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RecruitingNCT05880407hallux valgusUpdated May 4, 2026

Pilot Study of Percutaneous Correction of Hallux Valgus

An interventional study of SERI osteotomy and percutaneous osteotomy according to Chevron in Hallux Valgus, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Feb 2022, registered Feb 2023).
  • Started Feb 2022; still recruiting 4 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a pilot study with a randomized controlled design.

02

Conditions studied

  • Hallux Valgus

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03

In context

Hallux Valgus

144 studies on the registry are indexed under Hallux Valgus; 31 are open to participants now.

This study's planned enrollment of 40 is below the median of 56 across 106 interventional studies indexed under Hallux Valgus.

Browse Hallux Valgus studies →

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    standard treatment

    SERI osteotomy

    Procedure: SERI osteotomy

  • Experimental
    experimental treatment

    percutaneous osteotomy according to Chevron

    Procedure: percutaneous osteotomy according to Chevron

Interventions

  • ProcedureSERI osteotomy

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

  • Procedurepercutaneous osteotomy according to Chevron

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

06

What researchers measure

Primary outcomes

  1. Visual Analog Score

    pain visual analog assessment

    Time frame: baseline

  2. Visual Analog Score

    pain visual analog assessment

    Time frame: 1 year

Secondary outcomes

  1. American Orhtopaedic Foot and Ankle Society forefoot score

    range of motion evaluation

    Time frame: baseline and aftef 1 year

07

Study locations

1 of 1 sites recruiting
  • Istituto Ortopedico Rizzoli
    Bologna, 40136, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05880407
Lead sponsor
Istituto Ortopedico Rizzoli
Responsible party
Sponsor
First posted
May 30, 2023
Start date
Feb 22, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 4, 2026

Study contacts

Lisa Berti, MD
Contact
lisa.berti@ior.it
051.63.66 ext. 571

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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