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Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hip Arthroplasty | Procedure | Total Hip Arthroplasty with SMS Femoral Stem (Medacta) |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate of SMS femoral stem | Survival analysis accordin to the Kaplan-Meier method | From enrollment to the end of treatment at 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the clinical performance of the SMS femoral stem | Clinical performance of the SMS femoral stem evaluated through the Harris Hip Score. The Harris Hip Score is a standardized measure used to assess the severity of hip pain and functional limitations in individuals with hip conditions. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffering from a severely painful and/or disabling hip joint (osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, avascular necrosis of the femoral head) requiring a total hip prosthesis and who will receive a Medacta SMS femoral stem.
Patients will be able to participate in other non-interventional research for the duration of the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Maisongrosse | Contact | 0033 05 61 37 85 93 | paul.maisongrosse@hotmail.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de l'Union | Recruiting | Saint-Jean | 31240 | France |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D005271 | Femur Head Necrosis |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal 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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| From enrollment to the end of treatment at 10 years |
| Evaluation of the hip function | Hip function evaluated through the Oxford Hip Score. The Oxford Hip Score (OHS) is a short 12-item patient-reported PRO specifically designed and developed to assess function and pain with patients undergoing hip replacement surgery. The total gives a minimum score of 12 and a maximum of 60. A higher score implies a greater degree of disability. | From enrollment to the end of treatment at 10 years |
| Evaluation of the quality of life | Quality of life evaluated through the EuroQol Score (EQ-5D-5L). The EQ-5D family of instruments has been developed to describe and value health across a wide range of disease areas. Each EQ-5D instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS) that are cognitively undemanding, taking only a few minutes to complete. The questionnaire provides a simple descriptive profile of a respondent's health state. The EQ VAS provides an alternative way to elicit an individual's rating of their own overall current health | From enrollment to the end of treatment at 10 years |
| Evaluation of the safety (adverse events) of the SMS femoral stem | Safety of the SMS femoral stem evaluated through the collection of the intraoperative and postoperative complications | From enrollment to the end of treatment at 10 years |
| Evaluation of the stability and the fixation of the SMS femoral stem | Stability and fixation of the SMS femoral stem evaluated through the radiographic anaysis, assessing the position of the implant (subsidence and migration), the presence of radiolucent lines, the implant breakage. | From enrollment to the end of treatment at 10 years |
| D012216 |
| Rheumatic Diseases |
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |