Status:
COMPLETED
A Safety and Efficacy Study of the Birmingham Hip Resurfacing System
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Arthritis
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
The purpose of this study is to meet a PMA condition of approval of the BHR System. The study will evaluate the long term safety and effectiveness of the BHR system in patients with non-inflammatory a...
Detailed Description
This is a post-approval, prospective, non-randomized, longitudinal, unmasked, multi-center, clinical trial designed to evaluate the longer-term safety and effectiveness of the BHR system. The data col...
Eligibility Criteria
Inclusion
- At least 21 years of age and skeletally mature
- Patients requiring primary hip resurfacing due to:
- Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH
- Inflammatory arthritis such as rheumatoid arthritis
- Subject or his/her legal guardian is willing to consent to participate in the study by signing and dating the approved consent form
- Subject is available for clinical follow-up through at least ten years
- Subject meets none of the exclusion criteria
Exclusion
- Subjects with infection or sepsis
- Subjects with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery
- Female subjects of child-bearing age
- Subjects with bone stock inadequate to support the device
- Subjects with known moderate to severe renal insufficiency
- Subjects with known or suspected metal sensitivity (e.g. jewelry)
- Subjects who are immunosuppressed with diseases such as AIDS or persons receiving high doses of corticosteroids
- Subjects with psychological or neurological conditions which would pre-empt their ability or unwillingness to participate in the study
- Subjects who are severely overweight
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2025
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00611585
Start Date
September 1 2006
End Date
May 12 2025
Last Update
November 20 2025
Active Locations (7)
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1
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85713
2
Center for Orthopaedics
Lake Charles, Louisiana, United States, 70601
3
Hospital for Special Surgery
New York, New York, United States, 10021
4
University of Rochester Medical Center
Rochester, New York, United States, 14672