[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595137":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":30,"collaborators":11,"id":32,"slug":11,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":11,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":11,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":51,"overallStatus":57,"whyStopped":11,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":11},{"fullName":5,"class":6},"Bioretec Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RemeOs™ DrillPin for Fixation of Distal Radius Fractures","EXPERIMENTAL",null,[13],"Device: Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children","This is a first-in-child clinical investigation of a bioresorbable magnesium alloy DrillPin (RemeOs™) for fixation of distal radius fractures in children aged 5 to \\\u003C14 years. The implant is investigational, not CE-marked or FDA-approved, and represents a novel alternative to traditional metallic implants. It gradually degrades in vivo, eliminating the need for removal. The study focuses on safety and feasibility in a pediatric population, supported by preclinical data from a similar Mg-based RemeOs™ Screw. The DrillPin's material and design are intended to support bone healing without growth disturbances, offering a state-of-the-art, bioresorbable solution tailored for growing patients.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Dr Clemens Seidl","CONTACT","+432236 9004","unfallchirurgie@baden.lknoe.at",{"name":27,"role":23,"phone":28,"phoneExt":11,"email":29},"Prof. Dr. Dr. Thomas Klestil","+43 2236 9004 13201","thomas.klestil@moedling.lknoe.at",{"type":31,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100595137",false,"NCT07028541","RemeOs™ DrillPin for Fixation of Distal Radius Fractures in Children","To Evaluate the Feasibility of the Clinical Application of Mg-based RemeOs™ DrillPin for Fixation of Fractures of the Distal Radius in Children From the Age of Over 5 and Under 14.","Inclusion Criteria:\n\n* Distal Radius Fractures\n* Written informed consent of the parent, oral agreement of the patient documented as informant consent of the child\n* Subject and parents have been informed of the nature of the study, agrees to participate and parent signs the approved consent form. • Female patients in childbearing age (female patients who have begun menstruation) perform a pregnancy test prior inclusion\n\nExclusion Criteria:\n\n* Pathological bone lesions (e.g. bone cyst or osteomyelitis)\n* Underlying diseases (kidney diseases, uncontrolled diabetes mellitus)\n* Polytraumatized patients\n* Suspicion of child abuse\n* Inability or unwillingness to give informed consent\n* Multiple fracture (excluding associated ulna fracture)\n* Open Fracture\n* Pregnancy (tested in all female patients who have begun menstruation)","ALL","5 Years","13 Years",{"count":42,"type":43},20,"ESTIMATED","INTERVENTIONAL",[46],"NA","This is a pre-market, single-arm, open-label, monocenter clinical investigation evaluating the safety and performance of the magnesium (Mg)-based bioresorbable RemeOs™ DrillPin for surgical fixation of distal radius fractures in pediatric patients. The study will enroll 20 children aged over 5 and under 14 years to assess implantation success, early safety outcomes, and long-term effects on growth and bone healing.",[49,50],"Fracture Fixation, Internal","Distal Radius Fracture",[52,53,54,55,56],"Distal radius","fracture","RemeOs","DrillPin","Biodegradable Implant","NOT_YET_RECRUITING","2025-06-11",{"date":60,"type":61},"2025-06-19","ACTUAL",{"date":63,"type":43},"2025-09",{"date":65,"type":43},"2027-12",{"name":5,"class":6}]