A Safety and Efficacy Study of the Birmingham Hip Resurfacing System (NCT00611585) | Clinical Trial Compass
CompletedNot Applicable
A Safety and Efficacy Study of the Birmingham Hip Resurfacing System
United States329 participantsStarted 2006-10-06
Plain-language 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 and inflammatory arthritis.
Who can participate
Age range21 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
A. Males or females, at least 21 years of age, inclusive, and skeletally mature.
B. The BHR System is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component. The BHR System is intended for use in patients requiring primary hip resurfacing arthroplasty due to:
* non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH, or
* inflammatory arthritis such as rheumatoid arthritis.
The BHR System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision.
C. The subject or his/her legal guardian was willing to consent to participate in the study by signing and dating the approved consent form;
D. The subject was available for clinical follow-up through at least ten years postoperative;
E. The patient met none of the exclusion criteria.
Exclusion Criteria:
A. Subjects with infection or sepsis,
B. Subjects with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery,
C. Female subjects of child-bearing age due to unknown effect on the fetus of medal ion release.
D. Subjects with bone stock inadequate to support the device including:
* Subjects with se…
What they're measuring
1
Proportion of Participants with Revision by 10 Years