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

NCT06028971 | Active Not Recruiting

• 1 other identifier: 1156
• Study Type: observational
• Target: 60
• Locations: 2 countries
• Sites: 5

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.

Conditions

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

Keywords

Biphasic Plate DF; Distal Femur Fracture; Femur Fracture; Periprosthetic Fractures; Intra-Articular Fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Bone Healing

  until clinically healed or up to 12 months

• Patient-reported outcome measures

  until clinically healed or up to 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eledgible patients will be identified at the sites (primary care clinics)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• 41medical AG: lead
• AO Innovation Translation Center: collaborator

Study Sites (5)

Univeritätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Diakonie Jung-Stilling Siegen

Siegen, North Rhine-Westphalia, 57074, Germany

Location

Universitätsspital Zürich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Kantonsspital Graubünden

Chur, Kanton Graubünden, 7000, Switzerland

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Femoral Fractures, Distal; Periprosthetic Fractures; Intra-Articular Fractures; Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Christoph Sommer, Dr. med.

  Kantonsspital Graubünden Chur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: February 29, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); CH (3)