NCT07378917

Orthotic Impact on MTP Alignment in Hallux Valgus

Evaluation of Metatarsophalangeal Joint Alignment in Mild and Moderate Hallux Abducto Valgus Through Orthotic Intervention

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: University of Valencia · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the effectiveness of an external corrector in realigning the first metatarsophalangeal joint in patients with mild to moderate Hallux Abducto Valgus, according to the Manchester scale. Changes in valgus angle will be assessed through radiographs, along with pain, comfort and adherence, comparing results with a control group.

Detailed description

Introduction and Rationale Hallux Abducto Valgus (HAV) is the most common forefoot deformity, often associated with pain and functional limitations. Its development is multifactorial, and although surgical and conservative treatments exist, evidence regarding the real effectiveness of corrective orthopedic devices in early stages is scarce. This study seeks to provide scientific rigor to a device frequently recommended in clinical practice by evaluating its ability to correct alignment and improve symptoms. Main and Secondary Objectives The primary objective is to assess the effectiveness of the corrector in realigning the first toe by measuring the valgus angle radiographically at three time points: without the corrector, immediately after application, and after 3 months. Secondary objectives include evaluating pain (VAS), comfort, adherence, device fit, changes in plantar pressure (static and dynamic), patient satisfaction, and differences compared to the control group. Study Design and Population This is an experimental study involving a group of 35 subjects diagnosed with mild or moderate HAV according to the Manchester scale, recruited at the Aquilesia podiatry clinic (Vila-real, Castelló). Recruitment will be carried out through local media, social networks, and referrals from healthcare professionals. Informed consent, anonymity, and compliance with data protection regulations will be ensured. Intervention and Measurements The intervention consists of applying an external hallux alignment corrector. Three radiographic measurements of the metatarsophalangeal angle will be taken: baseline, after corrector placement, and at 3 months. Additional data will include pain, comfort, adherence and device adjustment. Standardized scales (VAS, satisfaction questionnaires) and Excel-based data recording will be used. Data Processing and Analysis Data will be collected by a podiatrist and anonymized before analysis. Intra- and intergroup differences will be evaluated using appropriate statistical tests, considering variables such as sex, age, and degree of deformity. The study aims to determine whether the corrector produces significant improvements in alignment and other clinical parameters, providing evidence for its usefulness in podiatric practice.

Conditions

• Hallux Valgus

Interventions

Type	Name	Description
DEVICE	Hallux Valgus Orthosis	This study evaluates the effectiveness of an external hallux valgus orthosis in realigning the first metatarsophalangeal joint in patients with mild to moderate HAV. Two radiographic measurements of the valgus angle will be taken: at baseline and after 3 months of daily orthosis use. Participants will receive instructions for proper placement and adjustment. Secondary outcomes include pain (VAS), comfort, satisfaction, plantar pressure analysis (static/dynamic), device fit, and adherence. Data will be collected by podiatrists and anonymized for analysis.

Timeline

• Start date: 2025-11-22
• Primary completion: 2026-03-30
• Completion: 2026-04-01
• First posted: 2026-01-30
• Last updated: 2026-02-03

Locations

1 site across 1 country: Spain