Onlay vs Inlay Techniques for Shoulder Replacement

Overseen By Grace SanAgustin, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: William Beaumont Hospitals

Disqualifiers: Rheumatoid arthritis, Infection, Acute trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Surgery and immediate postoperative care

154 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the most effective method for placing a part in shoulder replacement surgery. It specifically compares two techniques for attaching the humeral tray, a component at the top of the upper arm bone. One technique places it on top of the bone (onlay humeral component), while the other places it inside the bone (inlay humeral component). The goal is to discover if one method enhances arm movement after surgery. The trial seeks participants who require shoulder replacement due to conditions like a torn rotator cuff or severe arthritis and can move their arm past neutral. As an unphased trial, it offers patients the chance to contribute to valuable research that may improve future shoulder replacement outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these techniques are safe for shoulder replacement?

Research has shown that both onlay and inlay humeral components have been tested for safety and effectiveness in reverse total shoulder replacement surgery. A study on the onlay component reported good results in patient recovery and X-ray findings, with most patients handling the surgery well and experiencing few serious issues. Another study found that the inlay component also performed well, yielding successful results and few side effects.

These studies suggest that both implant types are generally safe and well-tolerated by patients. However, individual experiences can differ, so discussing any concerns with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the onlay and inlay techniques for shoulder replacement because they offer potential improvements in how reverse total shoulder arthroplasty is performed. The onlay humeral component involves placing the tray at the top of the humerus, which could enhance stability and range of motion. Meanwhile, the inlay humeral component places the tray within the humerus, potentially offering a more natural shoulder contour and reducing the risk of impingement. These approaches aim to refine surgical outcomes and patient satisfaction compared to traditional shoulder replacement methods.

What evidence suggests that this trial's techniques could be effective for shoulder replacement?

This trial will compare the onlay humeral component with the inlay humeral component for shoulder replacement. Research has shown that the onlay humeral component, placed on top of the upper arm bone, can provide stable support and good results, even for older patients. Studies have found that patients with this component often experience positive clinical and X-ray results. The inlay humeral component, inserted inside the upper arm bone, has also demonstrated good outcomes. Some research suggests that the position of the inlay component can affect shoulder function after surgery. Both methods aim to improve shoulder movement, but each offers unique benefits that may suit different patients. ^{2 6 7 8 9}

Who Is on the Research Team?

Alex Martusiewicz, MD

Principal Investigator

Beaumont Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need a reverse total shoulder arthroplasty due to rotator cuff tears or arthritis, and can rotate their arm outward. It's not for those with previous open shoulder surgery, cognitive impairments, pregnancy, minors, or conditions like rheumatoid arthritis.

Inclusion Criteria

I have been diagnosed with a severe shoulder condition due to a tear or arthritis.

I can rotate my arm outward past its neutral position without lag.

I am having a specific type of shoulder replacement surgery.

Exclusion Criteria

I am having or have had a joint replacement redone.

I have had open shoulder surgery before.

I have been diagnosed with rheumatoid arthritis, an infection, acute trauma, or instability.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo reverse total shoulder arthroplasty with either inlay or onlay humeral component

Surgery and immediate postoperative care

1 visit (in-person)

Follow-up

Participants are monitored for range of motion, strength, and functional outcomes at 3 months, 12 months, and 24 months postoperatively

24 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Inlay Humeral Component
• Onlay Humeral Component

Trial Overview The study compares two surgical techniques of placing the humeral component in shoulder replacement: 'inlay' (inside the bone) versus 'onlay' (on top of the bone), using Tornier Ascend Flex stem and Perform Stem Reverse+ implants.

How Is the Trial Designed?

Group I: Onlay Component-Tornier Ascend Flex stem Active Control 1 Intervention

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

Group II: Inlay Component-Tornier Perform Stem Reverse+ Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials

153

Recruited

113,000+

Stryker Nordic

Industry Sponsor

Trials

35

Recruited

4,400+

Published Research Related to This Trial

In a study of 6707 patients, the inlay humeral components (in-RSA) in reverse shoulder arthroplasty showed a significantly lower revision rate compared to onlay components (on-RSA), indicating better medium-term implant survival.

While the onlay components had better functional outcomes at 6 months post-surgery, this difference was not clinically significant, and by 5 years, both designs showed similar functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medium-term results of inlay vs. onlay humeral components for reverse shoulder arthroplasty: a New Zealand Joint Registry study. Zhou, Y., Mandaleson, A., Frampton, C., et al.[2023]

In a review of four studies involving 298 patients, onlay humeral components in reverse shoulder arthroplasty (RSA) showed significantly better external rotation compared to inlay components, indicating a potential advantage in shoulder mobility.

The onlay design also had a lower incidence of scapular notching (7.74%) compared to the inlay design (23.18%), suggesting it may reduce complications related to shoulder anatomy, although both designs resulted in similar overall patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Onlay versus inlay humeral components in reverse shoulder arthroplasty: A systematic review and meta-analysis. Jackson, GR., Meade, J., Young, BL., et al.[2023]

In a systematic review of 12 studies involving 1447 patients, both inlay and onlay humeral designs in reverse total shoulder arthroplasty showed significant clinical improvements, with the inlay design yielding a higher American Shoulder and Elbow Surgeons score.

While the onlay design provided slightly better postoperative motion, it was associated with a lower rate of scapular notching but a higher rate of scapular spine fractures, highlighting the need for tailored surgical approaches based on patient risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inlay versus onlay humeral design for reverse shoulder arthroplasty: a systematic review and meta-analysis. Larose, G., Fisher, ND., Gambhir, N., et al.[2023]

The study analyzed 12 CT scans to create a 3D biomechanical model of the shoulder, testing 17 different positions for the humeral tray in reverse shoulder arthroplasty, revealing that the direction of the offset significantly affects impingement and muscle functionality.

Maximizing impingement-free range of motion was best achieved with a posterolateral tray offset, while maximizing muscle moment arms required a medial tray offset, indicating that optimal tray placement should be tailored to individual patient needs due to the conflicting outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of humeral tray placement on impingement-free range of motion and muscle moment arms in reverse shoulder arthroplasty. Glenday, J., Kontaxis, A., Roche, S., et al.[2020]

In a study using 20 fresh-frozen cadaveric shoulders, inlay humeral implants for reverse total shoulder arthroplasty (rTSA) resulted in lower rotator cuff forces compared to onlay implants, which may lead to less muscle fatigue and potentially better long-term outcomes for patients with an intact rotator cuff.

However, inlay implants also showed reduced passive elevation range of motion (ROM) compared to onlay implants, indicating a trade-off between muscle force requirements and joint mobility after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inlay versus onlay humeral components in reverse total shoulder arthroplasty: a biorobotic shoulder simulator study. Zitnay, JL., Tashjian, RZ., Walch, G., et al.[2023]

In a study of 150 patients who underwent reverse shoulder arthroplasty (RSA) with either inlay or onlay humeral tray designs, both groups showed similar improvements in range of motion and patient-reported outcomes after a follow-up of at least 2 years.

There were no significant differences in complication rates, including revision surgeries and scapular notching, between the inlay and onlay designs, suggesting that the choice of humeral tray design may not impact clinical outcomes for patients with glenohumeral osteoarthritis and intact rotator cuffs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lateralized glenosphere reverse shoulder arthroplasty: inlay and onlay designs have similar clinical outcomes in patients with glenohumeral osteoarthritis. Meshram, P., Joseph, J., Zhou, Y., et al.[2022]

In a study of 95 patients who underwent anatomic total shoulder arthroplasty, the positioning of the humeral articular component did not significantly affect patient-reported outcomes, such as pain and shoulder function, after an average follow-up of 4.3 years.

Despite 62% of patients experiencing a shift in the center of rotation greater than 2 mm, there were no significant correlations between the radiographic measurements of component positioning and improvements in functional scores, suggesting that other factors may influence postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does prosthetic humeral articular surface positioning associate with outcome after total shoulder arthroplasty? Chalmers, PN., Granger, EK., Orvets, ND., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11652425/

Humeral Stem Design in Reverse Total Shoulder Arthroplasty The purpose of this article is to review historical design features and their drawbacks and to summarize the clinical outcomes of modern designs.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666638325001410

Variability in ultimate humeral height of an inlay ... The aim of this study was to analyze the impact of humeral component position on clinical outcomes following reverse total shoulder arthroplasty. Methods.

3. ctv.veeva.com ctv.veeva.com/study/onlay-versus-inlay-humeral-component-in-reverse-total-shoulder-arthroplasty

Onlay Versus Inlay Humeral Component in Reverse Total ... 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 ...

4. stryker.com stryker.com/content/dam/stryker/trauma-and-extremeties/products/tornier-perform/documents/AP-012819D%20PERFORM%20Stem_Op%20Tech.pdf

Tornier Perform Humeral Stem Operative Technique The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7233693/

Onlay versus Inlay humeral steam in Reverse Shoulder ... In this study we compare two different reverse shoulder prosthesis designs, defined as Inlay (or typical Grammont type) and a relatively new model defined as ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02047955

Tornier Shoulder Outcomes Study to Examine Safety and ... Arthroplasty, Replacement, Shoulder. Fracture Fixation, Internal. Plan for Individual Participant Data (IPD). Plan to Share Individual Participant Data (IPD)?.

7. trials.arthritis.org trials.arthritis.org/trials/NCT05297305

Onlay Versus Inlay Humeral Component in Reverse Total ... 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 ...

8. stryker.com stryker.com/us/en/trauma-and-extremities/products/tornier-perform.html

Tornier Perform Humeral Stem Platform humeral system intended for anatomic, reverse and hemi-arthroplasty of the shoulder. Tornier Perform Humeral Stem

9. sciencedirect.com sciencedirect.com/science/article/pii/S1048666624000582

Reverse Shoulder Arthroplasty: History, Indications, Design ... JM Wiater, JYJ Lee, EJW Shields, et al. Humeral component version has no effect on outcomes following reverse total shoulder arthroplasty. JBJS, 106 (2024) ...