Real Life Weight Bearing After Tibial Fractures

Completed

• Conditions: Tibial Fractures; External Fixation Pin Site Infection

• Registration Number: NCT03166267
• Lead Sponsor: AO Innovation Translation Center

Brief 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.

Study Timeline

• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-25
• Study Start: 2018-05-24
• Status Verified: 2020-10
• Primary Completion: 2021-02-24
• Study Completion: 2021-02-24
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Loading patterns	Up to 4 months	Average peak force per step

Secondary Outcome Measures

Name	Time	Method
Activity	Up to 4 months	Patient activity measured as number of loading events per day
Healing	Up to 4 months	Expert opinion
Pain level	Up to 4 months	Numeric rating scale

Trial Locations

Locations (1)

BGU Tübingen; 🇩🇪 Tübingen, Germany