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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Clubfoot
• Intervention / Treatment: Other: scale Idiopathic Clubfoot

Detailed Description

Clubfoot is a congenital orthopedic deformity of the lower limb in newborns. It is characterized by a triple deformity of the foot: equinus, supination and adduction of the forefoot. It can be bilateral or unilateral. PBVE can be idiopathic or associated with another etiology such as neurological, rheumatological, etc.

There is a muscular hypoplasia of the muscles antagonistic to the PBVE and an imbalance of force between the agonists and antagonists to the benefit of the deformity. There is also an abnormality of the fibular and posterior tibial nerves.

The aim of the study is the muscular evaluation of the PBVE. The scientific literature is relatively poor on the subject. In the first year of life, if the articular evaluation of the PBVE is very precise, the muscular scoring seems less well taken into account. In the Dimeglio score, the muscular criterion counts for 1 point (against 16 articular points) if it is possible to obtain a muscular contraction of the antagonists. It does not specify which muscles are present nor the active reducibility of the deformity. A scale based on the Dimeglio score has been created to evaluate muscle activity. To fill it out, the practitioner will have to stimulate the muscles antagonistic to the deformity by tactile stimulation.

This will be an 8-year prospective cohort study that will look for a correlation between the muscle deficit and the risk of tenotomy before 1 year as well as the quality of inter-examiner reproduction of the scale. This duration is necessary to obtain a sufficient number of inclusions (100 feet).

Infants with idiopathic Clubfoot treated with the functional method at up to 15 days of life will be included. At the first consultation, we will perform the Dimeglio score and our muscle activity scale. The Dimeglio and the muscle activity scale will be performed at 3, 6 and 12 months. The population included will need to be sufficient to ensure that all levels of muscle scoring are represented.

The primary endpoint will be the need for Achilles tenotomy before 1 year. 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grégoire Peuchevrier; Phone Number: +33 492030323; Email: peuchevrier.g@hpu.lenval.com
• Study Contact Backup: Name: Dominique Donzeau; Phone Number: +33 492034560; Email: donzeau.d@chu-nice.fr

Study Locations

• France
  • Nice, France, 60200
    • Recruiting
    • Hôpitaux Pédiatriques de Nice CHU-Lenval
    • Contact: Grégoire PEUCHEVRIER; Phone Number: 492030323; Email: peuchevrier.g@hpu.lenval.com
    • Principal Investigator: Grégoire PEUCHEVRIER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Idiopathic Clubfoot	Other: scale Idiopathic Clubfoot; The Dimeglo and the muscle activity scale will be performed at 3, 6 and 12 months with patient with idiopathic clubfoot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery	number of patient who need for Achilles tenotomy	maximum 1 year after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-examiner reproducibility	measure with statistical study the Inter-examiner reproducibility	through study completion, an average of 8 years

Collaborators and Investigators

• Sponsor: Fondation Lenval

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2023
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Muscle activity; scale; Achilles tenotomy
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Clubfoot; Talipes; Equinus Deformity
• Other Study ID Numbers: 22-HPNCL-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No