NCT06114043

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

Randomised Controlled Trial; Is Operative Treatment of Mild to Moderate Hallux Valgus Deformity Superior to Conservative Treatment?

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Ostfold Hospital Trust · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

Randomized controlled trial (RCT) investigating the patient reported outcome after operative or conservative treatment in mild to moderate hallux valgus deformity. In this RCT study participants will be divided into operative group, non-operative group where the treatment will be orthopedic aids/wide shoes. The participants will be evaluated 6 months, 1 year and 2 years after starting the treatment. The clinical results will be evaluated using patient reported outcome measures (PROMs). Primary aim: Investigating the clinical result by PROM (Manchester Oxford Foot Questionnaire) Secondary aim: Investigating the radiological results according to newer and traditional parameters. Operative group -correction achieved, residual rate. Conservative group -progression of deformity. Statistical power calculations have been made within the research group. Calculations are based on the main outcome MOxFQ, with the power of 80 and confidence interval 95%. The investigators concluded that a sample size of 49 participants will be needed to perform a regression analysis. To account for loss to follow-up (estimated 20%),120 participants (60 per group) will be recruited.

Conditions

• Hallux Valgus Deformity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2028-03-01
• Completion: 2030-03-01
• First posted: 2023-11-02
• Last updated: 2025-08-03

Locations

1 site across 1 country: Norway