[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100385462":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":27,"locations":36,"responsibleParty":109,"collaborators":10,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":10,"eligibilityCriteria":117,"healthyVolunteers":113,"sex":118,"minAge":10,"maxAge":10,"enrollmentInfo":119,"targetDuration":122,"studyType":123,"phases":10,"briefSummary":124,"conditions":125,"keywords":133,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"LifeNet Health","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospective Registry",null,"Treatment for diagnoses of long bone non-union involving the tibia or femur and other nonunion diagnosis (i.e. clavicle, humerus, and femur) with Vivigen Cellular Bone Matrix",[13],"Other: Vivigen Cellular Bone Matrix",{"label":15,"type":10,"description":16,"interventionNames":10},"Retrospective Data Collection","Treatment of diagnoses of long bone non-union involving the tibia or femur and other nonunion diagnosis (i.e. clavicle, humerus, and femur) with adjunct bone graft utilized in the acute, delayed, non-union and fusion settings.",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"OTHER","Vivigen Cellular Bone Matrix","Allograft bone matrix",[9],[24],{"name":25,"affiliation":5,"role":26},"Alyce Jones, Ph.D","STUDY_DIRECTOR",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Barry Saxton, P.A.-C.","CONTACT","404 314 4903","barry_saxton@lifenethealth.org",{"name":34,"role":30,"phone":10,"phoneExt":10,"email":35},"Alyce Jones, Ph.D.","alyce_jones@lifenethealth.org",[37,58,76,92],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"OrlandoHealth","RECRUITING","Orlando","Florida","32806","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-81.37924,28.53834,{"lat":49,"lon":48},[52,55],{"name":53,"role":30,"phone":10,"phoneExt":10,"email":54},"David Krol","david.krol@orlandohealth.com",{"name":56,"role":57,"phone":10,"phoneExt":10,"email":10},"M. Kareem Shaath, MD","PRINCIPAL_INVESTIGATOR",{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":43,"countryCode":44,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"RWJBarnabas Health","NOT_YET_RECRUITING","Jersey City","New Jersey","07302",{"type":46,"coordinates":65},[66,67],-74.07764,40.72816,{"lat":67,"lon":66},[70,74],{"name":71,"role":30,"phone":72,"phoneExt":10,"email":73},"Ian Hong, MD candidate","914 671 7325","ian.hong@rwjbh.org",{"name":75,"role":57,"phone":10,"phoneExt":10,"email":10},"Richard Yoon, MD",{"facility":77,"status":39,"city":78,"state":79,"zip":80,"country":43,"countryCode":44,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Duke University Medical Center","Durham","North Carolina","27710",{"type":46,"coordinates":82},[83,84],-78.89862,35.99403,{"lat":84,"lon":83},[87,90],{"name":88,"role":30,"phone":10,"phoneExt":10,"email":89},"Carrigan Creech, BS","carrigan.creech@duke.edu",{"name":91,"role":57,"phone":10,"phoneExt":10,"email":10},"Malcolm DeBaun, MD",{"facility":93,"status":39,"city":94,"state":95,"zip":96,"country":43,"countryCode":44,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Sentara Hospitals","Norfolk","Virginia","23507",{"type":46,"coordinates":98},[99,100],-76.28522,36.84681,{"lat":100,"lon":99},[103,107],{"name":104,"role":30,"phone":105,"phoneExt":10,"email":106},"Susan Steele, RN, CCRC","757 803 3280","srsteel1@Sentara.com",{"name":108,"role":57,"phone":10,"phoneExt":10,"email":10},"Richard Myers, MD",{"type":110,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100385462","safety-efficacy--use-of-vivigen-cellular-bone-matrix-allograft-in-orthopaedic-fracture-care-100385462",false,"NCT04299022","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","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.","ALL",{"count":120,"type":121},250,"ESTIMATED","24 Months","OBSERVATIONAL","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.",[126,127,128,129,130,131,132],"Fractures, Bone","Nonunion of Fracture","Fractures, Open","Fractures, Ununited","Fracture, Tibial","Fracture of Femur","Fracture Arm",[134,135,136],"fracture","nonunion","allograft","2025-03-28",{"date":139,"type":140},"2025-04-02","ACTUAL",{"date":142,"type":140},"2021-06-01",{"date":144,"type":121},"2026-07-31",{"name":5,"class":6},4]