Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Design
Study Description
Connect with a study center
Univeritätsklinikum Münster
Münster, Nordrhein-Westfalen 48149
GermanySite Not Available
Diakonie Jung-Stilling Siegen
Siegen, Nordrhein-Westfalen 57074
GermanySite Not Available
Kantonsspital Graubünden
Chur, Graubünden 7000
SwitzerlandSite Not Available
Universitätsspital Basel
Basel, 4031
SwitzerlandSite Not Available
Universitätsspital Zürich
Zürich, 8091
SwitzerlandSite Not Available

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