[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Globus Medical Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100637974","a-retrospective-review-outcomes-of-the-reflect-system-for-idiopathic-scoliosis-100637974",false,"NCT07589023","A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis","A Retrospective Review of Clinical and Radiographic Outcomes Following the Use of the REFLECT™ Scoliosis Correction System in the Treatment of Idiopathic Scoliosis","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be included in the study:\n\n1. Requires surgical treatment to obtain and maintain correction of idiopathic scoliosis\n2. Skeletally immature\n3. Major Cobb angle of 30° and 65°\n4. Bone structure adequate to safely accommodate screw fixation\n5. Failed bracing treatment and\u002For intolerant to brace wear\n6. Treated with the REFLECT™ Scoliosis Correction System, using single or dual REFLECT cord(s) per curve\n7. Availability of medical and radiographic records evaluating the product under study preoperatively through a minimum of 12 months postoperative\n\nExclusion Criteria:\n\nPatients were excluded from the study if they met any of the following conditions:\n\n1. Presence of any systemic infection, local infection, or skin compromise at the surgical site\n2. Prior spinal surgery at the level(s) to be treated\n3. Known poor bone quality, defined as a T-score of -1.5 or less\n4. Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, or patient unwillingness or inability to cooperate with postoperative care instructions","ALL",{"count":18,"type":19},100,"ESTIMATED","OBSERVATIONAL","This study reviews medical records of children and adolescents treated for idiopathic scoliosis (a sideways curve of the spine with no known cause) using the REFLECT™ Scoliosis Correction System.",[23],"Idiopathic Scoliosis",[25,26,27,28],"scoliosis","idiopathic scoliosis","spinal curve","REFLECT System","NOT_YET_RECRUITING","2026-05-11",{"date":32,"type":33},"2026-05-15","ACTUAL",{"date":35,"type":19},"2026-06-15",{"date":37,"type":19},"2027-07-31",{"name":39,"class":40},"Globus Medical Inc","INDUSTRY",3,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":5},"100539051","reflect-scoliosis-system-post-approval-study-100539051","NCT06298812","REFLECT Scoliosis System Post Approval Study","A Prospective, Single-Arm, Multi-Center, Registry Post-Approval Study of Growth Modulation in the Treatment of Idiopathic Scoliosis With the REFLECT™ Scoliosis Correction System","Inclusion Criteria:\n\n* Diagnosis of progressive idiopathic scoliosis\n* Preoperative major Cobb angle 30°-65°\n* Preoperative flexibility to ≤30° on side bending radiograph (left or right)\n* Skeletally immature at the time of surgery with Risser sign \\\u003C5 or Sanders score \\\u003C8\n* Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging\n* Failed or intolerant to bracing\n* Signed informed consent and\u002For assent forms specific to this study\n\nExclusion Criteria:\n\n* Prior spinal surgery at the level(s) to be treated\n* Documented poor bone quality, defined as a T-score of -1.5 or less\n* Presence of any systemic infection, local infection, or skin compromise at the surgical site\n* Any medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions\n* Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent\n* Active participation in a drug or device study that is more than minimal risk such that participation would confound the measurements of the present study",{"count":18,"type":19},"INTERVENTIONAL",[52],"NA","The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval",[23],"RECRUITING","2026-02-11",{"date":58,"type":33},"2026-02-13",{"date":60,"type":33},"2024-04-08",{"date":62,"type":19},"2032-03-31",{"name":39,"class":40},""]