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Study design: monocentric, retrospective, observational and post-market clinical study.
Purpose: To demonstrate the safety and performance of CL TRAUMA femoral stem. The eligible study population is represented by the entire population that underwent a hip replacement with CL TRAUMA femoral stem from 2017 to 2023 at Azienda Ospedaliera di Padova (IT) in accordance with the indication for use of the product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CL TRAUMA implanted patients | Patients who underwent hip arthroplasty with CL TRAUMA cemented femoral stem from 2017 to 2023. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CL TRAUMA femoral stem | Device | Hip arthroplasty according to the instruction for use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is based upon Harris Hip score evaluation. | The primary endpoint is based upon patients' clinical recovery at the Survival Follow-up visit measured as Harris Hip Score greater than 80. The Harris Hip Scale (HHS) was developed for the assessment of the results of hip surgery, and it is intended to evaluate various hip disabilities and methods of treatment in an adult population. It is a clinical outcome measurement administered by a qualified health care professional, such as a physician or a physical therapist. There are ten items covering four domains. The domains are: pain, function, absence of deformity, and range of motion. The maximum score is 100 points. Results can be interpreted with the following:
| Performed only at survival follow-up (up to 7 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic implant evaluation and stability assessment at different routinely post-operative timepoints. | Imaging will be collected to evaluate the radiographic performance of the device, which will contribute to the overall efficacy evaluation of the CL TRAUMA femoral stem. All X-rays performed during the clinical study fall within standard clinical practice. Radiological assessment was carried out postoperatively at discharge, at 1 month and 24 months after the surgery. It included standard views, such as antero-posterior (AP) of the pelvis and lateral (LAT) of the affected hip. |
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Inclusion Criteria:
Exclusion Criteria:
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The eligible study population is represented by the entire population that underwent a hip replacement with CL TRAUMA femoral stem from 2017 to 2023.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedale Università di Padova | Padova | Padova | 35128 | Italy |
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| Performed at discharge, 1 month follow-up, 2 years follow-up and at survival follow-up (up to 7 years). |
| Survivorship of the implant (Kaplan-Meier estimate) after surgery at survival follow-up. | The Kaplan-Meier estimate for implant revision will be calculated and shown graphically. The time from the initial operation to the revision date will be described in person-years, and the Poisson incidence rate and associated 95% CI (confidence interval) will be provided. | Performed only at survival follow-up (up to 7 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. | From surgery to survival follow-up (up to 7 years). |