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

Study Overview
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Brief Summary
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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
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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

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

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | until clinically healed or up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | until clinically healed or up to 12 months | 
| Patient-reported outcome measures | Quality of life questionaire Pain NRS (0-10) upon weightbearing | until clinically healed or up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biphasic Plate DF, Distal Femur Fracture, Femur Fracture, Periprosthetic Fractures, Intra-Articular Fractures