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Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

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

NCT06028971•41medical AG

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with fractures of the distal femur requiring internal fixation and treated with the Biphasic Plate DF as indicated according to the IFU. As per the IFU, the Biphasic Plate DF is indicated for:
•* Distal shaft fractures
•* Supracondylar fractures
•* Intraarticular fractures
•* Periprosthetic fractures
•No other major implant beside the Biphasic Plate DF is used for fixation of the distal femur fracture, with the exceptions of lag screw(s) and/or cerclage wire(s), and/or a joint replacement.
•Patients who are willing and able to comply with postoperative FUs per local standard of care.
•Ability to provide informed consent according to the IRB/EC defined and approved procedures.
•Patients over 18 years of age

Exclusion Criteria

•Patient is participating in another interventional clinical trial.
•Change of surgical plan intraoperatively at the discretion of the surgeon that Biphasic Plate DF is not used
•Necessity to apply a second (medial) plate (double plating) or an intramedullary nail in case of critical fixation distally

Locations (5)

Univeritätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Diakonie Jung-Stilling Siegen

Siegen, North Rhine-Westphalia, Germany

Universitätsspital Zürich

Zurich, Canton of Zurich, Switzerland

Kantonsspital Graubünden

Chur, Kanton Graubünden, Switzerland

Universitätsspital Basel

Basel, Switzerland

Key Dates

Start Date

February 29, 2024

Primary Completion Date

July 31, 2026

Completion Date

October 31, 2027

Last Updated

July 10, 2025

Enrollment

ESTIMATED participants

Conditions

Distal Femur FracturePeriprosthetic FracturesIntra-Articular FracturesSupracondylar Fracture

Carbo-fix Lateral Plate Devices and Standard Plate-Nail Constructs in Distal Femur Fractures

NCT07280169

Distal Femur Fracture

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RECRUITINGNA

pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

NCT05805774

Distal Femur FracturePeriprosthetic Fracture Around Prosthetic Joint Implant Knee+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Carbo-fix Lateral Plate Devices and Standard Plate-Nail Constructs in Distal Femur Fractures

pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement

Periprosthetic Fracture Registry (PPFx)

Opioid-Free Pain Treatment in Trauma Patients

Locking Plates for Distal Femur Fractures - a Multicenter Case Review

Far Cortical Locking Versus Standard Constructs for Distal Femur Fractures