Hallux Valgus Deformity
Conditions
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.
Interventions
OTHERConservative 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.
OTHEROperation 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
Ostfold Hospital Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomised controlled trial investigating patients with painful mild to moderate hallux valgus deformity
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical result VAS | 2 years | Visual analogue scale (VAS) 0-10 (0=best to 10=worst) |
| Clinical result SF-36 | 2 years | Short Form Health Survey (SF-36) (0=worst to 100=best) |
| Clinical result Likert scale | 2 years | Likert scale 0-5 (0=worst to 5=best) |
Countries
Norway
Contacts
Primary ContactMarius Molund
Backup ContactMikaela E Hamre
Outcome results
None listed