Actively Recruiting
Pilot Study of Percutaneous Correction of Hallux Valgus: Clinical-functional Evaluation of Outcome Randomized Study
Led by Istituto Ortopedico Rizzoli · Updated on 2026-05-04
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate two different surgical procedures for correcting hallux valgus, a common foot deformity. The study is a pilot randomized controlled trial focused on adult patients aged 18 to 65 years with specific angles of deformity (hallux valgus angle between 20 and 40 degrees and intermetatarsal angle between 10 and 20 degrees). It is designed to compare clinical and functional outcomes of these procedures over time. Participants will be randomly assigned to one of two surgical treatments: the SERI osteotomy, which corrects the deformity using Kirschnner wire stabilization, or the percutaneous osteotomy according to Chevron, which uses two screws inserted through small dorsal incisions for stabilization. Both procedures aim to correct the varus deformity of the first metatarsal bone. The study does not use blinding and involves standard surgical techniques. During the study, researchers will assess pain levels using the Visual Analog Score at the start and one year after surgery. They will also measure foot function with the American Orthopaedic Foot and Ankle Society forefoot score at baseline and after one year. Participants will be monitored for clinical-functional outcomes over this period. The total study duration spans several years, starting in February 2022 and ending in December 2026, under the sponsorship of Istituto Ortopedico Rizzoli.
CONDITIONS
Brief Title
Pilot Study of Percutaneous Correction of Hallux Valgus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of both sexes with adult hallux valgus with indication for corrective surgical treatment
- Hallux valgus angle (HVA) between 20° and 40°
- Intermetatarsal angle (IMA) between 10° and 20°
You will not qualify if you...
- Instability of the first metatarsophalangeal joint
- Severe morphostructural alterations or other pathologies in the foot and lower limb
- Need for additional surgical procedures
- Severe vascular and neurological systemic pathologies
- Systemic conditions that may impair bone healing
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.
Duration - Up to hospital discharge period
Participants undergo one of two types of corrective foot surgery and receive immediate care after the procedure.
1 surgery visit (in-person) and immediate post-operative care
Duration - 1 year
Participants are monitored to assess recovery and surgical outcomes over the course of one year after surgery.
Approximately 3 to 4 follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
Research Team
L
Lisa Berti, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here