NCT06028971

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: 41medical AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Distal Femur Fracture
• Periprosthetic Fractures
• Intra-Articular Fractures
• Supracondylar Fracture

Timeline

• Start date: 2024-02-29
• Primary completion: 2026-07-31
• Completion: 2027-10-31
• First posted: 2023-09-08
• Last updated: 2025-07-10

Locations

5 sites across 2 countries: Germany, Switzerland