[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498246":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":30,"responsibleParty":49,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Fondation Lenval","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Idiopathic Clubfoot","EXPERIMENTAL",null,[13],"Other: scale Idiopathic Clubfoot",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":11},"scale Idiopathic Clubfoot","The Dimeglo and the muscle activity scale will be performed at 3, 6 and 12 months with patient with idiopathic clubfoot",[9],[20,26],{"name":21,"role":22,"phone":23,"phoneExt":24,"email":25},"Grégoire Peuchevrier","CONTACT","492030323","+33","peuchevrier.g@hpu.lenval.com",{"name":27,"role":22,"phone":28,"phoneExt":24,"email":29},"Dominique Donzeau","492034560","donzeau.d@chu-nice.fr",[31],{"facility":32,"status":33,"city":34,"state":11,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Hopitaux Pediatriques de Nice Chu-Lenval","RECRUITING","Nice","60200","France","FR",{"type":39,"coordinates":40},"Point",[41,42],7.26608,43.70313,{"lat":42,"lon":41},[45,47],{"name":46,"role":22,"phone":23,"phoneExt":11,"email":25},"Grégoire PEUCHEVRIER",{"name":46,"role":48,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100498246","evertor-muscle-activity-as-a-predictor-of-achilles-tenotomy-in-the-management-of-idiopathic-varus-equinus-clubfoot-100498246",false,"NCT05767762","Evertor Muscle Activity as a Predictor of Achilles Tenotomy in the Management of Idiopathic Varus Equinus Clubfoot","Evertor Muscle Activity as a Predictor of Achilles Tenotomy Before 1 Year in the Management of Idiopathic Varus Equinus Clubfoot","PBVE-Muscle","Inclusion Criteria:\n\n* idiopathic clubfoot, managed by the functional method, managed before D15 to perform the initial assessment.\n\nExclusion Criteria:\n\n* syndromic clubfoot, management other than functional method, management after D15","ALL","0 Months","12 Months",{"count":63,"type":64},50,"ESTIMATED","INTERVENTIONAL",[67],"NA","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.\n\nThis 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.\n\nThe 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.\n\nThe expectation of this study would be to define a predictive factor of the evolution of the PBVE in order to refine the treatment earlier.",[70],"Clubfoot",[72,73,74],"Muscle activity","scale","Achilles tenotomy","2023-09-28",{"date":77,"type":78},"2023-09-29","ACTUAL",{"date":80,"type":78},"2023-04-26",{"date":82,"type":64},"2031-12",{"name":5,"class":6},1]