Spinal Stenosis Clinical Trial
Official title:
A Prospective Randomized Clinical Investigation of Posterolateral Lumbosacral Spinal Fusions With BMP-2 and Titanium Pedicle Screw Instrumentation Versus 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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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