[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"distal-humerus-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:distal-humerus-fracture":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100652309","clinical-outcomes-after-treatment-of-distal-humerus-fractures-with-the-lorraine-2535-mm-distal-humerus-system-100652309",false,"NCT07774091","Clinical Outcomes After Treatment of Distal Humerus Fractures With the LORRAINE 2.5\u002F3.5 mm Distal Humerus System","LORRAINE 2.5\u002F3.5 mm Distal Humerus System - Post-Market Surveillance Study","Inclusion Criteria:\n\n* Patient must be 18 years of age or older\n* Patient must have a distal humerus fracture requiring surgical intervention and be eligible for fixation by locking plate and screws\n* Patient must have a fracture pattern requiring a minimum construct of the medial and posterolateral plates. Additional fragment plates may be used in addition as necessary.\n* Unilateral or bilateral fractures.\n* Patient must be capable of understanding the doctor's explanation, following the doctor's instruction, is able to and willing to complete the protocol required followup.\n* Patient must have a signed IRB-approved informed consent.\n\nExclusion Criteria:\n\n* Active infection\n* Patients presenting conditions including blood supply limitations, insufficient quantity or quality of bone\n* Foreign body sensitivity where material sensitivity is suspected; testing is to be completed prior to implantation of the device.\n* Uncontrolled diabetes mellitus (e.g., investigator judgment or HbA1c above locally accepted surgical threshold).\n* Current systemic immunosuppressive therapy or known immunodeficiency that may impair healing or increase infection risk.\n* Morbid obesity (BMI ≥ 35 kg\u002Fm²) where, in the investigator's opinion, surgical risk or outcome assessment may be compromised.\n* Patient known to be pregnant or breastfeeding.\n* Patient is a current alcohol or drug abuser.\n* Severe psychiatric disorder or cognitive impairment interfering with informed consent, protocol compliance, or follow-up.\n* Likely problems with maintaining follow-up program (e.g., patient with no fixed address, long distance, plans to move during the course of study).\n* Not expected to survive the duration of the follow-up program.\n* Revision procedure at the target site (i.e., not a primary procedure).","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","Distal humerus fractures are fractures of the lower part of the upper arm bone near the elbow. These fractures often require surgery using plates and screws to stabilize the bone while it heals.\n\nThis observational study will evaluate adults with distal humerus fractures who are treated with the LORRAINE 2.5\u002F3.5 mm Distal Humerus System as part of routine clinical care. The study does not assign or change the treatment selected by the treating surgeon.\n\nUp to 100 participants will be enrolled and followed for up to 12 months after surgery. The study will evaluate radiographic and clinical fracture healing. It will also assess elbow function, range of motion, quality of life, pain, adverse events, radiographic findings, and reoperations.",[24,25],"Intra-Articular or Extra-Articular Distal Humerus Fracture","Distal Humerus Fracture",[25,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Elbow Fracture","Distal Humerus Fracture Fixation","Open Reduction and Internal Fixation","Internal Fixation","Locking Plate Fixation","Distal Humerus Plating","LORRAINE Distal Humerus System","Fracture Healing","Fracture Union","Elbow Range of Motion","Mayo Elbow Performance Score","EQ-5D-5L","Post-Market Surveillance","Distal Humerus Locking Plate System","NOT_YET_RECRUITING","2026-08-20",{"date":44,"type":45},"2026-08-21","ACTUAL",{"date":47,"type":20},"2026-09",{"date":49,"type":20},"2028-04",{"name":51,"class":52},"Bonebridge AG","INDUSTRY",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":66,"conditions":67,"keywords":73,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":95},"100625954","easy-algorithm-trial-elbow-trauma-assessment-using-sonography-in-children-and-youth-diagnostic-accuracy-and-safety-of-point-of-care-ultrasound-as-a-screening-tool-for-suspected-elbow-fractures-in-children-aged-5-to-15-years-a-multicenter-prospective-cohort-study-100625954","NCT07429344","EASY Algorithm Trial (Elbow Trauma Assessment Using Sonography in Children and Youth) Diagnostic Accuracy and Safety of Point-of-care Ultrasound as a Screening Tool for Suspected Elbow Fractures in Children Aged 5 to 15 Years: a Multicenter Prospective Cohort Study","EASY Algorithm Trial (Elbow Trauma Assessment Using Sonography in Children and Youth) Diagnostic Accuracy and Safety of Point-of-care Ultrasound as a Screening Tool for Suspected Elbow Fractures in Children Aged 5 to 15 Years: a Multicenter Prospective Cohort Study by the German Section for Pediatric Traumatology (SKT)","EASY Algorithm","Inclusion Criteria:\n\n* children and adolescents aged 5-15 years with anamnestic and clinically justified need for the exclusion of a fracture after elbow trauma\n\nExclusion Criteria:\n\n* elbow trauma as part of a polytrauma,\n* parents' insufficient German language skills (spoken or written),\n* trauma more than 72 hours ago,\n* presentation at the emergency room with current, post-traumatic external X-ray images of the affected elbow joint from another clinic or practice,\n* open fracture of the affected elbow joint,\n* skin avulsion of the affected elbow joint,\n* visible deformity of the affected elbow joint,\n* and pathological status of peripheral circulation, motor function, and\u002For sensitivity.","5 Years","15 Years",{"count":65,"type":20},543,"The goal of this observational study is to learn about the safety and accuracy of ultrasound as a screening tool to detect broken bones (fractures) in the elbow area in children and youth aged 5 to 15 years. The main question it aims to answer is:\n\n\\- Can ultrasound reliably show that there is a fracture in the elbow area after an accident?\n\nParticipants will:\n\n* Have an ultrasound of their elbow to look for fluid in the joint.\n* Have standard X-rays of their elbow to check if there is a fracture.\n* Have their medical records checked and answer a phone call 6 weeks later to see how their elbow has healed (only if no fracture was found during the first visit).",[68,25,69,70,71,72],"Elbow Fractures","Pediatric Trauma","Radius Fracture","Olecranon Fracture","Supracondylar Humerus Fracture",[74,75,76,77,78,79,80,81,82,83],"EASY Algorithm Trial","pediatric trauma","Diagnostic accuracy","point-of-care ultrasound","elbow fractures","children","Elbow Trauma Assessment using Sonography in Children and Youth","German Section for Pediatric Traumatology (SKT)","screening tool","supracondylar humerus fracture","RECRUITING","2026-04-02",{"date":87,"type":45},"2026-04-08",{"date":89,"type":45},"2026-03-02",{"date":91,"type":20},"2027-01-15",{"name":93,"class":94},"Timo Munz","OTHER",13,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":103,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":53},"100375030","elbow-hemiarthroplasty-versus-orif-for-distal-humeral-fractures-100375030","NCT04163172","Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures","Elbow Hemiarthroplasty Versus Open Reduction and Internal Fixation for AO\u002FOTA Type C2 and C3 Fractures of Distal Humerus in Patients Aged 50 Years or Above; a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Distal humeral fracture AO\u002FOTA type C2 or C3 confirmed by plain radiographs with 2 perpendicular views and CT scan.\n2. ASA score 1-3 and physically fit for surgery.\n3. Age of 50 years or above.\n\nExclusion Criteria:\n\n1. Patients unable to follow the rehabilitation protocol or answer the Danish questionnaires because of physical or cognitive inabilities as evaluated by the recruiting surgeon.\n2. Significant elbow osteoarthritis as evaluated by the recruiting surgeon based on plain radiographs and CT scan.\n3. Fractures that are older than 6 weeks.\n4. Other associated elbow fractures.\n5. Pathological fractures or relevant elbow pathology.","50 Years",{"count":105,"type":20},44,"INTERVENTIONAL",[108],"NA","This is a randomized control trial comparing the outcome of ORIF (open reduction and internal fixation) with EHA (elbow hemiarthroplasty) for distal humeral fractures in patients aged 50 years or above.",[25,111,112],"Comminuted Fracture","Intra-Articular Fractures","2023-10-05",{"date":115,"type":45},"2023-10-06",{"date":117,"type":45},"2020-02-01",{"date":119,"type":20},"2032-12-31",{"name":121,"class":94},"Herlev and Gentofte Hospital"]