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Clinical Trial Summary

In this prospective case series patients with a tibial fracture are monitored with smart biofeedback systems to document the healing progression and real life weight.


Clinical Trial Description

Ten patients treated with a large external fixator after tibial fracture will be enrolled for this prospective case series. Patients will be equipped with the AO Fracture Monitor (a data logger device) attached post-operatively to a connection rod of the external fixator. The device continuously measures deformation of the fixator frame due to normal weight bearing for up to 12 months by means of a strain gauge. The strain signal is processed on-board and several parameters related to the loading characteristics of the fracture are stored. Simultaneously, patients will be equipped with a fully integrated sensor insole (OpenGo Insole, Moticon GmbH, München). This product offers long-term weight bearing data (recording and storage) and allows non-invasive documentation of real life loading in patients without affecting the daily life activity of the patient. Recording of weight-bearing data will be obtained for a maximum of 4 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03166267
Study type Observational
Source AO Innovation Translation Center
Contact
Status Completed
Phase
Start date May 24, 2018
Completion date February 24, 2021

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