RecruitingNot ApplicableNCT07378917

Orthotic Impact on MTP Alignment in Hallux Valgus

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

Sponsor

University of Valencia

Enrollment

35 participants

Start Date

Nov 22, 2025

Study Type

INTERVENTIONAL

Conditions

Hallux Valgus

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria1

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)

Exclusion Criteria1

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

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Interventions

DEVICEHallux 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.