[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spinal-trauma-with-neurological-deficit\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spinal-trauma-with-neurological-deficit":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100570258","adult-patient-outcomes-after-spine-surgery-with-fibergraft-bg-puttyviper-prime-100570258",false,"NCT06704906","Adult Patient Outcomes After Spine Surgery With Fibergraft BG Putty\u002FViper Prime","Assess Clinical and Radiographic Outcomes of VIPER PRIME\u002FExpedium Spine System and Fibergraft BG Putty","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Have a radiograph-based diagnosis of degenerative disc disease, spondylolisthesis, spinal trauma (i.e., fracture or dislocation), spinal stenosis, or deformity (i.e., scoliosis, kyphosis, and\u002For lordosis), spinal tumor, or pseudoarthrosis\u002Ffailed fusion.\n3. Pathology of the thoracolumbar or sacral spine.\n4. Patients requiring fusion of 1-3 levels\n5. Patients receiving the surgery\u002Fdevices as standard of care prescribed by the treating physician.\n\nExclusion Criteria:\n\n1. Patients \\\u003C 18 years\n2. Patients with a cervical spine pathology\n3. Patients with spinal tumors\n4. Patients with bone density (DEXA) scores \\\u003C 2.0 will be excluded.\n5. Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded.\n6. Patients with a BMI \\> 40kg\u002Fm2\n7. Patients requiring fusion for more than 3 levels will be excluded","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","The Viper Prime\u002FExpedium spine systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracolumbar and sacral spine. The Fibergraft Bioactive Glass (BG) is engineered to mimic the body's natural bone healing process. While previous studies have compared the use of Viper prime\u002FExpedium spine system in minimally invasive and open surgeries, these studies did not specifically study the clinical and radiographic outcomes of patients who have received these implants in addition to Fibergraft. We aim to recruit patients with degenerative disc disease, spondylolisthesis, trauma, and\u002For pseudarthrosis who require spine surgery under standard of care and use these implants. We will then follow these patients for a duration of two years to report their clinical and radiographic outcomes to determine fusion, complication rate, and revision surgeries if any.",[24,25,26],"Spondylolisthesis, Lumbar Region","Spinal Trauma With Neurological Deficit","Degeneration of Lumbar Intervertebral Disc","RECRUITING","2026-01-20",{"date":30,"type":31},"2026-01-22","ACTUAL",{"date":33,"type":31},"2024-12-20",{"date":35,"type":20},"2029-03-30",{"name":37,"class":38},"Nitin Agarwal","OTHER"]