Actively Recruiting
Safety and Outcomes Study of CoCrMo LOCK Bipolar Femoral Heads for Hip Fractures After Hip Replacement Surgery
Led by Limacorporate S.p.a · Updated on 2026-07-07
60
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are observing patients who have undergone hip replacement surgery using CoCrMo LOCK bipolar femoral heads to assess the safety and performance of these devices. This study includes individuals with displaced intracapsular hip fractures treated at a single center starting from January 2023, focusing on long-term outcomes such as revision rates and dislocations. Participants receive a bipolar hemiarthroplasty with CoCrMo LOCK femoral heads and are followed over two years. Data collection occurs at six points before surgery, during surgery, at hospital discharge, and at 4, 12, and 24 months after surgery. The study evaluates outcomes including revision rates of the implant, dislocation rates, acetabular erosion, and patient-reported measures like hip function and pain. Throughout the study, patients undergo X-rays and complete questionnaires assessing hip function and pain levels. Walking ability and living situation are also tracked before surgery and at 4 months post-operation. Researchers monitor safety and performance through these repeated assessments, with the primary focus on revision rates 24 months after surgery. The total participation period for each patient is two years.
CONDITIONS
Brief Title
CoCrMo LOCK Bipolar Femoral Heads FU
Research Team
M
Monica Novello
F
Francesca Citossi
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