Real Life Weight Bearing After Tibial Fractures

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tibial Fractures, External Fixation Pin Site Infection

Intervention / Treatment
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* Device: External fixator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older Diagnosis of tibial fracture (AO 41-43) External fracture fixation with large external fixator Capable of at least partial weight-bearing Bone segment transport (if applicable) must be completed Informed consent obtained, i.e.: Ability to understand the content of the patient information/ Informed Consent Form (ICF) Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP) Signed and dated Ethics Committee (EC) Exclusion Criteria: External fixation as temporary stabilization Bone fragment compression Joint-bridging external fixation Any not medically managed severe systemic disease Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment Pregnancy or women planning to conceive within the study period Prisoner Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: External fixator|Tibia fracture (AO 41-43) treated with external fracture fixation (large external fixator)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loading patterns | Average peak force per step | Up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity | Patient activity measured as number of loading events per day | Up to 4 months | 
| Healing | Expert opinion | Up to 4 months | 
| Pain level | Numeric rating scale | Up to 4 months |