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Real Life Weight Bearing After Tibial Fractures

Sponsor
AO Innovation Translation Center (Other)
Overall Status
Completed
CT.gov ID
NCT03166267
Collaborator
(none)
10
Enrollment
1
Location
33.1
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
10 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Prospective Case Series Study to Monitor Healing Progression and Real Life Weight Bearing After Tibial Fracture Using Smart Biofeedback Systems
Actual Study Start Date :
May 24, 2018
Actual Primary Completion Date :
Feb 24, 2021
Actual Study Completion Date :
Feb 24, 2021

Outcome Measures

Primary Outcome Measures

  1. Loading patterns [Up to 4 months]

    Average peak force per step

Secondary Outcome Measures

  1. Activity [Up to 4 months]

    Patient activity measured as number of loading events per day

  2. Healing [Up to 4 months]

    Expert opinion

  3. Pain level [Up to 4 months]

    Numeric rating scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 BGU Tübingen Tübingen Germany D-72076

Sponsors and Collaborators

  • AO Innovation Translation Center

Investigators

  • Principal Investigator: Stefan Döbele, MD, BGU Tübingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AO Innovation Translation Center
ClinicalTrials.gov Identifier:
NCT03166267
Other Study ID Numbers:
  • SmartFix II - Moticon
First Posted:
May 25, 2017
Last Update Posted:
Jul 6, 2021
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures

Study Results

No Results Posted as of Jul 6, 2021