Hip resurfacing device shows promise in arthritis patients
NCT ID NCT00611585
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at the long-term safety and effectiveness of the Birmingham Hip Resurfacing System, a metal hip implant, in 329 adults with arthritis. The main goal was to see how many patients needed a revision (replacement or removal) within 10 years. The study also measured hip function and pain using the Harris Hip Score. Results help confirm the device's performance in real-world use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Birmingham Hip Resurfacing System (a metal-on-metal hip implant device)
- What this could lead to
- If successful, this could confirm that the Birmingham Hip Resurfacing System is a safe and effective long-term option for hip arthritis, potentially delaying or avoiding the need for a total hip replacement.
- What could go wrong
- This is a post-approval study, not a new breakthrough. The device has known risks like metal wear, implant loosening, or need for revision surgery. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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329 people
The number who actually took part.
- Started
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Oct 2006
- Finished
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May 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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. BHR System is intended for patients who, due to relatively younger age or increase activity level, may not be suitable for traditional total hip arthroplasty due to an increase possibility of requiring future ipsilateral hip joint revision.
- Ages
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21 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 severe osteopenia should not receive a BHR procedure. Patients with a family history of severe osteoporosis or sever osteopenia. * Subjects with osteonecrosis or avascular necrosis (AVN) with \>50% involvement of the femoral head (regardless of FICAT Grade) should not receive a BHR. * Note: In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock. E. Subjects with known moderate to severe renal insufficiency. Subjects on medications (such as high-dose or chronic aminoglycoside treatment) or with co-morbidities (such as diabetes) that increase the risk of future, significant renal impairment should be advised of the possibility of increase in system medal ion concentration. Preoperative and postoperative monitoring of renal function 9such creatinine, GFR, BUN) at 6wk/3month, 6 month (optional visit), 1-, 2-, 3-, 4,-, 5-, and 10-year time points was necessary. F. Patients who were immunosuppressed with disease such as AIDS or persons receiving high dose of corticosteroids. G. Patients with psychological or neurological conditions which would pre-empt their ability or unwillingness to participate in the study. H. Patients who were severely overweight.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Anderson Orthopaedic Clinic
Alexandria, Virginia, 22306, United States
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Aurora Medical Center
Grafton, Wisconsin, 53024, United States
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Center for Orthopaedics
Lake Charles, Louisiana, 70601, United States
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Hospital for Special Surgery
New York, New York, 10021, United States
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OrthoCarolina
Charlotte, North Carolina, 28207, United States
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Tucson Orthopaedic Institute
Tucson, Arizona, 85713, United States
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University of Rochester Medical Center
Rochester, New York, 14672, United States
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