[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intervertebral-disc-degeneration\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intervertebral-disc-degeneration":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,51,78,107,129,158,184,214],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100644645","degenerative-changes-after-treatment-of-thoracolumbar-junction-fractures-100644645",false,"NCT07672184","Degenerative Changes After Treatment of Thoracolumbar Junction Fractures","Degenerative Changes in Injured and Adjacent Spinal Motion Segments After Conservative and Surgical Treatment of AOSpine Type A2, A3, and A4 Thoracolumbar Junction Fractures","Inclusion Criteria:\n\nConservative Treatment Cohort:\n\n* Age 18 to 50 years.\n* Acute or subacute traumatic fracture of the thoracolumbar junction at the start of treatment.\n* AOSpine type A2, A3, or A4 fracture.\n* No clinical evidence of nerve root or spinal cord compression at the injured level.\n* Conservative treatment of the thoracolumbar junction fracture.\n* Minimum follow-up period of 1 year.\n* Written informed consent for prospective follow-up or additional study procedures, when applicable.\n\nSurgical Treatment Cohort:\n\n* Age 18 to 50 years.\n* Acute or subacute traumatic fracture of the thoracolumbar junction at the start of treatment.\n* AOSpine type A2, A3, or A4 fracture.\n* No clinical evidence of nerve root or spinal cord compression at the injured level.\n* Surgical treatment performed without disruption of the posterior supporting column.\n* Surgical treatment may include anterior fusion, transpedicular fixation, or combined surgery without direct posterior decompression.\n* Minimum follow-up period of 1 year.\n* Written informed consent for prospective follow-up or additional study procedures, when applicable.\n\nControl Cohort:\n\n* Age 18 to 50 years.\n* At least two computed tomography examinations covering the Th9-L4 vertebral levels.\n* Interval of at least 1 year between computed tomography examinations.\n* Computed tomography performed for reasons unrelated to traumatic or degenerative thoracolumbar junction disease.\n* No imaging artifacts at the spinal levels included in the study assessment.\n\nExclusion Criteria:\n\nConservative Treatment Cohort:\n\n* Severe combined trauma.\n* Severe concomitant disease.\n* Systemic bone or joint disease associated with changes in facet joints or intervertebral discs, including diffuse idiopathic skeletal hyperostosis, ankylosing spondylitis, rheumatoid arthritis, or similar disorders.\n* Verified osteoporosis.\n* Bone density of thoracolumbar vertebrae less than 100 Hounsfield units.\n* Previous spine surgery.\n* American Society of Anesthesiologists physical status class 4 or 5.\n* Participation in another clinical study related to treatment of spinal disease or spinal trauma.\n* Withdrawal of informed consent, when applicable.\n\nSurgical Treatment Cohort:\n\n* Severe combined trauma.\n* Severe concomitant disease.\n* Systemic bone or joint disease associated with changes in facet joints or intervertebral discs, including diffuse idiopathic skeletal hyperostosis, ankylosing spondylitis, rheumatoid arthritis, or similar disorders.\n* Verified osteoporosis.\n* Bone density of thoracolumbar vertebrae less than 100 Hounsfield units.\n* Previous spine surgery.\n* Direct posterior decompression or other surgery disrupting the posterior supporting column.\n* American Society of Anesthesiologists physical status class 4 or 5.\n* Participation in another clinical study related to treatment of spinal disease or spinal trauma.\n* Withdrawal of informed consent, when applicable.\n\nControl Cohort:\n\n* Complicated fracture of any spinal region.\n* Combined trauma or severe concomitant disease limiting patient mobility.\n* Systemic bone or joint disease associated with changes in facet joints or intervertebral discs, including diffuse idiopathic skeletal hyperostosis, ankylosing spondylitis, rheumatoid arthritis, or similar disorders.\n* Grade 4 facet joint degeneration according to the Pathria classification at the studied levels.\n* Bone density of thoracolumbar vertebrae less than 100 Hounsfield units.\n* Previous spine surgery, including surgery without implants.\n* Spinal fracture with injury to the posterior supporting column.\n* Participation in another clinical study related to treatment of spinal disease or spinal trauma.",true,"ALL","18 Years","50 Years",{"count":21,"type":22},150,"ESTIMATED","OBSERVATIONAL","This observational study will evaluate how degenerative changes in the facet joints and intervertebral discs develop over time after treatment of AOSpine type A2, A3, and A4 fractures of the thoracolumbar junction. Patients treated conservatively and patients treated surgically will be compared with each other and with a control group of patients who underwent repeated computed tomography examinations for reasons unrelated to traumatic or degenerative spinal disease.\n\nThe study will assess computed tomography findings at the injured spinal motion segment and adjacent segments, including facet joint degeneration, intervertebral disc degeneration, signs of ankylosis, facet joint space parameters, and facet joint angle. Clinical outcomes in the fracture cohort will be evaluated using pain scores and validated questionnaires. The purpose of the study is to identify factors associated with progression of degenerative changes after thoracolumbar junction fractures and to clarify whether treatment method is associated with long-term degeneration of the injured and adjacent spinal motion segments.",[26,27,28],"Thoracolumbar Spine Fracture","Facet Joint Degeneration","Intervertebral Disc Degeneration",[30,31,32,33,34,27,28,35,36,37],"Thoracolumbar Junction Fracture","AOSpine Classification","AOSpine Type A2 Fracture","AOSpine Type A3 Fracture","AOSpine Type A4 Fracture","Adjacent Segment Degeneration","Spinal Motion Segment","Computed Tomography","NOT_YET_RECRUITING","2026-06-27",{"date":41,"type":42},"2026-07-01","ACTUAL",{"date":44,"type":22},"2026-11-01",{"date":46,"type":22},"2027-12-31",{"name":48,"class":49},"Sklifosovsky Institute of Emergency Care","OTHER_GOV",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":50},"100605905","phase-1-evaluation-of-autologous-nucleus-pulposus-cells-anpc-in-degenerative-disc-disease-100605905","NCT07168603","EvaluatIon of Autologous Nucleus Pulposus Cells (aNPC) in Degenerative Disc Disease","A Phase I\u002FII Clinical Trial to Evaluate Safety and Efficacy of Autologous Nucleus Pulposus Cells (aNPC) Transplantation in the Treatment of Degenerative Disc Disease","Inclusion Criteria:\n\n* Main inclusion criteria:\n\n  1. Age≧20 years old.\n  2. Diagnosed with a disc herniation, can be having a discectomy.\n  3. Having low back pain with affecting the lower limbs.\n  4. Lower back pain should persist for more than six weeks and fail to improve with conservative treatments.\n  5. VAS score ≥ 6.\n  6. Single lumbar intervertebral disc degeneration or ruptured pinched nerve evaluated by Lumbar X-ray and MRI.\n  7. Informed consent has been signed by subjects of his own accord.\n\nExclusion Criteria:\n\n* 2\\. Main exclusion criteria:\n\n  1. Levels of coagulation, liver, and kidney functions do not meet reference ranges. Following the reference range announced by the medical laboratory department at clinical trial institution, as shown below, PT\u002FINR: 11-15 (sec)\u002F INR 0.78-1.12; BUN: 6.0-20.0 (mg\u002FdL); Creatinine: (Female)0.5-0.9 (mg\u002FdL)\u002F (Male)0.7-1.2 (mg\u002FdL); AST (GOT): \\\u003C 40 (U\u002FL); ALT (GPT): \\\u003C 41 (U\u002FL)\n  2. Bone marrow function did not meet specific criteria, including appropriate levels of white blood cells, platelets, and hemoglobin.\n\n     Following the reference range announced by the medical laboratory department at clinical trial institution, as shown below, White blood cells: 4.00-11.00 (\\*103\u002FμL); Platelets: 130-140 (\\*103\u002FμL); Hemoglobin: Female: 12.0-16.0 (g\u002FdL), Male: 13.0-17.0 (g\u002FdL)\n  3. Spinal inflammation, injury, or structural instability, including but not limited to the following：spondylodiscitis, spondylitis, spondylolisthesis, fracture, previous spinal trauma, severe spinal canal stenosis (hypertrophic fibrosis or ossification oof the ligamentum flavum), spinal tumor, metabolic bone disease.\n  4. Local tissue infection or inflammation near the surgical site.\n  5. Systemic infections require antibiotic treatment.\n  6. Immunodeficiency disease or current use of immunosuppressive drugs.\n  7. Tumor history.\n  8. Severely degenerated or damaged annulus fibrosis, and the Pfirrman grade exceeds V.\n  9. Hypersensitivity to penicillin, streptomycin, and amphotericin B or similar antibiotics.\n  10. Cannot undergo discectomy.\n  11. Autoimmune disease.\n  12. Blood disease. (ex, anemia, blood coagulation dysfunction, leukemia, ITP, etc.)\n  13. Spinal surgical treatment received.\n  14. Drug allergy.\n  15. Have been enrolled in other clinical trials in the past four weeks.\n  16. Pregnancy and breastfeeding.\n  17. Positive for HIV or VDRL in blood tests, as well as uncontrolled carriers of hepatitis B or C.\n  18. Cannot take an MRI scan.\n  19. Subjects who are not suitable for participating in this clinical trial diagnosed by PI.","20 Years",{"count":60,"type":22},12,"INTERVENTIONAL",[63,64],"PHASE1","PHASE2","This is an open-label, single-center Phase I\u002FII clinical trial investigating the safety and efficacy of autologous nucleus pulposus cells (aNPC) in patients with disc degeneration. Eligible participants are those assessed by the principal investigator to have disc herniation suitable for discectomy and confirmed disc degeneration. During the treatment period, participants will receive a single injection of autologous nucleus pulposus cells at a concentration of approximately 1×10⁶ viable cells\u002FmL with a total volume not exceeding 3 mL. The injection will be guided by C-arm X-ray to ensure accurate placement into the degenerated central nucleus pulposus of the disc from which tissue was previously harvested. Participants will be followed for 12 months. Safety assessments will primarily include monitoring for inflammatory responses using ESR and CRP after cell injection, as well as recording any treatment-emergent adverse events (AEs). Efficacy will be evaluated using pain assessment and imaging outcomes, including lumbar X-ray and MRI reviewed independently by a radiologist. Additionally, patient-reported outcomes will assess quality of life improvements following treatment using the Visual Analogue Scale (VAS), Activities of Daily Living (ADLs), and the Oswestry Disability Index (ODI). Laboratory tests, including CBC\u002FDC, BUN, creatinine, AST, and ALT, will also be conducted throughout the treatment and observation period to monitor participant safety.",[28],"RECRUITING","2026-03-29",{"date":70,"type":42},"2026-04-03",{"date":72,"type":42},"2025-09-26",{"date":74,"type":22},"2027-02-01",{"name":76,"class":77},"ASTEROGENE Biomedical Co. Ltd.","INDUSTRY",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100542430","safety-and-performance-of-the-spinevision-posterior-fixation-systems-in-thoracolumbar-spinal-treatment-100542430","NCT06342765","Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment","Safety and Performance of the SpineVision Posterior Fixation Systems Lumis®, Plus® and Ulis® in Thoracolumbar Spinal Degenerative Pathologies or Degenerative Disc Disease (DDD) Associated Pathologies Treatment - Fixed D3 Study","FixedD3","Inclusion Criteria:\n\n* Patient implanted with Lumis®, Plus® or Ulis® posterior fixation system\n* Patient of 18 years old and more\n* Patient has provided signed informed consent or did not oppose to his\u002Fher data collection, per local regulation\n\nExclusion Criteria: contra-indication\n\n* trauma (i.e., fracture or dislocation)\n* Known or suspected allergy or intolerance to the implanted material, mainly to metal (e.g., cobalt, chromium, nickel, etc.)\n* Any other medical or surgical condition likely to compromise the success of instrumented surgery, such as the presence of a malignant tumor or serious congenital abnormalities, raised erythrocyte sedimentation rate not explained by other diseases, high white blood cell count or a tendency to low white blood cell count\n* All cases not described in the indications\n* Localized infection of the operative site\n* All patients with insufficient tissue cover of the operative site\n* Local signs of inflammation\n* Fever or leukocytosis\n* Pathological obesity\n* Pregnancy\n* Mental illness\n* Rapidly evolving joint diseases, bone absorption, osteopenia and\u002For osteoporosis. Osteoporosis is a relative contraindication, as this medical condition can limit the expected correction gain and stability of mechanical fixation\n* All cases not requiring bone graft or bone fusion\n* When pedicular screws are used, absence or malformation of pedicles\n* All cases requiring a combination of different metals\n* All patients not agreeing to comply with post-operative instructions",{"count":87,"type":22},330,"The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal degenerative pathologies, or degenerative disc disease (disease that occurs when the spinal disk break down) associated pathologies.\n\nPart of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Spinevision posterior fixation system implant surgery. Those data will be collected up to twenty four (24) months after the Spinevision posterior fixation system implant surgery.",[28],[91,92,93,94,95,96],"Lumbar","Spine","Fusion","Posterior fixation","Oswestry disability index","Visual Analogue Score","2026-03-16",{"date":99,"type":42},"2026-03-18",{"date":101,"type":42},"2022-09-22",{"date":103,"type":22},"2028-05-30",{"name":105,"class":77},"SPINEVISION SAS",3,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100515869","safety-and-performance-of-the-hexanium-tlif-system-in-the-treatment-of-degenerative-disc-disease-100515869","NCT05997121","Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease","Safety and Performance of the Hexanium TLIF System in the Treatment of Skeletally Mature Patients Suffering From Degenerative Disc Disease - Hexanium TLIF Study","TLIF","Inclusion Criteria:\n\n* Patient planned for Hexanium TLIF system implant or patient implant with Hexanium TLIF system (not prior to July 2021)\n* Patient of 18 years old or more\n* Patient has provided signed informed consent, or did not oppose to his\u002Fher data collection, per local regulation\n\nExclusion Criteria: contra-indication\n\n* Infection, local to the operative site\n* Signed of local inflammation\n* Fever or leukocytosis\n* Morbid obesity\n* Pregnancy\n* Paediatric cases, or patient still having general skeletal growth\n* Spondylolisthesis unable to be reduced to Grade I\n* Suspected or documented allergy or intolerance to metal\n* Any case where the implant components selected for use would be too large or too small to achieve a successful result\n* Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality\n* Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance\n* Prior fusion at the level to be treated\n* Any case not needing a bone graft or fusion\n* Any abnormality present which affects the normal process of bone remodelling including, but not limited to severe osteoporosis involving spine, bone absorption, osteopenia, primary or metastasis tumours involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis\n* Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumours or congenital abnormalities, fracture local to operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count\n* Mental illness\n* Any patient unwilling to cooperate with post-operative instructions",{"count":116,"type":22},187,"The goal of this observational study is to confirm the safety and efficacy of the Hexanium TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk break down).\n\nPart of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Hexanium TLIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium TLIF system implant surgery.",[28],[91,92,120,93,121,95,96],"Arthrodesis","Stabilization",{"date":99,"type":42},{"date":124,"type":42},"2021-07-09",{"date":126,"type":22},"2027-10-30",{"name":105,"class":77},6,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":61,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":50},"100444354","phase-2-efficacy-of-intradiscal-injection-of-autologous-bm-msc-in-subjects-with-chronic-lbp-due-to-multilevel-lumbar-idd-100444354","NCT05066334","Efficacy of Intradiscal Injection of Autologous BM-MSC in Subjects With Chronic LBP Due to Multilevel Lumbar IDD","Intervertebral Disc Regeneration Mediated by Autologous Mesenchymal Stem\u002FStromal Cells Intradiscal Injection: a Phase IIB Randomized Clinical Trial - DREAM Trial","DREAM","Inclusion Criteria:\n\n* Signed informed consent.\n* Symptomatic chronic LBP due to moderate IDD (modified Pfirrmann score 3-4, Griffith score 3-7) at max.3 levels of the lumbar spine unresponsive to conservative treatment, physical and medical for at least 6 months. Physical treatment includes physiotherapy. Medical treatments includes nonsteroidal anti-inflammatory drugs (NSAID), paracetamol, opioids and myorelaxant.\n* Annulus fibrosus intact, demonstrated by MRI.\n* Pain baseline \\> 40 mm on VAS (0- 100).\n* NSAID washout of at least 2 days before screening.\n* Painkillers washout of at least 24 hours before screening.\n* For females of childbearing potential, a negative pregnancy test must be documented at Screening.\n* Men and women should use effective contraception during treatment and for at least 24 months after BM-MSC discontinuation. As a precautionary measure, breast-feeding should be discontinued during treatment with BM-MSC and should not be restarted after discontinuation of BM-MSC.\n\nExclusion Criteria:\n\n* Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and hemisacralization, degenerative spondylolisthesis).\n* Spinal segmental instability assessed by dynamic X-Ray.\n* Symptomatic facet joints syndrome on MRI (facet joints hyperintensity and hypertrophy evaluated at coronal T2 weighted MRI).\n* Prior to the screening visit, has received:\n* Oral corticosteroid therapy within the previous 3 months, OR\n* Intramuscular, intravenous or epidural corticosteroid therapy within the previous 3 months\n* Presence of a 4th level with symptomatic IDD (modified Pfirrmann score 3-4, Griffith score 3-7) in the lumbar spine.\n* Spinal canal stenosis (Schizas score \\> B).\n* History of spinal infection.\n* Lumbar disc herniation and sciatica.\n* Endplate abnormality such as Schmorl's Nodes.\n* Previous discal puncture or previous spine surgery.\n* IDD with Modic II and III changes on MRI images.\n* Patients not eligible to the intravertebral disc surgery.\n* Patients who have the risk to undergo a surgery in the next 6 months.\n* Patients with local infusion device\u002Fdevices for corticosteroids.\n* Obesity with body mass index (BMI in Kg\u002Fsize in m\\^2) greater than 35 (obesity grade II).\n* Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.\n* Abnormal blood tests: hepatic (alanine amino transferase \\[ALT\\] and\u002For aspartate aminotransferase \\[AST\\] \\> 1.5 × upper limit of normal \\[ULN\\]), renal, pancreatic or biliary disease, blood coagulation disorders, anemia or platelet count of \\\u003C 100 × 10\\^9\u002FL.\n* Pregnant or lactating women, or premenopausal women not using an acceptable form of birth control, are ineligible for inclusion. Contraception will be maintained during treatment and until the end of relevant systemic exposure. Additional pregnancy testing will be performed at the end of relevant systemic exposure. The patients will be required to use contraception from initial treatment administration until 24 months after the last dose of study drug.\n* In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is strongly recommended.\n* Positive serology for following infection: Syphilis, HIV, Hepatitis B, or C.\n* Contraindication to MRI assessed by the investigator.\n* Intolerance or allergy to local anaesthesia.\n* Any history of Cancer or immunodeficiency disease.\n* Previous transplantation.","65 Years",{"count":139,"type":22},52,[64],"DREAM is a phase II B efficacy monocentric, prospective, randomized, controlled double blinded trial, comparing intra-discal autologous adult bone marrow mesenchymal stem cells (BM-MSC) therapy and sham treated controls in subjects with chronic (\\> 6 months) Low Back Pain (LBP) due to lumbar multilevel (max. 3 levels) intervertebral disc degeneration (IDD) unresponsive to conventional therapy.\n\nDuration of the recruitment period has been estimated to be 12 months. The efficacy of intradiscal injection of autologous BM-MSC in reducing chronic LBP due to multilevel lumbar IDD will be evaluated after 24 months in terms of pain relief (VAS), functionality (ODI) and quality of life (SF36).",[28,143],"Chronic Low-back Pain",[145,92,28,146,147],"Low Back Pain","Mesenchymal Stem Cells","Bone Marrow","2025-05-21",{"date":150,"type":42},"2025-05-25",{"date":152,"type":42},"2021-03-22",{"date":154,"type":22},"2025-10-31",{"name":156,"class":157},"Fondazione Policlinico Universitario Campus Bio-Medico","OTHER",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":166,"conditions":167,"keywords":170,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":50},"100462292","a-post-market-surveillance-on-infuse-bone-graft-100462292","NCT05299762","A Post Market Surveillance on INFUSE Bone Graft","Inclusion Criteria:\n\n* Has degenerative disc disease and is indicated for lumbar interbody spine fusion from L2-S1 with INFUSE™ Bone Graft via ALIF or OLIF technique\n* Agrees to participate in the study and is able to understand and sign the Informed Consent\n* The procedure planned for the patient complies with the labeling of the devices that may be used in the surgical procedure\n* Has at least six months of nonoperative treatment prior to the study treatment\n* Is at least 18 years old at the time of informed consent\n\nExclusion Criteria:\n\n* Has a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen, or to other components of the formulation\n* Has any active malignancy or undergoes treatment for a malignancy, or operative site is in the vicinity of a resected or extant tumor\n* Is skeletally immature (\\\u003C18 years of age or no radiographic evidence of epiphyseal closure)\n* Is pregnant or lactating\n* Has an active infection at the operative site or with an allergy to titanium, titanium alloy, or polyetheretherketone\n* The use of the Infuse™ Bone Graft component implanted at locations other than the lower lumbar spine (e.g., cervical spine)\n* Repeat applications of the Infuse™ Bone Graft component\n* Has up to Grade 1 retrolisthesis\n* Has hepatic or renal impairment\n* Has metabolic bone disease\n* Has autoimmune disease\n* Has immunosuppressive disease or suppressed immune systems resulting from radiation therapy, chemotherapy, steroid therapy, or other treatments\n* Is illiterate or vulnerable (e.g., the participant is incapable of judgment or is under tutelage) as per the investigator's assessment\n* Concurrent participation in another clinical study that may confound study results\n* Has a considerable risk for surgery\n* Has a condition that could compromise study (e.g., mentally incompetent, alcohol or drug abuse) as per the investigator's assessment",{"count":165,"type":22},600,"This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.",[28,168,169],"Spinal Fusion","Lumbar Disc Disease",[171,172,173,174],"INFUSE Bone Graft","Lumbar Interbody Fusion","Anterior Lumbar Interbody Fusion","Oblique Lumbar Interbody Fusion","2025-03-17",{"date":177,"type":42},"2025-03-20",{"date":179,"type":42},"2022-08-10",{"date":181,"type":22},"2025-08-31",{"name":183,"class":77},"Medtronic Spinal and Biologics",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":193,"conditions":194,"keywords":199,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":50},"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":192,"type":22},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.",[28,195,196,197,198],"Stenosis, Spinal","Spondylolisthesis","Spinal Deformity","Spinal Instability",[92,200,201,202,203,204],"Surgery","Adult","Neuromonitoring","Electromyography","Somatosensory evoked potentials","2024-10-22",{"date":207,"type":42},"2024-10-24",{"date":209,"type":42},"2022-07-13",{"date":211,"type":22},"2025-12-31",{"name":213,"class":77},"Alphatec Spine, Inc.",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":16,"sex":17,"minAge":220,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":61,"phases":224,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":50},"100291658","open-access-database-of-standing-full-body-radiographs-in-asymptomatic-volunteers-100291658","NCT03076658","Open Access Database of Standing Full Body Radiographs in Asymptomatic Volunteers","Inclusion Criteria:\n\n* Males and females age 21-85 without a history of spine surgery.\n\nExclusion Criteria:\n\n* History of spine or neural axis surgery\n* History of cancer with or without metastatic disease\n* Connective tissue, rheumatologic (or other inflammatory arthropathies), or neurologic disorders\n* History of knee replacement surgery, as these may have contractures causing unexpected changes in alignment\n* Severe osteoarthritis of the hips\u002Fknees\u002Fankles\n* Spondylitis\n* Compression fractures or other trauma of the spinal column\n* Previous trauma\u002Ffractures of the pelvis whether or not surgery was required\n* Previous trauma or fractures of the lower extremities requiring surgery\n* Pregnant women\n* BMI \\>37\n* Oswestry Disability Index score \\>25","21 Years","85 Years",{"count":223,"type":22},60,[225],"NA","A study of the skeletal structure and how the structure changes over time. The aim of the study is to evaluate the skeleton in 10 year increments to determine an understanding of the normal skeleton as a person ages. By using x-ray analysis, a new low dose x-ray system (EOS) can be used to evaluate the whole body to see changes in the bone structure over time. Subjects will be asked to undertake one x-ray analysis of their whole body skeletal structure. There will be 25 male and 25 female subjects per decade. The averaging of the measured skeletal parameters will provide information on changes over time generating a standardized expectation of general changes in skeletal structure as participants age.",[28,228],"Osteoarthritis, Spine","2023-09-26",{"date":231,"type":42},"2023-09-28",{"date":233,"type":4},"2016-09",{"date":235,"type":22},"2031-01",{"name":237,"class":157},"University of Colorado, Denver"]