CoCrMo LOCK Bipolar Femoral Heads FU
A Post-market Study Evaluating Clinical and Safety Outcomes of Bipolar Hemiarthroplasty Using CoCrMo LOCK Bipolar Femoral Heads in Subjects With Hip Fracture
Limacorporate S.p.a
60 participants
Jan 28, 2026
OBSERVATIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria8
- 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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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06885359