46
Participants
Start Date
April 30, 2003
Primary Completion Date
November 30, 2006
Study Completion Date
March 31, 2007
INFUSE® Bone Graft/MASTERGRAFT® Granules/CD HORIZON®
The INFUSE® Bone Graft component of the investigational device consists of recombinant human Bone Morphogenetic Protein-2(rhBMP-2) and an absorbable collagen sponge (ACS)carrier. The MASTERGRAFT® Granules will be used as a type of bulking agent to provide compression resistance.
Autogenous Bone / CD HORIZON® Spinal System
The control will be autogenous bone taken from the iliac crest of the patient and placed bilaterally across two adjacent transverse processes and used in conjunction with the CD HORIZON® Spinal System.
Medtronic Spinal and Biologics
INDUSTRY