Pilot Study of Percutaneous Correction of Hallux Valgus (hallux valgus)

April 28, 2026 updated by: Istituto Ortopedico Rizzoli

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

This is a pilot study with a randomized controlled design.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Recruiting
        • Istituto Ortopedico Rizzoli
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard treatment
SERI osteotomy
Procedure: SERI osteotomy
Correction of varus deformity of the 1st Metatarsal that is stabilized with Kirschnner wire
Experimental: experimental treatment
percutaneous osteotomy according to Chevron
Procedure: percutaneous osteotomy according to Chevron
Correction of varus deformity by osteotomy stabilization with 2 screws inserted via dorsal percutaneous accesses to the 1st Metatarsal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Score
Time Frame: baseline
pain visual analog assessment
baseline
Visual Analog Score
Time Frame: 1 year
pain visual analog assessment
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Orhtopaedic Foot and Ankle Society forefoot score
Time Frame: baseline and aftef 1 year
range of motion evaluation
baseline and aftef 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hallux valgus

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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