NCT04399928

EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 479 (actual)
• Sponsor: Smith & Nephew Orthopaedics AG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Degenerative Joint Disease

Interventions

Type	Name	Description
DEVICE	Total Hip Arthroplasty	Total hip arthroplasty with the R3 Acetabular Hip system.

Timeline

• Start date: 2009-05-18
• Primary completion: 2022-02-18
• Completion: 2022-04-01
• First posted: 2020-05-22
• Last updated: 2025-04-11
• Results posted: 2025-04-11

Locations

8 sites across 7 countries: Belgium, Denmark, Finland, Germany, Netherlands, Spain, United Kingdom