[{"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","2026-08-13",{"date":34,"type":35},"2026-08-17","ACTUAL",{"date":37,"type":35},"2023-05-01",{"date":39,"type":20},"2031-05",{"name":41,"class":42},"Medtronic Spinal and Biologics","INDUSTRY",29,{"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":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100624831","phase-3-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\n* Requirement for bone fusion via consecutive 2-level spinal fusion due to disc degeneration or spinal deformity in the lumbosacral spine (L2-S1)\n* Symptomatic degenerative lesions from L2 to S1 confirmed by imaging (MRI or myelography within 12 months prior to enrollment) with neurological symptoms due to nerve root compression, including radiating pain, sensory disturbance, numbness, weakness, or neurogenic claudication\n* Degenerative disc disease with discogenic back pain, with or without leg pain, supported by clinical history and radiographic findings (e.g., CT, MRI, X-ray), with at least one of the following: instability (angular motion ≥5° and\u002For translation ≥4 mm), osteophyte formation, decreased intervertebral disc height, ligamentous thickening, disc degeneration or herniation, or facet joint degeneration\n* Preoperative Oswestry Disability Index (ODI) score ≥35%\n* Skeletally mature\n* Age 18 to 80 years at the time of surgery\n* Failure to respond to at least 3 months of non-operative treatment (e.g., bed rest, physical therapy, medication, nerve block, manipulation, or transcutaneous electrical nerve stimulation)\n* Ability to provide written informed consent after receiving adequate explanation of the study\n\nExclusion Criteria:\n\n* Prior spinal surgery at the target or adjacent intervertebral level, except for decompression procedures such as discectomy\n* Inability to complete both investigational device implantation and posterior fixation in a single procedure\n* Expected total rhBMP-2 dose greater than 12 mg\n* Planned use of an internal or external bone growth stimulator\n* Osteoporosis defined as T-score ≤ -2.5 within 12 months with fragility fracture\n* Body mass index (BMI) \\>40\n* Active malignancy\n* Active local or systemic infection\n* Use of bone formation promoting agents within 12 months prior to implantation\n* Use of medications that may interfere with bone or soft tissue healing within 30 days prior to implantation, including corticosteroids, antitumor agents, or immunosuppressants\n* History of autoimmune diseases affecting bone metabolism or the spine, including ankylosing spondylitis, inflammatory bowel disease, or rheumatoid arthritis\n* History of endocrine or metabolic disorders affecting bone formation, including Paget's disease or osteodystrophy\n* Prior exposure to modified proteins used for bone formation\n* Known hypersensitivity or allergy to device materials or related substances, including titanium, collagen, or protein-based products\n* History of severe allergic reactions such as anaphylaxis\n* Mental or psychiatric conditions that may interfere with study participation\n* Participation in another clinical study within 3 months or planned participation during this study period\n* Inability or unwillingness to use appropriate contraception during the study period and for 12 months after implantation\n* Presence of spinal tumors in adjacent vertebrae\n* Existing or planned implantation of non-study implants in the lumbosacral spine\n* Medical conditions that could interfere with evaluation of safety or effectiveness, including significant vascular or anatomical abnormalities\n* Contraindications to MRI\n* Smoking within 12 weeks prior to implantation or unwillingness to abstain during the study period\n* Alcohol or substance abuse\n* Any condition that, in the investigator's judgment, makes the subject unsuitable for the study","80 Years",{"count":53,"type":20},140,[55],"PHASE3","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.",[58,26],"Disc Degeneration","2026-07-02",{"date":61,"type":35},"2026-07-07",{"date":63,"type":35},"2026-04-24",{"date":65,"type":20},"2028-03-31",{"name":41,"class":42},14,{"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,""]