Actively Recruiting
Randomised Controlled Trial Investigating Operative Versus Conservative Treatment for Mild to Moderate Hallux Valgus Deformity
Led by Ostfold Hospital Trust · Updated on 2025-08-03
120
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the outcomes of operative versus conservative treatment in adults with mild to moderate hallux valgus deformity. This randomized controlled trial aims to determine whether surgery is superior to conservative care for this condition. The study focuses on patient-reported outcomes to assess the effectiveness of each treatment approach over a two-year period. Participants will be randomly assigned to one of two groups: the operative group receiving traditional surgery for hallux valgus, and the conservative group using orthopedic aids and wide shoes as non-surgical treatment. Both groups will be monitored and evaluated at 6 months, 1 year, and 2 years after starting treatment. The study also looks at radiological changes including correction and progression of the deformity. During the trial, participants will complete patient-reported outcome measures such as the Manchester-Oxford Foot Questionnaire (MOxFQ), the Visual Analog Scale (VAS), and the Likert scale to assess clinical results. The researchers will use these tools to compare the effectiveness of the treatments over the two-year follow-up. Safety and progress will be regularly assessed, and a total of 120 participants will take part in this study sponsored by Ostfold Hospital Trust.
CONDITIONS
Brief Title
Operative Versus Non-operative Treatment for Mild to Moderate Hallux Valgus Deformity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Painful Hallux Valgus deformity
- Hallux Valgus Angle less than 35 degrees
- Intermetatarsal angle less than 15 degrees
- Age between 18 and 80 years
You will not qualify if you...
- Advanced osteoarthritis in first metatarsophalangeal joint
- Rheumatic diseases
- Pregnancy
- Drug abuse
- Severe psychological disorder
- Lack of compliance
- Language barrier
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Treatment period varies depending on intervention
Participants receive either operative treatment or conservative treatment with orthopedic aid/wide shoe for mild to moderate hallux valgus deformity.
Participants are treated according to their assigned group; visit schedules may vary.
Duration - 2 years
Participants are evaluated using patient reported outcome measures and clinical assessments at multiple time points after starting treatment.
Visits at 6 months, 1 year, and 2 years post-treatment start
Trial Site Locations
Total: 1 location
1
Østfold Hospital Trust
Sarpsborg, Norway, 1714
Actively Recruiting
Research Team
M
Marius Molund
M
Mikaela E Hamre
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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