Zimmer Biomet
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.
Elbow Joint Destruction
Post-traumatic Lesions
Ankylosed Joints
Advanced Rheumatoid Arthritis
Joint Instability or Loss of Motion
Acute Comminuted Articular Fracture of Elbow Joint Surfaces
Bone Loss Contributing to Elbow Instability
Bilateral Ankylosis From Causes Other Than Active Sepsis
Post-traumatic Arthritis
Degenerative Arthritis
Nexel Total Elbow
NA
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 |
Estimated Enrollment : | 134 participants |
Masking : | NONE |
Primary Purpose : | TREATMENT |
Official Title : | Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow |
Actual Study Start Date : | 2015-06 |
Estimated Primary Completion Date : | 2035-12 |
Estimated Study Completion Date : | 2036-12 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Panorama Orthopedics and Spine Center
Golden, Colorado, United States, 80401
RECRUITING
OrthoCarolina Research Institute
Charlotte, North Carolina, United States, 28207
RECRUITING
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
RECRUITING
Campbell Clinic
Germantown, Tennessee, United States, 38138
TERMINATED
Sydney Shoulder & Elbow, NSW
Sydney, New South Wales, Australia, 2067
RECRUITING
Hospital Thigh
Tampere, Finland,
TERMINATED
PURPAN Hospital (Toulouse University Hospital Center)
Toulouse, France,
TERMINATED
Arcus Sportklinik
Pforzheim, Germany,
RECRUITING
Ao mauriziano
Torino, Italy, 10128
ACTIVE NOT RECRUITING
Amphia Hospital Breda
Breda, Netherlands,
RECRUITING
Wrightington
Wigan, United Kingdom,