NCT04507880

A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Signe Rosner Rasmussen · Academic / Other
• Sex: All
• Age: 65 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluated the efficacy and safety of the reverse total shoulder prosthesis (RTSA) for complex proximal humerus fractures. The clinical results of RTSA will be compared to clinical results from a historical cohort, that received a hemiarthroplasty of the shoulder.

Conditions

• Shoulder Fractures

Interventions

Type	Name	Description
DEVICE	Reverse Total Shoulder Arthroplasty	The RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes.
DEVICE	Hemiarthroplasty	The shoulder hemiarthroplasty

Timeline

• Start date: 2020-08-01
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2020-08-11
• Last updated: 2020-08-11

Regulatory

• FDA-regulated device study