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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hip Arthroplasty | Procedure | Patients who had a primary THA between 2002 and 2005 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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502 male and female 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.
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| Name | Affiliation | Role |
|---|---|---|
| Arnaud Fiquet, Dr. med. | Infirmerie Protestante de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique la Parisière | Bourg-de-Péage | 26300 | France | |||
| Infirmerie Protestante de Lyon |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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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 |
| Caluire-et-Cuire |
| 69300 |
| France |
| Centre Hospitalier du Forez- Montbrison | Montbrison | 42605 | France |
| Centre Hospitalier de Montélimar | Montélimar | 26200 | France |
| Clinique du Renaison | Roanne | 42300 | France |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |