Clinical Trial: Clinical Outcomes Study of the Nexel Total Elbow
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow
Brief 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.
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.
Current Primary Outcome: Survivorship [ Time Frame: 10 years ]
Based on removal or intended removal of the device and determined using the Kaplan-Meier method
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Zimmer Biomet
Date Received: June 8, 2015
Date Started: June 2015
Date Completion: December 2028
Last Updated: January 10, 2017
Last Verified: January 2017