Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
463 participants
INTERVENTIONAL
2002-03-31
2010-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Investigational
Open bilateral posterolateral implantation of the rhBMP-2/CRM/CD HORIZON® Spinal System.
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.
Control
The bilateral posterolateral implantation of the autogenous bone harvested from the iliac crest with the CD HORIZON® Spinal System.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Requires fusion of a single level disc space from L1 to S1.
3. Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of 6 months.
4. If of child-bearing potential, patient is non-pregnant, non-nursing, and agrees to use adequate contraception for 1 year following surgery.
Exclusion Criteria
1. Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level.
2. Had previous spinal fusion surgical procedure at the involved level.
3. Requires spinal fusion at more than one lumbar level.
4. Has been previously diagnosed with osteopenia.
5. Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
6. Has a history of autoimmune disease (e.g. Systemic Lupus Erythematosus or dermatomyositis).
7. Has a history of exposure to injectable collagen or silicone implants.
8. Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP 2/CRM implantation.
9. Has received any previous exposure to any/all BMP's of either human or animal extraction.
18 Years
ALL
No
Sponsors
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Medtronic Spinal and Biologics
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth Burkus, MD
Role: PRINCIPAL_INVESTIGATOR
The Hughston Clinic, P.C.
John Dimar, MD
Role: PRINCIPAL_INVESTIGATOR
Spine Institute
Locations
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Barrow Neurosurgical Associates
Phoenix, Arizona, United States
Orthopaedic Specialty Institute
Orange, California, United States
UCLA Orthopedic Hospital
Santa Monica, California, United States
Georgetown University Dept. of Orthopaedic Spine Surgery
Washington D.C., District of Columbia, United States
Brevard Orthopaedic Clinic, Inc.
Melbourne, Florida, United States
Florida Ortho Institute
Tampa, Florida, United States
Florida Neurological Consultants
Winter Park, Florida, United States
The Hughston Clinic P.C.
Columbus, Georgia, United States
Barrington Orthopedic Specialists
Hoffman Estates, Illinois, United States
Lutheran Spine Center
Park Ridge, Illinois, United States
The Spine Institute
Carmel, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Des Moines Orthopaedic Surgeons
West Des Moines, Iowa, United States
Spine Institute
Louisville, Kentucky, United States
Alvin & Lois Lapidus Cancer Insitute
Baltimore, Maryland, United States
Jeffrey S. Fischgrund
Southfield, Michigan, United States
Orthopedic Spine Care of Long Island, PC
Melville, New York, United States
Beth Israel Medical Center
New York, New York, United States
Duke University Hospital
Durham, North Carolina, United States
Central States Orthopedic Specialists
Tulsa, Oklahoma, United States
Medford Neurological & Spine Clinic
Medford, Oregon, United States
The Reading Neck & Spine Center
Wyomissing, Pennsylvania, United States
East Tennessee Brain & Spine
Johnson City, Tennessee, United States
Fort Worth Brain & Spine
Fort Worth, Texas, United States
Brain and Spine Center of Texas
Plano, Texas, United States
Azalea Orthopedic & Sports Medicine Clinic
Tyler, Texas, United States
University of Utah
Salt Lake City, Utah, United States
UVA Dept. of Neurosurgery
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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P01-05
Identifier Type: -
Identifier Source: org_study_id
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