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.
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 prospective multicenter case series. Eligible patients are those with fractures of the distal femur who are treated with the Biphasic Plate DF according to the Instruction for Use (IFU). The patient will be followed-up until healing or up to 12 months, whichever comes first. To assess the safety and performance following data is collected: * incidents of AEs/SAEs occurring in the affected lower extremity/extremities * Bone healing assessed by a surgeon * Weightbearing and function * Patients' quality of life and pain level
Study Type
OBSERVATIONAL
Enrollment
60
Univeritätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Diakonie Jung-Stilling Siegen
Siegen, North Rhine-Westphalia, Germany
Universitätsspital Zürich
Zurich, Canton of Zurich, Switzerland
Kantonsspital Graubünden
Chur, Kanton Graubünden, Switzerland
Occurrence of AEs/SAEs in the affected lower extremity/extremities
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
Time frame: until clinically healed or up to 12 months
Bone Healing
Radiographic bone healing assessment using the modified Radiographic Union Scale for Tibia (mRUST) Score (1: Callus absent, visible fracture line, 2: Callus present, visible fracture line, 3: Callus bridging, visible fracture line, 4: Callus remodeled, invisible fracture line) Bone healing as assessed by the surgeon
Time frame: until clinically healed or up to 12 months
Patient-reported outcome measures
Quality of life questionaire Pain NRS (0-10) upon weightbearing
Time frame: until clinically healed or up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitätsspital Basel
Basel, Switzerland