Status:
NOT_YET_RECRUITING
CoCrMo LOCK Bipolar Femoral Heads FU
Lead Sponsor:
Limacorporate S.p.a
Conditions:
Femoral Fractures
Hip Arthropathy
Eligibility:
All Genders
18+ years
Brief 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 pop...
Detailed Description
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 evalu...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06885359
Start Date
October 1 2025
End Date
December 1 2028
Last Update
March 26 2025
Active Locations (1)
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1
Splošna bolnišnica Celje
Celje, Slovenia, 3000