A Safety and Efficacy Study of the Birmingham Hip Resurfacing System

Study Overview
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Brief Summary
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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.

Detailed Description
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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 collected will permit clinical evaluation for the device performance in improving hip pain, function and range of motion through ten years. The study will permit radiographic evaluation of proper component fixation and alignment maintenance through 10 years post-operative. The incidence of revision is an especially important measure in this study. Data collected will allow analysis of the implant survivorship.

Official Title
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Birmingham Hip Resurfacing System (BHR) Post Approval Study: A Prospective, Multi-Centered Study of the Birmingham Hip Resurfacing System

Conditions
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Arthritis

Intervention / Treatment
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* Device: Birmingham Hip Resurfacing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hip Resurfacing<br>Birmingham Hip Resurfacing | Device: Birmingham Hip Resurfacing<br>* Hip resurfacing system: single use device for hybrid fixation in patients requiring primary hip resurfacing arthroplasty<br>* Other names: BHR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness evaluation based on incidence of revision, radiographic review and Harris Hip Score |  | 3 months, 1-10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | post op through 10 years |