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NCT05880407 Clinical Trial

Pilot Study of Percutaneous Correction of Hallux Valgus

Hallux Valgus Clinical Trial

— hallux valgus  

Official title:
Pilot Study of Percutaneous Correction of Hallux Valgus: Clinical-functional Evaluation of Outcome Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05880407
Other study ID # hallux valgus
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 22, 2022
Est. completion date December 31, 2024

Study information
Verified date May 2023
Source Istituto Ortopedico Rizzoli
Contact Lisa Berti, MD
Phone 051.63.66
Email lisa.berti@ior.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a pilot study with a randomized controlled design.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• SERI osteotomy
Correction of varus deformity of the 1st Metatarsal that is stabilized with Kirschnner wire
• percutaneous osteotomy according to Chevron
Correction of varus deformity by osteotomy stabilization with 2 screws inserted via dorsal percutaneous accesses to the 1st Metatarsal.

Locations
Country Name City State
Italy Istituto Ortopedico Rizzoli Bologna

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Analog Score pain visual analog assessment baseline
Primary Visual Analog Score pain visual analog assessment 1 year
Secondary American Orhtopaedic Foot and Ankle Society forefoot score range of motion evaluation baseline and aftef 1 year
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