[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04194138":3,"trial-entities:NCT04194138":369,"trial-summary:NCT04194138":372},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":72,"sex":84,"minimum_age":85,"maximum_age":26,"healthy_volunteers":15,"eligibility_criteria":86,"std_ages":99,"locations":102,"central_contacts":345,"overall_officials":353,"references":360,"see_also_links":368},"NCT04194138","2123","Complex Adult Deformity Surgery (CADS)","Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery","RECRUITING","2032-07-31","2026-02","2026-02-17","2018-07-30","International Spine Study Group Foundation","OTHER",false,"Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications.","Specific Aims:\n\n• Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications.\n\na. Complex ASD patients will be defined based upon clinical, radiographic and\u002For procedural criteria identified in an analysis of the existing ISSG ASD database: i. Magnitude of coronal and\u002For sagittal spinal deformity ≥75th percentile of patients in the ISSG database.\n\nii. Clinical or Radiographic parameters that corresponded to patients in the ISSG database that had complications requiring revision spine surgery and\u002For patients that had hospital length of stay \\>9 days.\n\niii. Procedures involving 3 column osteotomies and\u002For anterior column reconstruction (ACR) of the spine\n\n* Develop and validate a standardized, universal complications classification system for spine surgery\n* Evaluate perioperative blood management approaches, transfusion requirements, including variance in thresholds for blood transfusion and associated complications for adult spinal deformity surgery\n* Assess impact of opioid use and pain management on patient cost, complications and outcomes\n* Evaluate optimal opioid and analgesic usage and protocols for standard work development\n* Evaluate clinical outcomes utilizing legacy patient reported outcome measures (PROMs) including modified Oswestry Disability Index (mODI), Scoliosis Research Society Questionnaire 22r (SRS-22r), Veterans RAND-12 (VR-12), and numeric pain rating scale (NRS) and compare the results of these legacy PROMs to outcomes scores as measured by the NIH Patient Reported Outcomes Measurement Information System (PROMIS) - PROMIS Anxiety, Depression, Pain Interference, Physical Function, and Social Satisfaction. Secondary aims for PROM research for this study include\n\n  1. Validation of the PROMIS tool for ASD\n  2. Establish a core set of PROMs for best practice guidelines for ASD\n  3. Evaluate patient reported outcome variance for ASD according to SRS-Schwab spine deformity type including variance in baseline PROM domains impacted and variance in improvement in PROM domains\n  4. Evaluate ASD outcomes compared to population norms and investigate\u002Fdevelop appropriate measures of clinically significant improvement\n* Evaluate clinical outcomes stratifying by patient chronological and physiological age\n* Evaluate measures to quantify patient physiological age including patient frailty for ASD and validate a frailty measurement system for ASD\n* Evaluate the role of functional tests in patient's baseline frailty assessment including hand manometer and Edmonton Frail Scale. See appendix, pages 17 \\& 18 for details.\n* Evaluate the contribution of patient frailty to patient outcomes, cost of care, disability, and complications\n* Evaluate if patient frailty is a static measure or if frailty is a dynamic measure that can be improved through \"pre-habilitation\" and if the according associations with reductions in frailty correlate with reductions of cost, complications, and improvement in outcomes\n* Evaluate cost variance for ASD surgery according to patient, institution, and geographical region and evaluate the cost effectiveness of surgical intervention for ASD\n* Evaluate incidence of and risk factors for mental health (MH) compromise among ASD patients and establish best practice guidelines for assessing MH for ASD patients\n* Evaluate the association of MH with surgical complications, outcomes, hospital length of stay and cost for ASD surgery\n* Evaluate the association of social health surgical complications, outcomes, hospital length of stay and cost for ASD surgery and risk factors for routine (home) discharge vs. skilled nursing facility (SNF)\u002Frehabilitation facility\n* Broaden the evaluation of the surgically treated ASD patient to maximize evaluation of the entirety of the episode of care to include steps that can be taken prior to surgery including \"prehabilitation,\" pain management, and MH care to improve treatment outcomes, reduce cost, reduce hospital length of stay, reduce non-routing discharge and reduce early and late complications\n* Establish a core set of standard work guidelines to clinically and radiographically evaluate and treat ASD patients and evaluate the utility of standard work to improve outcomes for ASD and formulate best practice guidelines for surgical treatment of ASD\n* Develop predictive analytic algorithms to risk stratify for best\u002Fworst outcomes, complications, sentinel events, and economic loss for ASD surgery",[19,20,21,22],"Adult Spinal Deformity","Scoliosis","Kyphosis","Sagittal Imbalance",[20,21,22,24],"Spinal deformity","OBSERVATIONAL",null,[],{"count":29,"type":30},1500,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"PROCEDURE","Index or spine revision surgery for complex adult spinal deformity","Surgical interventions will be patient specified by treating surgeon.",[37],"Operative",[39,43,46,49,52,55,58,60,62,64,66,69],{"measure":40,"description":41,"timeFrame":42},"Scoliosis Research Society (SRS) 22r","Scoliosis specific patient reported outcome","Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up",{"measure":44,"description":45,"timeFrame":42},"Oswestry Disability Index (ODI)","Spine specific patient reported outcome",{"measure":47,"description":48,"timeFrame":42},"Veterans RAND 12 Item Health Survey (VR-12)","Patient reported outcome",{"measure":50,"description":51,"timeFrame":42},"Radiographic Evaluation","Cobb angles, Coronal \\& Sagittal balance, spinopelvic measures",{"measure":53,"description":54,"timeFrame":42},"Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety","Computer adaptive PROs",{"measure":56,"description":57,"timeFrame":42},"Patient-Reported Outcome Measurement Information System (PROMIS) - Depression","Computer adaptive PRO",{"measure":59,"description":57,"timeFrame":42},"Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference",{"measure":61,"description":57,"timeFrame":42},"Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function",{"measure":63,"description":57,"timeFrame":42},"Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role Satisfaction",{"measure":65,"description":57,"timeFrame":42},"Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA)",{"measure":67,"description":68,"timeFrame":42},"Visual Analog Scale - Back Pain","Self-reported back pain on scale of 0 (No pain) to 10 (severe pain)",{"measure":70,"description":71,"timeFrame":42},"Visual Analog Scale - Leg Pain","Self-reported leg pain on scale of 0 (No pain) to 10 (severe pain)",[73,77,80],{"measure":74,"description":75,"timeFrame":76},"Edmonton Frail Scale","Evaluate frailty on scale of 0 to 17 where higher scores mean more frail","Change from Preop to 3months and 1, 2, 5 & 10 year follow-up",{"measure":78,"description":79,"timeFrame":76},"Canadian Study of Health and Aging (CSHA)","Frailty scale of 1 to 8; higher scores mean more frail",{"measure":81,"description":82,"timeFrame":83},"Adverse Events","Occurrence of Adverse events meeting reporting criteria and their relationship to intervention throughout the study","3 months and 1, 2, 5 & 10 year post treatment","ALL","18 Years",{"inclusion":87,"exclusion":97,"raw_text":98},[88,89,90,91,92,93,94,95,96],"PI-LL ≥ 25 degrees","TPA ≥ 30 degrees","SVA\\>15cm","Thoracic scoliosis ≥ 70 degrees","Thoracolumbar\u002Flumbar scoliosis ≥ 50 degrees","Global coronal malalignment \\>7cm 2. Procedural criteria:","Posterior spinal fusion \\> 12 levels","3 column osteotomy or ACR 3. Geriatric criteria:","Age \\>65 years and minimum 7 levels of spinal instrumentation during surgery",[],"Criteria:\n\nInclusion Criteria:\n\n1. Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity\n2. Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)\n3. Complex patients are defined as and meeting any one of the subsequent criteria:\n\n   1. Radiographic criteria:\n\n      * PI-LL ≥ 25 degrees\n      * TPA ≥ 30 degrees\n      * SVA\\>15cm\n      * Thoracic scoliosis ≥ 70 degrees\n      * Thoracolumbar\u002Flumbar scoliosis ≥ 50 degrees\n      * Global coronal malalignment \\>7cm\n   2. Procedural criteria:\n\n      * Posterior spinal fusion \\> 12 levels\n      * 3 column osteotomy or ACR\n   3. Geriatric criteria:\n\n      * Age \\>65 years and minimum 7 levels of spinal instrumentation during surgery\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years of age\n2. Active spine tumor or infection\n3. Deformity due to acute trauma\n4. Neuromuscular conditions\u002Fdiseases (Parkinson's, Multiple Sclerosis, Post-polio syndrome)\n5. Syndromic scoliosis\n6. Inflammatory arthritis\u002Fauto immune diseases (Rheumatoid arthritis, Lupus, Ankylosing Spondylitis)\n7. Prisoners\n8. Women who are pregnant\n9. Non English speaking patients",[100,101],"ADULT","OLDER_ADULT",[103,124,132,145,160,176,190,204,218,231,241,251,261,275,289,303,316,331],{"facility":104,"status":8,"city":105,"state":106,"zip":107,"country":108,"contacts":109,"geoPoint":121},"Shiley Center for Orthopaedic Research and Education at Scripps Clinic","La Jolla","California","92037","United States",[110,115,118],{"name":111,"role":112,"phone":113,"email":114},"Paulina de la Garza","CONTACT","858-554-7124","delaGarza.Paulina@scrippshealth.org",{"name":116,"role":117},"Gregory Mundis, MD","PRINCIPAL_INVESTIGATOR",{"name":119,"role":120},"Robert Eastlack, MD","SUB_INVESTIGATOR",{"lat":122,"lon":123},32.84727,-117.2742,{"facility":125,"status":126,"city":127,"state":106,"zip":128,"country":108,"geoPoint":129},"University of California, Davis, Department of Orthopedic Surgery","ACTIVE_NOT_RECRUITING","Sacramento","05616",{"lat":130,"lon":131},38.58157,-121.4944,{"facility":133,"status":8,"city":134,"state":106,"zip":135,"country":108,"contacts":136,"geoPoint":142},"UCSF, Department of Neurosurgery","San Francisco","94143",[137,140],{"name":138,"role":112,"email":139},"Adrian Fu","Adrian.Fu@ucsf.edu",{"name":141,"role":117},"Christopher Ames, MD",{"lat":143,"lon":144},37.77493,-122.41942,{"facility":146,"status":8,"city":147,"state":148,"zip":149,"country":108,"contacts":150,"geoPoint":157},"Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center","Denver","Colorado","80218",[151,155],{"name":152,"role":112,"phone":153,"email":154},"Breton Line, BS","303-762-3472","breton.line@gmail.com",{"name":156,"role":117},"Shay Bess, MD",{"lat":158,"lon":159},39.73915,-104.9847,{"facility":161,"status":8,"city":162,"state":163,"zip":164,"country":108,"contacts":165,"geoPoint":173},"University of Kansas, Department of Orthopedic Surgery","Kansas City","Kansas","66160",[166,169,171],{"name":167,"role":112,"email":168},"Dave Turkowitch","dturkowitch@kumc.edu",{"name":170,"role":117},"Brandon Carlson, MD",{"name":172,"role":120},"Joshua Bunch, MD",{"lat":174,"lon":175},39.11417,-94.62746,{"facility":177,"status":8,"city":178,"state":179,"zip":180,"country":108,"contacts":181,"geoPoint":187},"Norton Leatherman Spine Center","Louisville","Kentucky","40207",[182,185],{"name":183,"role":112,"email":184},"Morgan Brown","morgan.brown2@nortonhealthcare.org",{"name":186,"role":117},"Jeff Gum, MD",{"lat":188,"lon":189},38.25424,-85.75941,{"facility":191,"status":8,"city":192,"state":193,"zip":194,"country":108,"contacts":195,"geoPoint":201},"Spine Institute of Louisiana","Shreveport","Louisiana","71101",[196,199],{"name":197,"role":112,"email":198},"Cody McConnell","CMcConnell@louisianaspine.org",{"name":200,"role":117},"Pierce Nunley, MD",{"lat":202,"lon":203},32.52515,-93.75018,{"facility":205,"status":8,"city":206,"state":207,"zip":208,"country":108,"contacts":209,"geoPoint":215},"John Hopkins University, Department of Orthopedic Surgery","Baltimore","Maryland","21224",[210,213],{"name":211,"role":112,"email":212},"Ahmed Sulieman","asuliem2@jh.edu",{"name":214,"role":117},"Khaled Kebaish, MD",{"lat":216,"lon":217},39.29038,-76.61219,{"facility":219,"status":8,"city":220,"state":220,"zip":221,"country":108,"contacts":222,"geoPoint":228},"NYU, Department of Orthopedics","New York","10016",[223,226],{"name":224,"role":112,"email":225},"Connie Maglaras","constance.maglaras@nyulangone.org",{"name":227,"role":117},"Themi Protopsaltis, MD",{"lat":229,"lon":230},40.71427,-74.00597,{"facility":232,"status":8,"city":220,"state":220,"zip":233,"country":108,"contacts":234,"geoPoint":240},"Hospital for Special Surgery, Department of Orthopedic Surgery","10021",[235,238],{"name":236,"role":112,"email":237},"Christopher Yoo","yooch@hss.edu",{"name":239,"role":117},"Han Jo Kim, MD",{"lat":229,"lon":230},{"facility":242,"status":8,"city":220,"state":220,"zip":243,"country":108,"contacts":244,"geoPoint":250},"Columbia University Medical Center","10032",[245,248],{"name":246,"role":112,"email":247},"Erik Lewerenz","el3191@cumc.columbia.edu",{"name":249,"role":117},"Lawrence G Lenke, MD",{"lat":229,"lon":230},{"facility":252,"status":8,"city":220,"state":220,"zip":253,"country":108,"contacts":254,"geoPoint":260},"Northwell Health","10075",[255,258],{"name":256,"role":112,"email":257},"Jonathan Elysee","jelysee@northwell.edu",{"name":259,"role":117},"Frank Schwab",{"lat":229,"lon":230},{"facility":262,"status":8,"city":263,"state":264,"zip":265,"country":108,"contacts":266,"geoPoint":272},"Duke University Health System","Durham","North Carolina","27710",[267,270],{"name":268,"role":112,"email":269},"Ronald Pegues","ronald.pegues@duke.edu",{"name":271,"role":117},"Christopher Shaffrey, MD",{"lat":273,"lon":274},35.99403,-78.89862,{"facility":276,"status":8,"city":277,"state":278,"zip":279,"country":108,"contacts":280,"geoPoint":286},"University Orthopedics","Providence","Rhode Island","02905",[281,284],{"name":282,"role":112,"email":283},"Krista Szatkowski","kszatkowski@universityorthopedics.com",{"name":285,"role":117},"Alan Daniels, MD",{"lat":287,"lon":288},41.82399,-71.41283,{"facility":290,"status":8,"city":291,"state":292,"zip":293,"country":108,"contacts":294,"geoPoint":300},"Medical City Spine Hospital - Southwest Scoliosis Institute","Dallas","Texas","75243",[295,298],{"name":296,"role":112,"email":297},"Mona Hedra","Mona.Hedra@HCAhealthcare.com",{"name":299,"role":117},"Richard Hostin, MD",{"lat":301,"lon":302},32.78306,-96.80667,{"facility":304,"status":8,"city":305,"state":292,"zip":306,"country":108,"contacts":307,"geoPoint":313},"University of Texas - Houston","Houston","77030",[308,311],{"name":309,"role":112,"email":310},"Olivia Nembhard","olivia.nembhard@uth.tmc.edu",{"name":312,"role":117},"Eric Klineberg, MD",{"lat":314,"lon":315},29.76328,-95.36327,{"facility":317,"status":8,"city":318,"state":319,"zip":320,"country":108,"contacts":321,"geoPoint":328},"University of Virginia","Charlottesville","Virginia","22908",[322,326],{"name":323,"role":112,"phone":324,"email":325},"Lorrie Sipe","434-924-8875","lag3k@virginia.edu",{"name":327,"role":117},"Justin Smith, MD",{"lat":329,"lon":330},38.02931,-78.47668,{"facility":332,"status":8,"city":333,"state":334,"country":335,"contacts":336,"geoPoint":342},"Toronto Western","Toronto","Ontario","Canada",[337,340],{"name":338,"role":112,"email":339},"Sofia Magana","Sofia.Magana@uhn.on.ca",{"name":341,"role":117},"Stephen Lewis, MD",{"lat":343,"lon":344},43.70643,-79.39864,[346,350],{"name":347,"role":112,"phone":348,"email":349},"Christine Baldus, MS","618-444-4130","baldusc@wustl.edu",{"name":351,"role":112,"email":352},"Ray Pinteric","ray.pinteric@outlook.com",[354,355,358],{"name":156,"role":117},{"name":356,"affiliation":357,"role":117},"Lawrence Lenke, MD","Columbia University, Department of Orthopedic Surgery",{"name":271,"affiliation":359,"role":117},"Duke University, Departments of Neurosurgery and Orthopaedic Surgery",[361,365],{"pmid":362,"type":363,"citation":364},"41761562","DERIVED","Boutros M, Assi A, Diebo BG, Prince G, Karam M, Daher M, Ames CP, Bess S, Daniels AH, Gupta MC, Hostin R, Kim HJ, Klineberg EO, Lenke LG, Nunley PD, Passias PG, Schwab FJ, Shaffrey CI, Smith JS, Lafage R, Lafage V; International Spine Study Group. A New Normative Zone for Acetabular Anteversion Positioning in ASD Patients. J Orthop Res. 2026 Mar;44(3):e70171. doi: 10.1002\u002Fjor.70171.",{"pmid":366,"type":363,"citation":367},"39576989","Passias PG, Tretiakov P, Onafowokan OO, Das A, Lafage R, Smith JS, Line BG, Nayak P, Diebo B, Daniels AH, Gum JL, Hamilton DK, Buell TJ, Soroceanu A, Scheer JK, Eastlack RK, Mullin JP, Schoenfeld AJ, Mundis GM, Hosogane N, Yagi M, Mummaneni PV, Chou D, Fu KM, Than KD, Anand N, Okonkwo DO, Wang MY, Klineberg E, Kebaish KM, Lewis S, Hostin R, Gupta M, Lenke L, Kim HJ, Ames CP, Shaffrey CI, Bess S, Schwab F, Lafage V, Burton D. When is staging complex adult spinal deformity advantageous? Identifying subsets of patients who benefit from staged interventions. J Neurosurg Spine. 2024 Nov 22;42(2):185-192. doi: 10.3171\u002F2024.8.SPINE24365. Print 2025 Feb 1.",[],{"nct_id":4,"conditions":370,"biomarkers":371},[19],[],{"nct_id":4,"found":373,"summary":374,"prompt_version":384},true,{"design":375,"status":376,"heading":377,"summary":378,"follow_up":379,"word_count":380,"commitments":381,"compensation":382,"drugs_mentioned":383},"This is an observational study, meaning researchers will collect information about your surgery and recovery without assigning you to a specific treatment. It plans to include 1500 participants.","completed","Complex Adult Deformity Surgery (CADS) Study","This study is looking at the results of surgery for complex adult spinal deformities like scoliosis (a sideways curve of the spine) and kyphosis (a rounded back). It aims to understand how well these surgeries work and to find the best ways to treat patients. Researchers will collect information on your health before and after surgery, including how your spine looks on X-rays and how your pain and daily activities are affected. They will also look at any complications and the need for additional surgeries. This study is for adults aged 18 and older who have a diagnosis of adult spinal deformity and meet certain criteria for complex cases. The study is currently unclear on its recruitment status and plans to enroll 1500 participants.","Your health and spine will be checked at 3 months, and then at 1, 2, 5, and 10 years after your surgery.",124,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]