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Real Life Weight Bearing After Tibial Fractures | Clinical Trials | Clareo Health

COMPLETED

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

NCT03166267•AO Innovation Translation Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

BGU Tübingen

Tübingen, Germany

Key Dates

Start Date

May 24, 2018

Primary Completion Date

February 24, 2021

Completion Date

February 24, 2021

Last Updated

July 6, 2021

Enrollment

ACTUAL participants

Conditions

Tibial FracturesExternal Fixation Pin Site Infection

Interventions

External fixator

DEVICE

Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study

NCT05022485

Tibial FracturesFracture Infection

View study

RECRUITINGPHASE3

Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial

NCT07006675

Tibial FracturesPain

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 6, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Real Life Weight Bearing After Tibial Fractures

Inclusion Criteria

Exclusion Criteria

Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study

Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial

Tibio-talo-calcaneal Fusion by Hindfoot Nail Versus Open Reduction and Internal Fixation in Treatment of Complex Fractures Distal Tibial and Fragility Ankle Fractures in Elderly

Conjoint Analysis of Patient Preferences in Joint Interventions

Distal Targeter vs Free-hand

A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System