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

Primary Purpose

Clubfoot

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
scale Idiopathic Clubfoot
Sponsored by
Fondation Lenval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Clubfoot focused on measuring Muscle activity, scale, Achilles tenotomy

Eligibility Criteria

0 Months - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopitaux Pediatriques de Nice Chu-LenvalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Idiopathic Clubfoot

Arm Description

Outcomes

Primary Outcome Measures

Surgery
number of patient who need for Achilles tenotomy

Secondary Outcome Measures

Inter-examiner reproducibility
measure with statistical study the Inter-examiner reproducibility

Full Information

First Posted
March 2, 2023
Last Updated
September 28, 2023
Sponsor
Fondation Lenval
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1. Study Identification

Unique Protocol Identification Number
NCT05767762
Brief Title
Evertor Muscle Activity as a Predictor of Achilles Tenotomy in the Management of Idiopathic Varus Equinus Clubfoot
Acronym
PBVE-Muscle
Official Title
Evertor Muscle Activity as a Predictor of Achilles Tenotomy Before 1 Year in the Management of Idiopathic Varus Equinus Clubfoot
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
March 2031 (Anticipated)
Study Completion Date
December 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clubfoot
Keywords
Muscle activity, scale, Achilles tenotomy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Idiopathic Clubfoot
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
scale Idiopathic Clubfoot
Intervention Description
The Dimeglo and the muscle activity scale will be performed at 3, 6 and 12 months with patient with idiopathic clubfoot
Primary Outcome Measure Information:
Title
Surgery
Description
number of patient who need for Achilles tenotomy
Time Frame
maximum 1 year after inclusion
Secondary Outcome Measure Information:
Title
Inter-examiner reproducibility
Description
measure with statistical study the Inter-examiner reproducibility
Time Frame
through study completion, an average of 8 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grégoire Peuchevrier
Phone
492030323
Ext
+33
Email
peuchevrier.g@hpu.lenval.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Donzeau
Phone
492034560
Ext
+33
Email
donzeau.d@chu-nice.fr
Facility Information:
Facility Name
Hopitaux Pediatriques de Nice Chu-Lenval
City
Nice
ZIP/Postal Code
60200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégoire PEUCHEVRIER
Phone
492030323
Email
peuchevrier.g@hpu.lenval.com
First Name & Middle Initial & Last Name & Degree
Grégoire PEUCHEVRIER

12. IPD Sharing Statement

Learn more about this trial

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

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