NCT02680340

POLARSTEM Retrospective Multicenter Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 502 (actual)
• Sponsor: Smith & Nephew Orthopaedics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Total Hip Arthroplasty	Patients who had a primary THA between 2002 and 2005

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2016-02-11
• Last updated: 2017-02-23

Locations

5 sites across 1 country: France