[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462292":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":10,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":10,"eligibilityCriteria":49,"healthyVolunteers":46,"sex":50,"minAge":51,"maxAge":10,"enrollmentInfo":52,"targetDuration":10,"studyType":55,"phases":10,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Medtronic Spinal and Biologics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients treated with the INFUSE™ Bone Graft",null,"Patients intended to be treated with the INFUSE™ Bone Graft are eligible for enrollment. The investigator screen candidate patients against inclusion\u002Fexclusion criteria and enroll a patient only when all inclusion\u002Fexclusion criteria meet, and the patient provide written informed consent.",[13],"Device: INFUSE™ Bone Graft",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","INFUSE™ Bone Graft","Ministry of Food and Drug Safety (MFDS) has approved the INFUSE™ Bone Graft for anterior (ALIF) or oblique (OLIF) lumbar interbody spine fusion as a substitute for autogenous bone graft for patients with degenerative disc disease (DDD) who have had at least 6 months of non-operative treatment for this condition.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Michelle Kim","CONTACT","+82-3404-7756","michelle.kim@medtronic.com",[27],{"facility":28,"status":29,"city":30,"state":10,"zip":31,"country":32,"countryCode":10,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Chung-Ang Gwangmyeong Hospital","RECRUITING","Seoul","14353","South Korea",{"type":34,"coordinates":35},"Point",[36,37],126.9784,37.566,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":10,"phoneExt":10,"email":10},"Seungwon Park",{"type":43,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100462292","a-post-market-surveillance-on-infuse-bone-graft-100462292",false,"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","ALL","18 Years",{"count":53,"type":54},600,"ESTIMATED","OBSERVATIONAL","This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.",[58,59,60],"Intervertebral Disc Degeneration","Spinal Fusion","Lumbar Disc Disease",[62,63,64,65],"INFUSE Bone Graft","Lumbar Interbody Fusion","Anterior Lumbar Interbody Fusion","Oblique Lumbar Interbody Fusion","2025-03-17",{"date":68,"type":69},"2025-03-20","ACTUAL",{"date":71,"type":69},"2022-08-10",{"date":73,"type":54},"2025-08-31",{"name":5,"class":6},1]