Dimensional Validation of the Hallux Valgus Orthosis

TOPMED

Status: Completed

Conditions: Hallux Valgus

Treatments: Device: Hallux Valgus orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05163431

RD-19-0241_HV_HV

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Painful Hallux Valgus

Experimental group

Treatment:

Device: Hallux Valgus orthosis