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This study is aimed to provide a clinical and radiographic evaluation of 120 suitable subjects who underwent a total hip arthroplasty with MINIMA stem coupled with Delta TT or Delta ST-C cup.
This is a post-market, interventional, prospective, randomized, not comparative, open label study designed to reflect real life clinical practice as closely as possible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minima Stem with ST-c Cup | Other | Minima Stem with ST-c Cup |
|
| Minima Stem with TT Cup | Other | Minima Stem with TT Cup |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TT cup and ST-C cup | Device | Patients are allocated in 2 different group (one with ST-C Cup and another one with TT Cup) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score (HHS) | Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 3 years after surgery | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score (HHS) | Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 5 years after surgery | 5 years |
| Implant stability | Radiographic implant evaluation and stability assessment at 6 months, 1 year, 3 years, 5 years after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Orthopedic Clinic University Hospital Martin | Martin | 036 59 | Slovakia |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 6 months, 1 year, 3 years, 5 years after surgery |
| Oxford Hip Score (OHS) | Functional changes in Oxford Hip Score (OHS) from preoperative (baseline) to 5 years after surgery | 5 years |
| Forgotten Joint Score (FJS) | Changes in Forgotten Joint Score (FJS) from 3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery | 3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery |
| Survival Rate | Survival rate expressed with Kaplan-Meier estimator at 5 years after surgery | 5 years |
| Safety assessment | Incidence, type, and severity of all the Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up. | Intra operative, 3 months, 6 months, 1 year, 3 years, 5 years |
| D012216 |
| Rheumatic Diseases |