Evertor Muscle Activity as a Predictor of Achilles Tenotomy Before 1 Year in the Management of Idiopathic Varus Equinus Clubfoot

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: f
View:

• idiopathic clubfoot, managed by the functional method, managed before D15 to perform the initial assessment.

Locations
Other Locations
France
Hopitaux Pediatriques de Nice Chu-Lenval
RECRUITING
Nice
Contact Information
Primary
Grégoire Peuchevrier
peuchevrier.g@hpu.lenval.com
492030323
Backup
Dominique Donzeau
donzeau.d@chu-nice.fr
492034560
Time Frame
Start Date: 2023-04-26
Estimated Completion Date: 2031-12
Participants
Target number of participants: 50
Treatments
Experimental: Idiopathic Clubfoot
Related Therapeutic Areas
Sponsors
Leads: Fondation Lenval

This content was sourced from clinicaltrials.gov