Clinical Outcomes Study of the Nexel Total Elbow
Start Date
6/1/2015
Completion Date
12/1/2036
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.
Detailed 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 Criteria
Age Range: 18 years to No maximum
Interventions
Nexel Total Elbow
Conditions
Locations
Panorama Orthopedics and Spine Center
Golden, Colorado 80401
United States
OrthoCarolina Research Institute
Charlotte, North Carolina 28207
United States
Rothman Institute
Philadelphia, Pennsylvania 19107
United States
Campbell Clinic
Germantown, Tennessee 38138
United States
Sydney Shoulder & Elbow, NSW
Sydney, New South Wales 2067
Australia
Coxa Hospital
Tampere,
Finland
Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)
Toulouse,
France
Arcus Sportklinik
Pforzheim,
Germany
AO Mauriziano
Torino, 10128
Italy
Amphia Ziekenhuis Breda
Breda,
Netherlands
Wrightington
Wigan,
United Kingdom