Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty

Stopped early · Not applicable

Conditions studied: Arthritis Shoulder, Rotator Cuff Injuries

In brief

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 humeral tray component sitting on the bone while others place it in the bone. Changing the way that the humeral component is placed may change how much the arm can raise up or turn out/in after surgery for some patients. This study compares patients with inlay humeral component (tray sits in the upper arm bone) versus onlay humeral component (tray sits on top of the upper arm bone) to see if there are differences in range of motion or function after surgery.

Key facts

Study ID

NCT05297305

Run by

Corewell Health East

People needed

19

Starts

2023-10-20

Expected to finish

2025-11-24

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• William Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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