Orthotic Impact on MTP Alignment in Hallux Valgus

NCT07378917 | Completed

• 1 other identifier: EJC_01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hallux Valgus

Keywords

Hallux Abducto Valgus (HAV); Metatarsophalangeal Joint Alignment; Orthotic Devices; Radiographic Assessment

Outcome Measures

Primary Outcomes (1)

• Radiographic Valgus Angle Correction

  Measurement of the hallux valgus angle on digital radiographs at baseline and after 3 months of orthosis use, to determine the degree of realignment of the first metatarsophalangeal joint.

  3 months

Secondary Outcomes (6)

• Pain Assessment (VAS)

  3 months

• Comfort and Satisfaction

  3 months

• Device Fit and Adjustment

  1day

• Orthosis Condition After Use

  3 months

• Adherence to Treatment

  3 months

Study Arms (1)

Orthosis

EXPERIMENTAL

The study group will consist of 35 adult subjects, both men and women, diagnosed with mild to moderate Hallux Abducto Valgus (HAV) according to the Manchester scale.

Device: Hallux Valgus Orthosis

Interventions

Hallux Valgus Orthosis DEVICE

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.

Orthosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sex: Male or female Age: 18 to 80 years Cooperative subject, informed of the need and duration of follow-up visits, ensuring full compliance with the protocol/study, and having signed informed consent No previous surgery on the foot and/or ankle Mild and/or moderate Hallux Valgus (Manchester Scale)

You may not qualify if:

• Patient with severe arteriopathy Patient with severe edema Patient with sensory neuropathy Patients who have used additional pharmacological treatments (analgesics/anti-inflammatories) during the entire study period Severe Hallux Valgus (Manchester Scale) Any systemic disease affecting the musculoskeletal system Rheumatoid arthritis involving the first metatarsophalangeal joint Instability of the first metatarsophalangeal joint History of previous foot and/or ankle surgery Hyperpronated foot with FPI \>10 Severe pathological genu varum or valgum Pregnant women or suspected pregnancy

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Carmen García Gomariz

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Officials

• CARMEN GARCÍA GOMARIZ

  UNIVERSITAT DE VALÉNCIA DEPARTAMENTO D'INFERMERIA

  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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Infirmary

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 30, 2026
• Study Start: November 22, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 27, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)