Randomised Controlled Trial; Is Operative Treatment of Mild to Moderate Hallux Valgus Deformity Superior to Conservative Treatment?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Clinical results MOxFQ
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Clinical results MOxFQ
Time Frame: 2 years
Manchester oxford foot questionnaire (MOxFQ) (Raw scores can be converted to a 0-100 metric where 100=most severe)
Secondary Outcomes
- Clinical result VAS(2 years)
- Clinical result Likert scale(2 years)
- Clinical result SF-36(2 years)
Investigators
Marius Molund
MD, phd, head of foot & ankle department Ostfold hospital trust
Ostfold Hospital Trust