NCT06885359

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Limacorporate S.p.a · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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).

Conditions

• Femoral Fractures
• Hip Arthropathy

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-03-20
• Last updated: 2025-03-26

Locations

1 site across 1 country: Slovenia