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RECRUITING

NCT05410587

Fracture Monitor - Femur

Sponsor: AO Innovation Translation Center

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-10-03

Completion Date

2026-07

Last Updated

2025-02-03

Healthy Volunteers

Conditions

Femoral Fracture

Interventions

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.

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

Locations (4)

Universitätsklinikum des Saarlandes

Homburg, Germany

Universitätsklinikum Münster

Münster, Germany

Berufsgenossenschaftliche Unfallklinik Tübingen

Tübingen, Germany

Universitätsklinikum Ulm

Ulm, Germany