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OpenTrials
Completed

NCT Number: NCT05163431

Dimensional Validation of the Hallux Valgus Orthosis

The goal of this project is to optimize the design of the orthosis by establishing the key volumetric characteristics of the custom iterations in order to subsequently transpose them to a standard model and establish the increment proportions of the different sizes. The final product should reduce the pain by repositioning the phalanges of the first toe with the first metatarsal in its axis.

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Key information

Conditions

Hallux Valgus Foot Deformities Musculoskeletal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TOPMED

Québec, Quebec, G1S1C1, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Painful hallux valgus
  • three people maximum per shoe size

Exclusion criteria

  • People with diabetes ;
  • People with severe obesity ;
  • People with hallux rigidus;
  • People wearing full-time foot orthosis;
  • People wearing high heel shoes regularly ;
  • People with degenerative disease ;
  • People with neuromuscular pathology ;
  • People with a circulatory disorder ;
  • People who have had major lower body surgery;
  • People with epilepsy or with a history of epilepsy.

Treatment and study plan

Hallux Valgus Orthosis

Device

Custom designed orthosis and manufactured by 3D printing.

Primary outcomes

  1. Change in big toe deviation angle during gait at 1 month

    Time frame: At baseline and 1 month

    The big toe deviation angle is the angle between the big toe and the gait axis and measured with a motion capture system.

  2. Change in pain at 1 month

    Time frame: At baseline and 1 month

    Pain is measured with a Likert scale from 1 (decrease of pain) to 5 (increase of pain).

  3. Change in comfort at 1 month

    Time frame: At baseline and 1 month

    Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).

Sponsors and collaborators

Lead sponsor

TOPMED

Other

Collaborators

  • Natural Sciences and Engineering Research Council, Canada
  • Orthèse Hallux Valgus Inc.

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 20, 2021
Registry last updated
Mar 6, 2023

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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