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

Not Applicable

Not yet recruiting

• Conditions: Hallux Valgus Deformity
• Interventions: Other: Operation for mild to moderate hallux valgus; Other: Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus

• Registration Number: NCT06114043
• Lead Sponsor: Ostfold Hospital Trust

Brief 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.

Study Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-11-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-10
• Study Start: 2024-10
• Primary Completion: 2028-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Operation	Operation for mild to moderate hallux valgus	60 participants will be operated for mild to moderate hallux valgus deformity
Conservative	Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus	60 participants will be treated conservatively with a wide shoe

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clinical result VAS	2 years	Visual analogue scale (VAS) 0-10 (0=best to 10=worst)
Clinical result Likert scale	2 years	Likert scale 0-5 (0=worst to 5=best)
Clinical result SF-36	2 years	Short Form Health Survey (SF-36) (0=worst to 100=best)