Evaluating muscle activity to predict Achilles tenotomy in clubfoot management
Official title: Evertor Muscle Activity as a Predictor of Achilles Tenotomy Before 1 Year in the Management of Idiopathic Varus Equinus Clubfoot
Run by Fondation Lenval · NCT05767762 · Data updated 2026-11-12
This study is testing if measuring muscle activity in infants with clubfoot can help predict whether they will need surgery on their Achilles tendon.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Months to 12 Months |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Fondation Lenval Academic / other |
| Locations | 1 site (Nice) |
| Status | Recruiting |
| Started | April 26, 2023 |
| Main results expected | March 2031 |
| Study ends | December 2031 |
| Registry record updated | September 29, 2023 |
| Trial ID | NCT05767762 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are infants diagnosed with idiopathic clubfoot who are treated using the functional method within the first 15 days of life.
✕Probably not a fit
Patients with syndromic clubfoot or those managed by methods other than the functional approach will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the relationship between muscle activity and the need for Achilles tenotomy in infants with idiopathic clubfoot. It utilizes a muscle scale inspired by the Dimeglio score to assess muscle activity and its correlation with the risk of tenotomy before the age of one. The study will follow a cohort of approximately 100 feet over eight years, with assessments at 3, 6, and 12 months. Additionally, it aims to evaluate the reproducibility of the muscle scale among different examiners.
Why it matters
Potential benefit: If successful, this study could improve the management of clubfoot by providing a better predictive tool for the need for surgical intervention.
How similar studies have gone: While the literature on muscle activity in clubfoot management is limited, this approach is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Hopitaux Pediatriques de Nice Chu-Lenval
Nice, France Recruiting
Study contacts
- Study coordinator: Grégoire Peuchevrier
- Email: peuchevrier.g@hpu.lenval.com
- Phone: 492030323
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Percutaneous Achilles tenotomy versus open tendo‑Achilles lengthening for neglected clubfoot in young children
This project tests whether percutaneous Achilles tenotomy or open tendo‑Achilles lengthening gives better function for children aged 2–5 with neglected clubfoot.
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Evaluating quality of life in children with clubfoot
This study looks at how living with clubfoot affects the quality of life for children aged 2 to 15 who have been treated with the Ponseti method, to see how they feel physically, emotionally, and socially over time.
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Evaluating treatments for clubfoot in infants
This study tests two different nonsurgical treatments for infants with clubfoot to see which one helps them the most.
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Original Denis Browne brace versus modified Denis Browne brace for relapsed idiopathic clubfoot after Ponseti casting
This project tests whether a modified Denis Browne brace works better than the original Denis Browne brace for 2- to 5-year-old children with relapsed idiopathic clubfoot after Ponseti casting.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.