Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe

Study Overview
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Brief Summary
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The purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by evaluating long-term (10 years after surgery) follow-up results.

Detailed Description
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This PAS is a long-term follow-up of the R3 delta Ceramic Acetabular System (DOD) hips enrolled in the study that was analyzed for the Premarket Approval Application (PMA) Study. The PMA Study analyzed 3 Year postoperative follow-up data on Biolox delta ceramic-on-Biolox delta ceramic (DOD) and Oxidized zirconium-on-Crosslinked Polyethylene (OxZr/XLPE) hips, enrolled and followed in a European Post-market Study (A prospective, multicenter, non-randomized, clinical outcome study of the R3 Acetabular System in patients with degenerative hip disease). The purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by evaluating long-term (10 years after surgery) follow-up results. Hips are evaluated at the following intervals: 5, 7, 10 years postoperative. The primary study endpoint is implant survivorship at 10 years post surgery.

Official Title
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Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe

Conditions
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Degenerative Joint Disease of Hip

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 18-75 years old and he/she is skeletally mature Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, post-traumatic arthritis, avascular necrosis, dysplasia/ developmental dysplasia of the hip) or inflammatory joint disease (e.g., rheumatoid arthritis) Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk The patient is willing to comply the follow-up schedule Exclusion Criteria: Patient has active infection or sepsis (treated or untreated) Patient is a prisoner or has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the study including mental illness, mental retardation, linguistic insufficiencies (i.e. immigrants), or drug/alcohol abuse, Patients with acute hip trauma (femoral neck fracture)

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post Approval Study<br>The PAS cohort consisted of 137 subjects who were implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study. These patients will continue to be followed to 10 years post-operatively. The primary endpoint for the PAS study is implant survivorship at 10 years post study procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survivor rate | Did hip survive with no revision through 10 years | 10 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Harris Hip Score | Effectiveness assessed by comparison of changes in parameters from baseline through 10 year post. 2 subscales (8 items), Scores summed and normalized to 100, Excellent: 90 - 100 points Good: 80 - 89 points Fair: 70 - 79 points Poor: < 70 points | 10 Years | 
| Radiographic outcomes | radiographic success defined as: No radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones; and No femoral or acetabular subsidence greater than or equal to 5mm from baseline; and No acetabular cup inclination changes greater than 4 degrees (4°) | 10 Years | 
| Adverse Events | All AEs will be collected and reported | 10 Years |