NCT05767762 Evertor Muscle Activity as a Predictor of Achilles Tenotomy in the Management of Idiopathic Varus Equinus Clubfoot
| NCT ID | NCT05767762 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Lenval |
| Condition | Clubfoot |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-04-26 |
| Primary Completion | 2031-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-04-26 with a primary completion date of 2031-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05767762 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 12 Months, studying Clubfoot. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05767762 currently recruiting?
Yes, NCT05767762 is actively recruiting participants. Contact the research team at peuchevrier.g@hpu.lenval.com for enrollment information.
Where is the NCT05767762 trial being conducted?
This trial is being conducted at Nice, France.
Who is sponsoring the NCT05767762 clinical trial?
NCT05767762 is sponsored by Fondation Lenval. The trial plans to enroll 50 participants.