Pilot Study of Percutaneous Correction of Hallux Valgus

N/ARecruitingNCT05880407

Istituto Ortopedico Rizzoli40 enrolled

Overview

This is a pilot study with a randomized controlled design.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hallux Valgus

Interventions

SERI osteotomyPROCEDURE

Correction of varus deformity of the 1st Metatarsal that is stabilized with Kirschnner wire

percutaneous osteotomy according to ChevronPROCEDURE

Correction of varus deformity by osteotomy stabilization with 2 screws inserted via dorsal percutaneous accesses to the 1st Metatarsal.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Istituto Ortopedico Rizzoli

Bologna, Italy

RECRUITING

Outcomes

Primary Outcomes

Visual Analog Score

pain visual analog assessment

Time frame: baseline

Visual Analog Score

pain visual analog assessment

Time frame: 1 year

Secondary Outcomes

American Orhtopaedic Foot and Ankle Society forefoot score

range of motion evaluation

Time frame: baseline and aftef 1 year

Central Contacts

Lisa Berti, MD

CONTACT

051.63.66 lisa.berti@ior.it

Data from ClinicalTrials.gov

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