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

Distal Femur Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06028971
• Other study ID #: 1156
• Status: Recruiting
• Start date: January 30, 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: 41medical AG
• Contact: Marcel Aeschlimann
• Phone: +41 32 645 41 41
• Email: clinicaltrials[@]41medical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Femur Fracture
• Femoral Fractures
• Fractures, Bone
• Intra-Articular Fractures
• Periprosthetic Fractures
• Supracondylar Fracture

Locations

Country	Name	City	State
Germany	Univeritätsklinikum Münster	Münster	Nordrhein-Westfalen
Germany	Diakonie Jung-Stilling Siegen	Siegen	Nordrhein-Westfalen
Switzerland	Universitätsspital Basel	Basel
Switzerland	Kantonsspital Graubünden	Chur	Graubünden
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
41medical AG	AO Innovation Translation Center

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Patient-reported outcome measures	Quality of life questionaire Pain NRS (0-10) upon weightbearing	until clinically healed or up to 12 months