Status:
ACTIVE_NOT_RECRUITING
Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series
Lead Sponsor:
41medical AG
Collaborating Sponsors:
AO Innovation Translation Center
Conditions:
Distal Femur Fracture
Periprosthetic Fractures
Eligibility:
All Genders
18+ years
Brief 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 prosp...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 29 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06028971
Start Date
February 29 2024
End Date
October 31 2027
Last Update
July 10 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Univeritätsklinikum Münster
Münster, North Rhine-Westphalia, Germany, 48149
2
Diakonie Jung-Stilling Siegen
Siegen, North Rhine-Westphalia, Germany, 57074
3
Universitätsspital Zürich
Zurich, Canton of Zurich, Switzerland, 8091
4
Kantonsspital Graubünden
Chur, Kanton Graubünden, Switzerland, 7000