Clinical Outcomes Study of the Nexel Total Elbow (NCT02469662) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Outcomes Study of the Nexel Total Elbow
United States, Australia134 participantsStarted 2015-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 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.
Exclusion Criteria:
* Patient has a …