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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
total shoulder replacement
The CORE Institute
Sun City West, Arizona, United States
Dearborn & Associates Institute for Joint Reconstruction
Menlo Park, California, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Orthopedics Rhode Island
Wakefield, Rhode Island, United States
Adjusted Constant-Murley Score
adjusted Constant Score of 70 or greater, no humeral radiolucency \>2mm or humeral migration/subsidence \>5mm, no revision surgery, no serious device related adverse event
Time frame: 24 months post-operative
no humeral radiolucency >2mm around the humeral component
on review of x-rays, there are no radiolucencies \>2mm around the humeral component
Time frame: 24 months post-operative
no subsidence or migration of the humeral component >5mm
on review of x-rays, there is no subsidence or migration of the humeral component greater than or equal to 5mm
Time frame: 24 months post-operative
no revision
there is no revision of the humeral components
Time frame: 24 months post-operative
no serious device related adverse event
there is no serious device related adverse event reported
Time frame: 24 months post-operative
QuickDASH
measures the ability to complete tasks, absorb forces and severity of symptoms
Time frame: 24 months post-operative
Visual Analog Scale for Pain (VAS)
on 100 point scale where 0 is no pain and 100 is severe pain
Time frame: 24 months post-operative
American Shoulder and Elbow Surgeon (ASES)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Texas Orthopedic Specialists
Bedford, Texas, United States
Carrell Clinic
Dallas, Texas, United States
patient-reported outcomes with questions on function and pain
Time frame: 24 months post-operative
Range of Motion of the shoulder joint
forward and lateral elevation, internal \& external rotation arm at side
Time frame: 24 months