Operative Versus Non-operative Treatment for Mild to Moderate Hallux Valgus Deformity
NCT ID: NCT06114043
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-06-01
2030-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Operation
60 participants will be operated for mild to moderate hallux valgus deformity
Operation for mild to moderate hallux valgus
60 participants will receive the traditional operative treatment for the deformity. Participants will be followed for 2 years.
Conservative
60 participants will be treated conservatively with a wide shoe
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.
Interventions
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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.
Operation for mild to moderate hallux valgus
60 participants will receive the traditional operative treatment for the deformity. Participants will be followed for 2 years.
Eligibility Criteria
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Inclusion Criteria
* Hallux Valgus Angle \<35 degrees
* Intermetatarsal angle \<15 degrees
* 18-80 years
Exclusion Criteria
* Rheumatic diseases
* Pregnancy
* Drug abuse
* Severe psychological disorder
* Lack of compliance
* Language barrier
18 Years
80 Years
ALL
Yes
Sponsors
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Ostfold Hospital Trust
OTHER
Responsible Party
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Marius Molund
MD, phd, head of foot & ankle department Ostfold hospital trust
Principal Investigators
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Marius Molund
Role: PRINCIPAL_INVESTIGATOR
Ostfold Hospital Trust
Locations
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Østfold Hospital Trust
Sarpsborg, , Norway
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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575297
Identifier Type: -
Identifier Source: org_study_id
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