Purpose of this Study
We are doing this study to find out how well an experimental system for performing total shoulder arthroplasty (shoulder joint replacement) works. The experimental shoulder joint replacement system is called the Shoulder Modular Replacement Stemless Reverse System. We want to know if this system works as well or better than the standard, approved system that is currently used for reverse total shoulder replacement surgeries.
Who Can Participate?
Eligibility
Adults ages 22-80 who:
- Are a candidate for primary total shoulder replacement
- Have a body mass index (BMI) that is less than 40 kg/m2
- Have not had surgery in the affected shoulder within the past 12 months (simple diagnostic procedures are okay)
- Do not have significant loss of function or weakness in their deltoid muscle
For more information about who can join this study, please contact the study team at Sportsmed_Research@dm.duke.edu
- Are a candidate for primary total shoulder replacement
- Have a body mass index (BMI) that is less than 40 kg/m2
- Have not had surgery in the affected shoulder within the past 12 months (simple diagnostic procedures are okay)
- Do not have significant loss of function or weakness in their deltoid muscle
For more information about who can join this study, please contact the study team at Sportsmed_Research@dm.duke.edu
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
This study has 3 periods: screening, surgery, and a follow-up period after surgery.
If you choose to join this study, during the screening period you will:
- Visit our clinic once
- Have a physical exam
- Perform a variety of strength and function tests for your affected shoulder
- Have images taken of your shoulder joint (CT and X-ray)
If you are found to be eligible after screening, we will schedule you for surgery. Before your surgery, you will:
- Be randomly assigned (fair, 50/50 chance) to 1 of 2 groups
-- One group will have reverse total shoulder replacement done using the experimental system
-- The other group will have reverse total shoulder replacement done using the standard system
The follow-up period begins once you return home from your surgery. You will begin a physical rehabilitation program for your shoulder, and we will schedule you to visit our clinic from time to time. During these follow-up visits, you will:
- Have physical exams
- Perform a variety of strength and function tests for your replaced shoulder
- Have images taken (CT and X-ray)
The follow-up period after surgery will last for approximately 2 years.
If you choose to join this study, during the screening period you will:
- Visit our clinic once
- Have a physical exam
- Perform a variety of strength and function tests for your affected shoulder
- Have images taken of your shoulder joint (CT and X-ray)
If you are found to be eligible after screening, we will schedule you for surgery. Before your surgery, you will:
- Be randomly assigned (fair, 50/50 chance) to 1 of 2 groups
-- One group will have reverse total shoulder replacement done using the experimental system
-- The other group will have reverse total shoulder replacement done using the standard system
The follow-up period begins once you return home from your surgery. You will begin a physical rehabilitation program for your shoulder, and we will schedule you to visit our clinic from time to time. During these follow-up visits, you will:
- Have physical exams
- Perform a variety of strength and function tests for your replaced shoulder
- Have images taken (CT and X-ray)
The follow-up period after surgery will last for approximately 2 years.
Locations
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Randomized, Multi-Center, Prospective, Safety and Efficacy Study comparing the outcome of total reverse shoulder arthroplasty (RSA) with SMR Stemless Reverse vs SMR Reverse Shoulder System
Principal Investigator
Oke
Anakwenze
Protocol Number
PRO00107397
NCT ID
NCT04697004
Phase
N/A
Enrollment Status
OPEN TO ACCRUAL