[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AO Foundation, AO Spine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":106},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,38,61,83],{"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":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100544389","durability-of-suppl-rod-constructs-supplementary-rod-technique-for-long-segment-posterior-instrumented-spinal-fusions-100544389",false,"NCT06368245","Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions","Durability of Supplementary Rod Constructs-SuppleMentAry Rod Technique (SMART)-for Long-segment Posterior Instrumented Spinal Fusion Procedures: A Multicenter Retrospective Comparative Study With Dual-rod Constructs","Inclusion Criteria:\n\n* Age 45 years and older.\n* Patients receiving long-segment posterior TL instrumented fusion using either supplementary rod constructs or dual-rod constructs (the index surgery).\n\n  * Long-segment is defined as the UIV at a thoracic level and the LIV at the sacrum\u002Filium.\n  * Supplementary rod constructs are defined as: in addition to the traditional two primary rods, at least one supplementary rod (eg, accessory rods or satellite rods) is used, and at least one supplementary rod and one primary rod (ie, at least two rods) together must span multiple (≥ 2) vertebral levels. The supplementary rod constructs do not include rods connected end-to-end or side-to-side that do not bridge multiple vertebral levels.\n  * The index surgery can be a primary surgery or a revision surgery.\n  * The index surgery, staged or non-staged, must use posterior spinal fusion but can be in combination with other approaches such as an anterior procedure.\n* If the index surgery is a revision surgery, the primary rods must be replaced in the revision surgery, with the exception of Harrington or Luque rods which can remain in place.\n\n  o If the Harrington or Luque rods remain in situ, they must already have the UIV at the thoracic level and the LIV at the sacrum\u002Filium, or an extension of the existing Harrington or Luque is performed such that the UIV is at the thoracic level and the LIV at the sacrum\u002Filium.\n* The index surgery was performed between January 1, 2014, and December 31, 2020, inclusive.\n* Minimum 3 months of FU after the index surgery.\n* Ability to provide informed consent according to the IRB\u002FEC defined and approved procedures if applicable for retrospective data analysis.\n\nExclusion Criteria:\n\n* Spinal fusion performed for acute trauma (ie, ≤ 1 year of trauma).\n* Spinal fusion performed for tumor.\n* Spinal fusion performed for infection.\n* Patients with Parkinson's Disease.\n* Patients with neuromuscular disorders.\n* Patients with spine malignancies requiring chemo- or radiation therapy.","ALL","45 Years",{"count":19,"type":20},1244,"ESTIMATED","OBSERVATIONAL","This is a multicenter retrospective comparative cohort study. The index surgery for this study is primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. Eligible patients who already had index surgery, will be identified for enrollment through a review of medical records of the participating surgeons at the study sites.",[24],"Spinal Fusion","RECRUITING","2026-06-29",{"date":28,"type":29},"2026-06-30","ACTUAL",{"date":31,"type":29},"2025-03-24",{"date":33,"type":20},"2029-07-31",{"name":35,"class":36},"AO Foundation, AO Spine","OTHER",17,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":16,"minAge":45,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":48,"conditions":49,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":60},"100595042","the-osteoporotic-fracture-classification-based-scoring-system-for-treatment-decision-in-thoracolumbar-osteoporotic-fractures-100595042","NCT07027306","The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures","The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures: An International Multicenter Prospective Study","Inclusion Criteria:\n\n* Postmenopausal women ≥ 50 years old or men \\> 60 years old\n\n  o Menopause refers to amenorrhea for 1 complete year.\n* Radiologically confirmed new diagnosis of symptomatic, single or multilevel TL (from T1 to L5) fractures, ie, the index fracture(s).\n\n  * In case of a multilevel fracture, the fracture must be contiguous.\n  * The index fracture is confirmed by MRI as an insufficiency (or fragility) fracture or is confirmed by CT or MRI as traumatic fracture (low-energy trauma)\n* The index fracture(s) is a result of primary osteoporosis. Diagnosis of primary osteoporosis is based on any of the followings in the absence of causes for secondary osteoporosis (such as long-term use of steroids, rheumatoid arthritis, type 1 diabetes mellitus \\[DM\\], and other metabolic bone disorders \\[eg, rickets\u002Fosteomalacia, Paget's disease, osteogenesis imperfecta, and primary hyperparathyroidism\\]) \\[13-15\\]:\n\n  * A T-score ≤ -2.5 in the lumbar spine, femoral neck, total hip, or 1\u002F3 radius\n  * Presence of fragility fracture (either a previous fragility fracture or the index fracture is a fragility fracture). Fragility fractures are fractures due to no or low-energy trauma, eg, slips, trips, or falls from less than double the body height, and heavy lifting.\n* The index osteoporotic TL fracture being classified based on the OF Classification from OF 1 to OF 5:\n\n  * OF 1: No deformation (vertebral body edema on MRI using short tau inversion recovery \\[STIR\\] sequence)\n  * OF 2: Deformation of one endplate\n  * OF 3: Deformation of one endplate with distinct posterior wall involvement\n  * OF 4: Deformation of both endplates with\u002Fwithout posterior wall involvement\n  * OF 5: Injuries with anterior or posterior tension band failure\n* Ability to provide informed consent according to the EC\u002FIRB defined and approved procedures\n\nExclusion Criteria:\n\n* Patients with spinal tumors\n* Patients with concomitant cervical fractures\n* Patients showing any signs of spinal infections\n* Patients with fractures due to high-energy or high-impact trauma, eg, a fall from double the body height or higher, motor vehicle accident with \\> 100 km\u002Fh in cars with airbags, or motor vehicle accident \\> 50 km\u002Fh without airbags, polytrauma\n* Patients with concomitant fracture in the pelvis, upper extremities, and\u002For lower extremities which could affect the main study outcomes (specifically, patient mobility and pain)\n* Patients for whom no FUs are possible\n* Previous instrumented surgery in the affected spine levels\n* Patients with single-level fracture or contiguous multilevel fracture adjacent to previous instrumented surgery\n* Patients who are mentally impaired and therefore not able to adhere to the study procedures and data collection\n* Patients who are bedridden before the index fracture\n* Recent history of substance abuse (ie, recreational drugs and alcohol) that would preclude reliable assessments\n* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study","50 Years",{"count":47,"type":20},648,"This is an international multicenter prospective observational study. Patients with radiologically confirmed, symptomatic, single- or multilevel contiguous TL (from T1 to L5) fractures as a result of primary osteoporosis will be recruited from participating clinics\u002Fhospitals (ie, study sites). Fractures included are insufficiency fractures (confirmed by magnetic resonance imaging \\[MRI\\]) and traumatic fractures (low-energy trauma, confirmed by computed tomography \\[CT\\] or MRI).",[50,51],"Osteoporotic Fractures","Osteoporosis","2026-05-11",{"date":54,"type":29},"2026-05-13",{"date":56,"type":29},"2026-03-19",{"date":58,"type":20},"2030-12-01",{"name":35,"class":36},15,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":68,"targetDuration":70,"studyType":21,"phases":4,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100580592","the-international-spinal-cord-injury-blood-biomarker-longitudinal-evaluation-i-scribble-study-100580592","NCT06839300","The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study","Inclusion Criteria:\n\n* Age ≥ 19 years\n* Blunt (non-penetrating) traumatic SCI\n* Baseline neurologic impairment deemed \"complete\" (AIS grade A) or \"incomplete\" (AIS grade B, C, or D) based on clinical history\u002Fexamination and\u002For diagnostic imaging\n* Bony spinal level involvement between C0 and L1, inclusive\n* Ability to have initial blood sample drawn within 24 hours of injury\n* Treated either surgically or non-surgically\n* Ability to provide informed consent according to the IRB\u002FEC defined and approved procedures\n\nInclusion criteria for non-spinal cord injury spinal trauma control participants:\n\n* Age ≥ 19 years\n* Traumatic spinal fracture and\u002For dislocation between C0 and L1 (inclusive) without SCI\n* Treated either surgically or nonsurgically\n* Ability to have initial blood sample drawn within 24 hours of injury\n* Ability to provide informed consent according to the IRB\u002FEC defined and approved procedures\n\nExclusion Criteria:\n\n* Penetrating SCI (eg, gunshot, stab)\n* Previous SCI\n* Isolated spinal injury below L1\n* Isolated radiculopathy without fracture\n* Isolated cauda equina injury\n* Patients with known diagnosis of multiple sclerosis\n* Preexisting thromboembolic disease or coagulopathy (disorders related to blood clotting), such as hemophilia or von Willebrand disease\n* Patients who in the investigator's opinion will not be compliant with the study procedures and patients who have any other conditions\u002Finjuries that in the investigator's opinion would render the study procedures dangerous","19 Years",{"count":69,"type":20},260,"12 Months","To determine the accuracy of serum NF-L and GFAP levels (ie the biomarkers) at different time points postinjury for predicting the severity of neurologic impairment at 6 months postinjury as either motor complete (AIS grade A\u002FB) or motor incomplete (AIS grade C\u002FD) a group of patients who suffer traumatic spinal fracture and\u002For dislocation of the spinal column but without neurologic injury will be enrolled as non-SCI spine trauma control participants.",[73],"Spinal Cord Injury","2026-05-04",{"date":76,"type":29},"2026-05-05",{"date":78,"type":29},"2026-02-09",{"date":80,"type":20},"2029-12-01",{"name":35,"class":36},8,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":91,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100573424","relieve-research-on-effectiveness-of-surgery-and-radiotherapy-on-relieving-spine-tumor-pain-in-patients-with-vertebral-metastases-100573424","NCT06746103","RELIEVE: Research on Effectiveness of Surgery and Radiotherapy on Relieving Spine Tumor Pain in Patients with Vertebral Metastases","RELIEVE Research on Effectiveness of Surgery and Radiotherapy on Relieving Spine Tumor Pain in Patients with Vertebral Metastases","RELIEVE","Inclusion Criteria:\n\n* Age 18 years and older\n* Patients diagnosed with metastatic spinal tumors with one index metastatic site that, confirmed by the treating clinicians, is causing spine pain\n* Patients experience at least one type of pain that is of interest of this study, namely, axial non-triggered pain, axial triggered\u002Fmechanical pain, radicular non-triggered pain, and radicular triggered\u002Fmechanical pain\n* At least one type of the pain experienced has an NRS \\> 4 of 10\n* Patients undergoing surgery and\u002For radiotherapy\n\n  * Surgery may be instrumented stabilization surgery alone, instrumented stabilization and decompression, or decompression surgery alone.\n  * Percutaneous screw fixation counts as instrumented stabilization surgery.\n  * Any kind of radiotherapy is includable.\n* Ability to provide informed consent according to the IRB\u002FEC defined and approved procedures\n\nExclusion Criteria:\n\n* Estimated survival \\\u003C 3 months\n* Patients with more than one symptomatic spine metastasis site\n\n  o An example is a patient with two metastasis sites: a lumbar metastasis (causing vertebral fracture and epidural compression leading to mechanical lower back pain and static radicular pain to legs) and a cervical metastasis (causing tumor-related pain at the neck).\n* Patients with other sources of pain that may confound the measurement of the primary outcome\n\n  o An example is a patient with liver metastasis which causes visceral pain that can confound the thoracic spinal pain caused by the spinal metastasis.\n* Patients undergoing the following treatments alone without the surgeries listed in the inclusion criteria or radiotherapy\n\n  * Cement augmentation, vertebroplasty, kyphoplasty, and other emerging interventions such as local ablative technique\n  * Chemotherapy or systemic therapy alone","18 Years",{"count":93,"type":20},250,"This is a prospective, multicenter, observational study focusing on assessing and managing pain in patients with metastatic spinal tumors. Pain from spinal metastases adversely impacts quality of life, function, and treatment outcomes. Advances in surgical techniques have shown significant benefits. However, previous studies either lacked nuanced differentiations or simply categorized pain as mechanical or non-mechanical; explaining the highly variable pain outcome measurements in these studies. This study employs the AO Spine Cancer-Related Pain Classification to better categorize neoplastic spinal pain by etiology.",[96],"Spinal Metastasis","NOT_YET_RECRUITING","2024-12-17",{"date":100,"type":29},"2024-12-24",{"date":102,"type":20},"2025-03-31",{"date":104,"type":20},"2027-11-30",{"name":35,"class":36},""]