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

NCT06114043 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-08-03

No results posted yet for this 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.

Conditions

  • Hallux Valgus Deformity

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • Ostfold Hospital Trust

    lead OTHER

Principal Investigators

  • Marius Molund · Ostfold Hospital Trust

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2028-03-31
Completion
2030-03-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06114043 on ClinicalTrials.gov