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

Study Overview
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Brief Summary
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The goal of this randomized controlled trial is to investigate operative treatment versus conservative treatment in patients 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, likert scale 0-10. Participants will be observed for a period og two years.

Detailed Description
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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%. We 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%) we will recruit 120 participants (60 per group).

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

Conditions
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Hallux Valgus Deformity

Intervention / Treatment
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* Other: Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus
* Other: Operation for mild to moderate hallux valgus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial investigating patients with painful mild to moderate hallux valgus deformity
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Operation<br>60 patients will be operated for mild to moderate hallux valgus deformity | Other: Operation for mild to moderate hallux valgus<br>* 60 participants will receive the traditional operative treatment for the deformity. Partipants will be followed for 2 years.<br>|
| Other: Conservative<br>60 patients will be treated conservatively with a wide shoe | Other: Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus<br>* 60 participants will receive conservative treatment with orthopedic aid/wide shoe. Participants will be followed for 2 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical results MOxFQ | Manchester oxford foot questionnaire (MOxFQ) (Raw scores can be converted to a 0-100 metric where 100=most severe) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical result VAS | Visual analogue scale (VAS) 0-10 | 2 years | 
| Clinical result SF-36 | Short Form Health Survey (SF-36) (0=worst to 100=best) | 2 years | 
| Clinical result Likert scale | Likert scale 0-10 | 2 years |