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Completed

NCT Number: NCT03166267

Real Life Weight Bearing After Tibial Fractures

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.

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Key information

Conditions

Tibial Fractures External Fixation Pin Site Infection Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

BGU Tübingen

Tübingen, D-72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External fixator

Device

Tibia fracture (AO 41-43) treated with external fracture fixation (large external fixator)

Primary outcomes

  1. Loading patterns

    Time frame: Up to 4 months

    Average peak force per step

Secondary outcomes

  1. Activity

    Time frame: Up to 4 months

    Patient activity measured as number of loading events per day

  2. Healing

    Time frame: Up to 4 months

    Expert opinion

  3. Pain level

    Time frame: Up to 4 months

    Numeric rating scale

Sponsors and collaborators

Lead sponsor

AO Innovation Translation Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 25, 2017
Registry last updated
Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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