Real Life Weight Bearing After Tibial Fractures

Status Completed

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

External Fixation Pin Site Infection
Fractures, Bone
Tibial Fractures

Clinical Trial Details

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

View Details

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