NCT01778777

Safety Study of Univers® Revers Shoulder Prosthesis

Safety, Function and Quality of Life in Patient With Rotator Cuff Tear Arthropathy Treated With the Univers® Revers Shoulder Prosthesis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Schulthess Klinik · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary safety objective is to demonstrate that severe device-related complication (Serious Adverse Device Effect = SADE) occur within 2 years after prosthesis implantation at a rate of less than 2%. Such adverse events include (but are not limited to) revisions due to dislocation or glenoid loosening, septic arthritis and scapular fractures requiring surgical repair.

Detailed description

Reverse shoulder arthroplasty and its principles are still recognized today as the gold standard for treatment of degenerative arthropathy of the shoulder associated with an irreparable tear of the rotator cuff. The new Arthrex Univers® Revers Shoulder Prosthesis shows a large and narrow range of components, whether it is a stem, cup, spacer, inlay or glenosphere. Adjustment can be done in very small steps to match anatomic and biomechanic needs. The Arthrex Univers Revers Shoulder Prosthesis is the only device up to date that can be configured in two different inclination angles without any limitation in component use. This multicentre case-series has the goal to evaluate whether patients with rotator cuff tear arthropathy benefit from the Univers® Revers shoulder prosthesis in terms of low complication risk, as well as high function and quality of life.

Conditions

• Rotator Cuff Tear Arthropathy

Interventions

Type	Name	Description
DEVICE	Universe Reverse Prosthesis	Implantation of an universe reverse prosthesis

Timeline

• Start date: 2013-09-01
• Primary completion: 2019-06-01
• Completion: 2023-04-15
• First posted: 2013-01-29
• Last updated: 2023-04-18

Locations

1 site across 1 country: Switzerland