[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spinal-deformity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spinal-deformity":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,44,77,101,124,149,176,197,222,242,272,303,332,357,378,407],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100505056","the-ailliance-post-market-clinical-study-100505056",false,"NCT05856370","The Ailliance Post-Market Clinical Study","The Ailliance Post-Market Clinical Study: All enablIng technoLogies, bioLogics, IDS, And Core spiNe produCt collEction","Inclusion Criteria:\n\n1. Subject provides written informed consent per institution and\u002For geographical requirements.\n2. Subject is intended to receive or be treated with an eligible Medtronic Cranial and Spinal Technology (CST) device(s) (see product appendices), used alone or in combination, for a cranial and\u002For spinal indication(s).\n3. Subject is at least 18 years of age or minimum legal age as required by local regulations.\n4. Subject agrees to complete all required assessments per the Schedule of Events.\n\nExclusion Criteria:\n\n1. Subject is currently enrolled or plans to enroll in concurrent drug\u002Fdevice\u002Fbiologic trial(s) that may confound this trial's results per investigator assessment (i.e. no required intervention that could affect interpretation of all-around device safety and or performance).\n2. Subject who is, or is expected to be, inaccessible for all required follow-up visits.\n3. Subject with exclusion criteria required by local law.\n4. Subject is considered vulnerable at the time of obtaining consent.","ALL","18 Years",{"count":19,"type":20},1000,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and\u002For spinal indication(s).\n\nSubjects are enrolled and followed postoperatively to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.",[26,27,28,29,30],"Spinal Deformity","Spinal Degenerative Disorder","Spinal Fusion Failure","Spinal Trauma","Spinal Tumor Case","RECRUITING","2026-06-29",{"date":34,"type":35},"2026-06-30","ACTUAL",{"date":37,"type":35},"2023-05-01",{"date":39,"type":20},"2031-05",{"name":41,"class":42},"Medtronic Spinal and Biologics","INDUSTRY",28,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100233306","phase-2-tranexamic-acid-to-reduce-blood-loss-in-spine-surgery-100233306","NCT02314988","Tranexamic Acid to Reduce Blood Loss in Spine Surgery","Topical Application of Tranexamic Acid (CYKLOKAPRON®) to Reduce Blood Loss During Spine Surgery","Inclusion Criteria:\n\n1. Thoracic or lumbar spinal column injury with or without neurologic deficit requiring surgical fixation\n2. Surgical fixation to be performed within 21 days of injury\n3. Adult patients undergoing long segment (\\>5 fusion levels) posterior spinal fusions\n\nExclusion Criteria:\n\n1. Age \\\u003C18 or \\>80 years old\n2. Severe soft tissue disruption around planned surgical site preventing adequate primary wound closure\n3. Physiologic instability or ongoing sepsis\u002Finfection\n4. Use of intravenous tranexamic acid during the pre-study period\n5. Ballistic spinal column injury\n6. Allergy to tranexamic acid\n7. Disturbances of color vision or color blindness\n8. Pre-operative hemoglobin value of \\\u003C7 g\u002FdL, or \\\u003C10 g\u002FdL if patient has comorbidities or symptoms which will require pre-operative allogeneic blood transfusion\n9. Refusal to consent for blood products\n10. Participation in another clinical trial\n11. Moderate or severe traumatic brain injuries that do not allow participation in individual patient outcomes surveys\n12. Subarachnoid hemorrhage, anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by TXA\n13. Concomitant use of Factor IX Complex concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased\n14. Preoperative use of anticoagulant therapy (heparin, low-molecular weight heparin, warfarin) within three days before surgery, or non-steroid inflammatory medication (aspirin, ibuprofen, naprosyn) use within seven days before surgery\n15. Fibrinolytic disorders requiring intraoperative antifibrinolytic treatment\n16. Disseminated intravascular coagulation (DIC)\n17. Coagulopathy (as identified by a preoperative platelet count of \\\u003C150,000\u002Fmm3, an international normalized ratio of \\>1.4, or a prolonged partial thromboplastin time \\>1.4 times normal)\n18. History of arterial or venous thromboembolic disease (such as a cerebrovascular accident, deep-vein thrombosis, or pulmonary embolus), as these patients may be at increased risk for venous or arterial thrombosis\n19. Upper urinary tract or ureteral injury (ureteral obstruction due to clot formation in patients with upper urinary tract bleeding has been reported)\n20. Pregnancy or breastfeeding (Category B)\n21. Substantial renal dysfunction (as assessed by a serum creatinine \\> 1.5 or calculated creatinine clearance of \\\u003C 50) or hepatic failure\n22. Major co-morbidities: alcohol or drug abuse, illnesses that affect bone or calcium metabolism, connective tissue disorders, coronary artery disease, severe ischemic heart disease \\[New York Heart Association Class III or IV\\], previous myocardial infarction, severe pulmonary disease \\[forced expiratory volume \\\u003C50% of normal\\], diabetes mellitus (Type I or Type II), immunosuppression, peripheral vascular disease, severe penetrating or hemorrhagic traumatic brain injury, a history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton.\n23. History of seizure or convulsive disorders, or currently concomitant use of other medications that are known to reduce seizure threshold\n24. History of dural tear or open subdural space","80 Years",{"count":53,"type":20},252,[55,56],"PHASE2","PHASE3","This study is designed to evaluate the efficacy of topical tranexamic acid to reduce perioperative blood loss, reduction in postoperative drain output and allogenic transfusion requirements.\n\nThe proposed study will be a prospective, randomized, double-blind (subject, surgeons, investigators, research coordinators) placebo-controlled study. Patients requiring posterior spinal fusion will be enrolled for this study. Furthermore, patients undergoing elective complex deformity surgery will also be enrolled. Both populations of patients will be randomized into two groups. Group I will receive standard of care operative fixation with topical tranexamic acid intervention (test); Group II will receive standard of care operative fixation with normal saline (placebo) intervention. This study will have a 2-year follow-up and will consist of three periods: screening\u002Fenrollment phase up to 21 days from the day of injury to the day of randomization and operative intervention, an inpatient data collection period for 4 days postoperative, and then a follow-up period for 2-years postoperative (visits occurring at 16 weeks, 1 year, and 2 year) time points.",[59,26],"Spinal Injuries",[61,62,63,64,65],"Tranexamic acid","Antifibrinolytic","Perioperative blood loss","Postoperative drain output","Allogenic transfusion","2026-05-04",{"date":68,"type":35},"2026-05-06",{"date":70,"type":35},"2020-06-15",{"date":72,"type":20},"2027-07",{"name":74,"class":75},"Columbia University","OTHER",4,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":51,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100450492","ai-powered-scoliosis-auto-analysis-system-multicenter-development-and-validations-100450492","NCT05146193","AI-Powered Scoliosis Auto-Analysis System Multicenter Development and Validations","Inclusion Criteria:\n\n* Idiopathic scoliosis, adult deformity (spondylolisthesis, idiopathic kyphosis, kyphoscoliosis, lordoscoliosis)\n\nExclusion Criteria:\n\n* Refusal for imaging, postoperative patients","10 Years",{"count":85,"type":20},2500,"OBSERVATIONAL","The investigators aim to use artificial intelligence (AI) to help clinicians in diagnosing and assessing spinal deformities.",[26],[90],"Adult deformity, scoliosis, spondylolisthesis","2026-04-27",{"date":93,"type":35},"2026-05-01",{"date":95,"type":35},"2022-05-01",{"date":97,"type":20},"2030-02-01",{"name":99,"class":75},"The University of Hong Kong",1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":100},"100328210","phase-3-tranexamic-acid-in-adult-spinal-deformity-surgery-100328210","NCT03553186","Tranexamic Acid in Adult Spinal Deformity Surgery","Topical Tranexamic Acid as a Adjunct to Intravenous Tranexamic Acid in Adult Spinal Deformity Surgery","Inclusion Criteria:\n\n* Age 18-80\n* Scheduled to undergo posterior long segment ( ≥ 5 levels) posterior spinal fusion for adult scoliosis or degenerative joint diseae\n* \\+ fusion to pelvis\n\nExclusion Criteria:\n\n* Surgical factors:\n\n  * Anterior Approach\n  * Presence or history of dural tear without repair as evidenced by pseudomeningocele on MRI imaging or by intraoperative exploration\n  * Patients donating autologous blood preoperatively\n\nPatient factors:\n\n* Diagnosis of renal (Cr\\>1.5 or CrCl \\\u003C30ml\u002Fmin) or hepatic insufficiency (AST, ALT 2x upper limit of normal)\n* Diagnosis of seizure disorder or prior seizure\n* History of thromboembolic events (CVA, TIA, DVT, PE) if within 1 year of surgery\n* Hypercoagulability (e.g. antiphospholipid syndrome)\n* History of coronary artery disease (stent, MI, +stress test) within 1 year of surgery\n* Atrial fibrillation\n* Concurrent anticoagulation therapy that cannot be discontinued within 3 days before surgery (Coumadin, plavix, LVX)\n* Concurrent anticoagulation with ASA 325 that cannot be discontinued 10 days before surgery\n* Bleeding disorder or abnormal preoperative coagulation profile (as identified by a preoperative platelet count of \\\u003C100,000\u002Fmm3, an international normalized ratio of \\>1.4, or a prolonged partial thromboplastin time \\>1.4 times normal)\n* Preexisting anemia \\\u003C10 g\u002FdL\n* Color blindness or disturbance of color vision\n* Leukemia or active cancer\n* Religious restrictions on blood transfusion\n* Pregnancy or women who are lactating\u002Fbreastfeeding",{"count":109,"type":20},100,[56],"Posterior spinal surgery for adult deformity is associated with high incidence of blood loss and need for blood transfusion and intraoperative blood salvage, with associated increased cost and risk for perioperative complications. Tranexamic acid (TXA) is relatively inexpensive anti-fibrinolytic agent that has been proven effective for decreasing intraoperative blood loss in various surgical specialties. Intravenous TXA (ivTXA) is routinely used at our institution for adult spinal deformity cases. Meanwhile, topical TXA (tTXA) is an attractive alternative\u002Fadjunct to ivTXA used with good results in orthopedic arthroplasty and cardiac surgery. To the investigators' knowledge, no data exists in the literature on the use of tTXA in either adult or pediatric spinal deformity surgery. The goal of this study is to determine the role tTXA has an adjunct to ivTXA in decreasing perioperative blood loss, drainage, transfusion requirements and length of stay following adult deformity spine surgery.",[26,113,114],"Degenerative Lumbar Spinal Stenosis","Blood Loss, Surgical","2026-04-23",{"date":117,"type":35},"2026-04-28",{"date":119,"type":35},"2018-07-11",{"date":121,"type":20},"2027-03",{"name":123,"class":75},"Hospital for Special Surgery, New York",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":100},"100452385","clariance-erys-registry-100452385","NCT05170815","Clariance ErYs Registry","Clariance Registry of ERISMA® and Idys® Devices","ErYs","Inclusion Criteria:\n\n* Considered as adult in the respective geography (18 years old or older for France and 21 years old or older for United-States).\n* Indicated for treatment with one or more commercially available sponsor spine device included into the study.\n* For France only, affiliated with or beneficiary of a social security scheme.\n\nExclusion Criteria:\n\n* Subjects who are not able to comply with the study procedures based on the judgment of the investigator (e.g., inability to comprehend study related questions, inability to keep scheduled assessment times).\n* Subjects who are considered as vulnerable: minor, pregnant woman or people under legal protection (guardianship or curatorship).\n* Contraindicated for spine surgery utilizing a commercially available sponsor spine device.",{"count":133,"type":20},760,"International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF).\n\nThe overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting.\n\nThe primary objective is to demonstrate that the use of the study devices is safe.\n\nThe secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.",[136,137,26,138,139],"Spine Degeneration","Spine Spondylosis Thoracic","Spinal Tumor","Spinal Fracture","2026-03-16",{"date":142,"type":35},"2026-03-17",{"date":144,"type":35},"2022-01-17",{"date":146,"type":20},"2028-12",{"name":148,"class":42},"Clariance",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":156,"sex":16,"minAge":17,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":163,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":174,"locationsCount":100},"100424886","multimodal-bio-mechanical-analysis-of-adult-spinal-deformity-with-sagittal-plane-misalignment-100424886","NCT04812730","Multimodal Bio-mechanical Analysis of Adult Spinal Deformity With Sagittal Plane Misalignment","ASD","Inclusion Criteria:\n\n* Pathological group\n\n  1. Age \\>= 45 years\n  2. Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity\n  3. Scoring at least 25 out of 30 on Mini Mental State Examination\n  4. Ability to walk at least 50 meters distance independently without a walking aid\n  5. Sagittal malalignment: PI-LL ≥ 25 degrees; sagittal vertical axis \\>5cm; pelvic tilt \\>25° and\u002For thoracic kyphosis \\> 60° and\u002For coronal malalignment: thoracic scoliosis 30 ≥ degrees; thoracolumbar\u002Flumbar scoliosis ≥ 30 degrees; global coronal malalignment \\>3cm, posterior spinal fusion \\> 4 levels + iliac fixation.\n  6. Ability and willingness of patient to attend follow-up visits and complete patient questionnaires\n  7. Completed patient informed consent\n* Control group\n\n  1. Asymptomatic adults not suffering from a spinal deformity leading to a pathological sagittal alignment presenting as volunteer in the University Hospitals Leuven, Belgium\n  2. Age \\>=45 years old\n  3. Scoring at least 27 out of 30 on Mini Mental State Examination\n  4. Ability to walk at least 1000 meters distance independently without a walking aid\n  5. Ability and willingness of patient to attend follow-up visits and complete patient questionnaires\n  6. Completed patient informed consent\n\nExclusion Criteria:\n\n* Pathological group\n\n  1. Age \\\u003C 45 years old\n  2. Absence of adult spinal deformity\n  3. Scoring less than 25 out of 30 on Mini Mental State Examination\n  4. Non-ability to walk at least 50 meters distance independently, with or without a walking aid.\n  5. Missing patient informed consent\n  6. Patients presenting with a neurological disease affecting balance other than Parkinson's disease such as stroke and\u002For Vestibular lesion\n  7. Patients with a current history of diagnosed musculoskeletal disorders of the trunk and\u002For lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (\\> 3 cm)\n  8. BMI\\>30\n* Control group\n\n  1. Age \\\u003C 45 years old\n  2. Backpain and\u002For Sciatica at time of the study\n  3. Presence of adult spinal deformity leading to a pathological sagittal alignment\n  4. Scoring less than 27 out of 30 on Mini Mental State Examination\n  5. Non-ability to walk at least 1000 meters distance independently without a walking aid\n  6. Missing patient informed consent\n  7. Patients presenting with a neurological disease affecting balance such as Stroke, Parkinson's disease and\u002For Vestibular lesion\n  8. Patients with a current history of diagnosed musculoskeletal disorders of the trunk and\u002For lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (\\> 3 cm)\n  9. BMI \\> 27",true,"79 Years",{"count":159,"type":20},265,[23],"A good understanding of the principles of balance is vital to achieve optimal outcomes when treating spinal disorders. A complex interaction of the neuromotor system and muscular recruitment is necessary for ergonomic balance and deliberate displacement of the human body. Sagittal plane misalignment in spinal deformities challenges balance mechanisms used for maintenance of an upright posture. The occurrence of postoperative complications after spinal deformity correction like under-correction of sagittal misalignment, postoperative reciprocal changes in thoracic kyphosis, proximal junctional kyphosis and failure of instrumentation are possibly due to the current state-of-the art inadequate diagnostic work-up.\n\nInvestigators do not fully understand the roll of vision and exact strategy of recruitment of neuromuscular units (trunk, pelvis, lower limbs) in patients with sagittal plane misalignment during standing and walking. To understand this, a dynamic evaluation of individuals with spinal deformities is needed. Currently there is only very little research performed in the field of clinical balance tests and instrumented movement analysis in patients with spinal deformity.\n\nThe challenge for future studies is to further unravel the relation between trunk and lower limb movements, grouped into functional movement patterns. Moreover, additional information on trunk and lower limb kinetics and muscle activity (using dynamic electromyography (EMG)) will highly contribute to the understanding of this functional relationship, and will provide more in-depth insights into compensatory mechanisms of the trunk versus the lower limbs and vice versa.",[26],[164,165,166,167],"Sagittal plane misalignment","Trunk and lower limb","Motion analysis","EOS stereo radiography","2026-03-12",{"date":170,"type":35},"2026-03-13",{"date":172,"type":35},"2016-01",{"date":146,"type":20},{"name":175,"class":75},"Universitaire Ziekenhuizen KU Leuven",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":156,"sex":16,"minAge":17,"maxAge":157,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":100},"100411815","balance-assessment-scale-and-strength-measurement-protocol-to-measure-functionality-in-adults-with-spinal-deformity-100411815","NCT04642456","Balance Assessment Scale and Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity","Development and Reliability of a Balance Assessment Scale and Trunk Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity","F-ASD","Inclusion criteria pathological subjects:\n\n1. Adult (\\>18 years old) subjects suffering from a adult spinal deformity with sagittal or coronal plane misalignment diagnosed on EOS imaging.\n2. Ability to walk at least 50 meters distance independently without a walking aid.\n3. No documented neurological disease or vestibular lesion affecting balance nor a current history of musculoskeletal disorders of the lower extremities affecting motor performance.\n\nInclusion criteria control group:\n\n1. Adults (\\> 18 year old)\n2. No current history of back pain and spinal deformity.\n3. Ability to walk at least 1000 meters distance independently without a walking aid.\n4. No documented neurological disease or vestibular lesion affecting balance nor a current history of musculoskeletal disorders of the lower extremities affecting motor performance.\n\nExclusion criteria ASD patients:\n\n1. Age \\\u003C 18 years old and \\> 79 years old\n2. Absence of adult spinal deformity\n3. Non-ability to walk at least 50 meters distance independently, with or without a walking aid.\n4. Missing patient informed consent\n5. Patients presenting with a neurological disease affecting balance other than Parkinson's disease such as stroke and\u002For Vestibular lesion\n6. Patients with a history of spinal fusion surgery.\n7. Patients with a current history of diagnosed musculoskeletal disorders of the trunk and\u002For lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (\\> 3 cm)\n\nExclusion criteria control group:\n\n1. Age \\\u003C 18 years old and \\> 79 years old\n2. Backpain and\u002For Sciatica at time of the study\n3. Presence of adult spinal deformity leading to a pathological sagittal alignment\n4. Non-ability to walk at least 1000 meters distance independently without a walking aid\n5. Missing patient informed consent\n6. Patients presenting with a neurological disease affecting balance such as Stroke, Parkinson's disease and\u002For Vestibular lesion\n7. Patients with a current history of diagnosed musculoskeletal disorders of the trunk and\u002For lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (\\> 3 cm)",{"count":185,"type":20},30,[23],"Develop reliable methods for functional assessment, for trunk strength, of Adult Spinal Deformity (ASD) patients and create a first clinical and normative database\n\n1. Compare functionality of ASD and control subjects\n2. Relate functionality of ASD patients to their pathology, in terms of spinal deformity and muscle condition",[26],"2026-03-06",{"date":191,"type":35},"2026-03-09",{"date":193,"type":35},"2021-05-01",{"date":195,"type":20},"2026-12-01",{"name":175,"class":75},{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":207,"conditions":208,"keywords":209,"overallStatus":212,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":100},"100624971","intraoperative-alignment-in-adult-spinal-deformity-surgery-100624971","NCT07416565","Intraoperative Alignment in Adult Spinal Deformity Surgery","A Prospective, Single-center Study of the Utility of the ATEC IOA Imaging Platform Tool in Intraoperative Imaging for Patients Undergoing Adult Spinal Deformity Surgery.","Inclusion Criteria:\n\n1. Skeletally mature patients\n2. Able to give informed consent\n3. Sagittal Spinal Deformity patients as defined by any of the following radiographic criteria:\n\n   * Coronal cobb angle \\>20 degrees\n   * Pelvic Tilt \\>25degrees\n   * Sagittal Vertical Axis \\>50mm\n   * Pelvic Incidence - Lordosis of \\>10 degrees\n   * Thoracic Kyphosis \\>60 degrees\n4. Or clinically indicated for spinal fusion T10-Pelvis or more levels fused\n5. Or adult degenerative pathology requiring 2 or more levels fused\n\nExclusion Criteria:\n\n1. Under the age of 18 years old\n2. Skeletally immature patients\n3. Active infection\n4. Presence of inflammatory spinal disease (e.g. ankylosing spondylitis, Diffuse Idiopathic Skeletal Hyperostosis (DISH), Rheumatoid Arthritis)\n5. Concurrent Spinal or pelvic fracture\n6. Vulnerable patient (pregnant, prisoner, inability to consent)",{"count":205,"type":20},40,[23],"The purpose of this study is to conduct a prospective study which assesses the utility of the ATEC Intraoperative Alignment (IOA) Imaging Platform tool in intraoperative imaging for patients undergoing adult spinal deformity surgery. The study aims to compare the precision of the ATEC IOA Imaging Platform to current standard 36\" cassette intraoperative x-rays, as well as compare intraoperative versus postoperative standing alignment.",[26],[210,211],"Spinal","Spinal Fusion","NOT_YET_RECRUITING","2026-02-17",{"date":215,"type":35},"2026-02-18",{"date":217,"type":20},"2026-02-09",{"date":219,"type":20},"2029-08-09",{"name":221,"class":75},"NYU Langone Health",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":229,"targetDuration":4,"studyType":21,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":212,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":241},"100624831","mdt-0123-japan-study-100624831","NCT07414745","MDT-0123 Japan Study","MDT-0123 Clinical Trial Targeting Patients Who Require Lumbar Vertebral Fusion in Japan","Inclusion Criteria:\n\n1\\) Subjects who require bone fusion via consecutive 2-level spinal fusion due to disc degeneration or spinal deformity etc. in the lumbosacral vertebrae (L2-S1). 2) Subjects who satisfies any of the following.\n\n1. Image findings of symptomatic degenerative lesions from L2 to S1(MRI or myelography within 12 months prior to enrollment) and subjects who have been observed to have a neurological disorder by nerve root compression etc. as follows. A) Radiating pain in the lower limbs or buttocks, sensory disturbance, numbness, symptoms of weakness B) B. Nervous claudication\n2. Subjects with degenerative disc disease with disc-derived low back pain, with or without leg pain, and the subject's medical history confirms disc degeneration \\[e.g., pain (symptoms of leg, back, or sciatic nerve distribution), functional deficits, and\u002For neurological defects)\\] and one or more of the following on image examination (e.g., CT, MRI, X-ray, etc.): A) Instability (defined as an angle of motion \\>greater than or equal to 5° and\u002For oscillation ≥4 mm, based on radiographs of anteroposterior flexion). B) Formation of osteophytes C) Decrease in the height of the intervertebral disc D) Thickening of ligamentous tissue E) Degeneration or herniation of the disc F) Degeneration of facet joints 3) Subjects with an ODI score of 35% or greater prior to the procedure. 4) Subjects with sufficiently mature skeletons. 5) Subjects who are 18 to 80 years of age or older at the time of surgery. 6) Subjects who has not responded to non-operative treatment (e.g., bed rest, physical therapy, medication, nerve block, manipulation, percutaneous electrical stimulation therapy (TENS)) for a period of 3 months. 7) Subjects who have received an adequate explanation of the details of this clinical trial and have given their written consent.\n\nExclusion Criteria:\n\n1. Has undergone previous spinal surgery at the intervertebral level in question or at an Intervertebral level (e.g., spinal fusion \u002F spinal surgery other than spinal fusion). Furthermore, the history of discectomy and\u002For discectomy surgery is acceptable.\n2. Subjects who cannot complete the implantation of the investigational device and the posterior fixation procedure in one procedure.\n3. Those whose total rhBMP-2 implantation is expected to exceed 12 mg.\n4. Subjects for whom use of an internal or external bone growth stimulator is planned.\n5. Subjects who have been diagnosed with osteoporosis with a T-score of -2.5 or lower within the past 12 months and who also present with fragility fractures at the time of informed consent.. If the subject has a history of fragility fracture and the T-score has not been assessed within the past 12 months, the subject must undergo a bone density test using Dual Energy X-ray Absorptiometry (DEXA).\n6. Subjects with morbid obesity with a Body Mass Index (BMI) exceeding 40.\n7. Subjects with an active malignancy.\n8. Overt or active bacterial infection, either local to surgical space or systemic.\n9. Those who received bone formation promotion agents within 12 months prior to implantation of the investigational device.\n10. Subjects who have been administered corticosteroids, anti-tumor drugs, immune stimulators, immunosuppressants, or systematic drugs that may interfere with the treatment of bone or soft tissue within 30 days prior to implantation of the investigational device.\n\n    * All other patients taking warfarin must be washed out for at least 5 days prior to the procedure. Steroid inhalers can be used both before and after surgery.\n    * Use of short-term steroids before and after surgery is permissible. In this clinical trial, short term usage is defined as 2 weeks or less. Steroid use beyond 2 weeks postoperatively is prohibited until the follow-up examination 12 months later.\n11. Subjects with a medical history of autoimmune diseases known to affect bone metabolism or the spine. Examples include spondylotic arthropathy (e.g., ankylosing spondylitis, clonal disease, ulcerative colitis), juvenile arthritis, rheumatoid arthritis, Graves' disease, and Hashimoto's disease.\n12. Subjects with a medical history of endocrinological or metabolic diseases that are known to affect bone formation (e.g., Paget's disease, renal osteodystrophy, G.Danlos's syndrome, and bone dysplasia).\n13. Subjects who have been exposed to a combination of proteins used for bone formation.\n14. Subjects who have a history of hypersensitivity, allergy, or intolerance to bone morphogenic proteins (BMPs) (BMPs used for dental treatment), injectable collagen, protein drugs (such as monoclonal antibodies or gamma globulins), bovine collagen products, and\u002For instrument materials (titanium alloy).\n15. Subjects with a medical history of allergy that may cause anaphylaxis.\n16. Subjects who have a mental disorder and have been judged by the investigator to be of an inappropriate level for enrollment into this clinical trial.\n17. Subjects who have received treatment in other clinical trials targeting spinal diseases within 3 months prior to the index procedure (drugs, devices, and\u002For biological products), subjects who have received treatment in other clinical trials within 28 days prior to the index procedure, or subjects who are scheduled to receive treatment in other clinical trials during the clinical trial period. Simultaneous enrollment into a clinical trial that is being conducted in parallel is permissible only if a prior approval document has been obtained from the clinical trial manager of Medtronic Sofamor Danek.\n18. Women of childbearing potential or men whose partners wish to become pregnant who are unable to agree to use appropriate contraception (ex: Barrier methods using condoms, intrauterine devices, oral contraceptives, vasectomy\u002Ftubal ligation, etc.) or abstain from sexual intercourse during the trial period and for 12 months after implantation of the investigational device. \"Women of childbearing potential\" refers to those who have not undergone permanent sterilization or entered menopause. Menopause refers to the absence of menstruation for 12 consecutive months or longer without any other underlying medical cause.\n19. Subjects with a spinal tumor in the upper or lower adjacent vertebral body between the vertebrae to which the investigational device is implanted.\n20. Subjects who have stainless steel implants or implants from other companies implanted in the lumbosacral vertebrae, or subjects who may be implanted during the study period.\n21. Subjects with other medical diseases or conditions that may interfere with the accurate clinical evaluation of the safety and efficacy of the treatment in this clinical trial (e.g.: Subjects with a neuromuscular disease or marked anatomical abnormality in the vasculature, have a considerably narrow right and left common iliac arteriovenous space, have a fragile vasculature, have difficulty performing angiography, have a history of surgery that expects advanced adhesions, etc.).\n22. Subjects with diseases or conditions contraindicated for MRI examination.\n23. Subjects who smoke within 12 weeks prior to implantation of the investigational device (including electronic cigarettes) and may smoke during the study period.\n24. A documented diagnoses of alcohol abuse and\u002For substance abuse.\n25. Subjects who are judged by the investigator to be unsuitable for inclusion in the clinical trial.",{"count":230,"type":20},140,[23],"The purpose of this clinical trial is to compare the efficacy and safety of this investigational device with autologous iliac bone graft (ICBG) in patients who are deemed to require bone fusion through spinal fixation at two levels (ALIF or OLIF) due to disc degeneration or spinal deformity in the lumbosacral spine (L2-S1) for intervertebral support and correction with the aim of stabilizing the spine.",[234,26],"Disc Degeneration",{"date":213,"type":35},{"date":237,"type":20},"2026-02-28",{"date":239,"type":20},"2028-03-31",{"name":41,"class":42},13,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":21,"phases":251,"briefSummary":253,"conditions":254,"keywords":258,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":100},"100494117","phase-4-the-effects-of-ferric-derisomaltose-on-postoperative-anemia-in-spinal-deformity-surgery-100494117","NCT05714007","The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery","The Effects of Ferric Derisomaltose on Postoperative Anemia in Patients Undergoing Spinal Deformity Surgery: A Prospective Randomized Controlled Study","Inclusion Criteria\n\n1. Age ≥18 years\n2. Received spinal deformity surgery\n3. 70 g\u002FL ≤ Hb ≤ 110 g\u002FL at POD1, or Hb at POD1 showed a decrease of\n\n   ≥20 g\u002FL compared with baseline\n4. Informed consent was obtained voluntarily\n\nExclusion Criteria\n\n1. Women who are pregnant, breastfeeding, or planning to become pregnant.\n2. known serious hypersensitivity to other parenteral iron products\n3. Non-iron deficiency anemia (e.g., hemolytic anemia)\n4. Decompensated liver insufficiency\n5. Coexisting active infection\n6. Drug abuse, including but not limited to opioids, amphetamines, methamphetamine, ketamine, etc.\n7. Other conditions that the investigator considers inappropriate for participation (e.g. deafness, Parkinson's disease, communication disorders, etc.)\n8. Participation in another clinical trial within three months prior to this study.",{"count":250,"type":20},120,[252],"PHASE4","The prognosis of patients undergoing spinal deformity surgery is often compromised by perioperative anemia due to iron deficiency. The aim of this randomized, controlled trial was to evaluate whether postoperative ferric derisomaltose intravenous injection may improve anemia and prognosis in patients undergoing spinal deformity surgery comparing with oral iron. Participants will be randomly assigned to the treatment group (intravenous ferric derisomaltose) and the control group (oral iron). Changes in hemoglobin concentration, percentage of anemia correction, changes in iron indicators, patient quality of life, and incidence of adverse events will be analyzed to evaluate the efficacy and safety of iron isomaltoside infusion.",[255,256,26,257],"Perioperative Anemia","Surgery","Adult",[259,260,261,262],"spinal deformity surgery","perioperative anemia","ferric derisomaltose","adult","2025-06-10",{"date":265,"type":35},"2025-06-13",{"date":267,"type":35},"2023-08-31",{"date":269,"type":20},"2025-12",{"name":271,"class":75},"Peking Union Medical College Hospital",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":100},"100562489","clinical-evaluation-and-cost-effectiveness-analysis-of-3d-digital-surgery-in-traumatology-100562489","NCT06603831","Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology","Randomized, Prospective and Multicenter Clinical Study for the Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology and Orthopedic Surgery","Inclusion Criteria:\n\n\\- Patients that requires one of the following surgical procedures \u002F interventions: Radius osteotomy due to non-articular metaphyseal malunion Complex acetabular arthroplasty Thoracic-lumbar spine arthrodesis.\n\n-Patients that can understand the clinical study and that are able to read, understand and sign the consent form\n\nExclusion Criteria:\n\n* Patients that are not able to read, understand or sign the consent form.\n* Patients that can't or have no support to complete the clinical trial.\n* Patients with complex deformities or complications that would require mandatory personalized digital surgery treatment",{"count":280,"type":20},180,[23],"Digital surgery, in combination with patient specific instrumentation (PSI) is being used more and more in traumatology due to its proven benefits and applications. Nowadays, medical case planning and an optimal preparation before surgery are still a challenge for surgeons. This lack of preparation is translated into longer surgical procedures, potential complications, unnecessary sterilization of materials and a high number of fluoroscopies. 2D techniques such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT) and X-rays remain essential for medical planning, however, in many cases, a 3D visualization is needed to achieve better results, especially in complex cases.The use of personalized medical instruments such as surgical guides has proven to increase clinical accuracy, assuring a better correction of bone deformities, and allowing a more precise location of implants and screw positioning. Furthermore, the use of 3D-printed patient-specific prosthesis can lead to better clinical outcomes as they reduce the number of complications as well as they present a longer lifespan compared to conventional generic implants.Despite the potential of 3D technology in the medical field, there is still a lack of robust studies that compares clinical benefits between digital surgery and conventional 2D surgery, and its economic impact is still unknown. Thus, the investigators propose this randomized, prospective and multi-center clinical study to evaluate the use of 3D technology in traumatology. The aim of this project is to prove that digital surgery is a cost-effective methodology and therefore it should be adopted by the public health system as a gold standard procedure.",[284,285,286,287,288,289,290,291,292,211,293,26],"Radius; Deformity","Hip Osteoarthritis","Hip Arthritis","Hip Arthropathy","Spine Injury","Radius; Anomaly","Vertebra; Degeneration","Vertebral Fracture","Hip Prosthesis Infection","Spine Osteoarthritis","2024-11-08",{"date":296,"type":35},"2024-11-12",{"date":298,"type":35},"2024-10-21",{"date":300,"type":20},"2027-12-31",{"name":302,"class":75},"Corporacion Parc Tauli",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":312,"conditions":313,"keywords":318,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":100},"100489081","intraoperative-monitoring-for-the-lateral-lumbar-interbody-fusion-procedure-100489081","NCT05648474","Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure","Advanced Techniques in Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure: a Utility Study","Inclusion Criteria:\n\n* At least 18 years of age at the time of planned surgery.\n* Indicated for 1- or 2-level instrumented LLIF surgery (in either prone or lateral decubitus positions), inclusive of the L4-5 disc space.\n* Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Patients requiring surgical treatment at more than 2 lumbar levels.\n* Patients with peripheral neuropathy such as from diabetes or other conditions that might affect the reliability of intraoperative neuromonitoring.\n* Patients with prior history of partial\u002Ffull hip or knee joint replacement surgery (i.e., arthroplasty or resurfacing) on the leg targeted for saphenous monitoring and electrode placement.\n* Patients with presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n* Female patients who are pregnant or wanting to become pregnant during the timeframe of study participation.\n* Patients participating in another clinical study which may compromise this study's results or compliance with this study's procedures.",{"count":311,"type":20},400,"This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk during the lateral lumbar interbody fusion (LLIF) procedure.",[314,315,316,26,317],"Intervertebral Disc Degeneration","Stenosis, Spinal","Spondylolisthesis","Spinal Instability",[319,256,257,320,321,322],"Spine","Neuromonitoring","Electromyography","Somatosensory evoked potentials","2024-10-22",{"date":325,"type":35},"2024-10-24",{"date":327,"type":35},"2022-07-13",{"date":329,"type":20},"2025-12-31",{"name":331,"class":42},"Alphatec Spine, Inc.",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":21,"phases":342,"briefSummary":343,"conditions":344,"keywords":345,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":355,"locationsCount":100},"100517659","pedicle-screw-malposition-in-spine-arthrodesis-surgeries-with-o-arm-guided-navigation-100517659","NCT06020417","Pedicle Screw Malposition in Spine Arthrodesis Surgeries With O-ARM-guided Navigation","Occurrence of Pedicle Screw Malposition in Spine Arthrodesis Surgeries Performed With O-ARM-guided Navigation at a University Hospital: a Randomized Controlled Trial","NoHARM","Inclusion Criteria:\n\n* spine deformities (spinal cord trauma, osteoarthritis, intervertebral disc degeneration, degenerative or isthmic spondylolisthesis, intervertebral disc degeneration, spinal stenosis and degenerative scoliosis).\n\nExclusion Criteria:\n\n* anatomical abnormalities that can not be used the neuronavigation.",{"count":341,"type":20},124,[23],"Background: Throughout the history of spinal deformity there have been continuous advances in the surgical treatment. Although many techniques have been successfully developed despite the anatomy complex, screw placement still remains difficult with a significant risk of misplaced implants. The O-ARM guided Navigation is a scanner that allows imaging of screws intraoperatively and could be a tool to facilitate screw revision and reduce the occurrence of misplaced implants. Methods: This is a prospective and randomized clinical study that will be carried out at the University Hospital of the Federal University of Piaui, which provides exclusive assistance to patients of the Unified Health System (UHS), in northeastern Brazil.",[211,26,288],[346,347,348],"neuronavigation","spinal deformity","Spine injury","2024-09-24",{"date":351,"type":35},"2024-09-25",{"date":353,"type":35},"2024-08-01",{"date":329,"type":20},{"name":356,"class":75},"Federal University of Piaui",{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":100},"100447631","research-of-factors-determining-the-improvement-of-quality-of-life-at-one-year-of-adult-patients-treated-for-spinal-deformity-coftasd-100447631","NCT05108948","Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity (COFTASD)","Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity : Observational Study (COFTASD)","COFTASD","Inclusion Criteria:\n\n* Age over 18 years-old\n* Diagnosis of Adult Spinal Deformity with any of the deformity characteristics following:\n\n  * Scoliosis with a Cobb angle ≥ 20 °\n  * Vertical sagittal axis (SVA) ≥ 5 cm\n  * Pelvic tilt ≥25 °,\n  * Thoracic kyphosis with a Cobb angle ≥ 60 °\n* Eligible for surgery\n* Having given their participation agreement\n* Affiliate or beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Age under 18 years-old\n* Patient unlikely to comply with follow-up\n* Patient with long-term complete paraplegia\n* Patient unable to understand and answer questionnaires in due to language difficulties or cognitive impairment\n* Pregnant or breastfeeding woman\n* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision",{"count":366,"type":20},866,"The objective of this study is to find the predictive factors of improvement of the quality of life of operated patients from spinal deformity.",[26],"2024-02-28",{"date":371,"type":35},"2024-02-29",{"date":373,"type":35},"2021-10-23",{"date":375,"type":20},"2041-10-23",{"name":377,"class":75},"Elsan",{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":16,"minAge":385,"maxAge":51,"enrollmentInfo":386,"targetDuration":4,"studyType":21,"phases":388,"briefSummary":389,"conditions":390,"keywords":391,"overallStatus":212,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":100},"100514769","clif-correction-vs-conventional-correction-strategy-for-asd-100514769","NCT05982808","CLIF Correction VS. Conventional Correction Strategy for ASD","A Novel Surgical Technique of CLIF Correction VS. Conventional Corrective Strategy on the Treatment of Adult Complex Spinal Deformity With a Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* adult spinal deformtiy;\n* 40yrs≤age≤80yrs;\n* Lenke-Silva classification II-V grade;\n* ineffective with conservative treatment;\n\nExclusion Criteria:\n\n* severe osteoprosis with T value \\\u003C-2.5;\n* with preliminary spinal surgery;\n* ASA score≥III grade;\n* more than II degree spondylisthesis;\n* with mental disease;","40 Years",{"count":387,"type":20},420,[23],"The present study intends to: 1）establish a multi-center large-sample randomized controlled trial to explore the technical advantages and surgical indications of the novel surgical technique of CLIF correction for ASD compared with the conventional correction strategy; 2）analyze the postoperative clinical and imaging results, and to explore the related complications and preventive measures; 3） establish 2-year follow-up to further quantify the clinical and radiographical outcomes of CLIF correction.",[26],[392,393,394,395,396,397],"adult spinal deformity","CLIF","crenal lumbar interbody fusion","minimal invasive","correction","surgical strategy","2023-08-07",{"date":400,"type":35},"2023-08-09",{"date":402,"type":20},"2024-07-01",{"date":404,"type":20},"2028-06-01",{"name":406,"class":75},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":21,"phases":416,"briefSummary":417,"conditions":418,"keywords":422,"overallStatus":212,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":435,"locationsCount":100},"100409325","prospective-i-factortm-analysis-fusion-rate-and-quality-of-life-100409325","NCT04610021","Prospective i-FactorTM Analysis Fusion Rate and Quality of Life","Prospective Analysis of the i-FactorTM Bone Graft on the Fusion Rate and Quality of Life of Patients With Adult Spine Deformity","Inclusion Criteria:\n\n* Patients of legal age.\n* Patients diagnosed with adult deformity, whether due to scoliosis, imbalance, thoracolumbar curves, etc. In which the minimum number of levels to be instrumented is 5, that is, 4 intervertebral discs.\n* Patients who provide their informed consent in writing. (In the event that the patient's circumstances do not allow him to grant consent, this may be provided by the legal representative).\n* Present radiological tests, computed tomography and \u002F or magnetic resonance imaging prior to surgery.\n* The implants used in the surgery are Cobalt Chrome bars and Titanium screws and interbody cages.\n\nExclusion Criteria:\n\n* Patients who are expected to be unavailable for follow-up.\n* Patients with mental disabilities that make it difficult for them to fill in the questionnaires.\n* Patients who have had other types of implants placed, other than Cobalt Chrome bars and Titanium screws and interbody cages.\n* Patients who are going to have cemented and \u002F or expansive screws, Peek boxes or another type of material other than Titanium.\n* Underlying neurological or neuromuscular disease.\n* Underlying inflammatory or tumor disease.",{"count":415,"type":20},128,[23],"Adult spinal deformity surgery is a complex procedure that involves many risks and complications. Bone grafts and bone substitutes are essential to achieve fusion and manage stability in spinal surgery.\n\nAutologous bone has been considered the \"gold-standard\" for obtaining a spinal fusion. However, the source from which to obtain it is limited. Furthermore, the problems of bone quality in patients with osteoporosis and the morbidity have forced the orthopedic community to seek other options.\n\nI-Factor ™ Bone Graft (Cerapedics, Inc., Westminster, CO) is a compound formed by peptide P-15 bound to an anorganic bone mineral of bovine origin that is composed of porous and smooth hydroxyapatite (ABM) particles.\n\nIn the literature there are no articles which identify bone formation with the i-Factor ™ graft in more than 4 instrumented levels, therefore the development of this study will allow assessing the fusion rate and quality of life of patients, which could lead to an improvement in the management and decision-making of surgical procedures, as well as better control of healthcare spending",[26,419,420,421],"Bone Graft","Fusion Rate","Quality of Life",[423,424,425,426,427,428],"Adult Spinal deformity","Bone graft","Fusion rate","Quality of life","Spinal Surgery","Functional limitations","2021-02-05",{"date":431,"type":35},"2021-02-09",{"date":433,"type":20},"2021-03",{"date":121,"type":20},{"name":436,"class":75},"Complejo Asistencial Universitario de León Urgencias"]