Status:
RECRUITING
Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty
Lead Sponsor:
Corewell Health East
Collaborating Sponsors:
Stryker Nordic
Conditions:
Arthritis Shoulder
Rotator Cuff Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this study is to compare the effect of different ways to place the component that goes at the top of the humerus (upper arm) in reverse total shoulder replacement. Some surgeons place the ...
Detailed Description
This study aims to determine if active external rotation two years postoperatively varies based on whether an inlay or onlay humeral component is used in reverse shoulder arthroplasty (RTSA). The stud...
Eligibility Criteria
Inclusion
- Patients undergoing primary reverse total shoulder arthroplasty with the following components:
- Onlay group: Ascend Flex stem, Perform Reversed standard +3 lateralized 25mm baseplate with standard 36 mm glenosphere or +6 lateralized 25mm baseplate with 39mm glenosphere
- Inlay group: Perform Stem Reverse, Perform Reversed +3 lateralized 25mm baseplate with standard 36mm glenosphere or +6 lateralized 25mm baseplate with 39mm glenosphere
- Diagnosis of cuff tear arthropathy, massive cuff tear, or primary osteoarthritis with cuff tear
- Negative external rotation lag sign, ability to externally rotate beyond neutral
- Age 18 years or older
Exclusion
- Revision arthroplasty
- Prior open shoulder surgery
- Concomitant tendon transfer (Latissimus Dorsi, Pectoralis Tendon, Lower Trapezius)
- Diagnosis of rheumatoid arthritis, infection, acute trauma or instability
- Patients not willing to undergo a standardized physical therapy protocol or home therapy program after surgical intervention
- Patient anatomy does not accommodate the study implants per surgeon discretion
- Pregnant, patient-reported
- Minors (under 18 years of age)
- Cognitively impaired based on a diagnosis of dementia, psychiatric disorder, or any cognitive deficit that will not allow for proper informed consent or answering of study questionnaires
Key Trial Info
Start Date :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT05297305
Start Date
October 20 2023
End Date
December 1 2025
Last Update
November 4 2024
Active Locations (1)
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1
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073