Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Idiopathic clubfoot managed by the functional method
- Treatment started before 15 days of age to perform the initial assessment
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
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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