POLARSTEM Retrospective Multicenter Study (PR)

Smith & Nephew

Status: Completed

Conditions: Osteoarthritis

Treatments: Procedure: Total Hip Arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT02680340

14-4562-05

Details and patient eligibility

About

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

Full 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.

Enrollment: 502 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject required and received primary total hip arthroplasty between 2002 and 2005.
2. Subject received the POLARSTEM™ Ti/HA unilateral or bilateral, due to severe hip joint damage resulting from arthrosis, degenerative disease, traumatic events, inflammatory or rheumatoid processes.
3. Subject received the non-cemented POLARSYSTEM (POLARSTEM™ Ti/HA in combination with POLARCUP™).
4. Subject was aged between 18 and 75 at time of surgery.
5. Signed Informed Consent (ICF).

Exclusion criteria

1. Subject received the cemented POLARSTEM™.
2. Previously failed endoprosthesis and/or THR components in relevant hip.
3. Medical or mental health conditions which could impair the stubject's ability or willingness to comply with the study.