POLARSTEM Retrospective Multicenter Study

Smith & Nephew Orthopaedics AG502 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

502

Conditions

Osteoarthritis

Interventions

Total Hip ArthroplastyPROCEDURE

Patients who had a primary THA between 2002 and 2005

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Clinique la Parisière

Bourg-de-Péage, France

Infirmerie Protestante de Lyon

Caluire-et-Cuire, France

Centre Hospitalier du Forez- Montbrison

Montbrison, France

Centre Hospitalier de Montélimar

Montélimar, France

Outcomes

Primary Outcomes

Femoral stem revision rate at 10 years for any reason

Long term cumulative femoral stem revision rate of Polarstem will be evaluated in 502 subjects

Time frame: since surgery until 10 years Follow Up

Secondary Outcomes

Number of subjects with revision of any components for any reason

Long-term cumulative revision rate of the cup will be evaluated in 502 subjects

Time frame: date of surgery until 10 years Follow Up

Standard radiographic assessment at least at 10 years

radiographic evaluation on x-rays to assess the osseointegration and orientation of cup and stem, heterotopic ossification, signs of radiolucent lines, osteolysis, atrophy and hypertrophy

Time frame: date of surgery and at 10 years Follow Up

Hip Disability and Osteoarthritis Outcome Score (HOOS) at least at 10-year assessment as patient reported outcome (PRO

Time frame: at 10 years Follow Up

Merle D'Aubigné and Postel (MAP) at least at 10-year assessment

Time frame: pre-operative and at 10 years Follow Up

Adverse Events

Time frame: through study completion, an average of 10 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.