EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System

Smith & Nephew

Status: Completed

Conditions: Degenerative Joint Disease

Treatments: Device: Total Hip Arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT04399928

SR 16-4845-15 (R11019)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 479 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design