Comparing two methods of placing the humeral component in shoulder replacement surgery
Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty: a Prospective, Randomized Trial
This study is testing whether placing a shoulder replacement component inside or on top of the bone affects how well people can move their shoulder and manage pain two years after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | William Beaumont Hospitals Academic / other |
| Locations | 1 site (Royal Oak, Michigan) |
| Trial ID | NCT05297305 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with specific shoulder conditions such as cuff tear arthropathy or primary osteoarthritis requiring reverse total shoulder arthroplasty.
Not a fit: Patients who have had prior shoulder surgeries, are undergoing revision arthroplasty, or have certain diagnoses like rheumatoid arthritis or acute trauma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved shoulder function and pain relief for patients undergoing shoulder replacement surgery.
How similar studies have performed: While similar studies have explored various surgical techniques in shoulder arthroplasty, this specific comparison of inlay versus onlay humeral component placement is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Royal Oak, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.