Purpose of this Study
This study does not require much extra time from patients, but doctors will check on them closely for two years. People in the study are placed into groups by chance. Two out of every three people will get the new shoulder device, and one out of three will get the regular device that uses a stem.
Who Can Participate?
Eligibility
People can join this study if they are older than 55 years. They must have shoulder arthritis or a rotator cuff tear that cannot be treated in other ways. They cannot join if they have cancer, serious mental health problems, or a chronic pain condition.
Age Range
55-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes
What is Involved?
Description
This study is being done to see if a new stemless reverse shoulder device works as well as or better than the shoulder replacements that are used now. Researchers hope the new device may lead to shorter surgeries, fewer problems, and better results for patients.
Locations
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System
Principal Investigator
Tally
Lassiter
Protocol Number
PRO00117873
NCT ID
NCT06323980
Phase
N/A
Enrollment Status
Pending Open to Enrollment