An interventional study of Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus and Operation for mild to moderate hallux valgus in Hallux Valgus Deformity, sponsored by Ostfold Hospital Trust. Recruiting at 1 site in Norway. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Ostfold Hospital Trust · Not applicable, Interventional, and Other
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.
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.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's planned enrollment of 120 is above the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Ostfold Hospital Trust is the lead sponsor of 50 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
60 participants will be operated for mild to moderate hallux valgus deformity
Other: Operation for mild to moderate hallux valgus
60 participants will be treated conservatively with a wide shoe
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.
60 participants will receive the traditional operative treatment for the deformity. Participants will be followed for 2 years.
Clinical results MOxFQ
Manchester oxford foot questionnaire (MOxFQ) (Raw scores can be converted to a 0-100 metric where 100=most severe)
Time frame: 2 years
Clinical result VAS
Visual analogue scale (VAS) 0-10 (0=best to 10=worst)
Time frame: 2 years
Clinical result SF-36
Short Form Health Survey (SF-36) (0=worst to 100=best)
Time frame: 2 years
Clinical result Likert scale
Likert scale 0-5 (0=worst to 5=best)
Time frame: 2 years
Plan to share: No
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Ostfold Hospital Trust