Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow
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.
• Patient is 18 years of age or older.
• Patient must have signed Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent.
• Patient is a candidate for primary or revision total elbow arthroplasty, based on symptoms including at least one of the following:
‣ Elbow joint destruction which significantly compromises daily living activities
⁃ Post-traumatic lesions or bone loss contributing to elbow instability
⁃ Ankylosed joints, especially cases of bilateral ankylosis from causes other than active sepsis
⁃ Advanced rheumatoid arthritis, post-traumatic, or degenerative arthritis with incapacitating pain
⁃ Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
⁃ Acute comminuted articular fracture of elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
• Patient is willing and able to complete scheduled follow-up evaluations as defined by the protocol.
∙ Additional Retrospective Arm Inclusion Criteria
• Patient must have undergone a total elbow replacement with the Nexel system between July 2013 and the date of the site initiation visit.
• 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.