Osteoarthritis
Conditions
Keywords
Total Hip Arthroplasty THA
Brief 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.
Interventions
PROCEDURETotal Hip Arthroplasty
Patients who had a primary THA between 2002 and 2005
Sponsors
Smith & Nephew Orthopaedics AG
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Femoral stem revision rate at 10 years for any reason | since surgery until 10 years Follow Up | Long term cumulative femoral stem revision rate of Polarstem will be evaluated in 502 subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with revision of any components for any reason | date of surgery until 10 years Follow Up | Long-term cumulative revision rate of the cup will be evaluated in 502 subjects |
| Standard radiographic assessment at least at 10 years | date of surgery and at 10 years Follow Up | 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 |
| 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 | — |
Countries
France
Outcome results
None listed