Real Life Weight Bearing After Tibial Fractures

Tibial Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03166267
• Other study ID #: SmartFix II - Moticon
• Status: Completed
• Start date: May 24, 2018
• Est. completion date: February 24, 2021

Study information

• Verified date: October 2020
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 24, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• External Fixation Pin Site Infection
• Fractures, Bone
• Tibial Fractures

Intervention

Device:
• External fixator
Tibia fracture (AO 41-43) treated with external fracture fixation (large external fixator)

Locations

Country	Name	City	State
Germany	BGU Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
AO Innovation Translation Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loading patterns	Average peak force per step	Up to 4 months
Secondary	Activity	Patient activity measured as number of loading events per day	Up to 4 months
Secondary	Healing	Expert opinion	Up to 4 months
Secondary	Pain level	Numeric rating scale	Up to 4 months