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Recruiting

NCT Number: NCT05880407

Pilot Study of Percutaneous Correction of Hallux Valgus

This is a pilot study with a randomized controlled design.

Recruiting

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Key information

Conditions

Hallux Valgus Foot Deformities Musculoskeletal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Lisa Berti, MD

CONTACT

[email protected]

051.63.66 ext. 571

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SERI osteotomy

Procedure

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

percutaneous osteotomy according to Chevron

Procedure

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

Primary outcomes

  1. Visual Analog Score

    Time frame: baseline

    pain visual analog assessment

  2. Visual Analog Score

    Time frame: 1 year

    pain visual analog assessment

Secondary outcomes

  1. American Orhtopaedic Foot and Ankle Society forefoot score

    Time frame: baseline and aftef 1 year

    range of motion evaluation

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Berti, MD

CONTACT

[email protected]

051.63.66 ext. 571

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: hallux valgus

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 30, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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