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Post-marketing clinical study,international, multi-centre, prospective, observational. The investigation will be carried out in 2 sites in Europe for a maximum total number of 160 patients.The aim of this study is to assess clinical, radiographic and subjective outcomes after hip arthroplasty with a cementless metaphyseal MINIMA short stem, define the survivorship of the implant and identify possible risk factors that may lead to failure.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINIMA stem | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score (HHS) | 24 months | |
| UCLA activity score | 24 months | |
| Time up and go test (TUG) | 24 months | |
| Range of motion (ROM) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hip disability and Osteoarthritis Outcome Score (HOOS) | 24 months | |
| Implant stability measured by radiographic evaluations | 24 months | |
| Revision rate |
| Measure | Description | Time Frame |
|---|---|---|
| Mid-term clinical outcomes: Harris Hip Score and Hip disability and Osteoarthritis Outcome Score (HOOS) | 60 months | |
| Incidence of device-related Adverse Events and Serious Adverse Events | 60 months | |
Inclusion Criteria:
Exclusion Criteria:
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Patients will be selected for recruitment into the study from the general diagnosis population of patients requiring a primary hip arthroplasty, due to symptomatic painful degenerative joint diseases (NDJD). Patients requiring a revision of a previous failed stem cannot be enrolled into the clinical evaluation.
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Zagra | I.R.C.C.S. Galeazzi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.R.C.C.S. Galeazzi | Milan | 20161 | Italy |
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| 24 months |
| Incidence of device-related Adverse Events/Serious Adverse Events | 24 months |
| Survival rate (Kaplan Meier) |
| 60 months |