[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467071":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":34,"responsibleParty":58,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":80,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":10,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Longitudinal Observational Group",null,"Pediatric patients indicated for the device-specific indication, per physician discretion and as indicated in the device IFU.",[13],"Device: Pediatric orthopaedic implant",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Pediatric orthopaedic implant","Patient receives a pediatric orthopaedic implant as a part of standard clinical care.",[9],[21],{"name":22,"affiliation":5,"role":23},"Bryn Zomar, PhD","STUDY_DIRECTOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","604-875-2359","bryn.zomar@cw.bc.ca",{"name":30,"role":26,"phone":31,"phoneExt":32,"email":33},"Harpreet Chhina, PhD","604-875-2000","6008","hchhina@cw.bc.ca",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"BC Children's Hospital","RECRUITING","Vancouver","British Columbia","V6H 3N1","Canada","CA",{"type":44,"coordinates":45},"Point",[46,47],-123.11934,49.24966,{"lat":47,"lon":46},[50,53,56],{"name":51,"role":26,"phone":27,"phoneExt":10,"email":52},"Emily Schaeffer, PhD","emily.schaeffer@cw.bc.ca",{"name":54,"role":55,"phone":10,"phoneExt":10,"email":10},"Anthony Cooper, FRCSC","PRINCIPAL_INVESTIGATOR",{"name":57,"role":55,"phone":10,"phoneExt":10,"email":10},"Kishore Mulpuri, FRCSC",{"type":55,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Kishore Mulpuri","Professor",[62],{"name":63,"class":64},"OrthoPediatrics","INDUSTRY","100467071","pediatric-orthopaedic-implant-safety--efficacy-100467071",false,"NCT05361980","Pediatric Orthopaedic Implant Safety & Efficacy","Global Pediatric Orthopaedic Implant Safety & Efficacy Clinical Follow-up Program","Global POISE","Inclusion Criteria:\n\n* Patients indicated for the device-specific indication, per physician discretion and as indicated in the device IFU. Off-label use is strongly discouraged; however, any and all on- and off-label indications for use of the products in this program will be collected and stratified accordingly\n* Patients must be able to adhere to the required length of follow-up for the endpoints of each individual product\n* Informed consent\u002Fassent is required\n\nExclusion Criteria:\n\n* Patients with a demonstrated sensitivity to metals\n* Patients with an inability to follow a post-operative regimen",true,"ALL","0 Years","25 Years",{"count":78,"type":79},4000,"ESTIMATED","2 Years","OBSERVATIONAL","Implant devices are important tools - their use is essential across a number of orthopaedic indications, including hip conditions, trauma and limb deformity.\n\nGiven the vital role fixation devices play in maintaining alignment, promoting healthy bone healing and preventing joint degeneration, it is essential to understand the expected lifetime outcomes of these implants, and evaluate their safety and efficacy.\n\nProspective implant efficacy and safety registries are needed to support this endeavour, especially considering new regulatory requirements from the European Union Medical Devices Regulation (EU MDR) in relation to post-market clinical follow-up (PMCF).",[84,85,86,87,88,89,90,91,92,93,94],"Fracture","Lengthening; Leg","Orthopedic Disorder","Deformity of Limb","Deformity; Bone","Implant Breakage","Implant Complication","Hip Dysplasia","Pediatric ALL","Hip Disease","Hip Dislocation","2025-11-19",{"date":97,"type":98},"2025-11-24","ACTUAL",{"date":100,"type":98},"2022-01-06",{"date":102,"type":79},"2029-12",{"name":5,"class":6},1]