EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

479 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-18

Study Completion Date

2022-04-01

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.

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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.

Conditions

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Degenerative Joint Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Total Hip Arthroplasty

Total hip arthroplasty with the R3 Acetabular Hip system.

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No