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Pilot Study of Percutaneous Correction of Hallux Valgus

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05880407
Acronym
hallux valgus
Enrollment
40
Registered
2023-05-30
Start date
2022-02-22
Completion date
2026-12-31
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus

Brief summary

This is a pilot study with a randomized controlled design.

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.

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scorebaselinepain visual analog assessment

Secondary

MeasureTime frameDescription
American Orhtopaedic Foot and Ankle Society forefoot scorebaseline and aftef 1 yearrange of motion evaluation

Countries

Italy

Contacts

CONTACTLisa Berti, MD
lisa.berti@ior.it051.63.66

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026