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POLARSTEM Retrospective Multicenter Study — PR  

Osteoarthritis Clinical Trial

Official title:
Longterm Clinical Outcome Study of the Femoral Cementless Ti/HA Polarstem - A Multicenter Retrospective 10-years Follow-up Study

Clinical Trial Summary

The primary purpose of this study is to demonstrate the POLARSTEM™ Ti/HA cumulative femoral stem revision rate at 10 years.

The secondary purpose of this study is to provide 10 years of safety and effectiveness data of POLARSTEM™ Ti/HA in terms of radiographic and clinical performance

Clinical Trial Description

This is a multicenter retrospective longterm clinical outcome study conducted in up to 6 hospitals in France. 502 subjects who have undergone THA with POLARSTEM™ from 2002 to 2005 will be enrolled in this study and clinical and radiographically followed up for at least 10 years. Subjects who have not reached the 10-year post surgery timepoint will be invited to a 10-year post-operative follow-up visit to obtain the clinical and radiographic outcome measures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02680340
Study type Observational
Source Smith & Nephew, Inc.
Contact
Status Completed
Phase N/A
Start date January 2016
Completion date December 2016
View Details
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