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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Marcel Aeschlimann; Phone Number: +41 32 645 41 41; Email: clinicaltrials@41medical.com
• Study Contact Backup: Name: Ladina Hofmann; Phone Number: +41 79 600 61 98; Email: ladina.hofmann@aofoundation.org

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Münster, Nordrhein-Westfalen, Germany, 48149
      • Recruiting
      • Univeritätsklinikum Münster
      • Contact: Marion Laumann; Phone Number: +49 251 - 83 51479; Email: marion.laumann@ukmuenster.de
      • Principal Investigator: Michael J. Raschke, Univ.-Prof. Dr. med.
      • Sub-Investigator: Moritz F. Lodde, Dr. med.
      • Sub-Investigator: Josef Stolberg-Stolberg, PD. Dr. med
      • Sub-Investigator: Elmar Herbst, Priv.-Doz. Dr. med. univ., PHD
    • Siegen, Nordrhein-Westfalen, Germany, 57074
      • Recruiting
      • Diakonie Jung-Stilling Siegen
      • Contact: Steffen Schröter, Prof. Dr. med.; Phone Number: +492713334505; Email: schroeter.steffen@t-online.de
      • Principal Investigator: Steffen Schröter, Prof. Dr. med.
      • Sub-Investigator: Thorsten Knott, Dr. med.
      • Contact: Isabella Thomas; Phone Number: +49271 333 4505; Email: Isabella.Thomas@diakonie-sw.de
• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Universitatsspital Basel
    • Contact: Karl Kilian Stoffel, Prof. Dr. med.; Phone Number: +41 61 328 50 51; Email: karl.stoffel@usb.ch
    • Contact: Marlene Mauch, Dr. rer. nat.; Email: marlene.mauch@usb.ch
  • Zürich, Switzerland, 8091
    • Recruiting
    • Universitatsspital Zurich
    • Contact: Sandro-Michael Heining, Dr. med.; Phone Number: +41 44 255 23 99; Email: sandro.heining@usz.ch
    • Principal Investigator: Sandro-Michael Heining, Dr. med.
  • Graubünden
    • Chur, Graubünden, Switzerland, 7000
      • Recruiting
      • Kantonsspital Graubünden
      • Contact: Christoph Sommer, Dr. med.; Phone Number: +41812566111; Email: Christoph.Sommer@ksgr.ch
      • Principal Investigator: Christoph Sommer, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 41medical AG
• Collaborators: AO Innovation Translation Center
• Investigators: Principal Investigator: Christoph Sommer, Dr. med., Kantonsspital Graubünden Chur

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Intra-Articular Fractures; Femur Fracture; Distal Femur Fracture; Periprosthetic Fractures; Biphasic Plate DF
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone; Periprosthetic Fractures; Intra-Articular Fractures; Femoral Fractures, Distal
• Other Study ID Numbers: 1156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No