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Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty

NCT05297305 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-01-16

No results posted yet for this study

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.

Conditions

  • Arthritis Shoulder
  • Rotator Cuff Injuries

Interventions

DEVICE

Tornier Ascend Flex stem

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

DEVICE

Tornier Perform Stem Reverse+

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

Sponsors & Collaborators

  • Stryker Nordic

    collaborator INDUSTRY

  • Corewell Health East

    lead OTHER

Principal Investigators

  • Alex Martusiewicz, MD · Beaumont Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-20
Primary Completion
2025-11-24
Completion
2025-11-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05297305 on ClinicalTrials.gov