[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lumbar-disc-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lumbar-disc-disease":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,46,78,112,139,176,197],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100551641","phase-1-ldgraft-in-single-level-anterior-lumbar-interbody-fusion-alif-100551641",false,"NCT06462729","LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)","A Randomized Study of LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)","RESTORE","Inclusion Criteria:\n\n1. Skeletally mature adults ≥22 and ≤80 years at the time of surgery\n2. Willing and able to give written informed consent and comply with study protocol and postoperative management program\n3. Degenerative disc disease of the lumbosacral spine in one level (L3 to S1) requiring fusion confirmed by patient history and radiographic imaging (CT\u002FMRI\u002FX-rays) with one or more of the following:\n\n   * instability (as defined by ≥3mm translation or ≥5° angulation);\n   * osteophyte formation of facet joints or vertebral endplates;\n   * decreased disc height, on average by \\>2mm, but dependent upon the spinal level;\n   * scarring\u002Fthickening of ligamentum flavum, annulus fibrosis, or facet joint capsule;\n   * herniated nucleus pulposus;\n   * facet joint degeneration\u002Fchanges; and\u002For\n   * vacuum phenomenon.\n4. Preoperative Oswestry Disability Index score ≥ 35\n5. Participant has not responded to conservative treatment (e.g. medications, injections, physical therapy, etc.) for a period of 6 months\n6. Participant is indicated for an ALIF approach to the lumbar spine\n\nExclusion Criteria:\n\n1. Previous lumbar spine instrumentation (i.e., anterior disc replacement, interspinous device) or a previous interbody fusion procedure in the lumbar spine\n2. More than one level lumbar spine level requiring fusion\n3. Three or more contiguous lumbar spine levels requiring decompression (Note: Up to two contiguous levels of decompression is acceptable)\n4. Known hypersensitivity or allergy to any components of the study treatments inclusive of hypersensitivity or allergy to any BMP-2 type recombinant proteins or peptides.\n5. Pregnant, planning to become pregnant during the follow-up time period, or breast-feeding women\n6. Presence of active malignancy\n7. Requires bone growth stimulation in the lumbar spine\n8. Active local or systemic infection\n9. Spondylolisthesis greater than Grade 1 (25% translation)\n10. Currently smoking or using nicotine products, including e-cigarette products (e.g., vaping) (Use within 30 days of screening date is considered 'current')\n11. Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis\n12. Any medical condition requiring treatment with any drug known to potentially interfere with bone\u002Fsoft tissue healing (e.g. chronic systemic steroids) or receiving radiation therapy that is expected to continue for the duration of the study\n13. Body Mass Index \\> 35\n14. Insulin-dependent diabetes mellitus\n15. Osteopenia or osteoporosis of the spine, DEXA T score of ≤ -1.0\n16. Any secondary causes of osteoporosis (e.g. chronic liver or kidney disease, uncontrolled hyper- or hypothyroidism, type I or type II diabetes mellitus, gastrointestinal malabsorption syndromes) or other conditions known to adversely affect osteogenesis (e.g. Paget's disease, Ehlers-Danlos syndrome or osteogenesis imperfecta)\n17. Participation in another investigational study within 30 days prior to surgery for investigational devices, or within the last three months for investigational drugs;\n18. Current or recent history of chemical\u002Falcohol abuse or dependency using standard medical definition of DSM-5 (Diagnostic and Statistical Manual) code\n19. In the opinion of the investigator, the participant has a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the product\n20. Radiographically compromised vertebral bodies at the index level due to current or past trauma, e.g., by the radiographic appearance of the fracture callus, deformity, malunion or nonunion\n21. Currently a prisoner\n22. Involved in active litigation relating to his\u002Fher spinal condition or workers compensation claimants.","ALL","22 Years","80 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The objective of this study is to evaluate the safety and effectiveness of LDGraft (investigational device) compared to 100% human tissue product allograft bone (control) when applied in an ALIF procedure in the treatment of patients with lumbar degenerative disc disease (DDD).",[29,30,31,32],"Degenerative Disc Disease","Lumbar Disc Disease","Spine Disease","Lumbar Spine Degeneration","RECRUITING","2026-05-22",{"date":36,"type":37},"2026-05-27","ACTUAL",{"date":39,"type":37},"2024-11-12",{"date":41,"type":22},"2027-12",{"name":43,"class":44},"Locate Bio Pty Ltd","INDUSTRY",3,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100411706","postoperative-scar-in-the-control-excess-of-mobility-induced-by-annulus-removal-on-inserting-a-lumbar-disc-prosthesis-100411706","NCT04641039","Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis","Effect of the Postoperative Prevertebral Scar on Controlling Excess After Removing the Anterior Lumbar Disc Annulus Fibrosus to Implant a Lumbar Disc Prosthesis. Biomechanical and Clinical Study","Inclusion Criteria:\n\n* Minimum age of 18 years and maximum of 50 years, given that above that age there is usually degenerative pathology of the lumbar joint facets, which can confuse the symptoms and make it difficult to interpret the results.\n* Pathology compatible with chronic low back pain accompanied or not by radiculopathy originating in one or a maximum of two degenerated intervertebral discs and without signs of degeneration \u002F osteoarthritis of the lumbar joint facets.\n* The type of lumbar pain must be discogenic, that is, worsen in flexion and not in extension, and in loading, as well as having a truncal distribution with possible anterior radiation towards the English or genital region.\n* Radiological confirmation by lumbar MRI study of lumbar discopathy of one or a maximum of two lumbar levels.\n* Absence in simple radiology studies of signs of vertebral instability or listhesis of the levels to be treated.\n* Absence of response for 6 weeks to conservative, non-surgical treatment, or presence of progressive symptoms. The treatment would also be carried out despite the absence of this study and the existence of the study does not condition in any way the treatment of the patients\n* Not having undergone any prior treatment of the type of microdiscectomy, laminectomy or lumbar arthrodesis, although these have been carried out at different levels than those involved on this occasion\n* Ability of the patient to comply with the proposed monitoring program\n* Patient's ability to follow the postoperative care program\n* Granting of informed consent\n\nExclusion Criteria:\n\n* Signs of arthropathy of the lumbar joint facets, osteoporosis, previous interventions on the lumbar spine\n* Deformity or instability of the lumbar spine\n* Lumbar canal stenosis\n* Previous intervention on lumbar spine\n* Previous lumbar spinal fracture\n* Mobile spondylolisthesis\\> 2 mm in translation and \u002F or more than 11 ° angular difference with respect to the adjacent level on neutral vertical or flexion-extension radiographs\n* Severe osteoporosis\n* Spinal metastasis\n* Metabolic bone disease that could interfere with the implant or the surgical procedure\n* Rheumatoid arthritis, lupus, or other autoimmune disease that affects the musculoskeletal system\n* Other conditions or anatomical alterations that make the treatment of the anterior approach to the lumbar spine unfeasible\n* Known allergy to stainless steel, titanium or their alloys\n* Fixed or permanent neurological deficit\n* Active systemic infection at any time or ongoing preventive treatment for it, infection in the surgical site, HIV or hepatitis C\n* Abusive drug or alcohol use\n* Uncontrolled seizure disorder\n* Psychiatric illness that could interfere with your participation in the study\n* Participation in a current research study or in the 3 months prior to surgery\n* History of malignancy or current malignancy (except non-melanoma skin cancer), unless the patient has been treated for curative purposes and no clinical signs or symptoms have been observed for at least 5 years\n* Obesity (Body Mass Index or BMI\\> 35)","18 Years","50 Years",{"count":56,"type":22},24,[58],"NA","To implant a complete lumbar disc prosthesis removal of the anterior portion of the annulus fibrosus is required. As the anterior portion of the annulus limits the movement in extension and axial rotation, we would like to know how much increase these two disc movements and also the effect on the postoperative prevertebral scar on the reduction of these abnormal movement ranges. We also aim to see if repairing intraoperatively the anterior portion of the annulus has any advantage in the final result achieved.",[30],[62,63,64,65,66],"Annulus fibrosus","Lumbar disc prosthesis","Lumbar disc replacement","Range of movement lumbar disc prosthesis","Quality of life after lumbar disc replacement","2026-04-18",{"date":69,"type":37},"2026-04-22",{"date":71,"type":37},"2020-11-01",{"date":73,"type":22},"2029-12-28",{"name":75,"class":76},"University of Valencia","OTHER",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100632663","clinical-and-mri-findings-in-lumbar-disc-disease-100632663","NCT07516613","Clinical and MRI Findings in Lumbar Disc Disease","Correlation Between Clinical Parameters and MRI Imaging Findings in Lumbar Disc Disease","Inclusion Criteria:\n\n* Adult patients aged 18-70 years presenting with clinical symptoms suggestive of lumbar disc disease (low back pain with or without radiculopathy).\n* Patients with MRI-confirmed lumbar disc pathology (disc bulge, protrusion, extrusion, or sequestration) at one or more levels.\n* Patients who have had lumbar MRI performed within 3 months prior to enrollment.\n* Patients able to communicate clearly and complete assessment questionnaires.\n* Patients providing written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients with previous lumbar spine surgery.\n* Patients with spinal fractures, tumors, infections, or inflammatory spondyloarthropathies (e.g., ankylosing spondylitis).\n* Patients with severe psychiatric disorders that interfere with assessment.\n* Patients with contraindications to MRI (e.g., pacemakers, metallic implants).\n* Patients with cauda equina syndrome requiring emergency surgical intervention.\n* Patients with peripheral neuropathy from systemic causes (e.g., diabetes mellitus with confirmed neuropathy, renal failure).\n* Pregnant women.\n* Patients who refuse to participate or provide informed consent.","70 Years",{"count":87,"type":22},96,"OBSERVATIONAL","Low back pain related to lumbar disc disease is a very common condition. Doctors frequently use Magnetic Resonance Imaging (MRI) to look at the spine and diagnose these problems. However, it is not always clear how well the severity of the damage seen on an MRI matches the actual symptoms a patient is experiencing. Sometimes, patients with severe MRI findings have mild symptoms, and vice versa.\n\nThe purpose of this observational study is to understand the relationship between a patient's clinical symptoms and their MRI results. Researchers want to see if the severity of the spinal damage shown on an MRI can accurately predict how much pain or disability a patient has.\n\nParticipants in this study are adults (ages 18-70) who are already experiencing symptoms of lumbar disc disease and have recently had an MRI. During the study, participants will:\n\n* Complete a questionnaire about the intensity of their back and leg pain.\n* Fill out a survey about how their back pain affects their daily activities.\n* Undergo a standard physical and neurological examination by a doctor to check their reflexes, muscle strength, and sensation.\n\nResearchers will then compare these physical examination and questionnaire results with the detailed findings from the patient's MRI scans. The goal of this research is to improve diagnostic accuracy and help doctors make better, more personalized treatment decisions for future patients with lower back pain.",[30,91,92,93],"Low Back Pain","Lumbar Disc Herniation","Lumbosacral Radiculopathy",[95,96,97,98,99,100,101],"Magnetic Resonance Imaging (MRI)","Visual Analog Scale (VAS)","Oswestry Disability Index (ODI)","Pfirrmann Grading System","Nerve Root Compression","Spinal Canal Stenosis","Disc Degeneration","NOT_YET_RECRUITING","2026-04-01",{"date":105,"type":37},"2026-04-08",{"date":107,"type":22},"2026-04",{"date":109,"type":22},"2027-05",{"name":111,"class":76},"Assiut University",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":19,"enrollmentInfo":119,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":135,"leadSponsor":137,"locationsCount":77},"100631040","patient-satisfaction-during-lomber-transforaminal-epidural-steroid-injection-the-role-of-sedation-anxiety-and-pain-100631040","NCT07495501","Patient Satisfaction During Lomber Transforaminal Epidural Steroid Injection: The Role of Sedation, Anxiety, and Pain","Patient Satisfaction During Lomber Transforaminal Epidural Steroid Injection: The Role of Sedation, Anxiety, and Pain: A Prospective Observational Study","Inclusion Criteria:\n\n* Adults aged 18 to 80 years\n* No prior history of any interventional pain procedure\n* Ability to read and write in Turkish and to complete the study questionnaires\n* Written informed consent provided.\n* Planned lumbar transforaminal epidural steroid injection for radicular pain\n\nExclusion Criteria:\n\n* Refusal to provide written informed consent.\n* Inability to complete the satisfaction questionnaires reliably due to lack of Turkish literacy, significant cognitive impairment or severe visual or hearing impairment\n* Presence of major comorbidities such as decompensated cardiac or respiratory failure, uncontrolled arrhythmia or angina, myocardial infarction or stroke within the past 3 months, advanced liver or kidney failure, uncontrolled obstructive sleep apnea associated with morbid obesity, or severe pulmonary hypertension.",{"count":120,"type":22},120,"Transforaminal epidural steroid injection (TFESI) is a minimally invasive procedure commonly used for the management of lumbar radicular pain. It is intended to reduce inflammation around the affected nerve root, limit edema, and modulate nociceptive transmission, with the aim of relieving pain, improving physical function, and potentially reducing the need for surgery. Although TFESI may improve function and quality of life, treatment benefit is not uniform, and the degree of pain relief and patient satisfaction may differ across individuals.\n\nThis prospective observational study aims to evaluate postprocedural pain intensity and patient satisfaction in individuals undergoing lumbar TFESI and to identify clinical and demographic factors associated with satisfaction. Demographic and clinical characteristics, medical and surgical history, procedural pain scores, anxiety level, postprocedural pain scores, sedation status, fluoroscopy-related metrics, and intraprocedural events will be recorded. Patient satisfaction will be assessed 1 hour after the procedure using a Likert-based questionnaire, and operator satisfaction will also be documented.\n\nBy examining patient-reported outcomes together with procedural and clinical variables, this study seeks to provide a more standardized assessment of real-world TFESI outcomes and to support better patient selection and follow-up strategies.",[30,123,124],"Radiculopathy Lumbar","Radicular Pain",[126,127,128,129,130],"Patient satisfaction","Sedation","Anxiety","Epidural steroid injection","Pain intensity","2026-03-21",{"date":133,"type":37},"2026-03-27",{"date":103,"type":22},{"date":136,"type":22},"2026-09-15",{"name":138,"class":76},"Mersin University",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":150,"conditions":151,"keywords":160,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":77},"100579522","auriculotherapy-neuroimaging-100579522","NCT06825390","AuriculoTherapy NeuroImaging","Mechanistic Clinical Trial of Auricular Stimulation and Cryogenic Auriculotherapy in Patients With Chronic Low-back Pain, Using Functional Near-infrared Spectroscopy and Magnetic Resonance Imaging","ATNI","Inclusion Criteria:\n\n1. Adult, at least 18 years old\n2. Episodes of chronic low back pain at least daily for at least 6 months, with an average pain score within the last week of 3\u002F10.\n\nExclusion Criteria:\n\n1. active lesions, skin disruptions, or neuropathy of either ear;\n2. recent (\\\u003C1 month) analgesic procedures or surgery;\n3. recent (\\\u003C1 month) start of new analgesic or psychoactive medication (including marijuana, opioids, tramadol, methadone, gabapentinoids, anti-depressants, anti-epileptics, mood-stabilizers, anti-psychotics, or stimulants);\n4. history of chronic pain in shoulder or thumb (to avoid confounding at control stimulation points);\n5. recent (\\\u003C 3 months) illicit drug use;\n6. prior substance misuse\u002Fabuse;\n7. cold-activated diseases (including: agammaglobulinemia, cold urticaria, cold agglutinin disease, cryofibrinogenemia, cryoglobulinemia, immunosuppression, Raynaud's disease, collagen or autoimmune diseases, multiple myeloma, platelet deficiency disorders, pyoderma gangrenosum.)\n\n   \\- MRI-specific exclusions additionally include:\n8. Pregnancy or active attempts at conception;\n9. Implanted metal or electronic device;\n10. severe claustrophobia",{"count":148,"type":22},60,[58],"This is a clinical study of patients who have low back pain (for at least 6 months). The goal is to understand, with brain imaging, how auriculotherapy (an acupuncture-like stimulation of the ear) may work to relieve pain. There are 4 total study visits, divided into two pairs of visits that occur before and 5-7 days after receiving either a real or sham auriculotherapy treatment. The cryo-IQ device will be used, to stimulate 7 small areas on both ears with a focused jet of cold as a small amount of compressed gas is released. This is generally not painful, and less invasive, compared to using needles for auriculotherapy.",[91,152,153,30,154,155,156,157,158,159],"Chronic Low-back Pain","Back Pain, Low","Lumbar Discogenic Pain","Lumbar Pain Syndrome","Lumbar Post-Laminectomy Syndrome","Back Pain Lower Back Chronic","Back Pain Without Radiation","Pain;Back Low;Chronic",[161,162,163,164,165,166],"auriculotherapy","auricular stimulation","functional near-infrared spectroscopy","functional magnetic resonance imaging","functional connectivity","cryo-auriculotherapy","2026-02-13",{"date":169,"type":37},"2026-02-18",{"date":171,"type":37},"2025-07-30",{"date":173,"type":22},"2029-04-30",{"name":175,"class":76},"Keith M Vogt",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":23,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":194,"locationsCount":196},"100365790","phase-2-a-single-dose-of-brtx-100-for-patients-with-chronic-lumbar-disc-disease-cldd-100365790","NCT04042844","A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)","A Phase 2, Double-Blind, Controlled, Randomized Study to Evaluate the Safety and Preliminary Efficacy of a Single Dose Intradiscal Injection of BRTX-100 for Patients With Chronic Lumbar Disc Disease (cLDD)","Subject Inclusion Criteria:\n\nA subject is eligible for inclusion if all the following criteria are met:\n\n1. A high index of suspicion for discogenic pain, (i.e., painful degenerative disc(s) with or without protrusions less than or equal to 5 mm)\n\n   1. Chronic Lower Back Pain for at least 6 months\n   2. Pain commonly provoked by prolonged sitting, forward bending, lifting, twisting, coughing, sneezing, or Valsalva maneuvers\n   3. Failure of at least 6 months of conservative back pain care (can include any or all of the following: rest, anti-inflammatory medication, analgesics, narcotics, epidural injections or selective nerve root injections at the target level, facet joint injections, muscle relaxers, massage, acupuncture, chiropractic care)\n   4. Failure of supervised therapy (such as physical therapy)\n   5. Screening of ≥ 40 mm and ≤ 80 mm on low back pain visual analog scales (VAS) (average pain in the last week)\n   6. Screening Oswestry Disability Index (ODI) score ≥ 30 and \\\u003C 90 on a 100-point scale\n   7. No localized and significant pain below beltline (i.e., potential sacroiliac joint pain) without lumbar pain component\n   8. Thigh or Leg pain, if present, is non prevailing and of nonradicular origin, i.e., not due to stimulation of nerve roots or dorsal root ganglion of a spinal nerve by compressive forces\n   9. Diagnostic medial branch block or facet joint injection (bilateral unless the symptoms are purely unilateral in nature) in the last 12 months prior to the informed consent date indicates no prevailing facet joint involvement\n2. Has degenerative disc disease (DDD) as defined by the following:\n\n   1. Changes from normal disc morphology of the affected disc as defined by radiographic evaluation\n   2. Modified Pfirrmann score of 2 to 7 on MRI, may contain a contained protrusion and\u002For annular tear on MRI\n   3. Modified Pfirrmann score of 1 must contain a contained protrusion and\u002For annular tear on MRI\n   4. Modic Grade I or II changes or no change on MRI\n   5. Maintained intervertebral disc heights of at least 50% on MRI.\n   6. Discography, if not performed within the last 6 months prior to informed consent date, has to be performed if more than one degenerative disc is identified by MRI, and the symptomatic disc cannot be otherwise reasonably determined\n   7. If more than one degenerative disc is identified by MRI, no disc shall demonstrate greater degenerative change than the symptomatic disc or contain a protrusion greater than 5mm\n3. Aged ≥18 years of age at the time of consent\n4. Willing and able to provide written informed consent\n5. No evidence of contraindications to the procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer\n\nSubject Exclusion Criteria:\n\nA subject is not eligible to participate if any of the following criteria are met:\n\n1. Spinal Deformity (Scoliosis greater than or equal to 20 degrees, spondylolysis, clinically or radiographically significant retrolisthesis or spondylolisthesis) detected on MRI or plain film radiographic assessment\n2. Disc extrusions, sequestered fragments, facet cysts, or greater than moderate spinal stenosis on MRI.\n3. Presence of a Grade V annular fissure observed within the index disc level during discography in a subject for whom provocation discography has been performed\n4. Intervertebral disc with radiographic evidence of Modified Pfirrmann Grade 8 or greater\n5. Any bleeding disorder, intrinsic or extrinsic\n6. Required anticoagulation (with either antiplatelet agents or antithrombotics) that cannot be interrupted for harvest and injection procedures\n7. Platelet count less than or equal to 100,000\n8. International Normalized Ratio (INR) greater than or equal to 1.5\n9. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI greater than or equal to 40)\n10. Clinically relevant instability on flexion-extension as determined by the investigator by overlaying films (flexion \\& extension films)\n11. Has undergone any previous lumbosacral spine surgery (e.g. discectomy, laminectomy, foraminotomy, fusion, intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation.), ablation of lumbar basiverterbral nerve or therapeutic percutaneous disc intervention\n12. Have any acute or chronic lumbosacral spine fracture\n13. Have a history of lumbosacral epidural steroid injections within 1 month prior to informed consent date.\n14. Planned\u002Fexpected use of systemic nonsteroidal anti-inflammatory drugs (NSAIDs) within 72 hours prior to study treatment.\n15. Have a known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO)\n16. Active significant non lumbosacral spinal orthopedic pain generators including, not limited to arthritic hip and\u002For knee, cervical disc disease\n17. More widespread and ill-defined myofascial pain\n18. Have had treatment with any cellular or biological investigational therapy or device within 6 months of informed consent date and\u002For plans to participate in any other autologous or allogeneic stem cell\u002Fprogenitor cell therapy trial during the 2 year follow-up period\n19. Have been a recipient of any lumbosacral intervertebral disc injection for therapeutic purposes\n20. Are transient or has been treated in the last 6 months before enrollment for alcohol and\u002For drug abuse in an inpatient substance abuse program\n21. Apparent ongoing and poorly controlled psychological or somatic disease that may impact treatment outcomes\n22. Social, familial, or geographical hindrances to compliance with the study protocol or the informed consent process\n23. Known autoimmune disease with primary impact on the musculoskeletal and\u002For neurological systems (e.g., systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, myasthenia gravis, polymyositis\u002Fdermatomyositis, Guillain-Barre syndrome, autoimmune vasculitis)\n24. Required chronic immunosuppression\n25. Positive hepatitis C virus (HCV) antibody test\n26. Positive human immunodeficiency virus (HIV) Antigen\u002FAntibody (Ag\u002FAb) Combo test\n27. Pregnant or lactating women\n28. Women of childbearing potential not protected by a highly effective method of birth control.\n\n    Highly effective methods of contraception \\[defined as those, alone or in combination, that result in a low (\\\u003C1%) failure rate\\] include, but are not limited to, combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (either oral, intravaginal, transdermal or injectable), progestogen-only hormonal contraception associated with inhibition of ovulation (either oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence, or a double-barrier method (i.e., male condom combined with diaphragm with spermicide). The investigator is responsible for review of medical history, contraception history, menstrual history and recent sexual activity to decrease the risk of including a woman with an undetected early pregnancy. Additionally, the investigator is responsible for determining if, in the investigator's judgment, a woman's planned contraceptive method (including an assessment of her reliability for consistent use of this method) meets the protocol requirement of \"highly effective.\"\n29. Hematology and chemistry values including, but not limited to:\n\n    1. Total bilirubin level 1.5 times institutional upper limit of normal (ULN)\n    2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2 x ULN\n    3. Absolute neutrophil count (ANC) \\\u003C 1000\u002Fmm3\n    4. Hemoglobin less than or equal to 10 g\u002FdL\n    5. Creatinine clearance use calculated clearance (Cockcroft-Gault equation) of less than or equal to 50 mL\u002Fmin\n    6. Other labs deemed clinically significant which, in the opinion of the investigator, might influence the subject's health or safety during the trial.\n30. Have any other active medical conditions, medical or psychiatric illness which, in the opinion of the Investigator, would preclude adequate evaluation of the safety and efficacy of the study or put the participant at risk\n31. Inability to comply with the requirements of the study protocol\n32. Actively on workers compensation or no-fault case for this complaint or any other active case or litigation pertaining to their lumbosacral pain.\n33. History of drug or alcohol abuse or documented history of noncompliance with controlled substances that, in the investigator's opinion, could interfere with adequate evaluation of the study drug's safety or efficacy or otherwise make the subject unsuitable for the study.\n34. History of regular, long term, daily opioid drug use (greater than or equal to 30 MME)",{"count":184,"type":22},99,[26],"This is a double-blind, controlled, randomized study with blinded assessments using a single dose. Subjects that have a current diagnosis of chronic lumbar disc disease and meet eligibility criteria will be enrolled. Chronic lumbar disc disease is defined as back and\u002For radicular pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic measures such as computed tomography (CT), magnetic resonance imaging (MRI), plain film, myelography, discography, or other acceptable means.",[30],"2025-08-20",{"date":190,"type":37},"2025-08-26",{"date":192,"type":37},"2022-06-30",{"date":41,"type":22},{"name":195,"class":44},"BioRestorative Therapies",19,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":205,"conditions":206,"keywords":209,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":77},"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":204,"type":22},600,"This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.",[207,208,30],"Intervertebral Disc Degeneration","Spinal Fusion",[210,211,212,213],"INFUSE Bone Graft","Lumbar Interbody Fusion","Anterior Lumbar Interbody Fusion","Oblique Lumbar Interbody Fusion","2025-03-17",{"date":216,"type":37},"2025-03-20",{"date":218,"type":37},"2022-08-10",{"date":220,"type":22},"2025-08-31",{"name":222,"class":44},"Medtronic Spinal and Biologics"]