Recruiting NCT05880407
Pilot Study of Percutaneous Correction of Hallux Valgus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SERI osteotomy, percutaneous osteotomy according to Chevron.
- Who it may be relevant to
- Registry conditions: Hallux Valgus. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study of Percutaneous Correction of Hallux Valgus: Clinical-functional Evaluation of Outcome Randomized Study
Overview
This is a pilot study with a randomized controlled design.
Interventions
- Procedure SERI osteotomy
Correction of varus deformity of the 1st Metatarsal that is stabilized with Kirschnner wire - Procedure percutaneous osteotomy according to Chevron
Correction of varus deformity by osteotomy stabilization with 2 screws inserted via dorsal percutaneous accesses to the 1st Metatarsal.
Primary outcome measures
- Visual Analog Score [Time frame: baseline]
- Visual Analog Score [Time frame: 1 year]
Secondary outcome measures (1)
- American Orhtopaedic Foot and Ankle Society forefoot score [Time frame: baseline and aftef 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Istituto Ortopedico Rizzoli — Bologna
Identifiers
NCT: NCT05880407 · hallux valgus