EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System

Study Overview
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Brief Summary
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The objective of this study is to determine the long-term safety and effectiveness from the R3 Acetabular Hip System. The study hypothesis is that implant survivorship of the R3 cup is at least 97% at 3 years, 95% at 5 years, 93% at 7 years, and 90% at 10 years follow-up.

Detailed Description
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This is a multicenter prospective observational post-market clinical follow-up study that will include 500 patients who will have total hip replacement with the R3 Acetabular System and either cemented or cementless hip stem. Effectiveness will be assessed by comparison of changes in parameters contained in the HOOS questionnaire and based upon incidence of revision and change in Harris Hip Score and UCLA Rating. Safety will be measured by assessing all adverse events experienced by patients from study enrolment through to study completion.

Official Title
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A Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3◊ Acetabular System in Patients With Degenerative Hip Disease

Conditions
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Degenerative Joint Disease

Intervention / Treatment
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* Device: Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the following characteristics for inclusion in the study. 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/DDH 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: Subjects with any of the following characteristics must be excluded from the participation in the study. 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

| Intervention/Treatment |
| --- |
|Device: Total Hip Arthroplasty|Total hip arthroplasty with the R3 Acetabular Hip system.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision for any reason | Implant survivorship at 10 years post study procedure. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants. | 10 years post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS) | The HOOS is developed as an instrument to assess the subject's opinion about their hip and associated problems. HOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec), and hip related Quality of Life (QOL). Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | 10 years post-op | 
| Patient Reported Outcome (PRO): modified Harris Hip Score (HHS) | 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 post-op | 
| Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) rating | UCLA Activity Score is a measure of physical activity levels in subjects undergoing total joint arthroplasty. The scale is from 1 - 10 with higher values indicating greater physical function. | 10 years post-op | 
| Safety Assessment | Safety will be measured by assessing all adverse events experienced by patients up to study completion or termination. | 10 years post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Degenerative joint disease, Total Hip Arthroplasty