[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648494":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":36,"locations":42,"responsibleParty":58,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":26,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":88,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Model-Guided Group","EXPERIMENTAL","Participants in this group will undergo standard posterior spinal fusion. Before surgery, preoperative clinical and radiographic variables will be entered into the locked Drum Tower Rule machine learning model. The model will generate a predicted risk of distal adding-on and a recommendation for lowest instrumented vertebra selection. The surgeon will make the final decision after considering the model output and clinical judgment.",[13,14],"Other: Drum Tower Rule Machine Learning-Guided Decision Support","Procedure: Posterior Spinal Fusion",{"label":16,"type":17,"description":18,"interventionNames":19},"Conventional-Experience Group","ACTIVE_COMPARATOR","Participants in this group will undergo standard posterior spinal fusion. The surgeon will select the lowest instrumented vertebra according to routine clinical experience and existing surgical principles. The Drum Tower Rule model output will not be provided to the surgeon for participants in this group.",[20,14],"Other: Conventional LIV Decision-Making",[22,27,31],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"Drum Tower Rule Machine Learning-Guided Decision Support","A locked machine learning-based decision support model will be used before surgery to estimate the risk of postoperative distal adding-on and provide a recommendation for lowest instrumented vertebra selection. The model output will be available to surgeons in the model-guided group only.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional LIV Decision-Making","The lowest instrumented vertebra will be selected by the surgeon according to routine clinical experience and existing surgical principles, without access to the Drum Tower Rule model output.",[16],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"PROCEDURE","Posterior Spinal Fusion","All participants will undergo standard posterior spinal fusion using an all-pedicle screw instrumentation system.",[16,9],[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Xiaodong Qin, MD, PhD","CONTACT","025-68182923","gyethics@163.com",[43],{"facility":44,"status":26,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School","Nanjing","Jiangsu","210008","China","CN",{"type":51,"coordinates":52},"Point",[53,54],118.77778,32.06167,{"lat":54,"lon":53},[57],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"type":59,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100648494","machine-learning-guided-liv-selection-for-adolescent-idiopathic-scoliosis-100648494",false,"NCT07723053","Machine Learning-Guided LIV Selection for Adolescent Idiopathic Scoliosis","A Prospective Randomized Controlled Trial of the Drum Tower Rule Machine Learning Model for Lowest Instrumented Vertebra Selection in Lenke Type 1 and Type 5 Adolescent Idiopathic Scoliosis","Inclusion Criteria:\n\n* Diagnosis of adolescent idiopathic scoliosis classified as Lenke type 1A or Lenke type 5C.\n* Age 10 to 18 years, inclusive.\n* Scheduled to undergo posterior spinal fusion using an all-pedicle screw instrumentation system.\n* Planned selective thoracic fusion or selective lumbar fusion, with a clinical need for lowest instrumented vertebra decision-making.\n* Availability of required preoperative standing full-spine radiographs and bending radiographs.\n* Ability and willingness to complete the planned 24-month postoperative follow-up.\n* Written informed consent provided by the participant and legal guardian.\n\nExclusion Criteria:\n\n* \\- Congenital scoliosis, neuromuscular scoliosis, syndromic scoliosis, or other non-idiopathic scoliosis.\n* History of spinal trauma, spinal tumor, spinal tuberculosis, or spinal infection.\n* Previous spinal surgery.\n* Severe sagittal spinal deformity, such as Scheuermann disease, for which the study model is not applicable.\n* Neurological symptoms or signs.\n* Leg length discrepancy greater than 10 mm.\n* The surgeon determines that there is no clinical equipoise for lowest instrumented vertebra selection because one option is clearly contraindicated for safety or anatomical reasons.\n* Inability to complete follow-up or required study assessments.","ALL","10 Years","18 Years",{"count":71,"type":72},300,"ESTIMATED","INTERVENTIONAL",[75],"NA","This study will evaluate whether a machine learning-based decision support model, called the Drum Tower Rule, can help surgeons select the lowest instrumented vertebra during corrective surgery for adolescent idiopathic scoliosis.\n\nPatients with Lenke type 1 or Lenke type 5 adolescent idiopathic scoliosis who are scheduled for posterior spinal fusion will be randomly assigned to one of two groups. In the model-guided group, surgeons will receive the model-predicted risk of postoperative distal adding-on and a recommendation for lowest instrumented vertebra selection. In the conventional-experience group, surgeons will select the lowest instrumented vertebra according to routine clinical experience and existing surgical principles, without access to the model output.\n\nAll patients will receive standard posterior spinal fusion. The main outcome is the incidence of distal adding-on at 24 months after surgery, assessed by blinded radiographic reviewers.",[78,79,80],"Adolescent Idiopathic Scoliosis","Lenke Type 1 Adolescent Idiopathic Scoliosis","Lenke Type 5 Adolescent Idiopathic Scoliosis",[82,83,84,85,33,86,87],"Lowest Instrumented Vertebra","Distal Adding-on","Machine Learning","Surgical Decision Support","Lenke Classification","Drum Tower Rule","NOT_YET_RECRUITING","2026-07-19",{"date":91,"type":92},"2026-07-23","ACTUAL",{"date":94,"type":72},"2026-07-01",{"date":96,"type":72},"2030-09",{"name":5,"class":6},1]