Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow
Zimmer Biomet
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.
Description
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 by analysis of standard scoring systems, radiographs, and adverse event records. The safety of the device will be monitored using the frequency and incidence of reporting adverse events. The performance of the device will be evaluated by assessing the pain and functional performance, survival of the device, patient health status, and radiographic success of the implant.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceNexel Total Elbow
Nexel Total Elbow used in primary or revision total elbow arthroplasty
Locations (11)
- Panorama Orthopedics and Spine CenterGolden, Colorado
- OrthoCarolina Research InstituteCharlotte, North Carolina
- Rothman InstitutePhiladelphia, Pennsylvania
- Campbell ClinicGermantown, Tennessee
- Sydney Shoulder & Elbow, NSWSydney, New South Wales
- Coxa HospitalTampere