Dimensional Validation of the Hallux Valgus Orthosis

Hallux Valgus Clinical Trial

Official title:

Dimensional Validation of the Hallux Valgus Orthosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05163431
• Other study ID #: RD-19-0241_HV_HV
• Status: Completed
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2023
• Source: TOPMED
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bunion
• Hallux Valgus

Intervention

Device:
• Hallux Valgus orthosis
Custom designed orthosis and manufactured by 3D printing.

Locations

Country	Name	City	State
Canada	TOPMED	Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
TOPMED	Natural Sciences and Engineering Research Council, Canada, Orthèse Hallux Valgus Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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