Fracture Monitor - Femur

Prospective First in Human Clinical Investigation to Evaluate the Safety of the Fracture Monitor T1 in Patients With Femur Fractures Treated With a Locking Compression Plate

Thirty-seven patients diagnosed with femoral fracture to be treated with a compatible plate will be enrolled for this multicenter prospective interventional study. The Fracture Monitor T1 will be attached to the locking plate during osteosynthesis. Prior to discharge, it will be connected to an app installed either on the patients' smartphone or on the smartphone provided by the sponsor. The device will continuously collect and process data, which can automatically be downloaded via Bluetooth through the smartphone app and transferred in encrypted form to a dedicated cloud server. The smartphones will be equipped with a basic app version with rudimentary user interface that has no data visualization function. During the rehabilitation phase, data collected by the device will not be accessible to the surgeon nor the patient to ensure that no therapeutic decision will be made based on the acquired data. Every patient is treated as per standard of care.

The primary objective of the study is to collect safety information of the Fracture Monitor T1. The secondary objectives are to collect information on device performance, device handling, and usability.

All adverse events (AEs) and serious AEs (SAEs) will be recorded during the study. These will be reviewed and evaluated for their potential relationship to the device.

All patients will be followed up for 6 months after the surgery according to the local standard of care. Given that the removal of the Fracture Monitor T1 may occur beyond 6 months, a safety follow-up will take place at the time point when the Fracture Monitor T1 is removed as per the instructions for use if it has not been removed within the 6 months.

The results will be compiled into a clinical evaluation report to be submitted as part of the technical documentation for the conformity assessment procedure.

Study Overview

• Status: Recruiting
• Conditions: Femoral Fracture
• Intervention / Treatment: Device: Fracture Monitor (implantable device class III)

• Study Type: Interventional
• Enrollment (Estimated): 37
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Viola Grünenfelder; Phone Number: +41 79 696 33 97; Email: viola.gruenenfelder@aofoundation.org
• Study Contact Backup: Name: Aleksandra Vidakovic; Email: aleksandra.vidakovic@aofoundation.org

Study Locations

• Germany
  • Homburg, Germany
    • Recruiting
    • Universitätsklinikum des Saarlandes
    • Contact: Tim Pohlemann
  • Münster, Germany
    • Recruiting
    • Universitatsklinikum Munster
    • Contact: Michael Raschke
  • Tübingen, Germany
    • Recruiting
    • Berufsgenossenschaftliche Unfallklinik Tübingen
    • Contact: Benedikt Braun
  • Ulm, Germany
    • Recruiting
    • Universitatsklinikum Ulm
    • Contact: Konrad Schütze

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years or older
• Closed growth plates at time of injury

• Femoral fracture requiring osteosynthesis and treated with one of the following plates:

  • DePuy Synthes LCP® 4.5/5, Broad
  • DePuy Synthes LCP® 4.5/5, Broad Curved
  • DePuy Synthes LCP® Condylar Plate 4.5/5.0
  • DePuy Synthes VA-LCP® Condylar Plate 4.5/5.0
  • DePuy Synthes LCP® Distal Femur
  • DePuy Synthes LCP® Proximal Femoral Plate 4.5/5.0
  • DePuy Synthes LCP® Proximal Femur Hook Plate
  • 41medical AG, Biphasic Plate DF
• ASA score 1-3
• Full weight-bearing capacity prior to the injury
• The patient is foreseen to be capable of postoperative weight bearing of at least 15 kg
• Willingness to undergo an additional surgery to remove the Fracture Monitor T1 if its removal is not done together with the fixation plate within two years according to standard of care
• Ability to provide written informed consent

Preoperative exclusion Criteria:

• Concomitant fractures in the contralateral leg
• Electromagnetic hypersensitivity
• Implanted electromagnetic bone stimulators
• Pregnancy (determined by pregnancy test)
• Prisoner
• Known history of substance abuse (eg, recreational drugs and alcohol) that would preclude reliable assessments
• Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present clinical investigation

Intraoperative exclusion criteria:

• Use of compression lag screw across fracture fragment
• Compression osteosynthesis
• Precontouring of implant at the area of the attachment of Fracture Monitor T1
• Double-plating technique
• Soft-tissue coverage > 6 cm above the data logger
• Concurrent use of intramedullary nail
• Patients foreseen to require magnetic resonance imaging scanning at any part of the body or shockwave therapy at the proximity of the Fracture Monitor T1
• Fracture Monitor T1 not functional according to the instruction for use (IFU, section 24, A) and no functional replacement implant available

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Fracture Monitor T1 (implantable device class III)	Device: Fracture Monitor (implantable device class III); Femoral fracture fixation (bridge plating aiming at secondary bone healing) using a locking plate with an attached investigational Fracture Monitor T1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ADEs	To evaluate the safety, (ie the incidence of adverse device effects (ADEs), of the investigational device Fracture Monitor T1 in femoral fracture patients)	6 months postsurgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance: Relationship - implant load/bone healing	Relationship between relative implant load and bone healing status	6 months
Clinical performance: Relationship - implant load/weight bearing	Relationship between relative implant load and prescribed weight bearing	6 months
Clinical performance: Relationship - implant load/Function Index for Trauma(FIX-IT)	Relationship between relative implant load and Function Index for Trauma (FIX-IT) score FIX-IT: max 12 points - 0 worse/12 best	6 months
Clinical performance: Relationship - implant load/Patient reported outcomes	Relationship between relative implant load and Patient reported outcomes: pain, EuroQol 5- dimension (EQ-5D) EQ-5D health states can be summarised using a 5-digit code or represented by a single summary number (index value) which reflects how good or bad a health state is according to the preferences of the general population of a country/region.	6 months
Clinical performance: Relationship - implant load/Modified Radiographic union score for tibia(mRUST)	Relationship between relative implant load and mRUST score. mRUST: The mRUST score ranges from 4-16 as the four cortices assessed in two orthogonal planes have a score range from 1 to 4 (1: absent callus - 4 callus remodeled)	6 months
Clinical performance: Curve drop	Analyses of the loading curve drop based on: -Time to curve drop	6 months
Clinical performance: Difference curve drop/soc x-ray	Analyses of the loading curve drop based on: Difference in the timing between drop in the loading curve (50%) and standard-of-care x-ray	6 months
Other safety parameters: AEs	- Incidence of adverse events (AEs)	6 months
Other safety parameters: DD	- Incidence of device deficiencies within 6 months	6 months
Technical performance in a clinical setup	• Average minimum sensor strain per loading event	6 months
Technical performance in a clinical setup	• Daily active time of implant (patient activity triggers recording of implant)	6 months
Technical performance in a clinical setup	• Number of daily activations (implant switches from idle to recording)	6 months
Technical performance in a clinical setup	• User calibration range (patient-specific calibration on stiffness of fixation construct)	6 months
Technical performance in a clinical setup	• Data down and upload frequency	6 months
Technical performance in a clinical setup	• Number of Bluetooth adverts	6 months
Technical performance in a clinical setup	• Bluetooth signal strength (dBm)	6 months
Technical performance in a clinical setup	• Bluetooth connection time (s)	6 months
Technical performance in a clinical setup	• Battery voltage after each month	6 months
Technical performance in a clinical setup	• Power consumption (device lifetime)	6 months
Technical performance in a clinical setup	• Internal device temperature	6 months
Technical performance in a clinical setup	• Initialization and daily system test results	6 months
Technical performance in a clinical setup	• Internal clock accuracy	6 months

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Investigators: Principal Investigator: Benedikt Braun, University Hospital Tübingen

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Fracture healing; Femur; Fracture fixation, internal
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: FM_AO_001

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