NCT01790113

Arthrex Eclipse™ Shoulder Prosthesis

A Prospective, Randomized, Multicenter Study Comparing the Safety and Effectiveness of Arthrex's Eclipse™ Shoulder Prothesis to the Univers™ II Shoulder Prosthesis in Patients With a Degenerative Joint Disease

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Arthrex, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

A Prospective, Randomized, Multicenter Study comparing the Safety and Effectiveness of Arthrex's Eclipse™ Shoulder to the Univers™ II Shoulder Prosthesis in patients with a degenerative joint disease.

Detailed description

The purpose of this study is to demonstrate non-inferiority of the Arthrex Eclipse™ Shoulder Prosthesis to the Arthrex Univers™ II Shoulder Prosthesis for the treatment of degenerative joint disease in subjects who are candidates for total shoulder replacement. Non-inferiority in terms of safety and effectiveness will be measured by a 2 year composite clinical success (CCS) that requires functional improvement, radiographic success, absence of reoperations and revision, and lack of serious device-related adverse events.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Univers™	Control
DEVICE	Eclipse™ Total Shoulder Replacement	Investigational

Timeline

• Start date: 2013-02-04
• Primary completion: 2019-06-07
• Completion: 2019-06-07
• First posted: 2013-02-13
• Last updated: 2021-02-03
• Results posted: 2021-01-29

Locations

16 sites across 1 country: United States