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

Recruiting

• Conditions: Distal Femur Fracture; Supracondylar Fracture; Periprosthetic Fractures; Intra-Articular Fractures

• Registration Number: NCT06028971
• Lead Sponsor: 41medical AG

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-08
• Study Start: 2024-02-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Primary Completion: 2025-02
• Last Update Posted: 2025-02-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Bone Healing	until clinically healed or up to 12 months	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
Patient-reported outcome measures	until clinically healed or up to 12 months	Quality of life questionaire Pain NRS (0-10) upon weightbearing

Trial Locations

Locations (5)

Univeritätsklinikum Münster; 🇩🇪 Münster, Nordrhein-Westfalen, Germany

Diakonie Jung-Stilling Siegen; 🇩🇪 Siegen, Nordrhein-Westfalen, Germany

Kantonsspital Graubünden; 🇨🇭 Chur, Graubünden, Switzerland

Universitätsspital Basel; 🇨🇭 Basel, Switzerland

Universitätsspital Zürich; 🇨🇭 Zürich, Switzerland