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EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System

NCT04399928 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 479

Last updated 2025-04-11

Study results available
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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.

Conditions

  • Degenerative Joint Disease

Interventions

DEVICE

Total Hip Arthroplasty

Total hip arthroplasty with the R3 Acetabular Hip system.

Sponsors & Collaborators

  • Smith & Nephew Orthopaedics AG

    lead INDUSTRY

Principal Investigators

  • Remes, Associate Professor · University of Helsinki

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-18
Primary Completion
2022-02-18
Completion
2022-04-01

Countries

  • Belgium
  • Denmark
  • Finland
  • Germany
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04399928 on ClinicalTrials.gov