[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"degenerative-disc-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:degenerative-disc-disease":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,44,73,99,135,166,194,217,239,261,286,312,346,374,399,421,445,466,498,535,555,576,599,623,648],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100533473","clinical-outcome-measure-at-stryker-spine-100533473",false,"NCT06226272","Clinical Outcome Measure at Stryker Spine","Clinical Outcome Measure at Stryker Spine: COMPASS","COMPASS","Inclusion Criteria:\n\n• To be eligible to participate in the study, the potential subject must meet all inclusion criteria specific to the Stryker system being evaluated, please contact one of the participating investigators or see the device-specific cleared IFU, for further details.\n\nExclusion Criteria:\n\n• The exclusion criteria are based on the contraindications as presented in the Stryker device cleared IFUs, please contact one of the participating investigators or see the device-specific cleared IFU, for further details.","ALL","18 Years",{"count":21,"type":22},5222,"ESTIMATED","OBSERVATIONAL","This is a multicenter, prospective, retrospective, Post Market Clinical Follow-up (PMCF) study in subjects who have undergone or will undergo surgery utilizing one or more Stryker devices according to Stryker cleared Instructions for Use (IFU).",[26,27],"Degenerative Disc Disease","Degenerative Scoliosis",[29,30],"Device: Cervical or Thoracolumbar Spinal fusion","Device: Adult Spinal Deformities","RECRUITING","2026-06-23",{"date":34,"type":35},"2026-06-26","ACTUAL",{"date":37,"type":35},"2025-01-28",{"date":39,"type":22},"2032-01-29",{"name":41,"class":42},"VB Spine, LLC","INDUSTRY",7,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100612532","phase-3-a-study-to-evaluate-the-effectiveness-of-idct-intradiscal-cell-therapy-in-subjects-with-one-level-symptomatic-mild-to-moderate-lumbar-degenerative-disc-disease-100612532","NCT07254806","A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease","A Prospective, Randomized, Double-Blinded, Sham-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of IDCT in Subjects With Single-Level, Symptomatic Mild to Moderate Lumbar Intervertebral Disc Degeneration","IDCT","Inclusion Criteria:\n\n1. Has a diagnosis of mild to moderate, symptomatic, single-level degenerative disc disease (DDD) from L3-S1.\n2. Has a target disc that meets Modified Pfirrmann Grade 3-7, as determined by a central radiologist.\n3. Is ≥18 and ≤75 years of age, skeletally mature, and has a body mass index (BMI) ≥18 kg\u002Fm2 and ≤38 kg\u002Fm2 at Screening.\n4. Has been experiencing chronic low back pain for at least 6 months prior to Screening.\n5. Has had low back pain that is unresponsive to at least 3 months of conservative care (nonoperative treatment) to include at least one non-pharmacological intervention which may include physical therapy, acupuncture, chiropractic manipulation, massage, and at home medically supervised exercise program and two pharmacological interventions which may include NSAIDs, acetaminophen, duloxetine, and\u002For injectable therapy.\n6. Has pre-treatment low back pain score of 45 to 90 on VAS (Visual Analogue Scale) for low back pain at Screening and Day 1.\n7. Has pre-treatment ODI score of 35 to 90 at Screening and Day 1.\n8. Is willing to voluntarily sign the informed consent form and agrees to the release of previous medical history for purposes of this study (i.e., HIPAA authorization) at Screening.\n9. Is physically and mentally able to comply with the protocol, able to understand and complete the required forms, and willing and able to adhere to the requirements of the protocol in the opinion of the Investigator.\n10. Female-born subjects of childbearing potential must agree to and comply with using highly effective methods of birth control for the duration of the study (e.g., oral contraceptive, implant, injectable, indwelling intrauterine device, sexual abstinence, condoms, or a vasectomized partner).-\n\n    Exclusion Criteria:\n\n    Physical\u002F Medical History Exclusion Criteria\n11. Has low back pain that in the Investigator's opinion is predominately myofascial in nature.\n12. Has constant, unchanging low back pain that is not improved in any spinal position.\n13. Has radiculopathy resulting from nerve compression.\n14. Has non-radicular unilateral or bilateral leg pain with intensity greater than 50% of the intensity of the low-back pain, as measured by VAS.\n15. Leg pain that is of radicular origin, i.e., due to stimulation of nerve roots or dorsal root ganglion of a spinal nerve by compressive forces.\n16. Has frequent leg pain that extends below the knee.\n17. Has severe unilateral or bilateral osteoarthritis of the knee or hip.\n18. Severe spinal arthritis\n19. Has cauda equina syndrome.\n20. Has had previous lumbar spine surgery.\n21. Has had previous disc invasive treatment procedures (i.e., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation) or intradiscal injections (i.e., injection of corticosteroids, methylene blue, dextrose, or glucosamine and chondroitin sulfate) or diagnostic discography at L3-S1 within the 3 months prior to Screening.\n22. Subjects who have had basivertebral nerve ablation at L3-S1.\n23. Has clinical suspicion of facet pain as the primary pain generator.\n24. Has current infection at the planned procedure site, active systemic infection, or current or prior history of lumbar spinal infection (i.e., discitis, septic arthritis, epidural abscess).\n25. Has a history of fibromyalgia.\n26. Has tested positive for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human Immunodeficiency Virus (HIV).\n27. Has presence of an active malignancy or tumor, or a prior history of malignancy within the last five years (except for basal cell carcinoma of the skin).\n28. Has presence or prior history of a spinal malignancy.\n29. Has significant systemic disease, such as unstable angina or autoimmune disease, such as rheumatoid arthritis. Has a history of congenital or acquired coagulopathy or thrombocytopenia.\n\n31\\. Is currently taking anticoagulant, antiplatelet, or thrombolytic medications (except for aspirin or nonsteroidal anti-inflammatory drugs \\[NSAIDS\\]) and at the Investigator's medical discernment and discretion is unable to withhold medications for the time required per site standard or care, prior to the IDCT injection or is taking antineoplastic medications.\n\n32\\. Is at higher risk for post-surgical infection (e.g., taking immunosuppressants), has a severe infection or a history of serious infection.\n\n33\\. Has concomitant conditions requiring daily oral steroid usage for more than 30 days in the preceding 90 days before Screening.\n\n34\\. Is taking opioids greater than 20 MME per day on an intermittent (as needed) basis OR is taking 20 MME or greater daily for more than 3 months prior to Screening\n\n35\\. Has a history of unexplained, easy, or persistent bruising or bleeding, bleeding from the gums, or bleeding problems experienced in previous surgical procedures.\n\n36\\. Has a history of hypersensitivity or anaphylactic reaction to bovine products, sodium hyaluronate\u002F hyaluronan\u002F hyaluronic acid, gentamicin, amphotericin b, dimethyl sulfoxide (DMSO), crustaceous\u002F shellfish, or porcine products.\n\n37\\. Has an uncontrolled psychiatric condition or substance\u002Falcohol abuse that would potentially interfere with the subject's participation in the study within 2 years prior to Screening in the opinion of the Investigator.\n\n38\\. Has positive serum pregnancy test or nursing at time of Screening or has plans to become pregnant within the planned length of the study (2 years).\n\n39\\. Has a body habitus that precludes adequate fluoroscopic visualization for the procedure or the procedure is physically impossible.\n\n40\\. Has or requires an implantable electronic defibrillator, pacemaker, or has other contraindication to MRI scanning or cannot tolerate MRI scanning. Subjects who are expected to require a defibrillator or pacemaker, as determined by the Investigator should be excluded.\n\n41\\. Has participated in another clinical study within the 6 months prior to Screening.\n\n42\\. Has been a recipient or plans to be a recipient during trial participation of stem cell product to treat the lumbar spine.\n\n43\\. Has participated in a prior IDCT clinical study.\n\n44\\. Has pending litigation against a health care professional, except where required by the insurer as a condition of coverage.\n\n45\\. A person who would not be available for the entire planned length of the trial.\n\n46\\. Has active or pending worker's compensation claims. 47. In the Investigators opinion, the subject is not suitable for participation in the clinical trial.\n\nImaging Exclusion Criteria:\n\n48\\. Three discs (L3-S1) that have a Modified Pfirrmann Grade 4-7.\n\n49\\. Has evidence of prior lumbar vertebral body fracture at L3-S1.\n\n50\\. Has scoliosis with curvature \\> 10 degrees.\n\n51\\. Has congenital spinal irregularities such as segmentation.\n\n52\\. Has an acute fracture of the spine at the time of enrollment in the study. Clinically compromised vertebral bodies within L3-S1 due to current or past trauma, e.g., sustained pathological fracture or multiple fractures of vertebrae.\n\n53\\. Has evidence of dynamic instability on lumbar flexion extension per screening radiographs as indicated by \\>4.5 mm of translational motion at L3-S1; \\>15° of angular motion at L3\u002F-L4; \\>20° of angular motion at L4-L\u002F5; or \\>25° angular motion at L5\u002F-S1.\n\n54\\. Has Grade 2 or higher spondylolisthesis at L3-S1, as assessed by Meyerding classification.\n\n55\\. Has lumbar spondylitis or other undifferentiated spondyloarthropathy.\n\n56\\. Has Modic Type III Changes at L3-S1.\n\n57\\. Has radiographic evidence or suspicion of a full thickness annular tear at L3-S1.\n\n58\\. Has evidence of abnormal disc morphology defined as an extrusion or sequestration according to Fardon classification at L3- S1.\n\n59\\. Has herniation \\> 3 mm in AP dimension that is associated with nerve root compression.","75 Years",{"count":54,"type":22},162,"INTERVENTIONAL",[57],"PHASE3","This is a Phase III, randomized, double-blinded, Sham-controlled, multi-center study in subjects with single-level, symptomatic lumbar (L3- S1) intervertebral disc degeneration. The study will have a 52-week primary period followed by 52 week Follow-up Period (total of 104 weeks).\n\nThe study protocol will be approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), and the study will be conducted in accordance with Good Clinical Practice (GCP). All subjects will provide written informed consent prior to Screening.\n\nApproximately 162 subjects will be enrolled in the study. Up to 45 days prior to treatment, subjects will be screened for study inclusion, which includes obtaining baseline MRI and X-ray imaging. Imaging results for subjects initially eligible for study participation will be sent to a central imaging vendor for review and confirmation of eligibility, including the number of levels with degeneration. Subjects meeting all inclusion\u002Fexclusion criteria will be assigned to the corresponding treatment arm group and subsequently randomized to IDCT or Sham.\n\nRandomization will occur approximately 7 to 14 days prior to the scheduled treatment administration date.\n\nOverall, 162 subjects will be enrolled and randomized to IDCT or Sham in a 2:1 ratio.\n\n* IDCT (n=108)\n* Sham (n=54)",[26],[61,62,63],"DDD","low back pain","degenerative disc disease","2026-06-19",{"date":32,"type":35},{"date":67,"type":35},"2025-12-23",{"date":69,"type":22},"2028-11-24",{"name":71,"class":42},"DiscGenics, Inc.",14,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100464548","ossdsign-spine-registry-study-propel-100464548","NCT05329129","OssDsign® Spine Registry Study (\"Propel\")","PROSPECTIVE OBSERVATIONAL SPINE FUSION REGISTRY FOR OssDsign® BONE GRAFT SUBSTITUTES IN REAL WORLD CLINICAL PRACTICE","* The patient has been diagnosed as a candidate for spinal fusion surgery for which the surgeon has decided an OssDsign® bone graft is appropriate.\n* The patient is ≥21 years old.\n* The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent\n* The patient is willing and able to participate in post- operative clinical and radiographic follow up evaluations for 2 years.\n\nExclusion Criteria:\n\n* Patients not meeting all of the inclusion criteria","21 Years",{"count":82,"type":22},450,"The purpose of this multi-center, prospective, observational registry is to gather information on the clinical outcomes and real-world use of commercially available bone graft substitutes manufactured by OssDsign® AB, in patients who require spine fusion.",[26,85],"Spinal Stenosis",[87,26,88],"Synthetic bone grafts","Bone fusion","2026-06-04",{"date":91,"type":35},"2026-06-08",{"date":93,"type":35},"2022-03-23",{"date":95,"type":22},"2030-04-01",{"name":97,"class":42},"OssDsign",15,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":105,"sex":18,"minAge":80,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":55,"phases":109,"briefSummary":111,"conditions":112,"keywords":119,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":134},"100437952","early-phase-1-brain-mechanisms-supporting-cannabis-induced-pain-relief-100437952","NCT04982965","Brain Mechanisms Supporting Cannabis-induced Pain Relief","Inclusion Criteria:\n\n* Between 21-65 years old\n* Currently 30 days cannabis free\n* Lower back pain for three months or more\n* Are not taking opioids\n* If female and of a child bearing potential age, are not pregnant or nursing mothers\n* Do not have mental or neurological conditions inhibiting sensory\u002Fmotor functions\n* Do not have a lifetime history of dependence on cannabis\n* Do not have a lifetime history of DSM-IV schizophrenia, bipolar disorder, panic disorder, or psychosis\n* Prior THC-containing cannabis experience within the past two years\n* Agrees not to use cannabis outside of the study during participation in the study\n* Agrees not to use opioids or barbiturates during participation in the study\n* Agrees not to drive a motor vehicle within 4 hours following last use of inhaled cannabis during participation in the study\n\nExclusion Criteria:\n\n* Active pulmonary disease\n* Allergy or past adverse effects or negative past experiences from cannabis\n* Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone\n* Any significant illness, including cardiovascular disease, diabetes, renal and liver disease.\n* Any current or history of an immunocompromising disease or condition (such as lupus, psoriasis, multiple sclerosis, etc.)\n* Any current or history of neurologic conditions, including Parkinson disease, dementia, cognitive impairment, history of seizure disorder, and history of traumatic brain injury\u002Fhead injury\n* Any current major psychiatric illness, such as bipolar disorder, major depression, psychosis, substance use disorder, or schizophrenia\n* Any current or history of suicidal ideation or attempt\n* Overt sensitivity to thermal stimulation\n* Resting blood pressure \\> 140\u002F90\n* Resting heart rate \\> 100 beats\u002Fminute\n* Prisoner\n* Institutionalized\n* Claustrophobia\n* MRI contraindications\n* Participation in any new (within 2 weeks prior or any time after enrollment) pain management procedures during the study period\n* Known history of vasovagal fainting, syncope, or severe adverse reactions associated with blood draws or needle procedures",true,"65 Years",{"count":108,"type":22},100,[110],"EARLY_PHASE1","Chronic low back pain is a common and disabling condition that affects millions of people in the United States. Many people with chronic low back pain do not get enough relief from current treatments. Cannabis may help reduce pain, but researchers do not fully understand how it affects the brain in people with chronic pain. The purpose of this study is to examine how inhaled cannabis changes brain activity and reduces pain in people with chronic low back pain. Results from this study may help researchers better understand how cannabis works for pain and support the development of improved pain treatments.",[113,114,115,26,116,117,118],"Sciatica","Lumbar Radiculopathy","Lower Back Pain","Chronic Low-back Pain (cLBP)","Chronic Low Back and Leg Pain","Back Pain",[120,121,122,123],"Cannabis","Vaporized cannabis","THC","chronic low back pain","2026-05-30",{"date":126,"type":35},"2026-06-03",{"date":128,"type":35},"2021-05-07",{"date":130,"type":22},"2027-03-15",{"name":132,"class":133},"University of California, San Diego","OTHER",1,{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":18,"minAge":142,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":55,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100478314","lumbar-operatively-inserted-perqdisc-artificial-implant-following-nulcectomy-lopain2-100478314","NCT05508360","\"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy\" (LOPAIN2)","LOPAIN2","Inclusion Criteria:\n\n* Patient is skeletally mature aged 22-70.\n* Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but the discogenic pain must be limited to a single level.\n* Patient has adequate disc height (6mm) at the level to be treated\n* Patient has exhausted a minimum of 6 months of conservative treatment for their back (e.g. physical therapy, medications, injections, life style changes, etc).\n* Patient has a preoperative Oswestry Disability questionnaire score ≥ 40 out of 100 points (40\u002F100)\n* Patient has a low back pain Visual Analog Scale (VAS) ≥ 40 mm (4 cm)\n* Patient has signed the approved Informed Consent Form.\n* All surgeries must be approved by the Medical Advisory Board (MAB)\n\nExclusion Criteria:\n\n* Patient has less than 6 mm of disc height.\n* Patient has had prior lumbar spine surgery (nucleoplasty at non-index level is considered acceptable).\n* Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces. Cervical fusion is allowed as long as there are no neurologic deficits in the lower extremities.\n* Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm.\n* Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.\n* Patient has significant facet disease. Significant is defined as pain improvement of 80% or more following image-guided medial branch blocks of the target level according to SIS guidelines (diagnostic, contrast controlled).\n* Patient has any known active malignancy.\n* Patient has previously undergone or currently on immunosuppressive therapy. Steroids used to treat inflammation are allowed.\n* Patient has active or local systemic infection.\n* Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease including AIDS, ARC and HIV.\n* Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management.\n* Patient has osteopenia of the spine (T-score of -1.0 or lower). A DEXA scan should be performed to rule out patients considered at risk for osteopenia.\n* Patient has morbid obesity defined as a body mass index (BMI) more than 40 or a weight of more than 45 kg (100 lbs.) over ideal body weight.\n* Patient has a known allergy to silicone or barium sulfate.\n* Patient has a significant disc herniation at the level to be treated. Significant is defined as a large, extruded herniation that creates a risk for expulsion.\n* Patient has a significant Schmorl's node in the level to be treated. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes).\n* Patient has motion of less than 3 degrees on pre-operative lateral flexion\u002Fextension radiographs.\n* Patient belongs to a vulnerable population or has a condition such that his\u002Fher ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g. developmentally, disabled, prisoner, chronic alcohol\u002F substance abuser)\n\nIntraoperative Exclusion Criteria:\n\n* Protrusion of the 20A Imaging Balloon up to or beyond the outer margin of the vertebra during the imaging steps.\n* Patient has a violated endplate as determined by imaging balloons during fluoroscopy.\n* Patient has a disc space that is too narrow for implantation. MIPL Specific\n* Poor radiological visualization of Kambin's triangle.\n* Sustained irritation of the exiting nerve root during any aspect of the annular dilation technique (leg movement or if performing with electrical monitoring) in spite or repositioning instruments.","22 Years",{"count":144,"type":22},72,[146],"NA","This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.",[26,149],"Chronic Low-back Pain",[26,61,151,152,153,154,155],"Chronic Low Back Pain","cLBP","Disc Herniation","Nucleus Replacement","Low Back Pain","2026-05-25",{"date":158,"type":35},"2026-05-27",{"date":160,"type":35},"2022-08-22",{"date":162,"type":22},"2030-08-22",{"name":164,"class":42},"Spinal Stabilization Technologies",10,{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":18,"minAge":142,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":55,"phases":177,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":193},"100551641","phase-1-ldgraft-in-single-level-anterior-lumbar-interbody-fusion-alif-100551641","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.","80 Years",{"count":176,"type":22},40,[178,179],"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).",[26,182,183,184],"Lumbar Disc Disease","Spine Disease","Lumbar Spine Degeneration","2026-05-22",{"date":158,"type":35},{"date":188,"type":35},"2024-11-12",{"date":190,"type":22},"2027-12",{"name":192,"class":42},"Locate Bio Pty Ltd",3,{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":18,"minAge":142,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":55,"phases":204,"briefSummary":205,"conditions":206,"keywords":207,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":4},"100527223","phase-1-study-to-determine-the-safety-and-tolerability-of-tg-c-in-subjects-with-back-pain-due-to-degenerative-disc-disease-100527223","NCT06144970","Study to Determine the Safety and Tolerability of TG-C in Subjects With Back Pain Due to Degenerative Disc Disease","A Phase I, Double-blind, Randomized, Sham-controlled, Dose-response, Study Evaluating the Safety and Tolerability of TG-C in Subjects With Chronic Discogenic Lumbar Back Pain Due to Degenerative Disc Disease at 6 and 12 Months","Inclusion Criteria:\n\n* Between the ages of \\>= 22 and \\\u003C= 70\n* Provides written informed consent before undergoing any study specific procedures\n* Chronic lower back pain for at least 6 months. Back pain twice as great as leg pain measured using NRS\n* VAS between \\>= 40 and \\\u003C= 90\n* ODI Index \\>30 and \\\u003C= 80\n* Inadequate response to at least one medication (e.g., NSAID, acetaminophen, muscle relaxant) and some form of formal physical therapy over a period of at least 6 months, within 6-9 months of screening.\n* Diagnosis of DDD from L1 to S1, confirmed by patient history and radiographic studies\n* Modified Pfirrmann score of 3-7 on MRI\n* With or without contained disc herniations of \\\u003C3 mm protrusion\n* If more than 1 degenerative disc is identified. PD must be performed 30 days prior and ensure only one level is the pain generator\n* BMI \\>15 and \\\u003C 30 kg\u002Fm2\n* Use birth control\n\nExclusion Criteria:\n\n* Co-morbid medical condition of the spine or upper extremities\n* Grade 2 or higher spondylolisthesis and type III Modic changes around target disc\n* Suspicion of full thickness annular tear at disc\n* History of endocrine or metabolic disorder\n* Rheumatoid or psoriatic arthritis\n* Compressive pathology due to stenosis or herniated or sequestered discs\n* Symptomatic involvement of more than one lumber disc\n* Intact disc bulge\u002Fprotrusion at \\>3 mm\n* Lumbar intervertebral foraminal stenosis\n* Previous surgery at the target disc level\n* Epidural or facet joint steroid, platelet rich plasma (PRP) or bone marrow concentrate (BMC) injections, or radio frequency ablation (RFA), within 6 months prior to baseline.\n* Pregnant\n* Presence of ferromagnetic implants\n* Involved in current or pending spinal litigations\n* Care is provided under a Worker's Compensation claim\n* Physical or mental conditions\n* 3 or more of the 5 Waddell signs\n* Positive screen for HIV\n* Immediate family member of other participating patients\n* Participated within 3 months or is concurrently enrolled in non-interventional research\n* Transient or has a history of any substance use disorder\n* Currently incarcerated\n* Investigator site personnel or immediate family or sponsor employee\n* On chronic anti-coagulation therapy or have confirmed coagulopathy\n* Tested positive on RCR testing at screening","70 Years",{"count":203,"type":22},24,[178],"The goal of this study is to evaluate the safety and tolerability of TG-C in subjects with chronic discogenic lumbar back pain due to degenerative disc disease. Participants will be administered a single intradiscal injection or subcutaneous injection for sham and followed up with in-clinic visits and telephone calls for 24 months.",[26],[26],"NOT_YET_RECRUITING","2026-05-21",{"date":158,"type":35},{"date":212,"type":22},"2027-01-19",{"date":214,"type":22},"2029-07-28",{"name":216,"class":42},"Kolon TissueGene, Inc.",{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":55,"phases":226,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":134},"100532198","carbofix-pedicle-screw-system-evaluation-of-the-clinical-and-radiographic-outcomes-of-the-use-of-a-carbon-fiber-device-compared-to-titanium-devices-in-patients-undergoing-spinal-arthrodesis-for-degenerative-spinal-diseases-100532198","NCT06209684","Carbofix Pedicle Screw System: Evaluation of the Clinical and Radiographic Outcomes of the Use of a Carbon Fiber Device Compared to Titanium Devices in Patients Undergoing Spinal Arthrodesis for Degenerative Spinal Diseases","Carbofix Pedicle Screw System: Randomized Clinical Trial to Evaluate the Clinical and Radiographic Outcomes of the Use of a Carbon Fiber Device Compared to Titanium Devices in Patients Undergoing Spinal Arthrodesis for Degenerative Spinal Diseases","Inclusion Criteria:\n\n* Patients suffering from degenerative spinal pathology or spondylolisthesis who require instrumented stabilization on 1-2 levels;\n* Age greater than or equal to 18 years;\n* Ability to understand and sign the informed consent to the study and to follow the required follow-ups.\n\nExclusion Criteria:\n\n* Metabolic bone disease.\n* History of Paget's disease or other osteodystrophies, whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism, Ehlers-Danlos syndrome, osteogenesis imperfecta, achondroplasia.\n* Neoplastic disease.\n* History of mental disorder or current psychiatric treatment.\n* Pregnancy.\n* Immunodeficiency diseases.\n* Infectious bone disease (discitis, osteomyelitis)\n* Treatment with drugs that can interfere with bone metabolism\n* Inability to understand and sign the informed consent to the study and to follow the required follow-up visits.\n* Alcohol and\u002For drug abuse\n* Obesity\n* Metal allergy\n* Participation in other studies on drugs or devices (within 30 days)",{"count":225,"type":22},118,[146],"Previous clinical study carried out on cancer patients at IOR Spine Surgery (approved in October 2014). The carbon device is indicated in patients suffering from vertebral tumors who need stabilization and will then carry out radiotherapy, because carbon has a practically zero level of interference with ionizing radiation. Carbon also allows for better visualization of the implants on MRI\u002FCT and X-ray. There are no studies in the literature analyzing the use of carbon fiber devices in lumbar degenerative pathologies.\n\n118 patients suffering from degenerative spinal pathology requiring 1 or 2 levels of lumbar or lumbosacral fusion will be valutated.",[26],[230],"degenerative spine disease","2026-05-20",{"date":185,"type":35},{"date":234,"type":35},"2022-04-29",{"date":236,"type":22},"2027-04-29",{"name":238,"class":133},"Istituto Ortopedico Rizzoli",{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":174,"enrollmentInfo":246,"targetDuration":4,"studyType":55,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":260},"100594299","phase-3-efficacy-and-safety-of-novosis-putty-in-transforaminal-lumbar-interbody-fusion-for-patients-with-lumbar-degenerative-disc-disease-100594299","NCT07017634","Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease","Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study","Inclusion Criteria:\n\n* Has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more than a Grade 2 (≤50% translation) spondylolisthesis. Symptomatic lumbar degeneration (L1 to S1) that may be associated with a co-morbid condition.\n* Has a history of failure conservative treatment (e.g. bed rest, physical therapy, medications, transcutaneous electrical nerve stimulation (TENS), manipulation, and\u002For spinal injections) for at least 6 months\n* Has preoperative Oswestry Disability Index score ≥ 40\u002F100 at baseline\n* Male or Female, 21-80 years of age and skeletally mature at the time of surgery\n* Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms\n* Signed informed consent\n\nExclusion Criteria:\n\n* Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level;\n* Degenerative or lytic spondylolisthesis greater than Grade 2 (50% translation);\n* Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he\u002Fshe has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;\n* 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;\n* Has chronic or acute renal and\u002For hepatic impairment and\u002For failure or prior history of renal and\u002For hepatic parenchymal disease;\n* Lactating, pregnant or interested in becoming pregnant in the next 3 years;\n* Is currently participating in an investigational therapy (device and\u002For pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study.\n* 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.",{"count":247,"type":22},316,[57],"Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients with Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study",[26],"2026-05-06",{"date":253,"type":35},"2026-05-08",{"date":255,"type":22},"2026-05",{"date":257,"type":22},"2031-11",{"name":259,"class":42},"CGBio Inc.",5,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":55,"phases":270,"briefSummary":271,"conditions":272,"keywords":273,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":4},"100639588","long-term-assessment-of-bdyn-dynamic-stabilization-device-in-patients-with-lumbar-degenerative-disc-disease-100639588","NCT07580664","Long-term Assessment of BDyn Dynamic Stabilization Device in Patients With Lumbar Degenerative Disc Disease","MOBIDYN","Inclusion Criteria:\n\n* Patient, male or female, aged ≥ 18 years old\n* Patient treated with BDyn device until end of December 2021, with between one and four fused level(s) maximum for the following indications: Degenerative intervertebral disc disease and\u002For articular facets confirmed by further examinations, Spinal canal stenosis, Degenerative spondylolisthesis grade 1, Segmental instability\n* Patient who signed the informed consent form\n* Patient affiliated with a social security scheme\n\nExclusion Criteria:\n\n* Patients who are unable to provide informed consent due to cognitive impairment, language barrier, or any other condition that limits their ability to understand the nature, objectives, or potential risks of the study\n* Patient that is pregnant or breastfeeding;\n* Patient with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code;\n* Patient who cannot comply with the protocol requirements based on the investigator's judgment",{"count":269,"type":22},150,[146],"The goal of this clinical trial is to estimate the cumulative reoperation rate at upper adjacent segment level in patients treated with BDyn dynamix stabilization for lumbar degenerative disc diseases over long-term follow-up.\n\nPatients will provide baseline socio-demographic and surgical data, complete patient-reported outcome measures (ODI, pain NRS, satisfaction), undergo imaging assessments (dynamic X-rays, EOS, MRI), and participate in safety evaluations including adverse event monitoring throughout follow-up.",[26],[274,275,276],"BDyn","Dynamic stabilization","Lumbar stabilization","2026-05-05",{"date":279,"type":35},"2026-05-12",{"date":281,"type":22},"2026-04",{"date":283,"type":22},"2027-04",{"name":285,"class":42},"Cousin Biotech",{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":172,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":18,"minAge":142,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":55,"phases":296,"briefSummary":297,"conditions":298,"keywords":301,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":311},"100575912","clinical-trial-evaluating-the-safety-and-efficacy-of-nucleus-pulposus-allograft-in-participants-with-degenerative-disc-disease-100575912","NCT06778447","Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease","Randomized, Sham-Controlled, Multi-Center, Double-Blind Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft to Supplement Nucleus Pulposus Tissue in Participants With Lumbar Discogenic Pain Associated With Degenerative Disc Disease","Inclusion Criteria:\n\n* Age 22 to 85 years old\n* Diagnosis of moderate to severe DDD on MRI, Modified Pfirrmann Grade 3-7\n* Chronic axial midline low-back pain in the absence of lower extremity motor\u002Fsensory\u002Freflex changes with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care\n* Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS\n* ODI score of ≥ 40 to ≤ 80\n* Positive sustained hip flexion test\n* Demonstrated intolerance to sitting\n* Able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study\n* Willing and able to comply with all study procedures and availability for the duration of the study with a life expectancy of \\> 2 years\n\nExclusion Criteria:\n\n* Contraindications to the proposed sedation\u002Fanesthetic protocol\n* Involvement of more than two lumbar discs as evidenced by 3 or more discs with Modified Pfirrmann grade of 3 or greater\n* Disc height of less than 4mm for any disc between L1-S1\n* Symptomatic vertebral compression fracture\n* Previous surgical treatment of the lumbar spine\n* History of sacroiliac (SI) joint fusion within the past six months\n* Received lumbar epidural or intradiscal steroid injection, lumbar facet joint steroid injection, lumbar radiofrequency ablation, provocative or anesthetic discography, SI joint pain injection, injection of methylene blue, dextrose, glucosamine, and chondroitin sulfate, or biacuplasty within 3 months of the Day 0 procedure\n* Received intraosseous radiofrequency nerve ablation procedure at the same or adjacent level (e.g., Basivertebral nerve ablation or sinuvertebral nerve ablations)\n* Received prior intradiscal stem cell\u002Fprogenitor cell therapy or other biological intervention (e.g., MSC, PRP) at the target level within 12 months of the Day 0 procedure\n* Evidence of dynamic instability on lumbar flexion-extension radiographs (\\>3 mm)\n* Grade 2 or higher spondylolisthesis at the target level, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes adjacent to the target disc\n* Radiographic evidence of a full thickness annular tear at the target disc or other abnormal disc morphology\n* Clinical suspicion of facet pain as primary pain generator\n* A systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, recent history of myocardial infarction, uncontrolled diabetes (\\>7.0% HbA1C), etc.)\n* Received VIA Disc NP previously.\n* Deemed unsuitable for clinical study participation by the Investigator\n* Evidence of substance abuse (including marijuana); note: subjects using prescribed extended-release narcotics (e.g., fentanyl patch, MS Contin, oxycontin) within the 3 months prior to screening and subjects on long-acting opioids may be given option to wean off opiates before enrollment; subjects on short-acting opiates (e.g., hydrocodone, oxycodone, tramadol, etc.) may be included and utilization monitored after the treatment\n* Opioid use of more than 90 MME\u002Fday\n* Currently receiving treatment with radiation, chemotherapy, immunosuppression, or chronic steroid therapy (prednisone, or its equivalent, use of up to 5 mg\u002Fqd, or inhalation steroids for asthma is allowed)\n* Metal or ceramic implants in the lumbar spine region\n* Contraindications to MRI, including non-MRI compatible devices and active implantable devices such as spinal cord stimulators, intrathecal pumps, etc.\n* Involved in ongoing or closed (within 6 months of screening visit) litigation related to their back pain condition\n* Any mental instability, unstable bipolar disorders, unmanaged post-traumatic stress disorder (PTSD) or uncontrolled anxiety\u002Fdepression and\u002For require new or changed anti-depressants or anti-psychotic medications within 3 months of enrollment\n* Diagnosis of any traumatic neurological disorders that may impact the study as per the judgement of the Investigator\n* Women who are pregnant or breastfeeding at the time of enrollment and\u002For plan to become pregnant during the study; pregnancy is confirmed by:\n* a positive pregnancy test during the screening visit\n* self-reported pregnancy\n* Women of childbearing potential (WOCBP) who are not using a reliable form of contraception (as determined by the Investigator)\n* Received any experimental drug or device to treat the same condition used within 6 months prior to the screening visit or during the course of the clinical trial\n* Other persistent pain\u002Fnerve issues including, for example, radiculopathy, leg pain, cauda equine syndrome, etc.","85 Years",{"count":295,"type":22},496,[146],"VIA Disc NP is a non-surgical intervention intended to supplement nucleus pulposus tissue in degenerated intervertebral discs.\n\nThis is a randomized, sham-controlled, multi-center, double-blind clinical trial with an open label roll-in period of one participant per site in which participants with lumbar discogenic pain associated with DDD will receive one VIA Disc NP treatment to each affected level (up to 2 levels). Participants enrolled after the roll-in stage will be randomized on a 2:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or the sham procedure at 1 or 2 levels. At 12 months, participants in the sham arm with continued symptoms may cross-over, receive VIA Disc NP, and will restart the study visit schedule, completing an additional 12 months of follow-up post-cross-over.",[26,299,300],"Disc Degeneration","Lumbar Discogenic Pain",[26,300],"2026-04-23",{"date":304,"type":35},"2026-04-24",{"date":306,"type":35},"2025-02-17",{"date":308,"type":22},"2028-05",{"name":310,"class":42},"VIVEX Biologics, Inc.",19,{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":55,"phases":322,"briefSummary":323,"conditions":324,"keywords":333,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":134},"100622663","biologic-injection-for-adults-with-lumbar-disc-herniation-100622663","NCT07386548","Biologic Injection For Adults With Lumbar Disc Herniation","Bone Marrow Aspirate Concentrate Injection With MRI's - A Prospective Randomized Control Trial","BMAC","Inclusion Criteria:\n\n* Male or female patients ≥ 18 years of age\n* Clinically and\u002For radiographically (MRI) confirmed diagnosis of degenerative disc disease of the lumbar spine, lumbar disc herniation, and indication for lumbar microdiscectomy surgery\n* Unresponsive to conservative\u002Fnon-operative treatment for \\>3 months\n* Psychosocial, mental and physical ability to understand and to adhere to this protocol, especially adhering to the visit schedule follow-ups and observe the treatment plan\n\nExclusion Criteria:\n\n* Prisoners\n* Individuals who are not yet adults (infants, children, teenagers)\n* Individuals who are not able to clearly understand English\n* Adults with diminished capacity to consent\n* Major cognitive impairment causing to inability to understand and provide informed consent\n* Active malignancy\n* Active chronic or acute infection\n* Autoimmune disorder that impacts the lumbar spine (ankylosing spondylitis, lupus e.g.)\n* Bone marrow-derived or non-bone marrow-derived cancer\n* Low platelet count or clotting disorders\n* Prior surgery at the level to be treated or the adjacent level",{"count":321,"type":22},90,[146],"The goal of this clinical trial is to find out whether adding a bone-marrow aspirate concentrate (BMAC) injection during surgery can improve recovery in adults undergoing lumbar microdiscectomy for a lumbar disc herniation.\n\nThe main questions it aims to answer are:\n\n* Does the BMAC injection lead to better disc tissue health after surgery (as seen on MRI scans)?\n* Does the BMAC injection lead to greater improvement in pain and disability compared to surgery alone?\n\nParticipants will be adults aged 18 and older who are scheduled for lumbar microdiscectomy surgery.\n\nResearchers will compare one group of participants receiving the standard-of-care surgery plus the BMAC injection with another group receiving the same surgery without the injection to see if the injection offers added benefit.\n\nParticipants will:\n\n* Have surgery (microdiscectomy) with or without the injection.\n* Complete pain and disability questionnaires at several times over 2 years.\n* Undergo MRI scans at baseline and follow-up to assess disc structure and tissue health.\n* Provide samples of leftover disc or bone-marrow tissue (as applicable) from surgery for analysis.",[26,61,325,326,327,328,329,330,155,331,332],"Degenerative Disc Disease Lumbar","Degenerative Disc Disease, Lumbar","Lumbar Disc Herniation","Disc Herniation, Lumbar","Bone Marrow Aspirate Concentrate","Intervertebral Disc Displacement","Chronic Low Back Pain (CLBP)","CLBP - Chronic Low Back Pain",[63,334,335,336,62],"lumbar disc herniation","bone marrow aspirate concentrate","intervertebral disc displacement","2026-04-14",{"date":339,"type":35},"2026-04-16",{"date":341,"type":22},"2026-05-01",{"date":343,"type":22},"2030-12",{"name":345,"class":133},"Weill Medical College of Cornell University",{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":356,"conditions":357,"keywords":362,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":373},"100462071","post-market-clinical-follow-up-study-on-the-safety-and-performance-of-ennovate-cervical-100462071","NCT05296889","Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical","Multicenter Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical - a Prospective Study on Total Indications","CERISE","Inclusion Criteria:\n\n* Patient is minimum 18 years old\n* Informed Consent in the documentation of clinical and radiological results\n* Patient has indication according to Instructions for Use (IFU)\n* Patient is not pregnant\n\nExclusion Criteria:\n\n* Patient's clear unability or unwillingness to participate in follow-up examinations",{"count":355,"type":22},200,"Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications",[358,26,359,360,361],"Spine Fracture","Spinal Instability","Spinal Tumor","Degenerative Myelopathy",[363],"Cervical Spine","2026-03-26",{"date":366,"type":35},"2026-03-31",{"date":368,"type":35},"2021-07-21",{"date":370,"type":22},"2026-07",{"name":372,"class":42},"Aesculap AG",4,{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":55,"phases":384,"briefSummary":385,"conditions":386,"keywords":388,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":398},"100414686","post-marketing-study-of-magnetos-easypack-putty-standalone-compared-to-demineralized-bone-matrix-or-fibers-mixed-with-autograft-in-patients-undergoing-posterolateral-lumbar-fusion-100414686","NCT04679844","Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion","A Prospective, Randomized, Multi-Center Study to Assess the Safety and Performance of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers (DBX or Grafton) Mixed With Local Autograft in Patients Undergoing One to Two-Level Instrumented Posterolateral Lumbar\u002FThoracolumbar Fusion (PLF)","PROOF","Inclusion Criteria:\n\n* Patient is able to read\u002Fbe read, understand, and provide written informed consent and has signed the Institutional Review Board (IRB) approved informed consent.\n* Male or female patient ≥ 18 years old.\n* Patients with segmental mechanical spinal instability requiring arthrodesis surgery.\n\nInstability can be either caused by degenerative disc disease or by traumatic injury to the spinal column. Patient requiring a maximum of two-level instrumented posterolateral lumbar\u002Fthoraco-lumbar fusion (T11 - S1) will be enrolled. Mechanical instability is defined by the presence of one or more of the following:\n\n1. instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion\u002Fextension radiographs),\n2. decreased disc height by \\> 2 mm, but dependent upon the spinal level\n3. Grade II or more listhesis\n4. TLICS equal or greater than 5\n5. Unstable burst fracture\n\n   * Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment (if the patient undergoes elective surgery). Patients who have spinal instability (as defined above in inclusion criteria number three), caused by acute trauma requiring urgent surgical treatment are excluded from this criterion.\n\nExclusion Criteria:\n\n* Requires \\> two-level fusion or expected to need secondary intervention within one year following surgery.\n* Had prior PLF fusion or attempted PLF fusion at the involved levels.\n* Had previous decompression at the involved levels.\n* Women who are or intend to become pregnant within the next 12 months.\n* To treat conditions in which general bone grafting is not advisable.\n* In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g. defect site stabilization is not possible).\n* In case of significant vascular impairment proximal to the graft site.\n* In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta, history of or active Pott's disease, stage \\>4 renal disease or Paget's Disease) that affect bone or wound healing.\n* In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).\n* When intraoperative soft tissue coverage is not planned or possible.\n* Receiving treatment with medication interfering with calcium metabolism.\n* Has degenerative disc disease (DDD) related to a benign or malignant tumor.\n* Has history or presence of active malignancy.\n* Has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements.\n* Is involved in active litigation relating to his\u002Fher spinal condition.\n* Has participated in an investigational study within 30 days prior to surgery for study devices.",{"count":383,"type":22},60,[146],"This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery.\n\nIn this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in the posterolateral spine.",[26,387,118],"Spine Fusion",[26,387],"2026-03-18",{"date":391,"type":35},"2026-03-20",{"date":393,"type":35},"2024-12-06",{"date":395,"type":22},"2027-08-30",{"name":397,"class":42},"Kuros Biosurgery AG",6,{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":55,"phases":408,"briefSummary":409,"conditions":410,"keywords":412,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":43},"100442175","magnetos-flex-matrix-compared-to-trinity-elite-mixed-with-local-autograft-in-patients-undergoing-up-to-four-level-instrumented-posterolateral-fusion-100442175","NCT05037968","MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion","A Prospective, Randomized, Multi-center Study to Assess the Performance of MagnEtOs Flex Matrix Mixed With Local Autograft Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar\u002FThoraco-lumbar Fusion (PLF)","PRECISE","Inclusion Criteria:\n\n* Patient is able to read\u002Fbe read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved informed consent.\n* Male or female patient ≥ 18 years old.\n* Patients with leg pain, and\u002For back pain requiring up to four-level instrumented posterolateral lumbar\u002Fthoraco-lumbar fusion (T11 - S1)\n* Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment.\n\nExclusion Criteria:\n\n* Requires \\> four-level fusion or expected to need secondary intervention within one year following surgery.\n* Had prior PLF fusion or attempted PLF fusion at the involved levels\n* Had previous decompression at the involved levels.\n* Women who are or intend to become pregnant within the next 12 months\n* To treat conditions in which general bone grafting is not advisable.\n* In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g., defect site stabilization is not possible).\n* In case of significant vascular impairment proximal to the graft site.\n* In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing.\n* In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).\n* When intraoperative soft tissue coverage is not planned or possible.\n* Receiving treatment with medication interfering with calcium metabolism.\n* Had leg pain, and\u002For back pain related to a benign or malignant tumor.\n* Had history or presence of active malignancy.\n* Has known substance abuse, psychiatric disorder, or condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements.\n* Is involved in active litigation relating to his\u002Fher spinal condition.\n* Has participated in an investigational study within 30 days prior to surgery for study devices.",{"count":108,"type":22},[146],"This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery.\n\nIn this study, MagnetOs Flex Matrix will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine.\n\nTrinity Elite will also be used according to its latest IFU approved in the US. Specifically, this cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.",[26,387,411],"Leg Pain and\u002For Back Pain",[26,387],"2026-02-23",{"date":415,"type":35},"2026-02-25",{"date":417,"type":35},"2024-06-10",{"date":419,"type":22},"2026-12",{"name":397,"class":42},{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":55,"phases":430,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":134},"100549778","phase-1-novel-soluble-epoxide-hydrolase-inhibitor-for-neuropathic-pain-in-patients-with-spinal-cord-injury-100549778","NCT06438471","Novel Soluble Epoxide Hydrolase Inhibitor for Neuropathic Pain in Patients With Spinal Cord Injury","Development of a Novel Soluble Epoxide Hydrolase Inhibitor as a Strategy for Treating Neuropathic Pain in Patients With SCI","Inclusion Criteria:\n\nEach subject must meet all of the following criteria to be enrolled in this study:\n\n1. Male and female subjects must be 18 and older.\n2. Subjects must be willing to provide written informed consent to participate in the study.\n3. Subjects must be able to provide own transportation to study site every day for the duration of the study.\n4. Subjects with either a traumatic or a non-traumatic SCI may be eligible to enroll in this study. For subjects with complete or incomplete traumatic spinal cord injuries (tSCI), or complete non-traumatic spinal cord injury: Subjects must have a complete or incomplete T6 or below tSCI, or complete non-traumatic SCI of at least 12 months duration, with below-level neuropathic pain identified by the International Spinal Cord Injury Pain (ISCIP) classification criteria. Importantly, subjects must not be ventilator-dependent as detailed in Exclusion Criteria 1. For subjects with degenerative partial spinal cord injuries (pSCI): Subjects must have an incomplete, non-traumatic, SCI at any level secondary to degenerative spinal disorders such as disc degeneration, spinal stenosis, or spondylosis, with associated chronic neuropathic pain. The injury and the associated pain must be of at least 12 months duration. Neuropathic pain should meet the ISCIP classification criteria. Importantly, subjects must not be ventilator-dependent as detailed in Exclusion Criteria 1.\n5. Subjects must have completed a minimum of 6 of the 7 daily assessments for average and worst daily pain prior to final screening, using an 11-point numerical rating scale (NRS) for average daily pain intensity, and the arithmetic average daily SCI neuropathic pain score must be ≥4 and ≤9, with a standard deviation less than or equal to 1.2. Daily pain assessment screenings will be done over the phone with the study coordinator after informed consent is obtained.\n6. Subjects must have failed at least 2 classes of medications for their neuropathic pain due to SCI (classes may include antidepressants, antiepileptics, opioids, anti-inflammatories, topical treatments, etc.).\n7. Subjects must be in overall stable condition, as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12 lead ECG measurements\n8. Subjects must have normal or not clinically significant clinical laboratory test results, as determined by the study investigator, including coagulation panel, blood cell counts, comprehensive metabolic panel analytes, and creatinine clearance (60 cm3\u002Fmin or greater). Clinical laboratory tests results that are consistent with known, stable comorbidities will be allowed as long as the comorbidities do not represent an exclusion criteria per se.\n9. Subjects must have a negative screening for HIV, Hepatitis C, and Hepatitis B within 30 days of randomization.\n10. Subjects must have a normal hypothalamic-pituitary-adrenal and hypothalamic-pituitary-gonadal axes screening study.\n11. Subjects must have a negative urinary drug screen (UDS) for illicit drugs (marihuana\u002FTHC are allowed) and serum ethanol level \\\u003C80 mg\u002FdL.\n12. Male subjects who are not surgically sterile (vasectomized) and their female sexual partners must agree to use contraception during the study period and for 2 months afterward.\n13. Male subjects must not donate sperm during the study and for 12 months after receiving the last dose of study drug.\n14. Female subjects must be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, or surgically sterile (bilateral tubal ligation ('clipping or tying tubes' or hysterectomy) for at least 3 months, or they must agree to use two forms of highly effective contraception method (less than 1 pregnancy per 100 people using the method for one year), from 28 days and\u002For their last confirmed menstrual period prior to study enrollment (whichever is longer) until 2 months after clinic discharge. Postmenopausal status will be defined as follow: minimum 1 year; amenorrhea duration of 12 consecutive months and a serum FSH value \\>40 IU\u002FL; postmenopausal status must be confirmed by an FSH test at Screening). Highly effective contraception methods include: Intra-uterine device (IUD) containing either copper or levonorgestrel (e.g., Mirena®), and\u002For barrier methods of contraception, including condoms (external or internal) and diaphragm ('cap'). Hormonal methods of contraception (with the exception of hormonal IUD) are not permitted within this study. Female participants will refrain from using hormonal contraceptives for at least 28 days prior to study entry until the end of the study period. Participants\u002FParticipant's partner(s) must also use a barrier form of contraception, from the first dose of study drug through until 2 months after the last dose. For all females of childbearing potential, the pregnancy test result must be negative at Screening and Pre-Study Baseline (Day -1).\n15. Subjects must be able to speak, read, and understand English sufficiently to allow comprehension and completion of all study assessments.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will be excluded from the study:\n\n1. Ventilator-dependent subjects, with the exception of nocturnal use of CPAP or BiPAP.\n2. Subjects with pain that is not present every day (chronic) or where the pain description does not have a classic neuropathic phenotype.\n3. Subjects with other chronic neuropathic pain conditions, including painful diabetic neuropathy, HIV-associated neuropathic pain, chemotherapy or ethanol-associated neuropathy.\n4. Subjects with other pain syndromes that may confound assessment or self-evaluation of the SCI neuropathic pain.\n5. Subjects with only negative symptoms, defined as numbness without clear evidence of spontaneous pain, either constant or episodic.\n6. Non-opioid pain medications will be allowed if at a fixed stable dose for more than 1 month prior to Screening with no anticipation of the dose changing during the study, and if they do not interfere with the subject's ability to rate pain as per Investigator's discretion. Allowed non-opioid medications include gabapentin, pregabalin, duloxetine, acetaminophen, ibuprofen, celecoxib, meloxicam, other antidepressants including amitriptyline and other antiepileptics, as well as topical capsaicin and topical lidocaine.\n7. Subjects using opioid medications will be required to be on a dose of 60 morphine milligrams equivalents (MME) per day or less, and with a stable dose for at least four (4) weeks prior to consent, with no anticipation of dose changing during the study.\n8. Subjects with active Hepatitis A, Hepatitis B and\u002For Hepatitis C.\n9. Subjects with any clinically unstable or significant cardiovascular (including acute coronary syndrome within the prior year to Screening), renal, hepatic, respiratory, gastrointestinal, hematological, endocrine, or infectious disease (including HIV infection).\n10. Subjects with clinically significant abnormalities on screening vital signs, laboratory tests, and\u002For ECG. Subjects with poor venous access will also be excluded.\n11. Subjects with a history of disorders of the hypothalamic-pituitary-adrenal axis, including adrenal insufficiency and Cushing's, or with a history of disorders of the hypothalamic-pituitary-gonadal axis, including hypogonadism.\n12. Subjects who have used any topical, oral, or intravenous exogenous corticosteroids within 12 weeks and\u002For intra-articular exogenous corticosteroids within 6 months prior to the start of the trial, or who plan on using them during the study.\n13. Subjects who have used fludrocortisone or exogenous testosterone products within 12 weeks prior to the start of the trial or who plan on using them during the study.\n14. Subjects who have used (within 14 of randomization) or plan on using during the duration of the study any renin-angiotensin system (RAS)-acting drugs (including angiotensin-receptor blockers, or ARBs; angiotensin-converting enzyme inhibitors, or ACE-inhibitors; and direct renin inhibitors) or mineralocorticoid receptor antagonists (such as spironolactone and eplerenone)\n15. Subjects who have used chemotherapy agents, or who have a personal history of cancer or cancer in first degree relatives suggestive of elevated cancer risk, other than nonmetastatic skin cancer that has been completely excised, within 5 years prior to Screening.\n16. Subjects with a history of bacterial, fungal, or viral infection requiring treatment with antibiotics, antifungal agents, or antivirals within 1 month prior to randomization.\n17. Subjects who have used (within 14 days of randomization) or plan on using during the duration of the study any prescription or over-the-counter drugs that are moderate-strong CYP3A4 inducers or inhibitors.\n18. Subjects who have used (within 14 days of randomization) or plan on using during the duration of the study any dietary aids, supplements, or foods that are moderate-strong CYP3A4 inhibitors (e.g., grapefruit juice).\n19. Subjects with difficulty in swallowing oral medications.\n20. Subjects with serious psychosocial comorbidities as determined by the Investigator.\n21. Subjects with current cognitive or major psychiatric disorders, or any other condition that could interfere with compliance with study procedures.\n22. Subjects with a positive drug or alcohol test (\\>80 mg\u002FdL) during Screening and\u002For admission (a positive THC test will be allowed as long as it consists of minimal social use, per discretion of Investigator), or with a recent history of binge drinking within 1 week of randomization.\n23. Subjects who have used any other investigational drug within 1 month prior to enrollment. If the investigational drug is known to have a long half-life, a longer washout period will be done.\n24. Subjects with a presence or history of active gastrointestinal disorder, including esophageal or gastroduodenal ulceration, or renal, hepatic, or coagulant disorder within 1 month prior to enrollment.\n25. Subjects with a family history of significant cardiac disease (i.e., sudden death in first degree relative; myocardial infarction before the age of 50).\n26. Subjects with confirmed COVID-19, or suspected COVID-19 (e.g., developed symptoms of a respiratory infection such as cough, sore throat, shortness of breath, or fever, but did not get tested for COVID 19) within 30 days of randomization.\n27. Subjects who have received a COVID-19 vaccine within 30 days of randomization or are planning on receiving it during the study duration.\n28. Exclude subjects with spinal cord injury at T6 or higher with a history of neurogenic bladder.\n29. Exclude subjects with documented autonomic dysreflexia (AD) or a history of episodes consistent with undiagnosed AD as determined by an experienced clinician.",{"count":429,"type":22},36,[178],"The goal of this clinical trial is to evaluate safety and tolerability of multiple oral doses of EC5026 in male and female patients with neuropathic pain due to traumatic or non-traumatic (degenerative) spinal cord injury. The main question it aims to answer is whether EC5026 is safe and well tolerated in SCI patients with neuropathic pain. In addition, this trial will also study the effects of EC5026 on pain.\n\nResearchers will compare EC5026 to placebo.\n\nParticipants will be asked to:\n\n* Take EC5026 or placebo in a masked fashion, once daily, for 14 consecutive days.\n* Undergo physical exams, vital signs assessments, ECGs, and blood draws\n* Complete assessments of pain, sleep, functional status, and perception of change",[433,434,26,85,435],"Spinal Cord Injuries","Neuropathic Pain","Spondylosis","2026-02-13",{"date":438,"type":35},"2026-02-17",{"date":440,"type":22},"2026-02-28",{"date":442,"type":22},"2027-06",{"name":444,"class":42},"EicOsis Human Health Inc.",{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":174,"enrollmentInfo":453,"targetDuration":4,"studyType":55,"phases":455,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":134},"100520182","phase-1-safety-tolerability-and-effectiveness-of-intramuscular-injection-of-celz-201-ddt-for-the-treatment-of-chronic-lower-back-pain-100520182","NCT06053242","Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain","A Double-blinded, Randomized, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Effectiveness of CELZ-201-DDT Administered by Intramuscular Injection for the Treatment of Chronic Lower Back Pain in Patients With Degenerative Disc Disease","ADAPT","Inclusion Criteria:\n\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n* Between 18-80 years of age and may be of either gender or any race.\n* Subjects must have failed at least two standard of care (SOC) therapies before being enrolled in the study: 1) exercise\u002Fphysical therapy; 2) oral analgesic including nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen; 3) skeletal muscle relaxants. Subjects must have tried each SOC therapy for at least 3 months before failure is determined.\n* Patients must have failed the SOC therapies within 12 months of enrollment in the clinical trial.\n* Proof for one of the following tests already performed in the clinical care of the patient for lower back pain: 1) MRI scan demonstrating at least one disc level with grade II or greater disc degeneration using the Pfirrmann grading system; 2) Oswestry Disability Index for Back Pain score of 21-80%; 3) Visual Analogue Scale for pain of \\>5 on a scale of 0-10.\n* Female subjects must not be breast feeding and must have no intention to become pregnant during the study, and she is using contraceptive drugs or devices.\n* Any male subject must agree to use contraceptives and not donate sperm during the study.\n* Subjects may be on stable opioids, narcotics, or muscle relaxants for ≥30 days before screening.\n\nExclusion Criteria:\n\n* History of cancer in the last five years.\n* Spinal infections and spinal tumors.\n* Renal insufficiency requiring dialysis or an eGFR of less than 60 mL\u002Fmin\u002F1.73m2.\n* ALT, AST greater than 2 times or Total Bilirubin 1.5 times the upper limit of the normal range.\n* Positive pregnancy test.\n* History of blood cell diseases.\n* Uncontrolled diabetes mellitus - HgA1c \\>8%.\n* Uncontrolled hypertension defined as a systolic blood pressure of \\>140 mmHg or diastolic blood pressure of \\>90 mmHg at the time of screening. If subjects have their hypertension appropriately treated, then they would be eligible to enroll.\n* Patients known to have any active infection, including infection of the injection site(s), and\u002For any active systemic or local infection.\n* Patients on chronic immunosuppressive transplant therapy. Patients receiving \\\u003C5 mg of Prednisone daily may be included.\n* Subjects having a concomitant life-threatening disease in which their life expectancy is estimated to be less than 2 years.\n* Recent smoking history or substance abuse (within six weeks).\n* Heavy alcohol use (greater than 14 drinks per week for men or 7 drinks per week for women per NIAAA)\n* Use of an investigational drug, device or product, or participation in a drug research study within a period of 30 days prior to receiving study treatment.\n* Any patient who has received gene therapy in the past.\n* Subjects with an average baseline MED \\>90 mg\u002Fday during the screening period are excluded. The average will be calculated over a 7-day time period.\n* Body Mass Index (BMI) \\> 40 kg\u002Fm2.",{"count":454,"type":22},45,[178,179],"The brief purpose of this research study is to learn about the safety, tolerability, and efficacy of paraspinal intramuscular injection of CELZ-201-DDT in patients with chronic lower back pain.",[149,26],"2026-02-11",{"date":436,"type":35},{"date":461,"type":35},"2024-05-21",{"date":463,"type":22},"2027-05-01",{"name":465,"class":42},"Creative Medical Technology Holdings Inc",{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":174,"enrollmentInfo":473,"targetDuration":4,"studyType":55,"phases":475,"briefSummary":477,"conditions":478,"keywords":486,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":134},"100441542","phase-4-regional-anesthesia-in-minimally-invasive-lumbar-spine-surgery-100441542","NCT05029726","Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery","Randomized, Placebo-controlled Trial of Erector Spinae Plane Blocks (ESPB) for Perioperative Pain Management for Minimally Invasive (MIS) Lumbar Spine Surgery","Inclusion Criteria:\n\n* Age 18-80\n* Undergoing one of 3 procedure types: 1) 2 or more levels of MIS decompression (e.g., discectomy, foraminotomy, laminectomy); 2) 1-3 levels of MIS transforaminal lumbar interbody fusion (TLIF) (with or without additional levels of MIS decompression for no greater than 3 total operative levels); 3) 1-3 levels of anterior lumbar interbody fusion (ALIF) or MIS lateral lumbar interbody fusion (LLIF) accompanied by posterior percutaneous instrumentation at the same levels\n* Willing and able to give consent\n\nExclusion Criteria:\n\n* Opioid tolerant at the time of the surgical procedure--defined as consuming greater than 30mg of morphine milligram equivalents (MME) daily (https:\u002F\u002Fwww.cdc.gov\u002Fdrugoverdose\u002Fprescribing\u002Fguideline.html)\n* Presence of an indwelling pain device (e.g., intrathecal opioid pump, spinal cord stimulator, dorsal root ganglion stimulator)\n* Known allergy to bupivacaine, clonidine or similar local anesthetics\n* Indication for surgery other than degenerative disease (e.g., neoplasm, infection, trauma)\n* Chronic kidney disease (stage 3 or greater), or hepatic failure\n* Active pregnancy\n* Disease process or mental illness that would preclude accurate evaluation of pain in the perioperative period\n* Active Worker's Compensation litigation",{"count":474,"type":22},125,[476],"PHASE4","Opioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients. This study will serve to demonstrate the efficacy of the addition of regional analgesic techniques in reducing post-operative opioid requirements in patients undergoing common lumbar spinal surgical procedures.",[479,327,480,481,114,482,483,26,484,485],"Lumbar Spinal Stenosis","Lumbar Spondylolisthesis","Lumbar Spondylosis","Lumbar Spine Instability","Synovial Cyst","Degenerative Spondylolisthesis","Degenerative Intervertebral Discs",[487,488,489,490],"erector spinae plane block","minimally invasive spine surgery","regional anesthesia","randomized controlled trial",{"date":438,"type":35},{"date":493,"type":35},"2022-02-01",{"date":495,"type":22},"2027-04-30",{"name":497,"class":133},"John O'Toole",{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":505,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":508,"conditions":509,"keywords":513,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":134},"100493123","comparison-of-artificial-disc-implants-in-cervical-disc-arthroplasty-100493123","NCT05701059","Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty","Comparison of Unconstrained and Semi-constrained Artificial Disc Implants Used in Cervical Disc Arthroplasty","Inclusion Criteria:\n\n* Patient is skeletally mature and between 18 to 60 years of age\n* Experiences cervical spondylotic myelopathy and\u002For radiculopathy typically caused by disc herniation or degenerative disc disease at a single level between C3 to C7\n* Is unresponsive to at least six weeks of non-surgical conservative care\n* Has the intention of undergoing cervical arthroplasty for their chief complaint\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Patient has had prior cervical spine surgery\n* Has more than two diseased levels requiring surgery\n* Has a known allergy to a metal alloy or polyethylene\n* Is morbidly obese\n* Has active local or system infection\n* Has any circumstances or conditions such that their ability to provide informed consent comply with follow-up requirements, or provide self-assessments is compromised (eg: psychiatric disorders, chronic alcohol or substance abuse, etc.)","60 Years",{"count":507,"type":22},20,"This study will comprehensively evaluate the outcomes and endpoints of these two different FDA-approved artificial disc implants used to treat cervical spondylotic myelopathy and\u002For radiculopathy today: Biomet Zimmer Mobi-C and Nuvasive Simplify. Both implants are structurally different with the Nuvasive Simplify implementing a three-piece design with two endplates and a semi-constrained mobile core while the Biomet Zimmer Mobi-C implements an unconstrained three piece design. Subjects will be age-matched and randomly assigned to either implant with informed consent. All subjects will undergo a variety of assessments that evaluate neck disability, quality of life, pain, physiological outcome (radiographic assessments), and neck range-of motion before and after their procedure. One baseline testing will be conducted along with three post-operation visits (three months, six months, and one year) in accordance to standard follow-up procedure. Thus, the duration of participation in the study will be approximately one and a half years.",[510,511,512,26],"Cervical Spondylosis With Myelopathy","Cervical Radiculopathy","Cervical Disc Herniation",[514,515,516,517,518,519,520,521,522,523,63,524,525,526],"cervical","spondylosis","myelopathy","radiculopathy","disc","cervical disc","artificial disc","artificial disc implantation","cervical arthroplasty","disc herniation","ACDF","Biomet Zimmer Mobi-C","Nuvasive Simplify","2026-02-10",{"date":436,"type":35},{"date":530,"type":35},"2023-05-01",{"date":532,"type":22},"2026-12-01",{"name":534,"class":133},"University of California, Los Angeles",{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":543,"conditions":544,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":134},"100570259","conduit-cages-and-fibergraft-bg-putty-100570259","NCT06704919","Conduit Cages and Fibergraft BG Putty","Assess Clinical and Radiographic Outcomes of Conduit Cages and Fibergraft in Cervical and Lumbar Procedures","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Have a radiograph-based diagnosis of degenerative disc disease, ruptured or herniated discs,\n3. Pathology of the cervical or lumbar spine.\n4. Pathology to be between C2-T1 in the cervical group.\n5. Pathology to be between L2-S1 in the lumbar group.\n6. Patients with 1-2 contiguous levels in both ACDF and Lumbar groups.\n7. Patients receiving the surgery\u002Fdevices as standard of care prescribed by the treating physician.\n\nExclusion Criteria:\n\n1. Patients \\\u003C 18 years\n2. BMI \\> 40 kg\u002Fm2 to be excluded\n3. Patients with a bone density (DEXA) score of \\\u003C2.0 to be excluded\n4. 3 or more levels for ACDF or Lumbar interbody to be excluded\n5. Patients with previous pseudoarthrosis or failed spondylodesis to be excluded\n6. Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded",{"count":108,"type":22},"The Conduit cages are intended to restore the intervertebral height and to facilitate the intervertebral body fusion in the cervical and lumbar spine in skeletally mature patients with degenerative disc disease and instabilities at one or more levels of the spine. The Fibergraft Bioactive Glass (BG) is engineered to mimic the body's natural bone healing process. While previous studies have described the use of conduit cages in interbody fixation procedures, these studies did not specifically study the clinical and radiographic outcomes of patients who have received these implants in addition to Fibergraft. We aim to recruit patients with degenerative disc disease, and instabilities at one to multilevel contiguous levels between C2-T1 and 1-2 contiguous levels between L2-S1 of the spine with accompanying radicular symptoms, ruptured or herniated discs, and pseudarthrosis and spondylodesis. We will then follow these patients for a duration of two years to report their clinical and radiographic outcomes to determine fusion, complication rate, and revision surgeries if any.",[26,545],"Herniated Disc","2026-01-20",{"date":548,"type":35},"2026-01-22",{"date":550,"type":35},"2024-11-04",{"date":552,"type":22},"2029-03-30",{"name":554,"class":133},"Nitin Agarwal",{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":564,"conditions":565,"keywords":4,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":134},"100611850","assessing-safety-of-cervical-spine-fusion-with-nmp-100611850","NCT07245940","Assessing Safety of Cervical Spine Fusion With NMP®","Assessing Safety of Cervical Spine Fusion With NMP® Graft Material: A Retrospective Chart Review","Inclusion Criteria:\n\n1. Patients treated with NMP® for Cervical (C2-T1) Interbody fusion (2022-2025) at the study site.\n2. Minimum of 90-day post-operative follow up data available\n\nExclusion Criteria:\n\n* Patients with no follow-up data within 3 months from the surgery date due to missed postoperative appointments.",{"count":563,"type":22},300,"The goal of this retrospective chart review study is to assess safety of NMP® in the treatment of cervical spine degenerative conditions by assessing the incidence and nature of AEs in follow-up (minimum of 90 days and up to 2 year post-operatively) as well as reoperation rates.",[26,484,566],"Spinal Stenosis Cervical","2025-11-17",{"date":569,"type":35},"2025-11-24",{"date":571,"type":22},"2026-01-15",{"date":573,"type":22},"2026-08-01",{"name":575,"class":42},"Red Rock Regeneration Inc.",{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":174,"enrollmentInfo":583,"targetDuration":4,"studyType":55,"phases":584,"briefSummary":585,"conditions":586,"keywords":587,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":597,"locationsCount":134},"100392310","acdf-using-structural-allograft-vs-tritanium-c-100392310","NCT04388332","ACDF Using Structural Allograft vs. Tritanium C","Comparison of Clinical Outcomes Following ACDF With Instrumentation Using Structural Allograft vs. Tritanium C","Inclusion Criteria:\n\n1. Males or females ≥18 years of age, ≤ 80 years of age\n2. Subject is skeletally mature\n3. Subject is diagnosed with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 -T1 disc\n4. Subject has received six weeks of non-operative therapy i.e. injections, physical therapy, oral steroids\n5. Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent (Prospective study)\n6. Subjects that will prospectively undergo one or two level anterior cervical discectomy and fusion with Tritanium C (Prospective study)\n7. Subjects that underwent one or two level anterior cervical discectomy and fusion with either standard of care structural allograft bone at any AHN facility from 01\u002F01\u002F2016 to 08\u002F14\u002F2023 (Retrospective study) • Note that these patients will be followed for a maximum of one year (up to 08\u002F14\u002F2024 for a patient enrolled at the end of this inclusion period)\n\nExclusion Criteria:\n\nPatients may not be enrolled in the study if any of the following exclusion criteria are present:\n\n1. Presence of an infection systemic or local\n2. Presence of marked local inflammation\n3. Subject has any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, primary or metastatic tumors involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis\n4. Use of bone growth stimulator\n5. Subject has prior fusion at the levels to be treated\n6. Subject has any neuromuscular deficit\n7. Subject has any condition of senility, mental illness, or substance abuse\n8. Subject has any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery in the judgement of the PI\n9. Subject has rapid joint disease, bone absorption, osteopenia, osteomalacia, and\u002For osteoporosis. Subject is pregnant or plans to become pregnant during the course of the study.\n10. BMI≥40 kg\u002Fm2\n11. Subject uses chronic corticosteroids\n12. Subjects with current active psychiatric diagnosis or a personality disorder likely to interfere with the study\n13. Subjects who smoke and do not plan to quit\n14. Mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care\n15. Subject has any open wounds\n16. Subject has inadequate tissue coverage over the operative site\n17. Subject may be sensitive to titanium materials\n18. Subject is missing 6 and\u002For 12 month clinical or radiographic follow-up (Retrospective study)",{"count":383,"type":22},[146],"This is an observational, descriptive, prospective and retrospective data collection study. The purpose of this study is to observe radiographic outcomes of patients who will undergo anterior cervical discectomy and fusion (ACDF) utilizing Tritanium C (Stryker Spine). The rate of fusion success and adverse events will be compared retrospectively to patients who underwent instrumented ACDF utilizing structural allograft bone with plates.",[26],[588,589,590],"Tritanium C","Structural Bone Graft","Anterior Cervical Discectomy and Fusion","2025-11-13",{"date":593,"type":35},"2025-11-14",{"date":595,"type":35},"2020-08-20",{"date":419,"type":22},{"name":598,"class":133},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":4,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":608,"conditions":609,"keywords":611,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":373},"100422031","ossimend-ba-in-posterolateral-instrumented-lumbar-fusion-100422031","NCT04775537","OssiMend BA in Posterolateral Instrumented Lumbar Fusion","OssiMend Bioactive Moldable in Posterolateral Instrumented Lumbar Fusion","Inclusion Criteria:\n\n* Subject must be 18 years of age or older at the time of consent and must have a documented diagnosis of degenerative disc disease (DDD) that has failed to respond to nonoperative treatment for at least 6 months. DDD is defined by back and\u002For radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings:\n\n  * Instability as defined by \\>3mm translation or \\>5 degrees 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  * Herniated nucleus pulposus\n  * Facet joint degeneration\u002Fchanges\n\nExclusion Criteria:\n\n1. Subject is under 18 years of age at the time of consent\n2. Subject has had prior lumbar spine fusion surgery at any level\n3. Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy\n4. Subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis\n5. Subject has an active (local or systemic) infection or is undergoing adjunctive treatment for infection\n6. Subjects under workers compensation or active litigation",{"count":607,"type":22},120,"The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material",[610,26],"Spinal Disease",[612,613],"Bone Graft","Lumbar Fusion","2025-10-14",{"date":616,"type":35},"2025-10-16",{"date":618,"type":35},"2021-01-21",{"date":620,"type":22},"2027-01-30",{"name":622,"class":42},"Collagen Matrix",{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":629,"eligibilityCriteria":630,"healthyVolunteers":105,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":631,"targetDuration":4,"studyType":55,"phases":633,"briefSummary":634,"conditions":635,"keywords":636,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":373},"100507134","investigation-of-dexa-c-anterior-cervical-interbody-system-100507134","NCT05883436","Investigation of DEXA-C Anterior Cervical Interbody System","A Prospective, Multi-Center Investigation of the DEXA- C Anterior Cervical Interbody System","DEXA-C","Inclusion Criteria:\n\n1. Must already be scheduled or planned for anterior cervical discectomy and fusion using the Dexa-C Anterior Interbody System C3-7 with supplemental fixation and\u002For allogenic bone graft composed of cancellous, cortical, and\u002For cortico-cancellous bone meeting on-label criteria.\n2. Radicular signs and symptoms in one or both arms (i.e., pain, paresthesia or paresis in a specific nerve root distribution).\n3. Diagnosis of cervical radiculopathy at one or two contiguous levels from C3-7 requiring open anterior cervical fusion and discectomy.\n4. Diagnosis of degenerative disc disease by radiographic evidence of cervical disc herniation and\u002For osteophytes accompanying clinical symptoms.\n5. At least 6 weeks prior conservative treatment (i.e. physical therapy, pain medication).\n\nExclusion Criteria:\n\n1. History of cervical spine surgery less than 12 months prior to surgery.\n2. Diagnosis of severe spondylosis.\n3. Patients requiring posterior cervical surgery, anterior cervical corpectomy, or revision surgery.\n4. Any member of a vulnerable population (ie. minors, adults who lack the ability to consent, pregnant women, etc.)",{"count":632,"type":22},80,[146],"FDA Cleared interbody product for the cervical spine, designed to match a patients DEXA scan for increase in fusion rate.",[26],[637,638],"fusion","subsidence","2025-09-29",{"date":641,"type":35},"2025-10-02",{"date":643,"type":35},"2023-02-22",{"date":645,"type":22},"2027-02-22",{"name":647,"class":42},"Aurora Spine and Pain",{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":4,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":201,"enrollmentInfo":655,"targetDuration":4,"studyType":55,"phases":657,"briefSummary":658,"conditions":659,"keywords":661,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":668,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":673,"locationsCount":134},"100457603","comparison-of-radiographic-fusion-rate-and-clinical-outcome-of-alif-and-xlif-performed-with-either-recombinant-human-bone-morphogenetic-protein-2-or-vivigen-100457603","NCT05238740","Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®","Comparison of Radiographic Fusion Rate and Clinical Outcome of Anterior Lumbar and Extreme Lateral Interbody Fusion Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen® Cellular Bone Matrix, a Prospective Randomised Assessor Blind, Monocentric Trial","Inclusion criteria:\n\nPatients who have an indication for a monosegmental ALIF procedure on the L5\u002FS1 segment or a monosegmental XLIF procedure on L4\u002F5 (both ALIF and XLIF procedure with or without an additional pedicular stabilisation), e.g., treating conditions such as spondylosis, spondylolisthesis and degenerative disc disorders with back and\u002For leg pain\n\n* Patients must be 18 - 70 years of age\n* Patients must have understood and signed the study information and the informed consent form\n* Patients are willing and able to complete scheduled follow-up evaluations \u002F questionnaires as described in the Informed Consent\n\nExclusion criteria:\n\n* Patients under 18 years and over 70 years of age\n* Patients with tumour \u002F spine trauma \u002F known bone disease \u002F Parkinson's disease and similar CNS disorders \u002F diseases or injuries of the peripheral nerves\n* Other procedures or segment than mentioned in the inclusion citeriaAdditional planed spine surgeries after index surgery\n* Current smoking\n* Pregnant or breastfeeding patients (or patient planning a pregnancy within one year after surgery)\n* Insufficient language skills in German\n* Inability to give informed consent\n* Refusal to participate in the study, unsigned study consent\n* Participation in another interventional study within the 30 days preceding and during the present study",{"count":656,"type":22},168,[146],"The aim of this study is to prospectively investigate the potential for bony fusion of ViviGen® bone graft substitute in comparison to rhBMP-2 in monosegmental ALIF procedure L5\u002FS1 and in monosegmental XLIF procedure L4\u002F5",[435,660,26],"Spondylolisthesis",[662,663,664,665,435,660,26,666],"ViviGen","Radiographic fusion rate","Anterior lumbar interbody fusion","Recombinant human bone morphogenetic protein-2","Extreme lateral interbody fusion","2025-06-04",{"date":669,"type":35},"2025-06-08",{"date":671,"type":35},"2022-10-27",{"date":190,"type":22},{"name":674,"class":42},"Lindenhofgruppe AG"]