Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty

Launched by WILLIAM BEAUMONT HOSPITALS · Mar 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different methods of placing a component in the shoulder during a reverse total shoulder replacement surgery. The component helps the shoulder function better after surgery and can be placed in one of two ways: either on top of the upper arm bone (onlay) or inside the bone (inlay). The researchers want to find out if the way the component is placed affects how well patients can move their arm afterward, especially when raising it or turning it.

To participate in this trial, individuals need to be 18 years or older and have specific shoulder conditions, such as arthritis related to a torn rotator cuff. Participants should not have had previous shoulder surgeries or have certain other medical issues that could complicate the procedure. Those who join the study can expect to undergo the surgery, followed by a structured physical therapy program to help with recovery. This trial aims to provide valuable information that could improve shoulder surgery outcomes for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Patients undergoing primary reverse total shoulder arthroplasty with the following components:
• • 1. 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
• • 2. 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 Criteria:
• • 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