NCT05163431

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

December 15, 2021

Last Update Submit

March 2, 2023

Conditions

Hallux Valgus

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Painful Hallux Valgus

EXPERIMENTAL
Device: Hallux Valgus orthosis

Interventions

Hallux Valgus orthosisDEVICE

Custom designed orthosis and manufactured by 3D printing.

Painful Hallux Valgus

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Painful hallux valgus
  • three people maximum per shoe size

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TOPMED

Québec, Quebec, G1S1C1, Canada

Location

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Study Officials

  • Edith Martin, PhD

    TOPMED

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2021

First Posted

December 20, 2021

Study Start

July 20, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

March 6, 2023

Record last verified: 2023-03

Locations

CA(1)