R3 Delta Ceramic Acetabular System PAS U.S.

Study Overview
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Brief Summary
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R3 Delta Post-Approval Study U.S.

Detailed Description
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Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US The R3 Ceramic Acetabular System is indicated for use in skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis. The expected timeline for the study is a total of approximately 5 years: 6 months for site initiation, 12 months for subject enrollment, 3 years until the last subject enrolled has reached the 3 year follow-up interval.

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

Conditions
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Degenerative Joint Disease

Intervention / Treatment
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* Device: R3 Biolox Delta Ceramic Acetabular System


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 (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic 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 Patient is willing and able to participate in required follow-up visits and to complete study procedures and questionnaires Patient has consented to participating in the study by signing the IRB/EC approved informed consent form Exclusion Criteria: Patients with insufficient quantity or quality of bone support; metabolic bone disease; osteoporosis Patients with neurological or muscular conditions that would place extreme load or instability upon the hip joint Patients with active joint infections or chronic systemic infection Obese patients where obesity is defined as BMI > 40 Skeletal immaturity Known allergy to implant materials

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

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: R3 Biolox Delta Ceramic Acetabular System|All study related procedures with the R3 delta Ceramic Acetabular System must be performed according to the recommended surgical technique described in the labeling and in the instructions for use (IFU).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall success at 3 years postoperative defined as no component revision | No component revision | 3 Years postoperative | 
| Overall success at 3 years postoperative defined as Modified Harris Hip Score of at least 80 points | Modified Harris Hip Score of at least 80 points | 3 Years postoperative | 
| Overall success at 3 years postoperative no radiographic failure defined as: no radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones | No Radiographic Failure | 3 Years postoperative | 
| Overall success at 3 years postoperative defined as No femoral or acetabular subsidence greater than or equal to 5 mm from baseline | No Radiographic Failure | 3 Years postoperative | 
| Overall success at 3 years postoperative defined as no acetabular cup inclination changes greater than 4 degrees from baseline. | No Radiographic Failure | 3 Years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoints include clinical assessments of pain and function using the Modified Hip Harris Score | Assessment of pain and function | 3 Years postoperative | 
| Secondary endpoints include clinical assessments of radiographic findings | Radiographic Findings | 3 Years postoperative | 
| Secondary endpoints include clinical assessments of implant survivorship. | Implant survivorship | 3 Years postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Total Hip Arthroplasty, Non-Inflammatory Arthritis, Degenerative Joint Disease, R3 Delta Ceramic Acetabular Insert