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Clinical Trials in Germany / NCT06028971
Active, not recruiting Observational

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

NCT06028971 · tracked via the Priya Life Science Germany tracker
Sponsor
41medical AG
Phase
Observational
Started
2024-02-29
Last updated
2026-09-09

Condition(s) studied

Distal Femur FracturePeriprosthetic FracturesIntra-Articular FracturesSupracondylar Fracture

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 (preoperatively): * Patient is participating in another interventional clinical trial. Exclusion Criteria (intraoperatively): * 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

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Univeritätsklinikum Münster Münster North Rhine-Westphalia
Diakonie Jung-Stilling Siegen Siegen North Rhine-Westphalia
Universitätsspital Zürich Zurich Canton of Zurich
Kantonsspital Graubünden Chur Kanton Graubünden
Universitätsspital Basel Basel Switzerland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06028971 on ClinicalTrials.gov ↗ ← All trials in Germany