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EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System

Degenerative Joint Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04399928
Study type Observational
Source Smith & Nephew, Inc.
Contact
Status Completed
Phase
Start date May 18, 2009
Completion date April 1, 2022
View Details
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