[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medtronic Spinal and Biologics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100505056","the-ailliance-post-market-clinical-study-100505056",false,"NCT05856370","The Ailliance Post-Market Clinical Study","The Ailliance Post-Market Clinical Study: All enablIng technoLogies, bioLogics, IDS, And Core spiNe produCt collEction","Inclusion Criteria:\n\n1. Subject provides written informed consent per institution and\u002For geographical requirements.\n2. Subject is intended to receive or be treated with an eligible Medtronic Cranial and Spinal Technology (CST) device(s) (see product appendices), used alone or in combination, for a cranial and\u002For spinal indication(s).\n3. Subject is at least 18 years of age or minimum legal age as required by local regulations.\n4. Subject agrees to complete all required assessments per the Schedule of Events.\n\nExclusion Criteria:\n\n1. Subject is currently enrolled or plans to enroll in concurrent drug\u002Fdevice\u002Fbiologic trial(s) that may confound this trial's results per investigator assessment (i.e. no required intervention that could affect interpretation of all-around device safety and or performance).\n2. Subject who is, or is expected to be, inaccessible for all required follow-up visits.\n3. Subject with exclusion criteria required by local law.\n4. Subject is considered vulnerable at the time of obtaining consent.","ALL","18 Years",{"count":19,"type":20},1000,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and\u002For spinal indication(s).\n\nSubjects are enrolled and followed postoperatively to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.",[26,27,28,29,30],"Spinal Deformity","Spinal Degenerative Disorder","Spinal Fusion Failure","Spinal Trauma","Spinal Tumor Case","RECRUITING","2026-06-29",{"date":34,"type":35},"2026-06-30","ACTUAL",{"date":37,"type":35},"2023-05-01",{"date":39,"type":20},"2031-05",{"name":41,"class":42},"Medtronic Spinal and Biologics","INDUSTRY",28,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"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.","80 Years",{"count":53,"type":20},140,[23],"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.",[57,26],"Disc Degeneration","NOT_YET_RECRUITING","2026-02-09",{"date":61,"type":35},"2026-02-17",{"date":63,"type":20},"2026-02-28",{"date":65,"type":20},"2028-03-31",{"name":41,"class":42},13,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100462292","a-post-market-surveillance-on-infuse-bone-graft-100462292","NCT05299762","A Post Market Surveillance on INFUSE Bone Graft","Inclusion Criteria:\n\n* Has degenerative disc disease and is indicated for lumbar interbody spine fusion from L2-S1 with INFUSE™ Bone Graft via ALIF or OLIF technique\n* Agrees to participate in the study and is able to understand and sign the Informed Consent\n* The procedure planned for the patient complies with the labeling of the devices that may be used in the surgical procedure\n* Has at least six months of nonoperative treatment prior to the study treatment\n* Is at least 18 years old at the time of informed consent\n\nExclusion Criteria:\n\n* Has a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen, or to other components of the formulation\n* Has any active malignancy or undergoes treatment for a malignancy, or operative site is in the vicinity of a resected or extant tumor\n* Is skeletally immature (\\\u003C18 years of age or no radiographic evidence of epiphyseal closure)\n* Is pregnant or lactating\n* Has an active infection at the operative site or with an allergy to titanium, titanium alloy, or polyetheretherketone\n* The use of the Infuse™ Bone Graft component implanted at locations other than the lower lumbar spine (e.g., cervical spine)\n* Repeat applications of the Infuse™ Bone Graft component\n* Has up to Grade 1 retrolisthesis\n* Has hepatic or renal impairment\n* Has metabolic bone disease\n* Has autoimmune disease\n* Has immunosuppressive disease or suppressed immune systems resulting from radiation therapy, chemotherapy, steroid therapy, or other treatments\n* Is illiterate or vulnerable (e.g., the participant is incapable of judgment or is under tutelage) as per the investigator's assessment\n* Concurrent participation in another clinical study that may confound study results\n* Has a considerable risk for surgery\n* Has a condition that could compromise study (e.g., mentally incompetent, alcohol or drug abuse) as per the investigator's assessment",{"count":75,"type":20},600,"OBSERVATIONAL","This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.",[79,80,81],"Intervertebral Disc Degeneration","Spinal Fusion","Lumbar Disc Disease",[83,84,85,86],"INFUSE Bone Graft","Lumbar Interbody Fusion","Anterior Lumbar Interbody Fusion","Oblique Lumbar Interbody Fusion","2025-03-17",{"date":89,"type":35},"2025-03-20",{"date":91,"type":35},"2022-08-10",{"date":93,"type":20},"2025-08-31",{"name":41,"class":42},1,""]