[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636757":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":18,"locations":24,"responsibleParty":38,"collaborators":10,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":10,"maxAge":10,"enrollmentInfo":50,"targetDuration":10,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":10,"overallStatus":26,"whyStopped":10,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},{"fullName":5,"class":6},"Istituto Ortopedico Rizzoli","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"patients who underwent subtalar arthroereisis with calcaneostop and endorthosis",null,[12],"Other: calcaneo stop and endorthesis",[14],{"type":6,"name":15,"description":16,"armGroupLabels":17,"otherNames":10},"calcaneo stop and endorthesis","To evaluate, at more than ten years' follow-up, the clinical and radiological outcomes of patients who underwent subtalar arthroereisis with calcaneostop and endorthosis for the correction of pediatric flatfoot.",[9],[19],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Antonio Mazzotti Prof","CONTACT","+39 3498798863","antonio.mazzotti@ior.it",[25],{"facility":5,"status":26,"city":27,"state":10,"zip":10,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"RECRUITING","Bologna","Italy","IT",{"type":31,"coordinates":32},"Point",[33,34],11.33875,44.49381,{"lat":34,"lon":33},[37],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Antonio Mazzotti","Principal Investigator","100636757","clinical-and-radiological-evaluation-over-10-years-after-bilateral-subtalar-arthrorisis-surgery-with-endorthesis-and-calcaneal-stop-for-the-correction-of-pediatric-flatfoot-100636757",false,"NCT07569835","Clinical and Radiological Evaluation Over 10 Years After Bilateral Subtalar Arthrorisis Surgery With Endorthesis and Calcaneal Stop for the Correction of Pediatric Flatfoot","ARTRO-LONG","INCLUSION CRITERIA:\n\nPatients already in follow-up after undergoing subtalar arthroereisis with calcaneostop and endorthosis, enrolled in the study \"Flatfoot treatment: comparison between resorbable endorthosis and resorbable calcaneal stop\" by Prof. Giannini, still in follow-up at IOR.\n\nEXCLUSION CRITERIA:\n\nPatients who have undergone subsequent surgical procedures on the foot and ankle","ALL",{"count":51,"type":52},20,"ESTIMATED","OBSERVATIONAL","VARIABLES TO BE COLLECTED AND SOURCE The primary efficacy endpoint will be the maintenance of flatfoot correction over time, assessed both clinically (tip-toe test, Jack test, tip-toe walking test) and radiologically (evaluation of Meary's angle on the lateral foot view and the talocalcaneal angle).\n\nThe secondary efficacy endpoint will be the absence of pain at follow-up, assessed using the VAS scale, and evaluation of the footprint using a podoscope.\n\nTIP-TOE TEST:\n\nThe patient is observed under weight-bearing conditions and then while rising onto the toes. If the foot is flexible, the plantar arch-previously absent-reappears when standing on tip-toe.\n\nJACK TEST:\n\nThis consists of passive dorsiflexion of the hallux under weight-bearing conditions. If the previously absent arch reappears, the flatfoot is considered flexible.\n\nTIP-TOE WALKING TEST:\n\nThe patient walks for about ten steps on tip-toe. The examiner observes any varus alignment of the hindfoot and reconstruction of the plantar arch.\n\nMEARY'S ANGLE:\n\nMeasured between the longitudinal axis of the talus and that of the first metatarsal on a weight-bearing lateral foot radiograph.\n\nTALOCALCANEAL ANGLE:\n\nMeasured between the longitudinal axis of the talus and that of the calcaneus on a weight-bearing dorsoplantar foot radiograph.\n\nVAS:\n\nThe Visual Analog Scale for pain is a tool used to measure the subjective characteristics of pain experienced by the patient, ranging from 0 (no pain) to 10 (worst imaginable pain).\n\nPODOSCOPE FOOTPRINT ASSESSMENT:\n\nEvaluation of the isthmus (the narrow portion of the footprint connecting the heel to the forefoot). The foot is considered normal when the width of the isthmus is between one-third and one-half of the maximum width of the forefoot.\n\nSAMPLE SIZE AND STATISTICS In Prof. Giannini's study, 30 patients were enrolled; approximately 30% were lost to follow-up over 12 years. Barring further losses, about 20 patients currently followed at Clinic I are expected to be available.\n\nENROLLMENT PROCEDURE Eligible patients will be enrolled in the study only after providing written informed consent. No data collection, procedures, or analyses will be performed prior to obtaining consent.\n\nDATA COLLECTION Clinical data required for the study will be extracted from patients' medical records and source documents.\n\nA dedicated data collection form will be used to record clinical information and the results of the analyses by the study.\n\nFor each enrolled patient, a Case Report Form (CRF) will be completed.",[56],"Flat Foot Acquired Bilateral (Pes Planus)","2026-04-29",{"date":59,"type":60},"2026-05-06","ACTUAL",{"date":62,"type":60},"2024-05-30",{"date":64,"type":52},"2026-05",{"name":5,"class":6},1]