Clinical Outcomes Study of the Nexel Total Elbow

Inclusion Criteria:

• 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 onsymptoms 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 otherthan active sepsis

• Advanced rheumatoid arthritis, post-traumatic, or degenerative arthritis withincapacitating pain

• Instability or loss of motion when the degree of joint or soft tissue damageprecludes reliable osteosynthesis

• Acute comminuted articular fracture of elbow joint surfaces that precludes lessradical procedures, including 13-C3 fractures of the distal humerus

• Patient is willing and able to complete scheduled follow-up evaluations as definedby the protocol.

Additional Retrospective Arm Inclusion Criteria

• Patient must have undergone a total elbow replacement with the Nexel system betweenJuly 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 examinformation, the index surgery operative report, and details of the devicesimplanted.

Exclusion Criteria:

• Patient has a currently active or history of repeated local infection at thesurgical site.

• Patient has a current major infection distant from the operative site.

• Patient has a history of prior sepsis.

• Patient suffers from paralysis or dysfunctional neuropathy at the elbow joint.

• Patient has significant ipsilateral hand dysfunction.

• Patient has excessive scarring near the surgical site, which could prevent adequatesoft tissue coverage.

• Patient participates in daily activities that may cause significant stress to animplanted 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 thestudy entails.

• Patient is a known alcohol or drug abuser.

• Patient is anticipated to be non-compliant.

• Patient is known to be pregnant.