NCT05880407

Brief Summary

This is a pilot study with a randomized controlled design.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Feb 2022Dec 2026

Study Start

First participant enrolled

February 22, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

4.9 years

First QC Date

February 1, 2023

Last Update Submit

April 28, 2026

Conditions

Hallux Valgus

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Score

    pain visual analog assessment

    baseline

  • Visual Analog Score

    pain visual analog assessment

    1 year

Secondary Outcomes (1)

  • American Orhtopaedic Foot and Ankle Society forefoot score

    baseline and aftef 1 year

Study Arms (2)

standard treatment

ACTIVE COMPARATOR

SERI osteotomy

Procedure: SERI osteotomy

experimental treatment

EXPERIMENTAL

percutaneous osteotomy according to Chevron

Procedure: percutaneous osteotomy according to Chevron

Interventions

SERI osteotomyPROCEDURE

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

standard treatment
percutaneous osteotomy according to ChevronPROCEDURE

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

experimental treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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°

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Central Study Contacts

Lisa Berti, MD

CONTACT

051.63.66lisa.berti@ior.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2023

First Posted

May 30, 2023

Study Start

February 22, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

IT(1)