A Prospective, Randomized Clinical Investigation of rhBMP-2 and Compression Resistant Matrix With the CD HORIZON® Spinal System for Posterolateral Lumbar Fusion in Patients With Symptomatic Degenerative Disc Disease
This clinical trial was conducted to evaluate the rhBMP-2/CRM/CD HORIZON® Spinal System for
posterolateral fusion treatment of patients with symptomatic degenerative disc disease
versus the control group of autogeneous bone with the CD HORIZON® Spinal System.
The investigational treatment was the open bilateral posterolateral implantation of the
rhBMP-2/CRM/CD HORIZON® Spinal System. One investigational implant was placed across two
adjacent transverse processes on each side of the spine during the spinal fusion procedure.
The control treatment was the bilateral posterolateral implantation of the autogenous bone
harvested from the iliac crest with the CD HORIZON® Spinal System.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Success
A patient will be considered an overall success if all of the following conditions are met: fusion; pain/disability (Oswestry) improvement; maintenance or improvement in neurological status; no serious adverse event classified as implant associated or implant/surgical procedure associated; no additional surgical procedure classified as a "failure."
24 months
Yes
Kenneth Burkus, MD
Principal Investigator
The Hughston Clinic, P.C.
United States: Food and Drug Administration
P01-05
NCT00707265
March 2002
February 2010
Name | Location |
---|---|
Beth Israel Medical Center | New York, New York 10003 |
University of Utah | Salt Lake City, Utah |
Duke University Hospital | Durham, North Carolina 27710 |
University of Iowa Hospitals & Clinics | Iowa City, Iowa 52242 |
Barrow Neurosurgical Associates | Phoenix, Arizona 85013 |
Orthopaedic Specialty Institute | Orange, California 92868 |
UCLA Orthopedic Hospital | Santa Monica, California 90404 |
Georgetown University Dept. of Orthopaedic Spine Surgery | Washington, District of Columbia 20007 |
Brevard Orthopaedic Clinic, Inc. | Melbourne, Florida 32901 |
Florida Ortho Institute | Tampa, Florida 33637 |
Florida Neurological Consultants | Winter Park, Florida 32789 |
The Hughston Clinic P.C. | Columbus, Georgia 31908 |
Barrington Orthopedic Specialists | Hoffman Estates, Illinois 60195 |
Lutheran Spine Center | Park Ridge, Illinois 60068 |
The Spine Institute | Carmel, Indiana 46032 |
Des Moines Orthopaedic Surgeons | West Des Moines, Iowa 50266 |
Spine Institute | Louisville, Kentucky 40202 |
Alvin & Lois Lapidus Cancer Insitute | Baltimore, Maryland 21215 |
Jeffrey S. Fischgrund | Southfield, Michigan 48034 |
Orthopedic Spine Care of Long Island, PC | Melville, New York 11747 |
Central States Orthopedic Specialists | Tulsa, Oklahoma 74136 |
Medford Neurological & Spine Clinic | Medford, Oregon 97504 |
The Reading Neck & Spine Center | Wyomissing, Pennsylvania 19610 |
East Tennessee Brain & Spine | Johnson City, Tennessee 37604 |
Fort Worth Brain & Spine | Fort Worth, Texas 76104 |
Brain and Spine Center of Texas | Plano, Texas 75093 |
Azalea Orthopedic & Sports Medicine Clinic | Tyler, Texas 75701 |
UVA Dept. of Neurosurgery | Charlottesville, Virginia 22908 |