[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552212":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":57,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":25,"overallStatus":81,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Xuanwu Hospital, Beijing","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with ASD undergoing correction surgery in reference to our novel criteria","EXPERIMENTAL","Correcting deformity according to the PI-dependent clustering of sagittal spinal alignment.",[13],"Procedure: Correction strategy in reference to our PI-dependent clustering of sagittal alignment",{"label":15,"type":6,"description":16,"interventionNames":17},"Patients with ASD undergoing correction surgery in reference to SAAS score.","Correcting deformity according to the SAAS score.",[18],"Procedure: Correction strategy in reference to the SAAS score",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Correction strategy in reference to our PI-dependent clustering of sagittal alignment","For type I patients (PI \\\u003C 39.56°), the target LL = -0.13\\*PI2+9.36\\*PI-134.08; for type II patients (39.56° ≤ PI \\\u003C 49.16°), the target LL = 0.45\\*PI+26.57; for type III patients (49.16° ≤ PI \\\u003C 58.31°), the target LL = -0.15\\*PI2+17.09\\*PI-420.57; for type IV patients (PI \\> 58.31°), the target LL = 0.06\\*PI2-7.55\\*PI+289.77. Prediction intervals of 95% confidence is adopted as the target LL range.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Correction strategy in reference to the SAAS score","This new score is composed of three sagittal parameters (PI-LL, PT and TPA). For these three parameters, points were assigned based on offset with age-adjusted targets 0 points if the parameter was within 10 years of the patient's age (Match). For each 20 years above the age-adjusted target, 1 point was added (e.g., + 1 point between + 10 and + 30, + 2 points between +30 and +50). Conversely, 1 point was subtracted for each 20 years below the age-adjusted target (e.g., -1 point between -10 and -30, -2 points between -30 and -50). SAAS was calculated by adding all 3 components, creating a discreet score that could have a negative value (under corrected) or positive value (over corrected). SAAS was sub-categorized into \"SAAS-Under\" if it was less than -1, \"SAAS-Match\" if it was between -1 and + 1 or \"SAAS-Over\" if it was greater than + 1.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Shibao Lu, M.D.","CONTACT","18810728213","wdfdoctor@126.com",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Dongfan Wang, M.D.","13821337116","1026607981@qq.com",[41],{"facility":42,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Xuanwu Hospital Capital Medical University","Beijing","Beijing Municipality","100053","China","CN",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":38,"phoneExt":25,"email":35},"Dongfan Wang",{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100552212","a-novel-classification-of-sagittal-spinal-alignment-to-aid-surgical-planning-for-adult-spinal-deformity-100552212",false,"NCT06470152","A Novel Classification of Sagittal Spinal Alignment to Aid Surgical Planning for Adult Spinal Deformity","Pelvic Incidence-Dependent Clustering of Sagittal Spinal Alignment: A Novel Classification to Aid Surgical Planning for Adult Spinal Deformity","CSSAASD","Inclusion Criteria:\n\n1. ≥ 18 years of age at the time of treatment;\n2. Complete radiographic data, including standing posteroanterior and lateral whole-spine radiographs, lumbar computed tomography, and lumbar magnetic resonance imaging;\n3. Radiographic evidence of ASD: sagittal vertical axis ≥ 50 mm, pelvic tilt ≥ 25°, pelvic incidence-lumbar lordosis mismatch ≥ 10°, and\u002For thoracic kyphosis ≥ 60°.\n\nExclusion Criteria:\n\n1. Any type of previous spinal surgery;\n2. Other musculoskeletal problems impeding walking ability, syndromic or neuromuscular diseases such as Parkinson\\&#39;s disease, inflammatory conditions such as ankylosing spondylitis, infectious conditions such as spinal tuberculosis, metabolic diseases such as severe osteoporosis, and\u002For serious general medical conditions such as sepsis or malignancy;\n3. Pathology of deformity as follows: post-traumatic deformity, adult idiopathic scoliosis of the thoracic spine, or de-novo lumbar scoliosis;\n4. Hip joint Kellgren-Lawrence grade ≥ II, history of hip joint and\u002For knee joint pain, and\u002For previous joint replacement.","ALL","18 Years",{"count":70,"type":71},200,"ESTIMATED","INTERVENTIONAL",[74],"NA","Surgical outcomes, including radiographic outcomes, patient-reported outcomes, postoperative complications, and revision surgery rates, were compared in patients with adult spinal deformity who underwent correction surgery with reference to our pelvic incidence-dependent (PI-dependent) clustering of sagittal spinal alignment and existing standards (sagittal age-adjusted score \\[SAAS\\], global alignment and proportion \\[GAP\\] score, and Roussouly classification). Our findings may provide tangible guidance for surgical decision-making in ASD.",[77,78,79,80],"Adult Spinal Deformity","Sagittal Deformity","Sagittal Alignment","Sagittal Imbalance","NOT_YET_RECRUITING","2024-06-17",{"date":84,"type":85},"2024-06-24","ACTUAL",{"date":87,"type":71},"2024-12-01",{"date":89,"type":71},"2027-12-01",{"name":5,"class":6},1]