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)
Occurrence of AEs/SAEs in the affected lower extremity/extremities — until clinically healed or up to 12 months The primary outcome measure is the occurrence of AEs/SAEs in the affected lower extremity/extremities that are deemed related, probably related, or possibly related to the surgical procedure or the Biphasic Plate DF
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.
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