Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This PAS is a long-term follow-up of the R3 delta Ceramic Acetabular System (DOD) hips enrolled in the study that was analyzed for the Premarket Approval Application (PMA) Study. The PMA Study analyzed 3 Year postoperative follow-up data on Biolox delta ceramic-on-Biolox delta ceramic (DOD) and Oxidized zirconium-on-Crosslinked Polyethylene (OxZr/XLPE) hips, enrolled and followed in a European Post-market Study ("A prospective, multicenter, non-randomized, clinical outcome study of the R3 Acetabular System in patients with degenerative hip disease"). 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. Hips are evaluated at the following intervals: 5, 7, 10 years postoperative. The primary study endpoint is implant survivorship at 10 years post surgery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03566082
Study type Observational
Source Smith & Nephew, Inc.
Contact
Status Completed
Phase
Start date May 28, 2009
Completion date October 15, 2021

See also
  Status Clinical Trial Phase
Terminated NCT04348968 - Maxera Large Cups - Canada
Recruiting NCT04754087 - G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study N/A