Evaluating muscle activity to predict Achilles tenotomy in clubfoot management
Evertor Muscle Activity as a Predictor of Achilles Tenotomy Before 1 Year in the Management of Idiopathic Varus Equinus Clubfoot
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 0 Months to 12 Months |
| Sex | All |
| Sponsor | Fondation Lenval Academic / other |
| Locations | 1 site (Nice) |
| Trial ID | NCT05767762 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are infants diagnosed with idiopathic clubfoot who are treated using the functional method within the first 15 days of life.
Not a fit: Patients with syndromic clubfoot or those managed by methods other than the functional approach will not benefit from this study.
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 performed: While the literature on muscle activity in clubfoot management is limited, this approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
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 this trial is running
Nice
- Hopitaux Pediatriques de Nice Chu-Lenval — Nice, France (Recruiting)
Study contacts
- Study coordinator: Grégoire Peuchevrier
- Email: peuchevrier.g@hpu.lenval.com
- Phone: 492030323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.