POLARSTEM Retrospective Multicenter Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject required and received primary total hip arthroplasty between 2002 and 2005. 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. Subject received the non-cemented POLARSYSTEM (POLARSTEM™ Ti/HA in combination with POLARCUP™). Subject was aged between 18 and 75 at time of surgery. Signed Informed Consent (ICF). Exclusion Criteria: Subject received the cemented POLARSTEM™. Previously failed endoprosthesis and/or THR components in relevant hip. Medical or mental health conditions which could impair the stubject's ability or willingness to comply with the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Total Hip Arthroplasty|Patients who had a primary THA between 2002 and 2005|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | since surgery until 10 years Follow Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 |  | at 10 years Follow Up | 
| Merle D'Aubigné and Postel (MAP) at least at 10-year assessment |  | pre-operative and at 10 years Follow Up | 
| Adverse Events |  | through study completion, an average of 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Hip Arthroplasty THA