NCT03806842

Easytech Reversed Shoulder System Clinical Study

Pivotal, Non-Randomized, Historically Controlled, Prospective, Multi-Center Clinical Study of the Easytech Reversed Shoulder System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: FX Shoulder Solutions · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to collect data to demonstrate the safety and effectiveness of the Easytech Reversed Shoulder System for the treatment of patients who require a reverse total shoulder arthroplasty.

Detailed description

The clinical study will enroll patient who require a reverse total shoulder arthroplasty as a result of osteoarthritis, post-traumatic arthritis, avascular necrosis and have a massive and non-repairable rotator cuff tear and a functional deltoid muscle. If patients meet the eligibility criteria, evaluations and x-rays will be completed pre-operatively and post-operatively out to 24 months.

Conditions

• Osteo Arthritis Shoulders
• Avascular Necrosis of the Head of Humerus
• Rotator Cuff Tear

Interventions

Type	Name	Description
DEVICE	Easytech group	total shoulder replacement

Timeline

• Start date: 2018-11-28
• Primary completion: 2024-12-28
• Completion: 2024-12-28
• First posted: 2019-01-16
• Last updated: 2023-09-28

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study