Percutaneous correction of bunions
Official title: Pilot Study of Percutaneous Correction of Hallux Valgus: Clinical-functional Evaluation of Outcome Randomized Study
Run by Istituto Ortopedico Rizzoli · NCT05880407 · Data updated 2026-11-12
This study tests a new, less invasive surgery for bunions to see if it works better and is safer than traditional surgery for people who need treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | February 22, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT05880407 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults with hallux valgus and specific angles indicating the need for corrective surgery.
✕Probably not a fit
Patients with severe foot or lower limb pathologies or those requiring additional surgical procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study evaluates the effectiveness of a percutaneous osteotomy technique, specifically the SERI osteotomy and Chevron method, for correcting hallux valgus, commonly known as bunions. It employs a randomized controlled design to assess outcomes in patients who meet specific criteria for surgical intervention. The study aims to gather preliminary data on the safety and efficacy of this minimally invasive approach compared to traditional surgical methods.
Why it matters
Potential benefit: If successful, this study could provide a less invasive option for patients suffering from hallux valgus, leading to improved recovery times and outcomes.
How similar studies have gone: While this approach is being explored in this pilot study, similar minimally invasive techniques have shown promise in other studies, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of both sexes with adult hallux valgus with indication for corrective surgical treatment * HVA (hallux valgus angle): 20°-40° * IMA (intermetatarsal angle): 10°-20° Exclusion Criteria: * Patients with instability of the first metatarsophalangeal joint * Patients with severe morphostructural alterations or other pathologies in the foot and lower limb * patients requiring additional surgical procedures * patients with severe vascular and neurological systemic pathologies * systemic pathologies that may impair bone consolidation
Where it's running
-
Istituto Ortopedico Rizzoli
Bologna, Italy Recruiting
Study contacts
- Study coordinator: Lisa Berti, MD
- Email: lisa.berti@ior.it
- Phone: 051.63.66
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Self-rehabilitation after foot surgery with a connected app
This study tests whether a connected rehabilitation app can help adults after hallux valgus surgery improve ankle and toe mobility at home.
-
Sciatic nerve block with extended-release bupivacaine (ALX006) for bunion surgery
This will test whether a single-dose extended-release bupivacaine (ALX006) given as a sciatic nerve block reduces pain after bunion surgery in adults.
-
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.
-
One versus two Kirschner wires for minimally invasive correction of severe hallux valgus
This trial tests whether adding a second Kirschner (K-) wire during minimally invasive bunion surgery helps people with severe hallux valgus keep their toe alignment and have fewer complications.
-
Custom 3D-printed toe spacer for bunion (hallux valgus) surgery recovery
This will test whether a custom 3D-printed toe spacer is more comfortable and better at keeping the big toe aligned than a standard folded-gauze spacer for adults after hallux valgus surgery.
-
Examining the relationship between second toe length and hallux valgus in older adults
This study looks at whether the length of the second toe affects the angle of the big toe in older adults with foot X-rays.
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.