[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616782":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":77,"collaborators":24,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":24,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":24,"enrollmentInfo":88,"targetDuration":24,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":99,"whyStopped":24,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Autograft","ACTIVE_COMPARATOR","Patients randomized to autograft",[13],"Procedure: Autograft",{"label":15,"type":10,"description":16,"interventionNames":17},"Allograft","Patients randomized to allograft.",[18],"Procedure: Allograft",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Surgeons will decide on the location and method of donor site based on the clinical situation. Most commonly, bone graft will be harvested from the anterior or posterior iliac crest or utilizing the Reamer Irrigator Aspirator in an appropriate long bone. Surgeons may choose to harvest autograft from proximal tibia or distal femur. Donor site location is at the discretion of treating surgeon for patients who randomize to autograft. This treatment arm will not include local autograft only. For large bone defects requiring expansion of autograft with allograft, this will be allowed and recorded. We will use intent-to-treat for statistical analysis of those with allograft expansion of autograft. This autograft will be applied to the nonunion site using the surgeon's typical technique. Internal fixation, revision of fixation, and\u002For augmentation of fixation will be performed at the discretion of the surgeon.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Allograft bone will consist of cancellous or corticocancellous sterile packaged human cadaveric bone. No bone morphogenetic protein, bone marrow aspirate, or other biologic augment will be added. Demineralized bone matrix may be added at the surgeon's discretion. This allograft will be applied to the nonunion site using the surgeon's typical technique. Internal fixation, revision of fixation, and\u002For augmentation of fixation will be performed at the discretion of the surgeon.",[15],[29],{"name":30,"affiliation":5,"role":31},"Joseph R Hsu, MD","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"Christine Churchill","CONTACT","704-355-6947","Christine.Churchill@advocatehealth.org",[39],{"facility":40,"status":24,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Atrium Health Carolinas Medical Center","Charlotte","North Carolina","28203","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-80.84313,35.22709,{"lat":50,"lon":49},[53,57,59,62,64,66,68,70,72,73,75],{"name":54,"role":35,"phone":55,"phoneExt":24,"email":56},"Rachel B Seymour, PhD","704-441-5365","Rachel.Seymour@advocatehealth.org",{"name":58,"role":35,"phone":24,"phoneExt":24,"email":37},"Christine Churchill, MA",{"name":60,"role":61,"phone":24,"phoneExt":24,"email":24},"Madhav Karunakar, MD","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":24,"phoneExt":24,"email":24},"Laurence Kempton, MD",{"name":65,"role":61,"phone":24,"phoneExt":24,"email":24},"Suman Medda, MD",{"name":67,"role":61,"phone":24,"phoneExt":24,"email":24},"Kevin Phelps, MD",{"name":69,"role":61,"phone":24,"phoneExt":24,"email":24},"Sarah Pierrie, MD",{"name":71,"role":61,"phone":24,"phoneExt":24,"email":24},"Sophia Traven, MD",{"name":54,"role":61,"phone":24,"phoneExt":24,"email":24},{"name":74,"role":61,"phone":24,"phoneExt":24,"email":24},"Meghan Wally, PhD",{"name":76,"role":61,"phone":24,"phoneExt":24,"email":24},"Garrett Bullock, MD",{"type":78,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100616782","allograft-vs-autograft-nonunion-100616782",false,"NCT07310082","Allograft vs. Autograft Nonunion","Allograft vs. Autograft to Improve Timely Return to Duty Following Nonunion","Inclusion Criteria:\n\n* Patients 18 years or older\n* Long bone (tibia, femur, and humerus) nonunion appropriate for either study treatment: to be treated with bone graft harvested from a remote site or using reamer harvester (RIA)\n* Nonunion surgery to be performed at least five months after initial fracture fixation\n* Prior operative fixation of fracture\n* Radiographic apparent bone gap (RABG) of \\>5cm\n\nExclusion Criteria:\n\n* Patient that speaks neither English nor Spanish\n* Patients whose treatment plan includes local autograft only (available callus from the nonunion site or no planned bone graft)\n* Known active infection (defined as any clinical signs or symptoms of active infection, such as fevers, wound redness, warmth, swelling, induration or drainage, and abnormal while blood cell count, erythrocyte sedimentation rate, or C-reactive protein) being treated with antibiotics\n* Body mass index greater than 50\n* Patients unlikely to follow-up due to homelessness, or planning follow-up at another institution\n* Prisoner","ALL","18 Years",{"count":89,"type":90},156,"ESTIMATED","INTERVENTIONAL",[93],"NA","The purpose of this research study is to find out if patients treated for nonunion fracture with autograft or allograft return to activity faster.",[96],"Nonunion Fracture",[15,9,98],"Nonunion","NOT_YET_RECRUITING","2026-08-10",{"date":102,"type":103},"2026-08-12","ACTUAL",{"date":105,"type":90},"2026-08",{"date":107,"type":90},"2030-12",{"name":5,"class":6},1]