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

NCT05767762 | Recruiting

• 1 other identifier: 22-HPNCL-09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Clubfoot

Keywords

Muscle activity; scale; Achilles tenotomy

Outcome Measures

Primary Outcomes (1)

• Surgery

  number of patient who need for Achilles tenotomy

  maximum 1 year after inclusion

Secondary Outcomes (1)

• Inter-examiner reproducibility

  through study completion, an average of 8 years

Study Arms (1)

Idiopathic Clubfoot

EXPERIMENTAL

Other: scale Idiopathic Clubfoot

Interventions

scale Idiopathic Clubfoot OTHER

The Dimeglo and the muscle activity scale will be performed at 3, 6 and 12 months with patient with idiopathic clubfoot

Idiopathic Clubfoot

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• syndromic clubfoot, management other than functional method, management after D15

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Hopitaux Pediatriques de Nice Chu-Lenval

Nice, 60200, France

RECRUITING

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Grégoire Peuchevrier

CONTACT

492030323; peuchevrier.g@hpu.lenval.com

Dominique Donzeau

CONTACT

492034560; donzeau.d@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 14, 2023
• Study Start: April 26, 2023
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: September 29, 2023

Record last verified: 2023-03

Locations

FR (1)