Pilot Study of Percutaneous Correction of Hallux Valgus

Not Applicable

Recruiting

• Conditions: Hallux Valgus
• Interventions: Procedure: percutaneous osteotomy according to Chevron; Procedure: SERI osteotomy

• Registration Number: NCT05880407
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

This is a pilot study with a randomized controlled design.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-22
• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-05-19
• Study First Posted: 2023-05-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental treatment	percutaneous osteotomy according to Chevron	percutaneous osteotomy according to Chevron
standard treatment	SERI osteotomy	SERI osteotomy

Primary Outcome Measures

Name	Time	Method
Visual Analog Score	1 year	pain visual analog assessment

Secondary Outcome Measures

Name	Time	Method
American Orhtopaedic Foot and Ankle Society forefoot score	baseline and aftef 1 year	range of motion evaluation

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy