NCT02469662

Clinical Outcomes Study of the Nexel Total Elbow

Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
DEVICE	Nexel Total Elbow	Nexel Total Elbow used in primary or revision total elbow arthroplasty

Timeline

• Start date: 2015-06-01
• Primary completion: 2035-12-01
• Completion: 2036-12-01
• First posted: 2015-06-11
• Last updated: 2025-10-29

Locations

11 sites across 8 countries: United States, Australia, Finland, France, Germany, Italy, Netherlands, United Kingdom

Regulatory

• FDA-regulated device study