[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659799":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":16,"studyPopulation":16,"armGroups":32,"interventions":45,"overallOfficials":54,"centralContacts":58,"locations":66,"responsibleParty":88,"collaborators":16,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":16,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":16,"enrollmentInfo":99,"targetDuration":16,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":16,"overallStatus":111,"whyStopped":16,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Kolosis Bio, LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of successful fusion at 1 year post-operatively","\\- Defined as the proportion of fusion sides achieving Grade A per the side-specific modified Lenke classification of fusion.","postoperative year 1",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Distribution of fusion grades, assessed by CT using the side-specific Modified Lenke classification of fusion grade",null,{"measure":18,"description":16,"timeFrame":19},"Changes from baseline (CFB) in Numerical Rating Scales (NRSs) on back pain and leg pain","baseline, postoperative months 3, 6, and year 1",{"measure":21,"description":16,"timeFrame":12},"Incidence and characterization of serious adverse events (SAEs) attributed to graft materials",{"allocation":23,"interventionModel":24,"interventionModelDescription":25,"primaryPurpose":26,"observationalModel":16,"timePerspective":16,"maskingInfo":27},"RANDOMIZED","CROSSOVER","This is an intra-patient controlled study. Every participant receives both interventions simultaneously. Randomization determines which product is applied to the left side versus the right side of the spine.","TREATMENT",{"masking":28,"maskingDescription":29,"whoMasked":30},"SINGLE","Outcomes assessor is masked to side assignment",[31],"OUTCOMES_ASSESSOR",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"Kore Fiber","EXPERIMENTAL","Kore fiber used standalone in instrumented posterolateral fusion per level at the randomized assigned side",[38],"Biological: Kore Fiber",{"label":40,"type":41,"description":42,"interventionNames":43},"Autologous bone graft","ACTIVE_COMPARATOR","Autologous bone graft used in instrumented posterolateral fusion per level at the randomized assigned control side of the spine.",[44],"Other: Autologous bone graft",[46,50],{"type":47,"name":34,"description":48,"armGroupLabels":49,"otherNames":16},"BIOLOGICAL","An aseptically processed demineralized bone fiber allograft comprised of 100% cortical bone fiber",[34],{"type":51,"name":40,"description":52,"armGroupLabels":53,"otherNames":16},"OTHER","Autograft bone",[40],[55],{"name":56,"affiliation":5,"role":57},"Suzanne Tabbaa, PhD","STUDY_DIRECTOR",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":16,"email":63},"Clinical Study Manager","CONTACT","440-242-9659","clinicalaffairs@kolosis.com",{"name":56,"role":61,"phone":62,"phoneExt":16,"email":65},"stabbaa@kolosis.com",[67],{"facility":68,"status":16,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"The Ohio State University Wexner Medical Center","Columbus","Ohio","43210","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-82.99879,39.96118,{"lat":78,"lon":77},[81,85],{"name":82,"role":61,"phone":83,"phoneExt":16,"email":84},"Clinical Research Manager","614-293-4876","aladdin.alqaisi@osumc.edu",{"name":86,"role":87,"phone":16,"phoneExt":16,"email":16},"Brian Park, MD","PRINCIPAL_INVESTIGATOR",{"type":89,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100659799","kore-fiber-plf-rct-100659799",false,"NCT07868510","Kore Fiber PLF RCT","A Prospective, Randomized Controlled Trial of Kore Fiber® Versus Autograft in Posterolateral Lumbar Fusion (PLF)","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Is undergoing standard of care of one- to four-level instrumented posterolateral fusion between L1 and S1\n3. Has failed 6 months or more of conservative, non-operative treatment\n4. Able to provide informed consent\n5. Agree to comply with study protocol\n\nExclusion Criteria:\n\n1. Prior lumbar fusion surgery at the index levels planned for study treatment\n2. Minimally invasive\u002Ftubular surgery\n3. History of osteoporosis, osteopenia, osteomalacia, or osteoporotic fracture that may compromise fusion outcomes\n4. Active or recent malignancy (within 3 years), or current treatment with chemotherapy, radiation, immunosuppressive agents, or chronic steroids\n5. Active systemic infection or localized infection at the operative site\n6. Cognitive, psychological, or neurological condition that may interfere with pain assessment or study compliance\n7. Pregnant or planning pregnancy during the study period\n8. Member of a vulnerable population (e.g., prisoners, cognitively impaired, unable to consent)\n9. BMI \\> 45","ALL","18 Years",{"count":100,"type":101},75,"ESTIMATED","INTERVENTIONAL",[104],"NA","This is a prospective, randomized controlled trial evaluating Kore Fiber® versus autograft in adults undergoing posterolateral lumbar fusion (PLF). Participants will receive Kore Fiber on one side of the spine and autograft on the opposite side according to randomized assignment. Fusion outcomes, pain outcomes, and safety will be assessed over 12 months.",[107,108,109,110],"Degenerative Lumbar Spine Diseases","Lumbar Degenerative Disc Disease","Lumbar Spinal Stenosis","Spondylolisthesis","NOT_YET_RECRUITING","2026-10-05",{"date":114,"type":115},"2026-10-09","ACTUAL",{"date":117,"type":101},"2026-11",{"date":119,"type":101},"2028-11",{"name":5,"class":6},1]