CoCrMo LOCK Bipolar Femoral Heads FU
Launched by LIMACORPORATE S.P.A · Mar 17, 2025
Trial Information
Current as of April 23, 2025
Not yet recruiting
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).
About Limacorporate S.P.A
Limacorporate S.p.A. is a leading global medical device company specializing in innovative solutions for orthopedic surgery and regenerative medicine. With a strong commitment to research and development, Limacorporate focuses on advancing surgical techniques and improving patient outcomes through its cutting-edge technologies and products. The company is dedicated to conducting rigorous clinical trials to ensure the safety and efficacy of its offerings, fostering collaboration with healthcare professionals and institutions worldwide to enhance the standard of care in musculoskeletal treatments.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Celje, , Slovenia
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported