[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04299022":3,"trial-entities:NCT04299022":143,"trial-summary:NCT04299022":149},{"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":26,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":33,"interventions":36,"primary_outcomes":43,"secondary_outcomes":48,"sex":55,"minimum_age":31,"maximum_age":31,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":62,"locations":66,"central_contacts":129,"overall_officials":137,"references":141,"see_also_links":142},"NCT04299022","CR-20-002","Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care","Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care: A Multi-Center Prospective Registry and Retrospective Data Collection Study","RECRUITING","2026-07-31","2025-03","2025-04-02","2021-06-01","LifeNet Health","INDUSTRY",true,"Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.","The prospective registry study and retrospective data collection study is planned to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.\n\nPatients will be assessed at hospital discharge, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment of a traumatic fracture with a bone graft.",[19,20,21,22,23,24,25],"Fractures, Bone","Nonunion of Fracture","Fractures, Open","Fractures, Ununited","Fracture, Tibial","Fracture of Femur","Fracture Arm",[27,28,29],"fracture","nonunion","allograft","OBSERVATIONAL",null,[],{"count":34,"type":35},250,"ESTIMATED",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41},"OTHER","Vivigen Cellular Bone Matrix","Allograft bone matrix",[42],"Prospective Registry",[44],{"measure":45,"description":46,"timeFrame":47},"Reintervention Rate","the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure","24 months",[49,52],{"measure":50,"description":51,"timeFrame":47},"Fusion Rate","Acute fracture, delayed union or nonunion rate as assessed with radiographs at 6 weeks, 3 months, 6 months, 12 months and 24 months",{"measure":53,"description":54,"timeFrame":47},"Patient Reported Outcome Measurement Information System (PROMIS) Scores","Patient reported outcome measures will be measured via PROMIS scoring tool (mental and physical). The PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population.","ALL",false,{"inclusion":58,"exclusion":60,"raw_text":61},[59],"Any skeletally mature patient treated with Vivigen bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will be eligible for inclusion.",[],"Prospective Cohort Inclusion Criteria:\n\n* Any skeletally mature patient treated with Vivigen bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will be eligible for inclusion.\n\nRetrospective Cohort Inclusion Criteria:\n\n\\- Any skeletally mature patient treated with adjunct bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will eligible for inclusion.\n\nProspective Cohort Exclusion Criteria:\n\n1. Patients unable to understand either an English or Spanish consent will be excluded.\n2. Patients unable to consent secondary to dementia and\u002For other mental\u002Fpsychiatric diagnoses will be excluded.",[63,64,65],"CHILD","ADULT","OLDER_ADULT",[67,84,100,114],{"facility":68,"status":8,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":81},"OrlandoHealth","Orlando","Florida","32806","United States",[74,78],{"name":75,"role":76,"email":77},"David Krol","CONTACT","david.krol@orlandohealth.com",{"name":79,"role":80},"M. Kareem Shaath, MD","PRINCIPAL_INVESTIGATOR",{"lat":82,"lon":83},28.53834,-81.37924,{"facility":85,"status":86,"city":87,"state":88,"zip":89,"country":72,"contacts":90,"geoPoint":97},"RWJBarnabas Health","NOT_YET_RECRUITING","Jersey City","New Jersey","07302",[91,95],{"name":92,"role":76,"phone":93,"email":94},"Ian Hong, MD candidate","914 671 7325","ian.hong@rwjbh.org",{"name":96,"role":80},"Richard Yoon, MD",{"lat":98,"lon":99},40.72816,-74.07764,{"facility":101,"status":8,"city":102,"state":103,"zip":104,"country":72,"contacts":105,"geoPoint":111},"Duke University Medical Center","Durham","North Carolina","27710",[106,109],{"name":107,"role":76,"email":108},"Carrigan Creech, BS","carrigan.creech@duke.edu",{"name":110,"role":80},"Malcolm DeBaun, MD",{"lat":112,"lon":113},35.99403,-78.89862,{"facility":115,"status":8,"city":116,"state":117,"zip":118,"country":72,"contacts":119,"geoPoint":126},"Sentara Hospitals","Norfolk","Virginia","23507",[120,124],{"name":121,"role":76,"phone":122,"email":123},"Susan Steele, RN, CCRC","757 803 3280","srsteel1@Sentara.com",{"name":125,"role":80},"Richard Myers, MD",{"lat":127,"lon":128},36.84681,-76.28522,[130,134],{"name":131,"role":76,"phone":132,"email":133},"Barry Saxton, P.A.-C.","404 314 4903","barry_saxton@lifenethealth.org",{"name":135,"role":76,"email":136},"Alyce Jones, Ph.D.","alyce_jones@lifenethealth.org",[138],{"name":139,"affiliation":13,"role":140},"Alyce Jones, Ph.D","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":144,"biomarkers":148},[145,146,147],"Bone fusion","Fracture","Fracture, ununited",[],{"nct_id":4,"found":15,"summary":150,"prompt_version":160},{"design":151,"status":152,"heading":153,"summary":154,"follow_up":155,"word_count":156,"commitments":157,"compensation":158,"drugs_mentioned":159},"This is an observational study, meaning researchers will collect information from patients who are already receiving ViviGen. It aims to include 250 participants.","completed","Observational Study of ViviGen Cellular Bone Matrix for Fractures","This study is looking at how well ViviGen Cellular Bone Matrix, a type of bone graft (material used to help bones heal), works and if it's safe for people with fractures (broken bones). This includes acute fractures (recent breaks), delayed or ununited fractures (breaks that aren't healing well), and when used in fusion procedures (joining bones together). The study will follow patients who receive ViviGen to see if they need further surgery or treatment related to their fracture over 24 months. Anyone who is skeletally mature (done growing) and receives ViviGen for a fracture or fusion can be included in this study. The current recruitment status is unclear.","Participants will be followed for 24 months after their treatment to see if they need further surgery.",108,"You would be assessed at hospital discharge, then at 6 weeks, 3 months, 6 months, 12 months, and 24 months after your fracture treatment with a bone graft.","Not stated in the trial record.",[39],"v2"]