NCT03166267

Real Life Weight Bearing After Tibial Fractures

A Prospective Case Series Study to Monitor Healing Progression and Real Life Weight Bearing After Tibial Fracture Using Smart Biofeedback Systems

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: AO Innovation Translation Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Tibial Fractures
• External Fixation Pin Site Infection

Interventions

Type	Name	Description
DEVICE	External fixator	Tibia fracture (AO 41-43) treated with external fracture fixation (large external fixator)

Timeline

• Start date: 2018-05-24
• Primary completion: 2021-02-24
• Completion: 2021-02-24
• First posted: 2017-05-25
• Last updated: 2021-07-06

Locations

1 site across 1 country: Germany