[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lumbar-spine-degeneration\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lumbar-spine-degeneration":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,76,106,133,163],{"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":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100373278","the-notice-study-neurosurgery-and-orthopedics-communication-evaluation-study-following-lumbar-fusions-100373278","NCT04140344","The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions","NOTICE","Inclusion Criteria:\n\n1. Primary lumbar fusion 1-4 levels\n2. 18 years or older\n3. Degenerative spine diagnosis\n4. Answers YES to all the following screening questions:\n\n   * Do you own a mobile phone that is capable of sending and receiving text messages?\n   * Do you know how to text and feel comfortable texting?\n   * Are you a regular (at least once a day) text-message user?\n   * Are you agreeable to regular contact?\n\nExclusion Criteria:\n\n1. Prior lumbar fusions\n2. Tumors\u002Finfection\u002Ftrauma\n3. Prisoners or institutionalized patients\n4. Non-English speaking patients\n5. Patients who smokes or with uncontrolled diabetes\n6. Participants will be removed from study if discharged to a rehabilitation center or discharged beyond 7 days post-operatively (we are expecting \\~15% of patients to be discharged to a rehabilitation center or discharged beyond 7 days post-operatively)","18 Years",{"count":55,"type":22},224,[57],"NA","The purpose of this single-blind, randomized, controlled study is to assess the efficacy of \"informative text messages\" vs \"traditional handouts\" provided to lumbar spine surgery patients post-operatively.",[32,60,61],"Lumbar Spine Instability","Lumbar Spondylosis",[63,64],"Lumbar Fusion","Text Message","2026-05-05",{"date":67,"type":37},"2026-05-08",{"date":69,"type":37},"2023-09-07",{"date":71,"type":22},"2027-10",{"name":73,"class":74},"Duke University","OTHER",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":75},"100496585","phase-4-the-effect-of-zolpidem-on-outcomes-following-lumbar-spine-fusion-100496585","NCT05746143","The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion","The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion: A Randomized Control Trial","Inclusion Criteria:\n\n* degenerative lumbar disease\n* age of 18-75\n* undergoing open primary one- to three-level lumbar fusion\n\nExclusion Criteria:\n\n* currently use a sleep aid nightly\n* diagnosed with insomnia or sleep apnea\n* history of delirium with opiates or zolpidem\n* allergic to opiates or zolpidem\n* had previous lumbar spine surgery\n* undergoing minimally invasive lumbar fusion,\n* undergoing lumbar fusion for fracture, infection, tumor, or an inflammatory spondyloarthropathy","75 Years",{"count":85,"type":22},140,[87],"PHASE4","The purpose of this study is to evaluate if peri-operative zolpidem for posterior lumbar spinal fusion improves patient reported outcomes following surgery.",[90,32,91,92],"Spine Fusion","Pain, Postoperative","Lumbar Spine Spondylosis",[94,95,96],"Lumbar Spine Fusion","Zolpidem","Postoperative Outcomes","2026-04-29",{"date":99,"type":37},"2026-05-01",{"date":101,"type":37},"2022-02-01",{"date":103,"type":22},"2030-12-31",{"name":105,"class":74},"University of Southern California",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":45},"100474038","opalgenix--personalized-postoperative-pain-management-following-lumbar-spinal-fusion-and-decompression-surgery-in-adults-100474038","NCT05452694","OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults","Pharmacogenetics and Pharmacokinetics of Oxycodone to Personalize Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults","Inclusion Criteria:\n\n* \\>18 years of age\n* American Society of Anesthesiologists (ASA) Physical Status 1, 2, or 3\n* Undergoing lumbar spine surgeries (lumbar spine decompression, multilevel posterior spine fusion, internal fixation or a combination) for degenerative lumbar spine and lumbar spinal stenosis and requiring opioids for perioperative pain management\n\nExclusion Criteria:\n\n* Children (\\\u003C18 years of age)\n* Pregnant women\n* American Society of Anesthesiologists (ASA) Physical Status 4 or above\n* Non-English speaking\n* Outpatient surgery\n* Concomitant additional surgical procedures\n* Significant liver or kidney dysfunction\n* Significant cardiorespiratory compromise\n* Patients with polysubstance use (e.g., cocaine, marijuana, amphetamine, etc.)","99 Years",{"count":115,"type":22},235,"OBSERVATIONAL","The proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research. This research focuses on two of the most commonly used oral opioid analgesics, oxycodone, and methadone, in adults following lumbar spinal fusion and decompression surgery. Genetic signature and combinatorial pharmacogenetic approaches perform better than single-gene associations. This innovative translational research will for the first time evaluate simultaneously the effects of multiple genes and interactions on oxycodone and methadone's pharmacokinetics and optimal clinical dosing and on its safety and efficacy in the highly vulnerable pediatric population. This research's multigenetic signature findings can be easily extrapolated to adults undergoing surgery or using oxycodone and\u002For methadone for chronic and cancer pain and in identifying opioid abusers at risk of severe respiratory depression and death.\n\nWhen methadone is given in addition to oxycodone for inpatient pectus excavatum repair and idiopathic scoliosis spinal fusions according to new departmental protocols, methadone pharmacokinetics and pharmacodynamics will also be evaluated.",[119,32],"Lumbar Spine Stenosis",[121,119,122,123],"Pain Management","Degenerative Lumbar Spine","Opioid Use","2025-04-28",{"date":126,"type":37},"2025-05-01",{"date":128,"type":37},"2022-11-01",{"date":130,"type":22},"2027-07-01",{"name":132,"class":44},"OpalGenix, Inc",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":149,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":75},"100578105","artificial-intelligence-enabled-decision-support-for-selection-of-patients-for-lumbar-spine-surgery-100578105","NCT06806969","Artificial Intelligence Enabled Decision Support for Selection of Patients for Lumbar Spine Surgery","Artificial Intelligence (AI) Enabled Decision Support Tool for Selection of Patients for Lumbar Spine Surgery: a Feasibility Study","Inclusion Criteria:\n\n* Patients with MRI-confirmed LDH or LSS referred to University hospital of North Norway Tromsø for assessment of indication for surgery\n* Specialists and physicians in training (for two years or more) in neurosurgery or orthopedic surgery who evaluate such patients at the neurosurgical outpatient clinic at University hospital of North Norway Tromsø\n\nExclusion Criteria:\n\n* Patients unable to consent because of\n\n  * Age \\\u003C 18 years\n  * Serious drug abuse of severe psychiatric disorders\n  * Language barriers (patients who cannot speak or read Norwegian)\n* Patients with a baseline ODI ≤14 (LDH) or ≤22 (LSS)\n* Patients undergoing non-elective\u002Femergency operations\n* Patients with degenerative conditions other that LDH and LSS, fractures, primary infections, or malignant conditions of the spine\n* Physicians in training with less than two years' experience with spine surgery","100 Years",{"count":142,"type":22},26,[57],"Background One third of patients operated for lumbar disc herniation (LDH) or spinal stenosis (LSS) do not achieve substantial improvement. Studies indicate that well informed shared decision making (SDM) can improve the selection to surgery, and thus the outcomes. Numerous algorithms for outcome prediction have therefore been developed, and some use artificial intelligence (AI). Most are trained on small datasets, few are accurate, all are stand-alone or web-based applications not integrated in the electronic health record (EHR), and none are implemented in routine clinical practice.\n\nThe Norwegian registry for spine surgery (NORspine) comprises a cohort of more than 69,000 cases. The investigators have used AI to analyze the dataset and predict the outcome, and developed a decision support tool (DST) which is seamlessly integrated in the EHR DIPS Arena®.\n\nThe investigators intend to use the tool to inform the SDM between surgeons and patients about the indication for surgery (yes or no), to increase the proportion with a successful outcome. The aim of the study is to assess the safety and feasibility of the DST for use in a subsequent pilot study.\n\nThe device The DST (the device) is an integrate compound of software-solutions. Baseline data are registered by patients and surgeons on questionnaires integrated in DIPS Arena®, and transferred to NORspine. The data are also transferred (de-identified) to the AI-enabled prediction algorithm which operates in a cloud-based model hosting service. The algorithm has been trained and validated on a dataset from NORspine. The area under the curve for prediction of the main outcome (Oswestry disability index after12 months) in receiver operating characteristic analysis is very high (0.85) for LDH and moderate (0.72) for LSS. The model host also calculates outcomes (proportions with substantial, slight, or no improvement, and worsening) for the 50 cases with baseline variables most similar to the present case (\"patients-like-me\"). Finally, the individual prediction and the outcomes for the \"patients-like-me\" are transferred back and displayed in the regular user interface of DIPS Arena® for use in the SDM.\n\nClinical investigations For this feasibility study, the investigators will use convergent qualitative and quantitative mixed methods. The comparator is decision making in routine clinical practice, without use of the DST. The study will include 20 patients with magnetic resonance imaging confirmed LDH or LSS referred for evaluation of the indication for surgery, and six surgeons who do the evaluations. The study will iteratively redesign the user interface of the DST until it is considered safe and feasible for use in a following pilot study.",[146,147,148,32],"Intervertebral Disc Displacement","Spinal Stenosis Lumbar","Lumbar Disc Herniation",[150,151,152],"artificial intelligence","decision support","surgery selection","NOT_YET_RECRUITING","2025-01-30",{"date":156,"type":37},"2025-02-04",{"date":158,"type":22},"2025-02-01",{"date":160,"type":22},"2027-06-30",{"name":162,"class":74},"University Hospital of North Norway",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":17,"minAge":170,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":23,"phases":174,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":75},"100479758","spinal-stenosis-and-listhesis-treated-with-percutaneous-interspinous-spacer-a-non-surgical-trial-100479758","NCT05527145","Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial","Treatment of Spinal Stenosis and Spolilolisthesis With Percutaneous Interspinous Spacers. A Phase III Trial","Inclusion Criteria:\n\n1. Age 50-85 years.\n2. Clinical symptoms of lumbar spinal stenosis (pseudoclaudication) indicating and motivating surgery. Numeric Rating Scale in lower limbs ≥3.\n3. MRI with finding of lumbar spinal stenosis at 1-3 lumbar levels. Dural sac area ≤75 mm2 or degree of stenosis C or D according to Schizas's classification.34\n4. The patient has given oral and written informed consent to participate.\n\nExclusion Criteria:\n\n1. Degenerative deformity with Cobb angle \\>20°.\n2. Symptomatic osteoarthritis in the lower limbs that affects and limits the patient's function.\n3. Arterial insufficiency (claudication intermittent).\n4. Former lumbar surgery other than disc hernia.\n5. Conditions that affect the spine, such as ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis, spondylodiscitis\u002Finfections, malignancy and neurological diseases.\n6. Heart and lung diseases presenting a significant risk for surgery or making it impossible for the patient to take part in a percutaneous arm of treatment (American Society of Anesthesiologists (ASA) score \\>3).\n7. Polyneuropathies.\n8. Psychological factors rendering the patient incapable of inclusion in the trial (eg, drug addiction, dementia).","50 Years","85 Years",{"count":173,"type":22},200,[57],"Symptomatic lumbar spinal stenosis is the most common indication for spinal surgery. However, more than one-third of the patients undergoing surgery for lumbar stenosis report dissatisfaction with the results. On the other hand, conservative treatment has shown positive results in some cases. This trial will compare the outcomes of surgical versus non-surgical treatment for lumbar stenosis.",[32,60,177,178],"Lumbar Spondylolisthesis","Lumbar Spinal Stenosis",[180,181],"spondylolisthesis","lumbar spine stenosis","2024-02-09",{"date":184,"type":37},"2024-02-12",{"date":186,"type":22},"2024-09",{"date":188,"type":22},"2026-07",{"name":190,"class":74},"University of Roma La Sapienza"]