Surgery versus non-surgical care for mild to moderate bunions (hallux valgus)
Randomised Controlled Trial; Is Operative Treatment of Mild to Moderate Hallux Valgus Deformity Superior to Conservative Treatment?
This project will test whether surgery or non-surgical care (orthopedic aids and wider shoes) works better for adults with painful mild to moderate hallux valgus.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ostfold Hospital Trust Academic / other |
| Locations | 1 site (Sarpsborg) |
| Trial ID | NCT06114043 on ClinicalTrials.gov |
What this trial studies
This randomized trial will assign adults with painful mild to moderate hallux valgus to either operative correction or conservative care with orthopedic aids and wider shoes. Outcomes will be measured primarily with the patient-reported Manchester-Oxford Foot Questionnaire (MOxFQ) and will also include pain VAS and Likert scales. Participants will be followed at 6 months, 1 year, and 2 years, with radiological secondary outcomes for correction or progression. The planned sample size is 120 participants (60 per group) to allow for loss to follow-up and achieve sufficient statistical power.
Who should consider this trial
Good fit: Adults aged 18–80 with painful mild to moderate hallux valgus (hallux valgus angle <35° and intermetatarsal angle <15°) are the intended participants.
Not a fit: People with advanced first metatarsophalangeal osteoarthritis, rheumatic disease, pregnancy, substance abuse, severe psychiatric disorder, or inability to comply (including language barrier) are excluded and unlikely to benefit from the trial interventions.
Why it matters
Potential benefit: If successful, the trial could identify which approach better reduces pain and improves foot function for people with mild to moderate hallux valgus.
How similar studies have performed: Prior surgical series and some comparative studies show that operative correction often improves pain and alignment more than conservative care, but high-quality randomized comparisons for mild-to-moderate deformities remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sarpsborg
- Østfold Hospital Trust — Sarpsborg, Norway (Recruiting)
Study contacts
- Principal investigator: Marius Molund — Ostfold Hospital Trust
- Study coordinator: Marius Molund
- Email: marius.molund@so-hf.no
- Phone: 90093988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.