Dimensional Validation of the Hallux Valgus Orthosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-20

Study Completion Date

2022-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of the Effects of Two Different Orthoses on Individuals With Hallux Valgus

NCT06128642

Hallux Valgus

COMPLETED

Comparison of Bioabsorbable and Steel Screw for the Treatment of Hallux Valgus With Chevron Osteotomy

NCT03470623

Hallux Valgus

UNKNOWN NA

Prospective, Multi-Center Clinical Evaluation of the Open Wedge Osteotomy and Low Profile Plate & Screw (LPS) System Compared to the Proximal Chevron Osteotomy for the Treatment of Hallux Valgus With an Increased Intermetatarsal Angle

NCT01791634

Hallux Valgus

COMPLETED NA

Hallux Valgus and Custom Orthotic Prescription

NCT02386631

Hallux Valgus

COMPLETED NA

Validation of an Ankle Foot Orthosis With Anterior Support for Foot Drop

NCT05163782

Foot Drop

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hallux Valgus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Painful Hallux Valgus

Group Type EXPERIMENTAL

Hallux Valgus orthosis

Intervention Type DEVICE

Custom designed orthosis and manufactured by 3D printing.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hallux Valgus orthosis

Custom designed orthosis and manufactured by 3D printing.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No