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

NCT ID: NCT06028971

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2027-10-31

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

Conditions

Distal Femur Fracture; Periprosthetic Fractures; Intra-Articular Fractures; Supracondylar Fracture

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

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

• Patient is participating in another interventional clinical trial.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO Innovation Translation Center

OTHER

Sponsor Role: collaborator

41medical AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Sommer, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Kantonsspital Graubünden Chur

Locations

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

Universitätsspital Basel

Basel, , Switzerland

Countries

Germany; Switzerland

Other Identifiers

1156

Identifier Type: -

Identifier Source: org_study_id