Comparing two methods of placing the humeral component in shoulder replacement surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the effects of two different placements of the humeral component in reverse total shoulder arthroplasty: the inlay method, where the component sits inside the bone, and the onlay method, where it sits on top of the bone. The goal is to determine if these different placements affect shoulder function, including range of motion and pain levels, two years after surgery. Patients will be randomly assigned to one of the two groups and will undergo evaluations at baseline, 3 months, 12 months, and 24 months post-surgery to assess their outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Alex Martusiewicz, MD — Beaumont Health
• Study coordinator: Grace SanAgustin, BSN
• Email: Grace.SanAgustin@beaumont.org
• Phone: 248-551-6679

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.