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Recruiting
NCT06885359
CoCrMo LOCK Bipolar Femoral Heads FU
Conditions: Femoral Fractures, Hip Arthropathy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 60
Sponsor: Limacorporate S.p.a
Location: Splošna bolnišnica Celje Celje
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Displaced intracapsular hip fracture (Garden III-IV).
* Subjects underwent a Bipolar Hemiarthroplasty with a CoCrMo LOCK Bipolar femoral head as per their Indication For Use from January 1st, 2023, onwards.
* No concurrent joint disease at the time of the surgery.
* Absence of severe cognitive dysfunction demonstrated by 3 or more correct answers on the Pfeiffer test.
* Ability to ambulate independently with or without walking aids before surgery.
* Subject willingness to participate.
Exclusion Criteria:
* Undisplaced or minimally displaced intracapsular hip fracture (Garden I-II).
* Any CoCrMo LOCK Bipolar femoral head contraindication for use as reported in the current Instruction For Use.
* Pathological fracture secondary to malignant disease.
* Subjects with rheumatoid arthritis or symptomatic osteoarthritis.
* Previous treatment to the same hip for a fracture at the time of the surgery.
* Subjects who were deemed unsuitable for the surgical procedures by the anesthesiologist.
* Severe cognitive dysfunction or cognitive impairment demonstrated by 2 or less correct answers on the Pfeiffer test.
* Unable to walk before surgery (e.g., wheelchair or bed-ridden subjects).
Source: ClinicalTrials.gov (NCT06885359). StuddyBuddy aggregates publicly available trial information.