[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100245148":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":31,"locations":42,"responsibleParty":206,"collaborators":36,"id":208,"slug":36,"hasResults":209,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":36,"eligibilityCriteria":213,"healthyVolunteers":209,"sex":214,"minAge":215,"maxAge":36,"enrollmentInfo":216,"targetDuration":36,"studyType":219,"phases":220,"briefSummary":222,"conditions":223,"keywords":234,"overallStatus":45,"whyStopped":36,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},{"fullName":5,"class":6},"Zimmer Biomet","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Retrospective","EXPERIMENTAL","Patients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and who have surgical 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Spine Center","RECRUITING","Golden","Colorado","80401","United States",{"type":51,"coordinates":52},"Point",[53,54],-105.2211,39.75554,{"lat":54,"lon":53},[57,60],{"name":58,"role":34,"phone":36,"phoneExt":36,"email":59},"Paul Lee","Paul.Lee@panoramaortho.com",{"name":61,"role":62,"phone":36,"phoneExt":36,"email":36},"David Schneider, MD","PRINCIPAL_INVESTIGATOR",{"facility":64,"status":45,"city":65,"state":66,"zip":67,"country":49,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"OrthoCarolina Research Institute","Charlotte","North Carolina","28207",{"type":51,"coordinates":69},[70,71],-80.84313,35.22709,{"lat":71,"lon":70},[74,78,82,84],{"name":75,"role":34,"phone":76,"phoneExt":36,"email":77},"Caleb Lifsey","704-323-2262","Caleb.Lifsey@orthocarolina.com",{"name":79,"role":34,"phone":80,"phoneExt":36,"email":81},"Justin Norwood","704-323-3845","Justin.Norwood@orthocarolina.com",{"name":83,"role":62,"phone":36,"phoneExt":36,"email":36},"Nady Hamid, 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MD",{"facility":185,"status":186,"city":187,"state":36,"zip":36,"country":188,"cosmosGeoPoint":189,"geoPoint":193,"contacts":36},"Amphia Ziekenhuis Breda","ACTIVE_NOT_RECRUITING","Breda","Netherlands",{"type":51,"coordinates":190},[191,192],4.77596,51.58656,{"lat":192,"lon":191},{"facility":195,"status":45,"city":196,"state":36,"zip":36,"country":197,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Wrightington","Wigan","United Kingdom",{"type":51,"coordinates":199},[200,201],-2.63706,53.54296,{"lat":201,"lon":200},[204],{"name":205,"role":62,"phone":36,"phoneExt":36,"email":36},"Adam Watts, MBBS",{"type":207,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","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":217,"type":218},134,"ESTIMATED","INTERVENTIONAL",[221],"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.",[224,225,226,227,228,229,230,231,232,233],"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",[235,236,237,238,227,239,233,224,240,226,241,242,243,244,245],"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","2025-10-28",{"date":248,"type":249},"2025-10-29","ACTUAL",{"date":251,"type":249},"2015-06",{"date":253,"type":218},"2036-12",{"name":5,"class":6},11]