TERMINATED

Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty: A Prospective, Randomized Trial

Quick Facts

Study Start:2023-10-20
Study Completion:2025-11-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05297305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients undergoing primary reverse total shoulder arthroplasty with the following components:
  2. 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
  3. 2. Inlay group: Perform Stem Reverse, Perform Reversed +3 lateralized 25mm baseplate with standard 36mm glenosphere or +6 lateralized 25mm baseplate with 39mm glenosphere
  4. * Diagnosis of cuff tear arthropathy, massive cuff tear, or primary osteoarthritis with cuff tear
  5. * Negative external rotation lag sign, ability to externally rotate beyond neutral
  6. * Age 18 years or older
  1. * Revision arthroplasty
  2. * Prior open shoulder surgery
  3. * Concomitant tendon transfer (Latissimus Dorsi, Pectoralis Tendon, Lower Trapezius)
  4. * Diagnosis of rheumatoid arthritis, infection, acute trauma or instability
  5. * Patients not willing to undergo a standardized physical therapy protocol or home therapy program after surgical intervention
  6. * Patient anatomy does not accommodate the study implants per surgeon discretion
  7. * Pregnant, patient-reported
  8. * Minors (under 18 years of age)
  9. * 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

Contacts and Locations

Principal Investigator

Alex Martusiewicz, MD
PRINCIPAL_INVESTIGATOR
Beaumont Health

Study Locations (Sites)

William Beaumont Hospital
Royal Oak, Michigan, 48073
United States

Collaborators and Investigators

Sponsor: Corewell Health East

  • Alex Martusiewicz, MD, PRINCIPAL_INVESTIGATOR, Beaumont Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-20
Study Completion Date2025-11-24

Study Record Updates

Study Start Date2023-10-20
Study Completion Date2025-11-24

Terms related to this study

Keywords Provided by Researchers

  • shoulder function
  • shoulder pain
  • shoulder range of motion

Additional Relevant MeSH Terms

  • Arthritis Shoulder
  • Rotator Cuff Injuries