Surgery versus non-surgical care for mild to moderate bunions (hallux valgus)
Official title: Randomised Controlled Trial; Is Operative Treatment of Mild to Moderate Hallux Valgus Deformity Superior to Conservative Treatment?
Run by Ostfold Hospital Trust · NCT06114043 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Ostfold Hospital Trust Academic / other |
| Locations | 1 site (Sarpsborg) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | March 2028 |
| Study ends | March 2030 |
| Registry record updated | August 3, 2025 |
| Trial ID | NCT06114043 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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VIRTUGUIDE System with DePuy Synthes Lapidus Implant for Hallux Valgus
This study tests how well the VIRTUGUIDE System with a compatible DePuy Synthes Lapidus implant works for people undergoing a primary Lapidus procedure to correct hallux valgus.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.