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

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.

Study Overview

• Status: Completed
• Conditions: Tibial Fractures; External Fixation Pin Site Infection
• Intervention / Treatment: Device: External fixator

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Germany
  • Tübingen, Germany, D-72076
    • BGU Tübingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All eligible patients from the participating clinic are invited to participate in the study.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Investigators: Principal Investigator: Stefan Döbele, MD, BGU Tübingen

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 24, 2018
• Primary Completion (ACTUAL): February 24, 2021
• Study Completion (ACTUAL): February 24, 2021

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (ACTUAL): May 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: SmartFix II - Moticon

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No