[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396385":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":54,"collaborators":19,"id":57,"slug":19,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":9,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":19,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":37,"whyStopped":19,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"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,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"AmsterdamUMC, location AMC","RECRUITING","Amsterdam","North Holland","1105AZ","Netherlands",{"type":43,"coordinates":44},"Point",[45,46],4.88969,52.37403,{"lat":46,"lon":45},[49,52],{"name":50,"role":27,"phone":51,"phoneExt":19,"email":19},"Dept of Orthopedics","+31(20)5662672",{"name":53,"role":27,"phone":51,"phoneExt":19,"email":19},"Dept of orthopaedics",{"type":24,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"BJ van Royen","clinical professor, principal investigator","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":67,"type":68},18,"ESTIMATED","INTERVENTIONAL",[71],"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.",[74],"Adolescent Idiopathic Scoliosis",[76,77,78,79,80,81],"scoliosis","nonfusion","surgery","fusionless","idiopathic","adolescent","2024-07-29",{"date":84,"type":85},"2024-07-30","ACTUAL",{"date":87,"type":85},"2020-06-01",{"date":89,"type":68},"2028-12-31",{"name":5,"class":6},1]