463
Participants
Start Date
March 31, 2002
Primary Completion Date
May 31, 2005
Study Completion Date
February 28, 2010
rhBMP-2/CRM/CD HORIZON® Spinal System
"The rhBMP-2/CRM component of the investigational device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and a compression resistant matrix (CRM) carrier consisting of an absorbable collagen sponge imbedded with biphasic calcium phosphate.~The posterior spinal fixation system, the CD HORIZON® Spinal System, is a commercially available rod-based spinal system intended for temporary stabilization of the spine in order to facilitate fusion. The CD HORIZON® Spinal System is available in either titanium or stainless steel. For this study, only titanium implant components will be used."
Autograft/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. When used as a posterior spine thoracic/lumbar system, the CD HORIZON® CANNULATED M8 MULTI-AXIAL SCREW components are intended for several indications including degenerative disc disease.
Beth Israel Medical Center, New York
Orthopedic Spine Care of Long Island, PC, Melville
The Reading Neck & Spine Center, Wyomissing
Georgetown University Dept. of Orthopaedic Spine Surgery, Washington D.C.
Alvin & Lois Lapidus Cancer Insitute, Baltimore
UVA Dept. of Neurosurgery, Charlottesville
Duke University Hospital, Durham
The Hughston Clinic P.C., Columbus
Florida Neurological Consultants, Winter Park
Brevard Orthopaedic Clinic, Inc., Melbourne
Florida Ortho Institute, Tampa
East Tennessee Brain & Spine, Johnson City
Spine Institute, Louisville
The Spine Institute, Carmel
Jeffrey S. Fischgrund, Southfield
Des Moines Orthopaedic Surgeons, West Des Moines
University of Iowa Hospitals & Clinics, Iowa City
Lutheran Spine Center, Park Ridge
Barrington Orthopedic Specialists, Hoffman Estates
Central States Orthopedic Specialists, Tulsa
Brain and Spine Center of Texas, Plano
Azalea Orthopedic & Sports Medicine Clinic, Tyler
Fort Worth Brain & Spine, Fort Worth
University of Utah, Salt Lake City
Barrow Neurosurgical Associates, Phoenix
UCLA Orthopedic Hospital, Santa Monica
Orthopaedic Specialty Institute, Orange
Medford Neurological & Spine Clinic, Medford
Medtronic Spinal and Biologics
INDUSTRY