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

I

Istituto Ortopedico Rizzoli

Status

Enrolling

Conditions

Hallux Valgus

Treatments

Procedure: percutaneous osteotomy according to Chevron
Procedure: SERI osteotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05880407
hallux valgus

Details and patient eligibility

About

This is a pilot study with a randomized controlled design.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

standard treatment
Active Comparator group
Description:
SERI osteotomy
Treatment:
Procedure: SERI osteotomy
experimental treatment
Experimental group
Description:
percutaneous osteotomy according to Chevron
Treatment:
Procedure: percutaneous osteotomy according to Chevron

Trial contacts and locations

1

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Central trial contact

Lisa Berti, MD

Data sourced from clinicaltrials.gov

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