Actively Recruiting

Phase Not Applicable
Age: 0Months - 12Months
All Genders
NCT05767762

Evertor Muscle Activity as a Predictor of Achilles Tenotomy in the Management of Idiopathic Varus Equinus Clubfoot

Led by Fondation Lenval · Updated on 2023-09-29

50

Participants Needed

1

Research Sites

448 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Clubfoot is an orthopedic congenital malformation of the lower limb of the newborn evaluated by the Dimeglio score. There is a deficit of muscular balance between the agonists and antagonists to the deformity. The Dimeglio score takes into account the muscular activity but only up to one point out of 20. This study proposes to use a muscle scale inspired by the Dimeglio score to see if there is a correlation between muscle activity and the risk of tenotomy before 1 year. It will also assess the inter-examiner reproducibility of this scale. This study is a prospective cohort study with a duration of 8 years to include about 100 feet. Infants with idiopathic Clubfoot treated with the functional method at up to 15 days of life will be included. Feet will be assessed at an inclusion visit and then at 3-6-12 months. The primary endpoint will be the need for Achilles tenotomy before 1 year of age. The secondary endpoint will be inter-examiner reproducibility determined by statistical analysis. The expectation of this study would be to define a predictive factor of the evolution of the PBVE in order to refine the treatment earlier.

CONDITIONS

Official Title

Evertor Muscle Activity as a Predictor of Achilles Tenotomy in the Management of Idiopathic Varus Equinus Clubfoot

Who Can Participate

Age: 0Months - 12Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Idiopathic clubfoot managed by the functional method
  • Treatment started before 15 days of age to perform the initial assessment
Not Eligible

You will not qualify if you...

  • Syndromic clubfoot
  • Treatment other than the functional method
  • Treatment started after 15 days of age

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hopitaux Pediatriques de Nice Chu-Lenval

Nice, France, 60200

Actively Recruiting

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Research Team

G

Grégoire Peuchevrier

CONTACT

D

Dominique Donzeau

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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