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1111","davide.blonna@virgilio.it",{"name":189,"role":63,"phone":36,"phoneExt":36,"email":36},"Davide Blonna, MD",{"facility":191,"status":192,"city":193,"state":36,"zip":36,"country":194,"countryCode":195,"cosmosGeoPoint":196,"geoPoint":200,"contacts":36},"Amphia Ziekenhuis Breda","ACTIVE_NOT_RECRUITING","Breda","Netherlands","NL",{"type":52,"coordinates":197},[198,199],4.77596,51.58656,{"lat":199,"lon":198},{"facility":202,"status":45,"city":203,"state":36,"zip":36,"country":204,"countryCode":205,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Wrightington","Wigan","United Kingdom","UK",{"type":52,"coordinates":207},[208,209],-2.63706,53.54296,{"lat":209,"lon":208},[212],{"name":213,"role":63,"phone":36,"phoneExt":36,"email":36},"Adam Watts, MBBS",{"type":215,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","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":226,"type":227},134,"ESTIMATED","INTERVENTIONAL",[230],"NA","The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or 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