rhBMP-2/CRM/CD HORIZON® Spinal System Pivotal Study

Completed · Phase 3

Conditions studied: Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT00707265

Run by

Medtronic Spinal and Biologics

People needed

463

Starts

2002-03-01

Expected to finish

2010-02-01

Last updated by the study team

2023-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.