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

Status Recruiting

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 ;

Related Conditions & MeSH terms

• Distal Femur Fracture
• Femoral Fractures
• Fractures, Bone
• Intra-Articular Fractures
• Periprosthetic Fractures
• Supracondylar Fracture

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