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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Infuse Bone Graft BMP-2, Large Kit will be used in all surgeries. Spine surgeries will be either instrumented or uninstrumented.
Capital Health Health Authority, QEII Health Sciences Centre, Halifax Infirmary site,
Halifax, Nova Scotia, Canada
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.