Clinical Outcomes Study of the Nexel Total Elbow

Prior treatment

• Patient has a history of prior sepsis.
• Patient has excessive scarring near the surgical site, which could prevent adequate soft tissue coverage.
• Patient is a known alcohol or drug abuser.

Other illness

• Patient has a currently active or history of repeated local infection at the surgical site.
• Patient has a current major infection distant from the operative site.

Other

• Patient suffers from paralysis or dysfunctional neuropathy at the elbow joint.
• Patient has significant ipsilateral hand dysfunction.
• Patient participates in daily activities that may cause significant stress to an implanted device such as heavy labor, torsional stress, and/or competitive sports.
• Patient is a prisoner.
• Patient is mentally incompetent or unable to understand what participation in the study entails.
• Patient is anticipated to be non-compliant.
• Patient is known to be pregnant.

• 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.