Percutaneous correction of bunions
Pilot Study of Percutaneous Correction of Hallux Valgus: Clinical-functional Evaluation of Outcome Randomized Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT05880407 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with hallux valgus and specific angles indicating the need for corrective surgery.
Not a fit: Patients with severe foot or lower limb pathologies or those requiring additional surgical procedures may not benefit from this study.
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 performed: While this approach is being explored in this pilot study, similar minimally invasive techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
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 this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Lisa Berti, MD
- Email: lisa.berti@ior.it
- Phone: 051.63.66
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.