Evertor Muscle Activity as a Predictor of Achilles Tenotomy in the Management of Idiopathic Varus Equinus Clubfoot
Launched by FONDATION LENVAL · Mar 2, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how muscle activity in babies with a condition called idiopathic clubfoot can help predict whether they will need a specific surgical procedure called Achilles tenotomy before their first birthday. Clubfoot is a birth defect that affects the way a baby’s foot is shaped, and it can make walking difficult if not treated. The researchers want to see if a new way of measuring muscle activity can provide better information about the need for surgery, which is currently only assessed using a scoring system that doesn’t focus much on muscle activity.
The trial is looking for infants with idiopathic clubfoot who are treated using a method called the functional method before they are 15 days old. About 100 babies will be involved over the course of eight years, and their feet will be checked at specific times—at the start, and then again at 3, 6, and 12 months. This study will not only help determine if measuring muscle activity is helpful in predicting surgery needs but will also check if different doctors get the same results when using this new measurement. If you have a baby with clubfoot, this study might offer a chance to participate in improving future treatments for this condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • idiopathic clubfoot, managed by the functional method, managed before D15 to perform the initial assessment.
- Exclusion Criteria:
- • syndromic clubfoot, management other than functional method, management after D15
About Fondation Lenval
Fondation Lenval is a prominent clinical trial sponsor dedicated to advancing pediatric healthcare through innovative research and development. Based in Nice, France, the foundation focuses on improving treatments and outcomes for children with various medical conditions, particularly in the fields of neonatology and pediatrics. By collaborating with leading healthcare professionals and institutions, Fondation Lenval aims to bridge the gap between clinical practice and research, ensuring that its studies adhere to the highest ethical standards and regulatory requirements. Through its commitment to enhancing child health and well-being, the foundation plays a crucial role in shaping the future of pediatric medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nice, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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