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

Active Not RecruitingN/A

Sponsor: 41medical AG

Conditions: Distal Femur Fracture, Periprosthetic Fractures, Intra-Articular Fractures, Supracondylar Fracture

Countries: Germany, Switzerland

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (5)

Münster, North Rhine-Westphalia, Germany
Siegen, North Rhine-Westphalia, Germany
Zurich, Canton of Zurich, Switzerland
Chur, Kanton Graubünden, Switzerland
Basel, Switzerland