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.

Study Overview

• Status: Completed
• Conditions: Hallux Valgus
• Intervention / Treatment: Device: Hallux Valgus orthosis

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1S1C1
      • TOPMED

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Painful Hallux Valgus	Device: Hallux Valgus orthosis; Custom designed orthosis and manufactured by 3D printing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in big toe deviation angle during gait at 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.	At baseline and 1 month
Change in pain at 1 month	Pain is measured with a Likert scale from 1 (decrease of pain) to 5 (increase of pain).	At baseline and 1 month
Change in comfort at 1 month	Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).	At baseline and 1 month

Collaborators and Investigators

• Sponsor: TOPMED
• Collaborators: Natural Sciences and Engineering Research Council, Canada; Orthèse Hallux Valgus Inc.
• Investigators: Principal Investigator: Edith Martin, PhD, TOPMED

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Hallux Valgus; Bunion
• Other Study ID Numbers: RD-19-0241_HV_HV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No