[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"disc-degeneration\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:disc-degeneration":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,75,99,127],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100575912","clinical-trial-evaluating-the-safety-and-efficacy-of-nucleus-pulposus-allograft-in-participants-with-degenerative-disc-disease-100575912",false,"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","RESTORE","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.","ALL","22 Years","85 Years",{"count":21,"type":22},496,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29,30],"Degenerative Disc Disease","Disc Degeneration","Lumbar Discogenic Pain",[28,30],"RECRUITING","2026-04-23",{"date":35,"type":36},"2026-04-24","ACTUAL",{"date":38,"type":36},"2025-02-17",{"date":40,"type":22},"2028-05",{"name":42,"class":43},"VIVEX Biologics, Inc.","INDUSTRY",19,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100596342","comparaison-of-interbody-bone-fusion-between-two-osteoinductive-bioactive-bone-substitutes-after-anterior-lumbar-interbody-arthrodesis-in-degenerative-lumbar-disc-surgery-in-adults-100596342","NCT07044206","Comparaison of Interbody Bone Fusion Between Two Osteoinductive Bioactive Bone Substitutes After Anterior Lumbar Interbody Arthrodesis in Degenerative Lumbar Disc Surgery in Adults","Prospective Randomized Comparative Study of Interbody Bone Fusion Between Two Osteoinductive Bioactive Bone Substitutes After Anterior Lumbar Interbody Arthrodesis in Degenerative Lumbar Disc Surgery in Adults","FUSALIF","Inclusion Criteria:\n\n* Patients aged between 18 and 80 years inclusive\n* Oswestry Disability Index (ODI) \\>25\n* Chronic low back pain and\u002For radicular pain lasting for more than 6 months\n* Failure of medical and rehabilitative treatment\n* Patient presenting with one of the following: grade 1 degenerative spondylolisthesis without isthmic lysis, or disc degeneration, or mixed pathology (degeneration and lumbar stenosis)\n* Patient eligible for anterior approach spinal fusion surgery with interbody cage\n\nExclusion Criteria:\n\n* History of spinal surgery at the lumbar level, excluding isolated discectomies for disc herniation\n* Confirmed osteoporosis\n* Surgical fusion at an adjacent level\n* Contraindication to Magnetos Putty or GlassBone Putty:\n\n  1. Use of medications interfering with calcium metabolism\n  2. Severe systemic or metabolic bone disorders affecting bone healing or lesions\n  3. Untreated acute or chronic infection requiring appropriate therapy\n  4. Patients with severe trauma and open external wounds near the defect site, at risk of infection\n  5. Known allergy to bioactive glass or its components (Ca2+, PO43-, Na+, and Si(OH)4), polyethylene glycol, and\u002For glycerol\n  6. Patients who have undergone or will undergo chemotherapy or radiotherapy at or near the implantation site\n  7. Severe renal or hepatic infections\n  8. Unrepaired dural tear in craniospinal surgery\n* Patients requiring placement of more than one implant\n* Subject unable to read and\u002For write fluent French, or illiterate\n* Subject already participating in another interventional clinical trial that could interfere with this study\n* Uncontrolled psychiatric illness\n* Lack of written informed consent after a reflection period\n* Individuals with a dependency or employment relationship with the sponsor or investigator\n* Subject enrolled in another study with an ongoing exclusion period (Article L1121-12)\n* Subject not affiliated with or not a beneficiary of the French social security system (L1121-8-1)\n* Protected populations under French Public Health Code:\n\n  1. Pregnant or breastfeeding women (L. 1121-5)\n  2. Individuals deprived of liberty (art. L. 1121-6) (by judicial, administrative decision or involuntary hospitalization)\n  3. Protected adults (under guardianship, curatorship, or legal protection) (L. 1121-8)\n* Women planning to become pregnant within the year","18 Years","80 Years",{"count":56,"type":22},100,[25],"Disc degeneration is a progressive deterioration process of the intervertebral disc, which can manifest as significant low back pain and a loss of mobility that interferes with daily activities. This condition is naturally age-related and exacerbated by traumatic events, lifestyle factors, and individual genetic susceptibilities. Treatment for advanced disc degeneration typically involves surgery (spinal fusion) aimed at addressing and fusing the affected intervertebral discs using an interbody implant combined with a bone graft.\n\nAlthough the use of interbody implants promotes temporary fusion, long-term success largely depends on the bone substitute used, with failure rates ranging from 10 to 20% (unsuccessful fusion, persistent symptoms, need for reoperation). Historically, autologous bone grafting was the standard, but it carries disadvantages related to pain and invasiveness. Synthetic, bioactive bone substitutes are now used, although their effectiveness varies.\n\nAnimal studies support the hypothesis that a new substitute based on specific osteo-immunology technology (MagnetOs, Kuros) could offer superior results compared to autologous bone grafts and competing osteo-inductive materials, while being minimally invasive. This study aims to evaluate its properties in terms of bone fusion and its impact on functional scores in patients, hypothesizing a significant improvement in fusion rates and functional scores with this new substitute.",[29],[61,62,63],"spinal surgery","spinal fusion","intervertebral disc","2026-03-09",{"date":66,"type":36},"2026-03-11",{"date":68,"type":36},"2026-01-28",{"date":70,"type":22},"2029-01",{"name":72,"class":73},"University Hospital, Montpellier","OTHER",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100624831","mdt-0123-japan-study-100624831","NCT07414745","MDT-0123 Japan Study","MDT-0123 Clinical Trial Targeting Patients Who Require Lumbar Vertebral Fusion in Japan","Inclusion Criteria:\n\n1\\) Subjects who require bone fusion via consecutive 2-level spinal fusion due to disc degeneration or spinal deformity etc. in the lumbosacral vertebrae (L2-S1). 2) Subjects who satisfies any of the following.\n\n1. Image findings of symptomatic degenerative lesions from L2 to S1(MRI or myelography within 12 months prior to enrollment) and subjects who have been observed to have a neurological disorder by nerve root compression etc. as follows. A) Radiating pain in the lower limbs or buttocks, sensory disturbance, numbness, symptoms of weakness B) B. Nervous claudication\n2. Subjects with degenerative disc disease with disc-derived low back pain, with or without leg pain, and the subject's medical history confirms disc degeneration \\[e.g., pain (symptoms of leg, back, or sciatic nerve distribution), functional deficits, and\u002For neurological defects)\\] and one or more of the following on image examination (e.g., CT, MRI, X-ray, etc.): A) Instability (defined as an angle of motion \\>greater than or equal to 5° and\u002For oscillation ≥4 mm, based on radiographs of anteroposterior flexion). B) Formation of osteophytes C) Decrease in the height of the intervertebral disc D) Thickening of ligamentous tissue E) Degeneration or herniation of the disc F) Degeneration of facet joints 3) Subjects with an ODI score of 35% or greater prior to the procedure. 4) Subjects with sufficiently mature skeletons. 5) Subjects who are 18 to 80 years of age or older at the time of surgery. 6) Subjects who has not responded to non-operative treatment (e.g., bed rest, physical therapy, medication, nerve block, manipulation, percutaneous electrical stimulation therapy (TENS)) for a period of 3 months. 7) Subjects who have received an adequate explanation of the details of this clinical trial and have given their written consent.\n\nExclusion Criteria:\n\n1. Has undergone previous spinal surgery at the intervertebral level in question or at an Intervertebral level (e.g., spinal fusion \u002F spinal surgery other than spinal fusion). Furthermore, the history of discectomy and\u002For discectomy surgery is acceptable.\n2. Subjects who cannot complete the implantation of the investigational device and the posterior fixation procedure in one procedure.\n3. Those whose total rhBMP-2 implantation is expected to exceed 12 mg.\n4. Subjects for whom use of an internal or external bone growth stimulator is planned.\n5. Subjects who have been diagnosed with osteoporosis with a T-score of -2.5 or lower within the past 12 months and who also present with fragility fractures at the time of informed consent.. If the subject has a history of fragility fracture and the T-score has not been assessed within the past 12 months, the subject must undergo a bone density test using Dual Energy X-ray Absorptiometry (DEXA).\n6. Subjects with morbid obesity with a Body Mass Index (BMI) exceeding 40.\n7. Subjects with an active malignancy.\n8. Overt or active bacterial infection, either local to surgical space or systemic.\n9. Those who received bone formation promotion agents within 12 months prior to implantation of the investigational device.\n10. Subjects who have been administered corticosteroids, anti-tumor drugs, immune stimulators, immunosuppressants, or systematic drugs that may interfere with the treatment of bone or soft tissue within 30 days prior to implantation of the investigational device.\n\n    * All other patients taking warfarin must be washed out for at least 5 days prior to the procedure. Steroid inhalers can be used both before and after surgery.\n    * Use of short-term steroids before and after surgery is permissible. In this clinical trial, short term usage is defined as 2 weeks or less. Steroid use beyond 2 weeks postoperatively is prohibited until the follow-up examination 12 months later.\n11. Subjects with a medical history of autoimmune diseases known to affect bone metabolism or the spine. Examples include spondylotic arthropathy (e.g., ankylosing spondylitis, clonal disease, ulcerative colitis), juvenile arthritis, rheumatoid arthritis, Graves' disease, and Hashimoto's disease.\n12. Subjects with a medical history of endocrinological or metabolic diseases that are known to affect bone formation (e.g., Paget's disease, renal osteodystrophy, G.Danlos's syndrome, and bone dysplasia).\n13. Subjects who have been exposed to a combination of proteins used for bone formation.\n14. Subjects who have a history of hypersensitivity, allergy, or intolerance to bone morphogenic proteins (BMPs) (BMPs used for dental treatment), injectable collagen, protein drugs (such as monoclonal antibodies or gamma globulins), bovine collagen products, and\u002For instrument materials (titanium alloy).\n15. Subjects with a medical history of allergy that may cause anaphylaxis.\n16. Subjects who have a mental disorder and have been judged by the investigator to be of an inappropriate level for enrollment into this clinical trial.\n17. Subjects who have received treatment in other clinical trials targeting spinal diseases within 3 months prior to the index procedure (drugs, devices, and\u002For biological products), subjects who have received treatment in other clinical trials within 28 days prior to the index procedure, or subjects who are scheduled to receive treatment in other clinical trials during the clinical trial period. Simultaneous enrollment into a clinical trial that is being conducted in parallel is permissible only if a prior approval document has been obtained from the clinical trial manager of Medtronic Sofamor Danek.\n18. Women of childbearing potential or men whose partners wish to become pregnant who are unable to agree to use appropriate contraception (ex: Barrier methods using condoms, intrauterine devices, oral contraceptives, vasectomy\u002Ftubal ligation, etc.) or abstain from sexual intercourse during the trial period and for 12 months after implantation of the investigational device. \"Women of childbearing potential\" refers to those who have not undergone permanent sterilization or entered menopause. Menopause refers to the absence of menstruation for 12 consecutive months or longer without any other underlying medical cause.\n19. Subjects with a spinal tumor in the upper or lower adjacent vertebral body between the vertebrae to which the investigational device is implanted.\n20. Subjects who have stainless steel implants or implants from other companies implanted in the lumbosacral vertebrae, or subjects who may be implanted during the study period.\n21. Subjects with other medical diseases or conditions that may interfere with the accurate clinical evaluation of the safety and efficacy of the treatment in this clinical trial (e.g.: Subjects with a neuromuscular disease or marked anatomical abnormality in the vasculature, have a considerably narrow right and left common iliac arteriovenous space, have a fragile vasculature, have difficulty performing angiography, have a history of surgery that expects advanced adhesions, etc.).\n22. Subjects with diseases or conditions contraindicated for MRI examination.\n23. Subjects who smoke within 12 weeks prior to implantation of the investigational device (including electronic cigarettes) and may smoke during the study period.\n24. A documented diagnoses of alcohol abuse and\u002For substance abuse.\n25. Subjects who are judged by the investigator to be unsuitable for inclusion in the clinical trial.",{"count":83,"type":22},140,[25],"The purpose of this clinical trial is to compare the efficacy and safety of this investigational device with autologous iliac bone graft (ICBG) in patients who are deemed to require bone fusion through spinal fixation at two levels (ALIF or OLIF) due to disc degeneration or spinal deformity in the lumbosacral spine (L2-S1) for intervertebral support and correction with the aim of stabilizing the spine.",[29,87],"Spinal Deformity","NOT_YET_RECRUITING","2026-02-09",{"date":91,"type":36},"2026-02-17",{"date":93,"type":22},"2026-02-28",{"date":95,"type":22},"2028-03-31",{"name":97,"class":43},"Medtronic Spinal and Biologics",13,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":17,"minAge":107,"maxAge":54,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":74},"100544359","phase-4-efficacy-and-safety-of-preemptive-intravenous-dexamethasone-in-mis-tlif-100544359","NCT06367855","Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF","MIS-TLIF","Inclusion Criteria:\n\n* Age range: 50-80 years old.\n* Undergoing MIS TLIF surgery at 1-2 spinal levels.\n\nExclusion Criteria:\n\n* Previously undergone spine surgery.\n* HbA1C greater than or equal to 7.5 mg%\n* Allergic to all types of experimental medication.\n* History of using systemic steroids.",true,"50 Years",{"count":109,"type":22},60,[111],"PHASE4","Researchers are considering Dexamethasone as preemptive medication before minimally invasive spine fusion surgery to minimize postoperative back pain with minimal side effects, aiming to enhance the effectiveness of surgery and improve patient outcomes.",[114,29,115,116,117],"Spinal Stenosis Lumbar","Disc Disease","Fusion of Spine","Surgery","2025-08-31",{"date":120,"type":36},"2025-09-08",{"date":122,"type":36},"2024-05-01",{"date":124,"type":22},"2025-12-31",{"name":126,"class":73},"Potsawat Surabotsopon",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":106,"sex":17,"minAge":18,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100513888","pilot-study-of-zetafuse-bone-graft-for-the-treatment-of-cervical-degenerative-disc-disease-100513888","NCT05971329","Pilot Study of ZetaFuse™ Bone Graft for the Treatment of Cervical Degenerative Disc Disease","Inclusion Criteria:\n\n1. Age 22 to 75 years (inclusive) at the time of enrollment.\n2. Diagnosis of radiculopathy and\u002For myelopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:\n\n   * Neck and\u002For arm pain (at least 3 on the 0 - 10 numeric rating scale for pain.\n   * Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.\n   * Abnormal sensation including hyperesthesia or hypoesthesia. and\u002For\n   * Abnormal reflexes.\n3. Symptomatic at one or two contiguous levels from C3 to C7.\n4. Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:\n\n   * Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc.\n   * Degenerative spondylosis on CT or MRI.\n   * Disc herniation on CT or MRI.\n5. Neck Disability Index Score ≥ 30\u002F100.\n6. Unresponsive to non-operative treatment (e.g., rest, heat, physical therapy, chiropractor, massage, pain medication) for approximately six weeks from the symptom onset; or has the presence of progressive symptoms or signs of nerve root\u002Fspinal cord compression in the face of continued non-operative management.\n7. No previous surgical intervention at the involved levels or any subsequent, planned\u002Fstaged surgical procedure at the involved or adjacent levels.\n8. Appropriate for treatment using an anterior surgical approach.\n9. Skeletally mature at the time of the surgery.\n10. Medically cleared for surgery.\n11. If a female of child-bearing potential, subject is non-pregnant, nonnursing, and agrees not to become pregnant during the study period.\n12. Willing and able to comply with the study plan.\n13. Signed written Patient Informed Consent Form.\n14. Willing to discontinue use of non-steroidal anti-inflammatory drugs (NSAIDs) from one week before the surgery to 3 months after the surgery.\n\nExclusion Criteria:\n\n1. A cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved levels.\n2. Documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion\u002Fextension) radiographs showing sagittal plane translation \\>3.5 mm or sagittal plane angulation \\> 20°.\n3. More than two cervical levels requiring surgical treatment.\n4. An immobile or spontaneously fused level adjacent to the levels to be treated.\n5. Severe pathology of the facet joints of the involved vertebral bodies.\n6. Previous surgical intervention at either one or both of the involved levels or at adjacent levels.\n7. History of trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.\n8. Previously diagnosed with osteomalacia;\n9. Any of the following that may be associated with an increased risk osteoporosis (if \"Yes\" to any of the below risk factors, a DEXA Scan is required to determine eligibility). If the level of bone mineral density (BMD) on DEXA scan is a T score of -2.5 or worse (i.e., -2.6, - 2.7, etc.) the subject is ineligible for the study.\n\n   * Postmenopausal non-Black female over 60 years of age who weighs less than 140 pounds.\n   * Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture.\n   * Male over the age of 60 who has sustained a non-traumatic hip or spine fracture.\n   * Taking bisphosphonate medication for the treatment of osteoporosis.\n   * Chronic use of high dose steroids.\n10. Reported active malignancy that included a history of any invasive malignancy (except non-melanoma skin cancer) unless the subject had been treated with curative intent and there had been no clinical signs or symptoms of the malignancy for at least five years.\n11. Overt or active systemic infection, or infection at the operative site.\n12. Insulin dependent diabetes.\n13. A tobacco user who does not agree to suspend smoking prior to surgery.\n14. Chronic or acute renal failure or prior history of renal disease.\n15. Mentally incompetent (If questionable, obtain psychiatric consult).\n16. A prisoner.\n17. An alcohol and\u002For drug abuser currently or recently undergoing treatment for alcohol and\u002For drug abuse.\n18. Involved with current or pending litigation regarding a spinal condition.\n19. Received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate) excluding routine perioperative anti-inflammatory drugs.\n20. A history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers- Danlos Syndrome, or osteogenesis imperfecta).\n21. A condition that requires post-operative medications that interfere with the stability of the implant, such as steroids. (This does not include low dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs).\n22. Received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation with the ZetaFuse™ Bone Graft device.","75 Years",{"count":135,"type":22},10,[25],"The goal of this pilot clinical trial is to test the safety and preliminary performance of the ZetaFuse Bone Graft in patient requiring fusion of the C3-C7 vertebral bones due to pain or loss of neurological function.\n\nParticipants will be treated with ZetaFuse during surgical intervention to reduce pain and the loss of neurological function.",[139,140,141,115,29],"Radiculopathy, Cervical","Myelopathy Cervical","Neurological Abnormality","2025-04-18",{"date":144,"type":36},"2025-04-24",{"date":146,"type":22},"2026-09",{"date":148,"type":22},"2027-09",{"name":150,"class":43},"Zetagen Therapeutics, Inc",2]