[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652562":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":34,"locations":34,"responsibleParty":39,"collaborators":34,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":34,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":34,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":65,"overallStatus":74,"whyStopped":34,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":34},{"fullName":5,"class":6},"Isto Biologics","INDUSTRY",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"TLIF - ProteiOS (Treatment)","EXPERIMENTAL","Influx™ demineralized cortical fibers combined 1:1 with ProteiOS®, ≥50% of total graft volume per level (5-15 cc total), optional cancellous allograft chip augmentation. If PLF indicated: 100% cortical fiber graft + ProteiOS + local bone in Fibrant PAK containment bag.",[13],"Other: Allograft-derived growth factor (ProteiOS®)",{"label":15,"type":16,"description":17,"interventionNames":18},"TLIF - Control","ACTIVE_COMPARATOR","5-15 cc locally harvested autograft, optional mineralized cancellous allograft chip augmentation, no ProteiOS. If PLF indicated: cortical fiber graft + local bone in Fibrant PAK containment bag.",[19],"Other: Standard of Care (SOC)",{"label":21,"type":10,"description":22,"interventionNames":23},"ALIF - ProteiOS (Treatment)","Same ProteiOS-based mixture as TLIF treatment arm",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"ALIF - Control","Same control graft composition as TLIF control arm",[19],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"OTHER","Allograft-derived growth factor (ProteiOS®)","Allograft-derived growth factor product (ProteiOS®) containing endogenous osteoinductive, angiogenic, and chemoattractant proteins bound to a scaffold of choice",[21,9],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Standard of Care (SOC)","Local autograft with optional mineralized cancellous allograft chip augmentation",[25,15],{"type":40,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100652562","prospective-study-of-proteios-in-lumbar-interbody-fusion-tlif-100652562",false,"NCT07775729","Prospective Study of ProteiOS in Lumbar Interbody Fusion (TLIF)","Prospective, Multicenter Evaluation of ProteiOS® Allograft Derived Growth Factor in Transforaminal Lumbar Interbody Fusion (TLIF)","Inclusion Criteria\n\n* Age 18-75 years, skeletally mature at time of surgery\n* Degenerative disease of the lumbar spine (L2-S1) requiring 1-2 level instrumented TLIF, with or without posterolateral fusion, as determined by the treating surgeon\n* For the ALIF study site only: degenerative disease of the lumbar spine (L2-S1) requiring 1-2 level instrumented ALIF\n* Radiographic evidence of degenerative lumbar disease on CT, MRI, or plain radiograph (decreased disc height, herniated nucleus pulposus, ligamentum flavum\u002Fannulus hypertrophy, facet arthrosis\u002Fosteophyte, spinal canal or foraminal stenosis, or vertebral translation \\>3 mm)\n* Symptoms of low back pain, radiculopathy, or neurogenic claudication consistent with radiographic findings\n* Preoperative back pain ≥4 on a 0-10 VAS\n* Preoperative leg pain ≥3 on a 0-10 VAS, consistent with radiculopathy or neurogenic claudication\n* Preoperative ODI score ≥30\n* Failure of ≥6 months non-operative treatment (may be waived for progressive neurological deficit, new\u002Fworsening motor weakness, bowel\u002Fbladder dysfunction, or cauda equina syndrome)\n* Willing and able to comply with follow-up schedule and provide written informed consent\n\nExclusion Criteria:\n\n* Scheduled for surgery with synthetic bone grafts containing hydroxyapatite, tricalcium phosphate, or other radio-opaque material\n* BMI \\>40\n* Prior lumbar spine fusion surgery at a level currently scheduled for surgery\n* Malignancy or treatment for malignancy within the last 5 years (benign skin cancer permitted)\n* Osteoporosis\u002Fosteopenia (≤2.5 SD below age-matched mean)\n* Use of rhBMP-2 (Infuse) or other active biologics\n* Active or systemic infection, malignancy, or severe metabolic bone disease\n* Chronic steroid use (\\>10 days)\n* Revision fusion at index levels\n* Participation in another interventional clinical study within 30 days of consent\n* Known pregnancy or intent to become pregnant during the study","ALL","18 Years","75 Years",{"count":52,"type":53},280,"ESTIMATED","INTERVENTIONAL",[56],"NA","This is a prospective, multicenter, randomized, controlled study evaluating Influx™ ProteiOS®, an allograft-derived growth factor product, in transforaminal lumbar interbody fusion (TLIF). Participants undergoing 1- to 2-level TLIF (L2-S1) are randomized 2:1 to receive ProteiOS or a control graft (local bone with optional cancellous chip augmentation, no ProteiOS). The primary objective is to determine whether the 12-month interbody fusion rate (assessed by CT using the Brantigan-Steffee-Fraser classification) with ProteiOS is non-inferior to control, using a 5-percentage-point non-inferiority margin. Patient-reported outcomes (ODI, VAS, EQ-5D-5L), safety, and healthcare utilization are also assessed. A separate exploratory cohort at one study site will evaluate the same outcomes in participants undergoing anterior lumbar interbody fusion (ALIF) with or without ProteiOS, without formal hypothesis testing.",[59,60,61,62,63,64],"Degenerative Disc Disease","Spinal Stenosis Lumbar","Lumbar Spine Fusion","Spondylolisthesis","Spinal Stenosis, Lumbar Region","Transforaminal Lumbar Interbody Fusion",[66,67,68,69,70,71,72,73],"ProteiOS","HCT\u002FP","bone graft","spinal fusion","lumbar interbody fusion","growth factor","allograft","TLIF","NOT_YET_RECRUITING","2026-08-18",{"date":77,"type":78},"2026-08-20","ACTUAL",{"date":80,"type":53},"2026-12",{"date":82,"type":53},"2030-01",{"name":5,"class":6}]