Study design: monocentric, retrospective, observational and post-market clinical study. Purpose: To demonstrate the safety and performance of CoCrMo LOCK bipolar femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with CoCrMo LOCK bipolar 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 LOCK Bipolar 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
60
Splošna bolnišnica Celje
Celje, Slovenia
Evaluation of the revision rate of CoCrMo LOCK Bipolar femoral heads at 24 months after surgery.
Time frame: At 24 months after intraoperative visit
Evaluation of the dislocation rate (including close reduction) in subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after bipolar hemiarthroplasty
Time frame: At 24 months after intraoperative visit
Evaluation of the revision incidence of any hip component for any reason at 24 months after bipolar hemiarthroplasty.
Time frame: At 24 months after intraoperative visit
Evaluation of acetabular erosion (according to Baker classification) in subjects with CoCrMo LOCK Bipolar femoral heads at 12 months after Bipolar Hemiarthroplasty.
Time frame: At 12 months after intraoperative visit
Assessment of Harris Hip Score (HHS) at 24 months after Bipolar Hemiarthroplasty with CoCrMo LOCK Bipolar femoral heads.
The Harris Hip Score goes from 0 to 100, which is the best result.
Time frame: At 24 months after intraoperative visit
Assessment of Oxford Hip Score (OHS) completed by subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after Bipolar Hemiarthroplasty.
The Oxford Hip Score goes from 0 to 48, with 48 being the best outcome
Time frame: At 24 months after intraoperative visit
Assessment of Pain Likert-scale in subjects with CoCrMo LOCK Bipolar femoral heads at 24 months after Bipolar Hemiarthroplasty.
The pain Likert-scale is a 6-point scale: - severe and spontaneous - severe when walking - tollerable - occurs after activity - light intermittent - no pain
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Time frame: At 24 months after intraoperative visit
Comparison between pre-operative and 4-month walking ability.
Functional evaluation At the pre-operative time-point, the ability to walk is categorized in: * "able to walk without aids", * "able to walk using one walking aid", * "able to walk using two walking aids", * "able to walk using the walking frame" * "unable to walk" (wheelchair or bed-ridden subjects) At the 4-month post-operative time-point, the ability to walk is investigated is categorized in: * "maintained" (if the subject is able to walk independently as before, with aids if necessary) * "not maintained" (if the subject needs support from another person or uses a wheelchair or is bed-ridden)
Time frame: Performed at preoperative visit and 4months follow up visit
Comparison between pre-operative and 4-month residential status.
Daily habit At pre-operative timepoint, subjects are categorized as subjects that before the fracture were used to live: * at their own home (alone or with assistance), * in a sheltered home for independent people, * in a nursing home for people who need assistance with personal care. At 4-month post-operative timepoint, the residential status is categorised in: * maintained (if the subject is living in the same dwelling as before fracture), * not maintained (if the subject moved to a sheltered accommodation or a nursing home)
Time frame: Performed at preoperative visit and 4months follow up visit