NCT06873568

Cephalic Femoral Heads Follow Up

A Post-market Study Evaluating Clinical and Safety Outcomes of Unipolar Hemiarthroplasty Using Cephalic Femoral Heads in Subjects with Hip Fracture

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 47 (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 cephalic femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with cephalic 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 cephalic 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

• Hip Arthroplasty Replacement
• Femoral Fractures

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-03-12
• Last updated: 2025-03-18

Locations

1 site across 1 country: Slovakia