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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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06885359). StuddyBuddy aggregates publicly available trial information.