CoCrMo LOCK Bipolar Femoral Heads FU

Launched by LIMACORPORATE S.P.A · Mar 17, 2025

Keywords

ClinConnect Summary

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).

Gender

ALL

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).