A Prospective Randomized Clinical Investigation of Posterolateral Lumbosacral Spinal Fusions With BMP-2 and Titanium Pedicle Screw Instrumentation Versus BMP-2 Alone.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Lumbar Disc Disease
- Sponsor
- Nova Scotia Health Authority
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- To evaluate bone fusion;
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
David Alexander
Principal Investigator
Nova Scotia Health Authority
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Patient has a systemic infection.
- •Patient has had more than one previous non-fusion spinal surgery at the involved level.
- •Patient requires fusion at more than 2 levels.
- •Patient has pseudoarthroses from a previous fusion attempt.
- •Patient has highly communicable diseases, inflammatory or autoimmune disease (e.g.osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis). A note to file written by the investigator will permit a patient into the study who experiences a mild case which will not affect the outcome of the study.
- •Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
- •Patient has a significant medical history that, in the Investigator's opinion would not make them a good study candidate.
- •Patient requires interbody cage fusion or non-pedicle screw instrumentation.
- •Pregnancy.
- •Has presence of active malignancy (except basal cell carcinoma of the skin)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Hospital and surgical data(hospitalization;)
- Adverse events(hospitalization, clinic visits, unscheduled visits)