Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty

NCT ID: NCT05297305

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2025-11-24

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 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.

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 study also aims to determine whether active forward elevation, abduction, scapular notching, and functional outcomes two years postoperatively vary based on whether an inlay or onlay humeral component is used in reverse shoulder arthroplasty. Patients undergoing primary RTSA by Dr. J. Michael Wiater, Dr. Brett Wiater, or Dr. Alexander Martusiewicz at Beaumont Health will be screened for eligibility. Following informed consent, participants will be randomised (1:1) to one of the following groups: 1) RTSA with inlay humeral component (Tornier Perform Stem Reverse+) or 2) RTSA with onlay humeral component (Tornier Ascend Flex stem). At baseline, participants will complete study questionnaires, receive a range-of-motion (ROM) exam, and standard of care x-rays and computed tomography (CT) scans. These evaluations will be repeated at 3 months, 12 months and 24 months.

Conditions

Arthritis Shoulder; Rotator Cuff Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Onlay Component-Tornier Ascend Flex stem

Reverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus)

Group Type: ACTIVE_COMPARATOR

Tornier Ascend Flex stem

Intervention Type: DEVICE

Reverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus)

Inlay Component-Tornier Perform Stem Reverse+

Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus)

Group Type: ACTIVE_COMPARATOR

Tornier Perform Stem Reverse+

Intervention Type: DEVICE

Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus)

Interventions

Tornier Ascend Flex stem

Reverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus)

Intervention Type: DEVICE

Tornier Perform Stem Reverse+

Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Nordic

INDUSTRY

Sponsor Role: collaborator

Corewell Health East

OTHER

Sponsor Role: lead

Responsible Party

Dr. Alex Martusiewicz

staff physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alex Martusiewicz, MD

Role: PRINCIPAL_INVESTIGATOR

Beaumont Health

Locations

William Beaumont Hospital

Royal Oak, Michigan, United States

Countries

United States

Other Identifiers

2022-000

Identifier Type: -

Identifier Source: org_study_id