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Study design: monocentric, retrospective, observational and post-market clinical study.
Purpose: To demonstrate the safety and performance of cephalic femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with cephalic femoral heads from 1st January 2023 onwards at the site in accordance with the indication for use of the product.
The study is aiming to demoranstrate safety and performance of cephalic femoral heads and will do it by considering the rate of revision of any prosthesis component and dislocation, by x-ray evaluation, by patient reported outcomes and walking/residential status. Patients are followed for 2 years after hemiarthroplasty and data are collected at 6 timepoints (pre-operative, intra-operative, at discharge, 4-months follow up, 12 months follow up and 24 months follow up).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who underwent hip arthroplasty with cephalic femoral heads from 1at January 2023 onwards. | The study population for this clinical investigation includes subjects who suffered from a traumatic proximal femur fracture and underwent a Unipolar hemiarthroplasty with Cephalic femoral head from January 1st, 2023, onwards. Due to the characteristics of patients who underwent this type of surgery, it is expected that a considerable number of eligible patients would be in the elderly age. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the revision rate of Cephalic femoral heads for any reason at 24 months after Unipolar Hemiarthroplasty. | From intraoperative to 24months follow up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the dislocation rate (including close reduction) in subjects with Cephalic femoral heads from intra-operative to 24 months after Unipolar Hemiarthroplasty. | From intraoperative to 24months follow up visit | |
| Evaluation of the revision incidence of any hip component for any reason from intra-operative to 24 months after Unipolar Hemiarthroplasty. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who underwent partial hip arthroplasty with cephalic femoral heads from 1st January 2023 onwards
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monica Novello | Contact | +39 3358162087 | monica.novello@enovis.com | |
| Francesca Citossi | Contact | +39 0432 945511 | clinicalresearch@enovis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital J.A. Reimana | Prešov | 5898 | Slovakia |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| From intraoperative to 24months follow up visit |
| Evaluation of acetabular erosion (according to Baker classification) in subjects with Cephalic femoral heads at 12 months after Unipolar Hemiarthroplasty. | Baker classification is graded from 0 to 3, where 3 is the worst case. Grade 0: no erosion Grade 1: narrowing the arthicular cartilage, no erosion Grade 2: acetabular erosion and early migration Grade 3: protrusion acetabuli | 12 months follow up visit |
| Assessment of Harris Hip Score (HHS) at 24 months after Unipolar Hemiarthroplasty with Cephalic femoral heads. | The Harris Hip Score goes from 0 to 100, which is the best result. | 24 months follow up visit |
| Assessment of Oxford Hip Score (OHS) completed by subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty. | The Oxford Hip Score goes from 0 to 48, with 48 being the best outcome | 24 months follow up visit |
| Assessment of Pain Likert-scale in subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty. | The pain Likert-scale is a 6-point scale:
| 24 months follow up visit |
| Comparison between pre-operative and 4-month walking ability. | Functional evaluation | Performed at preoperative visit to 4months follow up visit |
| Comparison between pre-operative and 4-month residential status. | Daily habit | Performed at preoperative visit and 4months follow up visit |