[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-comminuted-articular-fracture-of-elbow-joint-surfaces\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-comminuted-articular-fracture-of-elbow-joint-surfaces":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":22,"briefSummary":24,"conditions":25,"keywords":36,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100245148","clinical-outcomes-study-of-the-nexel-total-elbow-100245148",false,"NCT02469662","Clinical Outcomes Study of the Nexel Total Elbow","Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow","Inclusion Criteria:\n\n* Patient is 18 years of age or older.\n* Patient must have signed Institutional Review Board (IRB)\u002FEthics Committee (EC)-approved informed consent.\n* Patient is a candidate for primary or revision total elbow arthroplasty, based on symptoms including at least one of the following:\n\n  * Elbow joint destruction which significantly compromises daily living activities\n  * Post-traumatic lesions or bone loss contributing to elbow instability\n  * Ankylosed joints, especially cases of bilateral ankylosis from causes other than active sepsis\n  * Advanced rheumatoid arthritis, post-traumatic, or degenerative arthritis with incapacitating pain\n  * Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis\n  * Acute comminuted articular fracture of elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus\n* Patient is willing and able to complete scheduled follow-up evaluations as defined by the protocol.\n\nAdditional Retrospective Arm Inclusion Criteria\n\n* Patient must have undergone a total elbow replacement with the Nexel system between July 2013 and the date of the site initiation visit.\n* Patient information available for each retrospective patient must, at minimum, include preoperative demographic information, preoperative physical exam information, the index surgery operative report, and details of the devices implanted.\n\nExclusion Criteria:\n\n* Patient has a currently active or history of repeated local infection at the surgical site.\n* Patient has a current major infection distant from the operative site.\n* Patient has a history of prior sepsis.\n* Patient suffers from paralysis or dysfunctional neuropathy at the elbow joint.\n* Patient has significant ipsilateral hand dysfunction.\n* Patient has excessive scarring near the surgical site, which could prevent adequate soft tissue coverage.\n* Patient participates in daily activities that may cause significant stress to an implanted device such as heavy labor, torsional stress, and\u002For competitive sports.\n* Patient is a prisoner.\n* Patient is mentally incompetent or unable to understand what participation in the study entails.\n* Patient is a known alcohol or drug abuser.\n* Patient is anticipated to be non-compliant.\n* Patient is known to be pregnant.","ALL","18 Years",{"count":19,"type":20},134,"ESTIMATED","INTERVENTIONAL",[23],"NA","The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or revision total elbow replacement.",[26,27,28,29,30,31,32,33,34,35],"Elbow Joint Destruction","Post-traumatic Lesions","Ankylosed Joints","Advanced Rheumatoid Arthritis","Joint Instability or Loss of Motion","Acute Comminuted Articular Fracture of Elbow Joint Surfaces","Bone Loss Contributing to Elbow Instability","Bilateral Ankylosis From Causes Other Than Active Sepsis","Post-traumatic Arthritis","Degenerative Arthritis",[37,38,39,40,29,41,35,26,42,28,43,44,45,46,47],"Total Elbow Arthroplasty","TEA","Elbow Arthroplasty","Elbow Replacement","Post-Traumatic Arthritis","Post-Traumatic Lesions or Bone Loss","Acute Comminuted Articular Fracture","Significantly compromises daily living activities","Joint or soft tissue damage","Precludes less radical procedures","13-C3 fractures of the distal humerus","RECRUITING","2025-10-28",{"date":51,"type":52},"2025-10-29","ACTUAL",{"date":54,"type":52},"2015-06",{"date":56,"type":20},"2036-12",{"name":58,"class":59},"Zimmer Biomet","INDUSTRY",11]