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This is a post-marketing surveillance on MiniMAX Stem
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiniMAX | Device | Total or Partial Hip Arthroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate | Kaplan Meier method | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Functional evaluation | Harris Hip Score (HHS): the HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. 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. | Pre-op, 3 months, 1, 3, 5, 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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The sample size of 100 patients has been defined based on the literature data to guarantee a sufficient number of patients for the evaluation of the performance of the prosthesis, taking into account a 10% of lost patients (dead or lost at follow-up).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Clinical Angouleme Soyaux | Soyaux | France | 16800 | France |
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| Evaluation of patient satisfaction |
HOOS (hip disability and osteoarthritis outcome score) questionnaire: HOOS is a questionnaire intended to be used to assess patient's opinion about their hip and associated problems, and to evaluate their symptoms and functional limitations during a therapeutic process.The interval score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health. |
| Pre-op, 3 months, 1, 3, 5, 10 years |
| Evaluation of the stem fixation | Radiographic evaluation to assess the osteointegration of the stem, the implant positioning, radiolucent lines. | Pre-op, 3 months, 1, 3, 5, 10 years |
| Evaluation of the general and thigh pain | Echelle Visuelle Analogique (EVA) and pain location. Interpretation of the EVA scale: no pain 0, low pain 1-3, moderate pain 4-6, severe pain 7-9, extreme pain 10. | Pre-op, 3 months, 1, 3, 5, 10 years |
| Incidence of adverse events | Intraoperative and postoperative complications | Surgery, Immediate post-op, 3 months, 1, 3, 5, 10 years |
| Evaluation of the stability of the stem | Radiographic evaluation to assess the osteointegration of the stem, the implant positioning, radiolucent lines. | Pre-op, 3 months, 1, 3, 5, 10 years |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D006618 | Hip Dislocation, Congenital |
| D010020 | Osteonecrosis |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000082602 | Developmental Dysplasia of the Hip |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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