Status:
COMPLETED
rhBMP-2/CRM/CD HORIZON® Spinal System Pivotal Study
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Detailed Description
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 gr...
Eligibility Criteria
Inclusion
- Each patient participating in this clinical trial must meet all of the following inclusion criteria:
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
463 Patients enrolled
Trial Details
Trial ID
NCT00707265
Start Date
March 1 2002
End Date
February 1 2010
Last Update
May 10 2023
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
Barrow Neurosurgical Associates
Phoenix, Arizona, United States, 85013
2
Orthopaedic Specialty Institute
Orange, California, United States, 92868
3
UCLA Orthopedic Hospital
Santa Monica, California, United States, 90404
4
Georgetown University Dept. of Orthopaedic Spine Surgery
Washington D.C., District of Columbia, United States, 20007