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Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe

NCT03566082 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 135

Last updated 2024-05-30

Study results available
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Summary

The purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by evaluating long-term (10 years after surgery) follow-up results.

Conditions

  • Degenerative Joint Disease of Hip

Sponsors & Collaborators

  • eResearchTechnology, Inc

    collaborator INDUSTRY

  • M Squared Associates, Inc.

    collaborator INDUSTRY

  • ExecuPharm PAREXEL

    collaborator INDUSTRY

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Smith & Nephew Orthopaedics AG

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

Start
2009-05-28
Primary Completion
2021-10-15
Completion
2021-10-15

Countries

  • Belgium
  • Finland
  • 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 NCT03566082 on ClinicalTrials.gov