[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634199":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":41,"responsibleParty":60,"collaborators":40,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":40,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":95,"overallStatus":109,"whyStopped":40,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Children's Fractures Interest Group, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bioabsorbable intramedullary nail (BIN)","EXPERIMENTAL","Children in this arm receive surgical fixation with a bioabsorbable intramedullary nail, followed by above-elbow cast immobilization for 4 weeks.",[13],"Device: Bioabsorbable intramedullary nail",{"label":15,"type":16,"description":17,"interventionNames":18},"Titanium elastic nail (TEN)","ACTIVE_COMPARATOR","Children in this arm receive surgical fixation with a titanium elastic intramedullary nail, followed by above-elbow cast immobilization for 2 weeks.",[19],"Device: Titanium elastic intramedullary nail",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Bioabsorbable intramedullary nail","Bioabsorbable intramedullary: Surgical fixation of the forearm fracture with a bioabsorbable intramedullary nail made of PLGA (poly\\[lactic-co-glycolic acid\\]), performed under general anesthesia, followed by above-elbow cast immobilization for 4 weeks. The implant is designed to retain strength during early healing and gradually absorb over time, so routine implant removal is not planned.",[9],[27],"Activa IM-Nail™",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Titanium elastic intramedullary nail","Titanium elastic intramedullary nail arm: surgical fixation of the forearm fracture with a titanium elastic intramedullary nail, performed under general anesthesia, followed by above-elbow cast immobilization for 2 weeks. In Denmark, later elective implant removal is standard practice.",[15],[33,34],"Titanium Elastic Nail System","TEN",[36],{"name":37,"affiliation":38,"role":39},"Morten J Andersen, MD","Copenhagen University Hospital at Herlev","PRINCIPAL_INVESTIGATOR",null,[42],{"facility":43,"status":40,"city":44,"state":40,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Copenhagen University Hospital - Herlev","København NV","2400","Denmark","DK",{"type":49,"coordinates":50},"Point",[51,52],12.52343,55.71258,{"lat":52,"lon":51},[55,59],{"name":37,"role":56,"phone":57,"phoneExt":40,"email":58},"CONTACT","004526148624","mortenjonandersen@gmail.com",{"name":37,"role":39,"phone":40,"phoneExt":40,"email":40},{"type":39,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":38,"oldNameTitle":40,"oldOrganization":40},"Morten Jon Andersen","Head of Pediatric Trauma","100634199","time-to-healing-in-displaced-pediatric-diaphyseal-forearm-fractures-treated-with-bioabsorbable-compared-to-titanium-intramedullary-nails-100634199",false,"NCT07536581","Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails","Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails: A Single-Center, Multi-Blinded, Randomized Parallel-Group, Non-Inferiority Study","FOREST","Inclusion Criteria:\n\n* Diagnosis of a traumatic diaphyseal forearm fracture of the radius, ulna, or both\n* Operative fixation required\n* Fractures must be complete (not unicortical or greenstick) AND displaced \\>50% of bone width (after attempted closed reduction) AND\u002FOR angulated \\>10° in any plane (after attempted closed reduction)\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Conditions where internal fixation is contraindicated (e.g. active or potential infection)\n* Grossly open fractures (Gustilo Anderson grade \\> 2)\n* Fracture occurred more than 2 weeks prior\n* Fractures that are well managed conservatively (undisplaced or minimally displaced)\n* Previous ipsilateral forearm fracture (risk of closed medullary canal)\n* Fractures unsuited for intramedullary nailing (e.g. multifragmentary, metaphyseal or epiphyseal)\n* Concurrent ipsilateral wrist or elbow involvement (e.g. Monteggia or Galeazzi variants)\n* Unable to participate in follow-up\n* Existing bone pathology (e.g. tumor, osteogenesis imperfecta, degenerative disease)\n* Participation in any other medical device or medicinal product study within the previous month that could influence in opinion of the PI the results of the present study\n\nIntraoperative exclusion criteria:\n\n* Fractures suitable for closed reduction and casting (see 6.3.9)\n* Indication for treatment 1 (BIN) only\n* Indication for treatment 2 (ESIN) only\n* Intraoperative decision to use implants other than the devices under investigation","ALL","3 Years","13 Years",{"count":75,"type":76},60,"ESTIMATED","INTERVENTIONAL",[79],"NA","This study looks at children with forearm fractures that need surgery. The standard treatment uses titanium nails, which usually need to be removed in a second operation later. This study compares titanium nails with bioabsorbable nails, which gradually dissolve in the body and may help some children avoid another operation.\n\nThe study will compare how quickly the fractures heal on X-ray, and also look at complications, recovery, function, and the family's experience. Children who need surgery will be randomly assigned to one of the two treatments so the comparison is fair.\n\nHypothesis: The researchers expect that fractures treated with bioabsorbable nails will heal almost as quickly as fractures treated with titanium nails, while reducing the need for later implant removal surgery.",[82,83,84,85,86,87,88,89,90,91,92,93,94],"Forearm Injuries","Radius Fractures","Ulna Fractures","Fractures, Bone","Child","Adolescent","Fracture Fixation, Intramedullary","Internal Fixation","Orthopedic Operations","Polymers","Fracture Healing","Radiography","Randomized Controlled Trial (RCT)",[94,96,97,98,99,100,101,34,102,103,104,105,106,107,108],"pediatric forearm fracture","forearm shaft fracture in children","elastic stable intramedullary nailingelastic stable intramedullary nailing","ESIN","titanium elastic nail","bioabsorbable intramedullary nail","BIN","radiographic healing","radiographic union","modified Radiographic Union Score","mRUS","non-inferiority trial","randomized trial","NOT_YET_RECRUITING","2026-04-17",{"date":112,"type":113},"2026-04-22","ACTUAL",{"date":115,"type":76},"2026-04",{"date":117,"type":76},"2031-12",{"name":5,"class":6},1]