NCT02648152

POLARSTEM Cementless Hip Stem

Multicenter Clinical Observation Using the Cementless Version of the POLARSTEM

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 218 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art implant in terms of radiographic, clinical performance and long-term survivorship.

Detailed description

The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the POLARSTEM™. Efficacy evaluations: * Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, Hip disability and osteoarthritis outcome score (HOOS) \[7, 8\], an extension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). * Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration Safety evaluations: * Intra- and perioperative device-related adverse events (AE) and complications up to discharge * Postoperative AE up to 10 years

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Total Hip Arthroplasty	Total Hip Arthroplasty using Cementless version of the POLARSTEM

Timeline

• Start date: 2009-03-01
• Primary completion: 2020-11-01
• Completion: 2020-11-01
• First posted: 2016-01-06
• Last updated: 2026-01-21
• Results posted: 2026-01-21

Locations

3 sites across 2 countries: Germany, Switzerland