[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505385":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":46,"locations":55,"responsibleParty":72,"collaborators":26,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":26,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":57,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Istituto Ortopedico Rizzoli","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"mini invasive scoliosis surgery (MIS)","EXPERIMENTAL","This technique involves making small, noncontiguous, midline skin incisions at the levels to be instrumented, usually proximal and distal to the area of arthrodesis. A median fascial incision is then made to expose the vertebral segments on which to thread the screws while the bar is inserted submuscularly in a cranio-caudal direction, after appropriate maneuvers to correct the deformity.",[13],"Procedure: mini invasive scoliosis surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"posterior spinal fusion technique (PSF)","ACTIVE_COMPARATOR","This technique is the surgical gold standard. It consists of an instrumented arthrodesis with posterior access and requires a wide median incision with extensive muscle dissection.",[19],"Procedure: posterior spinal fusion technique",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","mini invasive scoliosis surgery","The minimally invasive technique, involves two small median skin incisions that allow the deep structures to be exposed. The muscle fibers are separated from the bony insertion by the process of subperiosteal \"skeletonization.\" The Investigators then proceed with the arthrectomy of the levels to be instrumented and the infiltration of pedicle screw pairs of the appropriate caliber according to the \"free-hand\" technique. After amplioscopic control of proper screw placement, osteotomies of the posterior elements are performed to facilitate correction of the metameres.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"posterior spinal fusion technique","The standard open technique involves a longitudinal incision along the midline extended along the entire thoracolumbar spine, the paravertebral muscles are incised and spread apart to expose the posterior vertebral structures, in a stretch extending more than 30 cm. The series of facetectomies are performed first, and then pairs of pedicle screws are infixed freehand.\n\nAfter performing the osteotomies necessary to mobilize the vertebral metameres at the apex of the deformity, correction by derotation maneuvers is continued, and the obtained correction is fixed with pre-shaped bars that are then connected to the screws and tightened to the nuts by dynamometric technique. Almost all vertebral levels of the thoracolumbar tract are included in the arthrodesis",[15],[32,36,40,42,44],{"name":33,"affiliation":34,"role":35},"Alessandro Gasbarrini, MD","Istituto Ortopedico Rizzoli - Chirurgia vertebrale","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":39},"Bruna Maccaferri, MD","Istituto Ortopedico Rizzoli -Chirurgia Vertebrale","STUDY_CHAIR",{"name":41,"affiliation":38,"role":39},"Francesco Vommaro, MD",{"name":43,"affiliation":38,"role":39},"Giovanni Ciani, MD",{"name":45,"affiliation":38,"role":39},"Lucrezia Leggi, MD",[47,52],{"name":33,"role":48,"phone":49,"phoneExt":50,"email":51},"CONTACT","6366528","051","alessandro.gasbarrini@ior.it",{"name":37,"role":48,"phone":53,"phoneExt":50,"email":54},"6366567","bruna.maccaferri@ior.it",[56],{"facility":5,"status":57,"city":58,"state":26,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Bologna","40136","Italy","IT",{"type":63,"coordinates":64},"Point",[65,66],11.33875,44.49381,{"lat":66,"lon":65},[69,70,71],{"name":33,"role":48,"phone":26,"phoneExt":26,"email":51},{"name":37,"role":48,"phone":26,"phoneExt":26,"email":54},{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":73,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100505385","minimally-invasive-surgery-vs-standard-posterior-approach-in-the-treatment-of-developmental-idiopathic-scoliosis-100505385",false,"NCT05860673","Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis","Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis: Randomized Trial.","Inclusion Criteria:\n\n1. Patients with AIS\n2. Age between 12 and 25 years;\n3. Site of scoliotic curve: thoracic and\u002For lumbar;\n4. Preoperative radiographic range of the main scoliotic curve between 40° and 70° according to Cobb;\n5. Ability and consent of patients\u002Fparents to actively participate in the study and clinical follow-up.\n\nExclusion Criteria:\n\n1. Patients already treated surgically for scoliosis;\n2. Site of the scoliotic curve: cervical;\n3. Patients with scoliosis other than adolescent idiopathic scoliosis;\n4. Patients who do not fall within the described parameters;\n5. Unbalanced sagittal profile;\n6. Patients unable to consent or perform follow-ups.\n7. Pregnant women.","ALL","12 Years","25 Years",{"count":85,"type":86},126,"ESTIMATED","INTERVENTIONAL",[89],"NA","This is a randomized trial with 1:1 allocation. The aim of the study is to evaluate clinical and radiographic outcomes in patients with developmental age idiopathic scoliosis treated with mini invasive scoliosis surgery (MIS) technique versus posterior spinal fusion (PSF) technique through clinical and radiographic evaluations.",[92],"Adolescent Idiopathic Scoliosis",[94,23,92,95],"posterior spinal fusion","randomized trial","2025-06-03",{"date":98,"type":99},"2025-06-04","ACTUAL",{"date":101,"type":99},"2023-07-15",{"date":103,"type":86},"2032-06",{"name":5,"class":6},1]