contact: Dr. David Alexander, M.D. | 902 473-4092 | david.alexander@cdha.nahealth |
Canada, Nova Scotia | |
Capital Health Health Authority, QEII Health Sciences Centre, Halifax Infirmary site, | Recruiting |
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 |
Responsible Party: | Principal Investigator ( DR. David Alexander M.D. ) |
Study ID Numbers: | CDHA016 |
Study First Received: | November 28, 2006 |
Last Updated: | May 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00405600 |
Health Authority: | Canada: Canadian Institutes of Health Research; Canada: Ethics Review Committee; Canada: Health Canada |
Lumbar degenerative disease spinal stenosis spondylolisthesis |
non instrumented surgery instrumented surgery BMP-2 |
Spinal Diseases Musculoskeletal Diseases Constriction, Pathologic |
Spondylolisthesis Bone Diseases Spinal Stenosis |