Ireland
--:--IST
Recruiting Not applicable

Operative Versus Non-operative Treatment for Mild to Moderate Hallux Valgus Deformity

NCT06114043 · tracked via the Priya Life Science Norway tracker
Phase
Not applicable
Started
2025-06-01
Last updated
2025-08-03

Condition(s) studied

Hallux Valgus Deformity

Investigational drug(s) / intervention(s)

Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgusOperation for mild to moderate hallux valgus

Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus: 60 participants will receive conservative treatment with orthopedic aid/wide shoe. Participants will be followed for 2 years.

Operation for mild to moderate hallux valgus: 60 participants will receive the traditional operative treatment for the deformity. Participants will be followed for 2 years.

Study summary

The goal of this randomized controlled trial is to investigate operative treatment versus conservative treatment in participants suffering from mild to moderate hallux valgus deformity. The main question it aims to answer are; Is surgery superior to conservative treatment?

The participants will be randomized in to two groups, operative and conservative group.

Investigators will compare the groups measuring the clinical results using the patient-reported outcome measure (PROM) Manchester-Oxford Foot Questionnaire (MOxFQ), Visual analog scale (VAS), likert scale 0-5. Participants will be observed for a period og two years.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Painful Hallux Valgus deformity * Hallux Valgus Angle \<35 degrees * Intermetatarsal angle \<15 degrees * 18-80 years Exclusion Criteria: * Advanced osteoarthritis in first metatarsophalangeal joint * Rheumatic diseases * Pregnancy * Drug abuse * Severe psychological disorder * Lack of compliance * Language barrier

Primary outcome measure(s)

  • Clinical results MOxFQ — 2 years
    Manchester oxford foot questionnaire (MOxFQ) (Raw scores can be converted to a 0-100 metric where 100=most severe)

Trial sites (1)

FacilityCityRegionStatus
Østfold Hospital Trust Sarpsborg Norway Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06114043 on ClinicalTrials.gov ↗ ← All trials in Norway