rhBMP-2/CRM/CD HORIZON® Spinal System Pivotal Study
CRM
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
1 other identifier
interventional
463
1 country
28
Brief Summary
The purpose of this study was to evaluate the rhBMP-2/CRM/CD HORIZON® Spinal System as a method of facilitating spinal fusion in patients with degenerative disc disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2002
Longer than P75 for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 26, 2008
CompletedFirst Posted
Study publicly available on registry
June 30, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedMay 10, 2023
May 1, 2023
3.2 years
June 26, 2008
May 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Success
A patient will be considered an overall success if all of the following conditions are met: 1. fusion; 2. pain/disability (Oswestry) improvement; 3. maintenance or improvement in neurological status; 4. no serious adverse event classified as implant associated or implant/surgical procedure associated; 5. no additional surgical procedure classified as a "failure."
24 months
Secondary Outcomes (9)
Fusion
24 months
Pain/Disability Status
24 months
Overall Neurological Status
24 months
General Health Status
24 months
Back Pain
24 months
- +4 more secondary outcomes
Study Arms (2)
Investigational
EXPERIMENTALOpen bilateral posterolateral implantation of the rhBMP-2/CRM/CD HORIZON® Spinal System.
Control
ACTIVE COMPARATORThe bilateral posterolateral implantation of the autogenous bone harvested from the iliac crest with the CD HORIZON® Spinal System.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history of pain and radiographic studies:
- Requires fusion of a single level disc space from L1 to S1.
- 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.
- If of child-bearing potential, patient is non-pregnant, non-nursing, and agrees to use adequate contraception for 1 year following surgery.
You may not qualify if:
- A patient meeting any of the following criteria is to be excluded from this clinical trial:
- Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level.
- Had previous spinal fusion surgical procedure at the involved level.
- Requires spinal fusion at more than one lumbar level.
- Has been previously diagnosed with osteopenia.
- Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
- Has a history of autoimmune disease (e.g. Systemic Lupus Erythematosus or dermatomyositis).
- Has a history of exposure to injectable collagen or silicone implants.
- 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.
- Has received any previous exposure to any/all BMP's of either human or animal extraction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Barrow Neurosurgical Associates
Phoenix, Arizona, 85013, United States
Orthopaedic Specialty Institute
Orange, California, 92868, United States
UCLA Orthopedic Hospital
Santa Monica, California, 90404, United States
Georgetown University Dept. of Orthopaedic Spine Surgery
Washington D.C., District of Columbia, 20007, United States
Brevard Orthopaedic Clinic, Inc.
Melbourne, Florida, 32901, United States
Florida Ortho Institute
Tampa, Florida, 33637, United States
Florida Neurological Consultants
Winter Park, Florida, 32789, United States
The Hughston Clinic P.C.
Columbus, Georgia, 31908, United States
Barrington Orthopedic Specialists
Hoffman Estates, Illinois, 60195, United States
Lutheran Spine Center
Park Ridge, Illinois, 60068, United States
The Spine Institute
Carmel, Indiana, 46032, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52241, United States
Des Moines Orthopaedic Surgeons
West Des Moines, Iowa, 50266, United States
Spine Institute
Louisville, Kentucky, 40202, United States
Alvin & Lois Lapidus Cancer Insitute
Baltimore, Maryland, 21215, United States
Jeffrey S. Fischgrund
Southfield, Michigan, 48034, United States
Orthopedic Spine Care of Long Island, PC
Melville, New York, 11747, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
Central States Orthopedic Specialists
Tulsa, Oklahoma, 74136, United States
Medford Neurological & Spine Clinic
Medford, Oregon, 97504, United States
The Reading Neck & Spine Center
Wyomissing, Pennsylvania, 19610, United States
East Tennessee Brain & Spine
Johnson City, Tennessee, 37604, United States
Fort Worth Brain & Spine
Fort Worth, Texas, 76104, United States
Brain and Spine Center of Texas
Plano, Texas, 75093, United States
Azalea Orthopedic & Sports Medicine Clinic
Tyler, Texas, 75701, United States
University of Utah
Salt Lake City, Utah, 84132, United States
UVA Dept. of Neurosurgery
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Burkus, MD
The Hughston Clinic, P.C.
- PRINCIPAL INVESTIGATOR
John Dimar, MD
Spine Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2008
First Posted
June 30, 2008
Study Start
March 1, 2002
Primary Completion
May 1, 2005
Study Completion
February 1, 2010
Last Updated
May 10, 2023
Record last verified: 2023-05