NCT00405600

Spine Fusion Instrumented With BMP-2 vs Uninstrumented With Infuse BMP-2 Alone

A Prospective Randomized Clinical Investigation of Posterolateral Lumbosacral Spinal Fusions With BMP-2 and Titanium Pedicle Screw Instrumentation Versus BMP-2 Alone.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Nova Scotia Health Authority · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Degenerative Lumbar Disc Disease
• Spondylolisthesis
• Spinal Stenosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-11-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2006-11-30
• Last updated: 2013-02-15

Locations

1 site across 1 country: Canada