[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468445":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":84,"collaborators":87,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":29,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":29,"overallStatus":47,"whyStopped":29,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Turku University Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Posterior column osteotomy","ACTIVE_COMPARATOR","Apical 3-5 posterior column osteotomies in addition to standard treatment",[13],"Procedure: Posterior column osteotomy",{"label":15,"type":16,"description":17,"interventionNames":18},"No osteotomies","PLACEBO_COMPARATOR","Standard treatment",[19],"Procedure: No osteotomies",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Apical full facet joint resection. Study intervention does not involve a device.",[9],[26],"Smith-Petersen osteotomy",{"type":22,"name":15,"description":17,"armGroupLabels":28,"otherNames":29},[15],null,[31],{"name":32,"affiliation":33,"role":34},"Ilkka Helenius, MD, PhD","Helsinki University Central Hospital","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":29,"email":40},"Matti Ahonen, MD, PhD","CONTACT","+35894711","matti.ahonen@hus.fi",{"name":42,"role":38,"phone":39,"phoneExt":29,"email":43},"Ilkka Helenius, Prof","ilkka.helenius@hus.fi",[45,68],{"facility":46,"status":47,"city":48,"state":29,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Helsinki University Hospital","RECRUITING","Helsinki","FI-00029","Finland","FI",{"type":53,"coordinates":54},"Point",[55,56],24.93545,60.16952,{"lat":56,"lon":55},[59,62,66],{"name":60,"role":38,"phone":61,"phoneExt":29,"email":40},"Matti Ahonen, Associate Professor","+358503583494",{"name":63,"role":38,"phone":64,"phoneExt":29,"email":65},"Ilkka Helenius, Professor","0443380034","ilkka.helenius@helsinki.fi",{"name":60,"role":67,"phone":29,"phoneExt":29,"email":29},"PRINCIPAL_INVESTIGATOR",{"facility":5,"status":47,"city":69,"state":29,"zip":70,"country":50,"countryCode":51,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Turku","20900",{"type":53,"coordinates":72},[73,74],22.26869,60.45148,{"lat":74,"lon":73},[77,81,82],{"name":78,"role":38,"phone":79,"phoneExt":29,"email":80},"Linda Helenius, MD","+358503609291","linda.helenius@tyks.fi",{"name":63,"role":38,"phone":64,"phoneExt":29,"email":65},{"name":83,"role":67,"phone":29,"phoneExt":29,"email":29},"Linda Helenius, Associate Professor",{"type":67,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Ilkka Helenius","Professor",[88,90],{"name":33,"class":89},"OTHER",{"name":91,"class":89},"Kuopio University Hospital","100468445","posterior-column-spinal-osteotomies-in-the-treatment-of-adolescent-idiopathic-scoliosis-100468445",false,"NCT05379868","Posterior Column Spinal Osteotomies in the Treatment of Adolescent Idiopathic Scoliosis","Posterior Column Spinal Osteotomies in the Treatment of Adolescent Idiopathic Scoliosis. A Randomized Clinical Trial","ASPO","Inclusion Criteria:\n\n* Adolescent idiopathic scoliosis (Lenke 1 to 4)\n* Age at surgery between 10 and 21 years\n* Cobb angle of 45 degrees or more\n* Posterior spinal fusion\n\nExclusion Criteria:\n\n* Anteroposterior surgery\n* Vertebral column resection\n* Smoking\n* Diabetes mellitus\n* Bleeding disorder","ALL","10 Years","21 Years",{"count":104,"type":105},90,"ESTIMATED","INTERVENTIONAL",[108],"NA","Background: Posterior column osteotomies (PCO) are routinely used to facilitate curve correction in surgical treatment of adolescent idiopathic scoliosis (AIS). Data regarding routine use of PCO is controversial, with conflicting data for coronal and sagittal plane correction and clinical benefit. Use of PCO has not been studied in the surgical treatment of AIS in a prospective randomized clinical trial.\n\nStudy Design: A randomized, multicenter clinical trial on children and adolescents undergoing posterior spinal fusion for idiopathic scoliosis using pedicle screw instrumentation. Sixty consecutive adolescents will be randomized into PCO or no PCO group after surgical exposure of the spine in 1:1 ratio.\n\nAims and Hypothesis: To compare PCO vs. no PCO groups for the correction of coronal and sagittal plane curve in children undergoing posterior spinal fusion for AIS. The investigators hypothesize that the correction of coronal curve and hypokyphosis will be better in PCO group without increasing blood loss or complications.\n\nInclusion criteria: Adolescents (aged 10 to 21 years of age) undergoing corrective surgery for idiopathic scoliosis using pedicle screw technique.\n\nExclusion criteria: Coagulation disorder, smoking, unwilling to consent, vertebral column resection, need for anteroposterior surgery.\n\nMain outcome parameters: Primary outcome is the radiographic correction (Coronal and sagittal plane). Secondary outcomes include health-related quality of life (Scoliosis Research Society 24 outcome questionnaire), postoperative pain, rib hump, operative time, blood loss, hospital stay, and complications.\n\nEthical aspects: Ethical committee approval will be obtained. An informed consent will be obtained from all children and their parents.\n\nTime schedule and budget: This study has ethical committee approval.There will be no extra costs as all information gathered will be part of normal surgical treatment of AIS. A part-time research nurse has been hired to take care of data collection into the database.",[111],"Adolescent Idiopathic Scoliosis","2024-11-27",{"date":114,"type":115},"2024-12-03","ACTUAL",{"date":117,"type":115},"2022-06-01",{"date":119,"type":105},"2029-06-01",{"name":5,"class":6},2]