[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525207":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":100,"collaborators":18,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":18,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":18,"overallStatus":55,"whyStopped":18,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Adductor tenotomy + Temporary Medial Hemi-epiphysiodesis of the proximal femur","EXPERIMENTAL","Standard care + intervention",[13],"Procedure: Temporary Medial Hemi-epiphysiodesis of the proximal femur",{"label":15,"type":16,"description":17,"interventionNames":18},"Adductor tenotomy","NO_INTERVENTION","Standard care",null,[20],{"type":21,"name":22,"description":22,"armGroupLabels":23,"otherNames":18},"PROCEDURE","Temporary Medial Hemi-epiphysiodesis of the proximal femur",[9],[25],{"name":26,"affiliation":5,"role":27},"Jaap Tolk, MD, PhD","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Merel Roelen, MD","CONTACT","+31639173455","m.roelen@erasmusmc.nl",{"name":35,"role":31,"phone":18,"phoneExt":18,"email":36},"Jaap Tolk, MD PhD","j.tolk@erasmusmc.nl",[38,53,65,76,87],{"facility":39,"status":40,"city":41,"state":18,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Amsterdam UMC","NOT_YET_RECRUITING","Amsterdam","Netherlands","NL",{"type":45,"coordinates":46},"Point",[47,48],4.88969,52.37403,{"lat":48,"lon":47},[51],{"name":52,"role":31,"phone":18,"phoneExt":18,"email":18},"Melinda Witbreuk, MD PhD",{"facility":54,"status":55,"city":56,"state":18,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"UMC Groningen","RECRUITING","Groningen",{"type":45,"coordinates":58},[59,60],6.56667,53.21917,{"lat":60,"lon":59},[63],{"name":64,"role":31,"phone":18,"phoneExt":18,"email":18},"Sophie Moerman, MD PhD",{"facility":66,"status":55,"city":67,"state":18,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Maastricht UMC","Maastricht",{"type":45,"coordinates":69},[70,71],5.68889,50.84833,{"lat":71,"lon":70},[74],{"name":75,"role":31,"phone":18,"phoneExt":18,"email":18},"Adhiambo Witlox, MD PhD",{"facility":77,"status":40,"city":78,"state":18,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Sint Maartenskliniek","Nijmegen",{"type":45,"coordinates":80},[81,82],5.85278,51.8425,{"lat":82,"lon":81},[85],{"name":86,"role":31,"phone":18,"phoneExt":18,"email":18},"Arno ten Ham, MD",{"facility":88,"status":55,"city":89,"state":18,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Erasmus MC","Rotterdam",{"type":45,"coordinates":91},[92,93],4.47917,51.9225,{"lat":93,"lon":92},[96,97,98],{"name":30,"role":31,"phone":18,"phoneExt":18,"email":18},{"name":35,"role":31,"phone":18,"phoneExt":18,"email":18},{"name":99,"role":31,"phone":18,"phoneExt":18,"email":18},"Renee van Stralen, MD",{"type":27,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Merel Roelen","MD, PhD candidate","100525207","guided-growth-of-the-proximal-femur-to-prevent-further-hip-migration-in-cerebral-palsy-patients-100525207",false,"NCT06118736","GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients","GUIDANCE","Inclusion Criteria:\n\n* Spastic CP\n* GMFCS level IV-V\n* Aged 2-8 years\n* At least one hip with an abduction in flexion ≤ 40 degrees\n* Migration percentage of 30-50%\n* Head shaft angle \\> 145\n\nExclusion Criteria:\n\n* Not fit for surgery\n* History of bony hip surgery to the affected hip\n* Severe acetabular dysplasia defined as a gothic arch, an incongruent joint or an acetabular index \\> 30 degrees, consistent with A2 and A3 acetabular deformity according to Robin and Graham in an adequately performed radiographs","ALL","2 Years","8 Years",{"count":114,"type":115},84,"ESTIMATED","INTERVENTIONAL",[118],"NA","In recent literature, the potential of guided growth of the proximal femur to modify hip growth in patients with cerebral palsy has been shown. Using medial hemi-epiphysiodesis of the proximal femur (TMH-PF) morphology of hips at risk of symptomatic (sub)luxation in cerebral palsy (CP) can be changed, aiming to reduce further hip migration and the need for more invasive surgical treatment modalities. Further research is necessary to assess if the results of TMH-PF in combination with adductor tenotomies are significantly better than the results of the current standard of care; adductor tenotomies alone.\n\nThe investigators objective is to determine whether guided growth of the proximal femur decreases the risk of further hip migration and need for further surgery in cerebral palsy patients.",[121,122],"Cerebral Palsy","Hip Dislocation","2024-10-07",{"date":125,"type":126},"2024-10-08","ACTUAL",{"date":128,"type":126},"2024-03-06",{"date":130,"type":115},"2030-12",{"name":5,"class":6},5]