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Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series

Distal Femur Fracture Clinical Trial

Official title:
Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series

Clinical Trial Summary

The goal of this observational multicenter case series is to assess the safety and performance of the CE-marked "Biphasic Plate Distal Femur" during standard of care.

Clinical Trial Description

The goal of this observational study is to assess the safety and performance of the CE-marked "Biphasic Plate Distal Femur" during standard of care. The study is conducted as a retrospective and prospective multicenter case series. Eligible patients are those with fractures of the distal femur who are treated with the Biphasic Plate DF according to the Instruction for Use (IFU). The patient will be followed-up until healing or up to 12 months, whichever comes first. To assess the safety and performance following data is collected: - incidents of AEs/SAEs occurring in the affected lower extremity/extremities - Bone healing assessed by a surgeon - Weightbearing and function - Patients' quality of life and pain level ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06028971
Study type Observational
Source 41medical AG
Contact Marcel Aeschlimann
Phone +41 32 645 41 41
Email clinicaltrials@41medical.com
Status Recruiting
Phase
Start date January 30, 2024
Completion date December 2025
View Details
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