[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06704906":3,"trial-entities:NCT06704906":84,"trial-summary:NCT06704906":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":17,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":33,"secondary_outcomes":38,"sex":46,"minimum_age":47,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":48,"std_ages":52,"locations":55,"central_contacts":71,"overall_officials":78,"references":82,"see_also_links":83},"NCT06704906","STUDY24040006","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","RECRUITING","2029-03-30","2026-01","2026-01-22","2024-12-20","Nitin Agarwal","OTHER",false,"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.",null,[19,20,21],"Spondylolisthesis, Lumbar Region","Spinal Trauma With Neurological Deficit","Degeneration of Lumbar Intervertebral Disc",[],"OBSERVATIONAL",[],{"count":26,"type":27},100,"ESTIMATED",[29],{"type":30,"name":31,"description":32},"DEVICE","Use of Viper Prime\u002FExpedium system with Fibergraft BG Putty","Patients who require spine surgery under standard of care and meet the inclusion and exclusion criteria identified, will be recruited from clinic. Consent for participation in study will be signed at the same time as consent for surgery. All PROMs and scans will be done as standard of care and data will be obtained through chart review for this study.",[34],{"measure":35,"description":36,"timeFrame":37},"Fusion","We will assess fusion with regular x-rays and CT scans at 1 and 2-year postoperatively.","2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)",[39,42,44],{"measure":40,"description":41,"timeFrame":37},"Visual Analog Scale (VAS)","We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively",{"measure":43,"description":41,"timeFrame":37},"Oswestry Disability Index (ODI)",{"measure":45,"description":41,"timeFrame":37},"Short form survey-12","ALL","18 Years",{"inclusion":49,"exclusion":50,"raw_text":51},[],[],"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",[53,54],"ADULT","OLDER_ADULT",[56],{"facility":57,"status":8,"city":58,"state":59,"zip":60,"country":61,"contacts":62,"geoPoint":68},"University of Pittsburgh Medical Center","Pittsburgh","Pennsylvania","15213","United States",[63],{"name":64,"role":65,"phone":66,"email":67},"Rida Mitha","CONTACT","3147327092","mithar@upmc.edu",{"lat":69,"lon":70},40.44062,-79.99589,[72,76],{"name":73,"role":65,"phone":74,"email":75},"Nitin Agarwal, MD","9085311947","nitin.agarwal@upmc.edu",{"name":77,"role":65,"phone":66,"email":67},"Rida Mitha, MD",[79],{"name":73,"affiliation":80,"role":81},"University of Pittsburgh","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":85,"biomarkers":94},[86,87,88,89,90,91,92,93],"Intervertebral Disc Degenerative Disorder","Kyphosis","Lordosis","Pseudoarthrosis","Scoliosis","Spinal Stenosis","Spinal Trauma","Spondylolisthesis",[],{"nct_id":4,"found":96,"summary":97,"prompt_version":106},true,{"design":98,"status":99,"heading":6,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is an observational study aiming to enroll 100 participants. It will look at how patients recover after receiving a specific surgical device and putty.","completed","This observational study is looking at how well adult patients do after spine surgery when doctors use the Viper Prime\u002FExpedium system along with Fibergraft BG Putty. This putty is designed to help your body's natural bone healing. You might be able to join if you are 18 or older and need spine fusion surgery for conditions like degenerative disc disease, spondylolisthesis (a spinal condition where one vertebra slips forward over another), or spinal trauma. The main goal is to see if your spine fuses (heals together) successfully over two years. The current recruitment status is unclear.","Participants will be followed for two years after surgery to assess fusion.",96,"You will be recruited from the clinic and consent for the study will be signed at the same time as consent for surgery. Follow-up appointments will occur at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery.","Not stated in the trial record.",[],"v2"]