Fracture Monitor - Femur

Recruiting now · Not applicable

Conditions studied: Femoral Fracture

In brief

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.

Key facts

Study ID: NCT05410587
Run by: AO Innovation Translation Center
People needed: 37
Starts: 2023-10-03
Expected to finish: 2026-07-01
Last updated by the study team: 2025-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:

Where it is running

Universitätsklinikum des Saarlandes — Homburg, Germany (enrolling)
Universitätsklinikum Münster — Münster, Germany (enrolling)
Berufsgenossenschaftliche Unfallklinik Tübingen — Tübingen, Germany (enrolling)
Universitätsklinikum Ulm — Ulm, Germany (enrolling)

Full record on ClinicalTrials.gov

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