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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
Nexel Total Elbow used in primary or revision total elbow arthroplasty
Panorama Orthopedics and Spine Center
Golden, Colorado, United States
RECRUITINGOrthoCarolina Research Institute
Charlotte, North Carolina, United States
RECRUITINGRothman Institute
Philadelphia, Pennsylvania, United States
RECRUITINGCampbell Clinic
Germantown, Tennessee, United States
RECRUITINGSydney Shoulder & Elbow, NSW
Sydney, New South Wales, Australia
TERMINATEDCoxa Hospital
Tampere, Finland
RECRUITINGHôpital Purpan (Centre Hospitalier Universitaire Toulouse)
Toulouse, France
TERMINATEDArcus Sportklinik
Pforzheim, Germany
TERMINATEDAO Mauriziano
Torino, Italy
RECRUITINGAmphia Ziekenhuis Breda
Breda, Netherlands
ACTIVE_NOT_RECRUITING...and 1 more locations
Survivorship
Based on removal or intended removal of the device and determined using the Kaplan-Meier method
Time frame: 10 years
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