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).
Study Type
OBSERVATIONAL
Enrollment
47
University Hospital J.A. Reimana
Prešov, Slovakia
Evaluation of the revision rate of Cephalic femoral heads for any reason at 24 months after Unipolar Hemiarthroplasty.
Time frame: From intraoperative to 24months follow up visit
Evaluation of the dislocation rate (including close reduction) in subjects with Cephalic femoral heads from intra-operative to 24 months after Unipolar Hemiarthroplasty.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 24 months follow up visit
Assessment of Pain Likert-scale in subjects with Cephalic femoral heads at 24 months after Unipolar Hemiarthroplasty.
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The pain Likert-scale is a 6-point scale: * severe and spontaneous * severe when walking * tollerable * occurs after activity * light intermittent * no pain
Time frame: 24 months follow up visit
Comparison between pre-operative and 4-month walking ability.
Functional evaluation
Time frame: Performed at preoperative visit to 4months follow up visit
Comparison between pre-operative and 4-month residential status.
Daily habit
Time frame: Performed at preoperative visit and 4months follow up visit