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

NCT05767762 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-09-29

No results posted yet for this study

Summary

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

  • Clubfoot

Interventions

OTHER

scale Idiopathic Clubfoot

The Dimeglo and the muscle activity scale will be performed at 3, 6 and 12 months with patient with idiopathic clubfoot

Sponsors & Collaborators

  • Fondation Lenval

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2031-03-31
Completion
2031-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05767762 on ClinicalTrials.gov