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Post-marketing observational case series to analyse the functional recover and radiographic outcomes in terms of implant stability and survivorship of primary hip arthroplasty with Friendly short cemented stem.
The aim of this case series is to verify the functional recover and radiographic outcomes of primary hip arthroplasty with Friendly short cemented stem.
This is a post-marketing clinical investigation, the product on study is CE marked and used according to the intended use.
It is a national, mono-centre, prospective, observational case series on 100 patients in 1 site.
Primary endpoint is to investigate clinical progression of patients with THA with Friendly short stem from baseline to 1-year follow-up.
The secondary endpoint is to evaluate implant stability and survivorship of implants up to 5 years Follow-up.
The evaluation has an internal control because the assessment of post-treatment data is compared to baseline measurements (pre-operative clinical analysis and radiographic analysis at discharge).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Friendly short stem | Device | Total Hip Arthroplasty with Friendly Short stem |
| Measure | Description | Time Frame |
|---|---|---|
| change in percentage of the results of the absolute and weighted (age, gender) Harris Hip Score score from baseline to 1 year | up to 5 years FU | |
| Change in percentage of the results of the Oxford Hip Score baseline to 1 year | up to 5 years FU | |
| Change in Range Of Motion from baseline to 1 year. | up to 5 years FU |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic stability | rate of signs of subsidence > 2mm or tilting | up to 5 years FU |
| Rate of failure | rate or revisions, loosening, failure of cement-stem interface, cement cracks, any definite change in the position of components |
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Inclusion Criteria:
Exclusion Criteria:
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Patients requiring a primary hip arthroplasty, due to primary and secondary coxarthrosis, avascular necrosis, rheumatoid arthritis, neck (but not diaphyseal) fractures
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Clinico Sant'Anna | Brescia | 25127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39729135 | Derived | Marega L, Gnagni P, Marega C, Marega F. Mid-term outcomes after primary total hip arthroplasty with a cemented short stem in an elderly patient cohort. Arch Orthop Trauma Surg. 2024 Dec 27;145(1):96. doi: 10.1007/s00402-024-05734-3. |
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| up to 5 years FU |
| Any possible adverse event or complication | up to 5 years FU |