[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396385":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":55,"collaborators":19,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":9,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":19,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":37,"whyStopped":19,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"NEMOST-AIS","This study is designed as a cohort study.",[12],"Device: NEMOST system",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","NEMOST system","Minimal invasive double rod posterior Non-Fusion Scoliosis Surgery",[9],null,[21],{"name":22,"affiliation":23,"role":24},"BJ Van Royen, MD, PhD","AmsterdamUMC","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","+31(0)5662672","bj.vanroyen@amsterdamumc.nl",{"name":31,"role":27,"phone":32,"phoneExt":19,"email":33},"AMC AmsterdamUMC","+31(0)205669111","amcfoundation@amc.nl",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"AmsterdamUMC, location AMC","RECRUITING","Amsterdam","North Holland","1105AZ","Netherlands","NL",{"type":44,"coordinates":45},"Point",[46,47],4.88969,52.37403,{"lat":47,"lon":46},[50,53],{"name":51,"role":27,"phone":52,"phoneExt":19,"email":19},"Dept of Orthopedics","+31(20)5662672",{"name":54,"role":27,"phone":52,"phoneExt":19,"email":19},"Dept of orthopaedics",{"type":24,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"BJ van Royen","clinical professor, principal investigator","100396385","non-fusion-surgery-in-adolescent-idiopathic-scoliosis-patients-100396385",false,"NCT04441411","Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients","Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients Using the Nemost-AIS System","Inclusion Criteria:\n\n* Adolescent idiopathic scoliosis ;\n* Primary Cobb angle greater than 30°;\n* Failed non-operative treatment defined as progression of the curve greater than 5° per year at any time;\n* Skeletally immature (Risser grade\\* ≤2 and Skeletal age of hand and wrist X-rays ≤14y);\n* In girl, either pre-menarchal or post-menarchal by no more than 1 year;\n* Age over 10 years;\n* Non rigid curve;\n* All Lenke type;\n* No previous spine surgery.\n\nExclusion Criteria:\n\n* Non-idiopathic scoliosis: musculoskeletal or neurologic conditions responsible for cause of the spine curvature (i.e. neuromuscular, congenital or syndromic scoliosis);\n* History of previous spine surgery;\n* Risser sign \\>2;\n* Disease or deformity likely to affect the stability of the device (i.e. inadequate anatomy of pedicles, trauma or tumor in fixation region, severe osteoporosis, bone destruction or poor bone quality);\n* Non-reductible scoliosis;\n* Known allergy or intolerance to one of the device material;\n* Acute or chronic infections, local or systemic;\n* Absence or insufficience of covering tissues;\n* Pathological obesity.","ALL","10 Years","17 Years",{"count":69,"type":70},18,"ESTIMATED","INTERVENTIONAL",[73],"NA","The primary objective of the study is to monitor the effectiveness of a minimal invasive non-fusion double rod bipolar posterior spinal implant (Nemost growing domino) to correct the scoliotic curve in growing patients suffering from progressive adolescent idiopathic scoliosis (AIS) who have failed conservative treatment.",[76],"Adolescent Idiopathic Scoliosis",[78,79,80,81,82,83],"scoliosis","nonfusion","surgery","fusionless","idiopathic","adolescent","2024-07-29",{"date":86,"type":87},"2024-07-30","ACTUAL",{"date":89,"type":87},"2020-06-01",{"date":91,"type":70},"2028-12-31",{"name":5,"class":6},1]