Shoulder Arthroplasty for Shoulder Osteoarthritis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Rheumatoid arthritis, Tumors, Alcohol abuse, others

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

Compensation: Varies

Number of Visits: 1

Duration: Surgery and immediate recovery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of shoulder replacement surgeries for individuals with shoulder arthritis. Researchers aim to determine if the reverse shoulder replacement (reverse total shoulder replacement) is as effective as the regular shoulder replacement (anatomic total shoulder replacement) and whether it might offer better outcomes and fewer complications post-surgery. Participants should have shoulder arthritis without major rotator cuff tears or severe bone loss in the shoulder joint. The trial involves two groups: one receiving a regular shoulder replacement and the other a reverse shoulder replacement. Both options use common, FDA-approved devices. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance future treatment options for shoulder arthritis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these shoulder replacement devices are safe for patients with shoulder osteoarthritis?

Research has shown that both anatomic and reverse total shoulder replacements are generally safe and effective for treating shoulder arthritis.

For anatomic total shoulder replacements, studies have found that these surgeries rarely require revision soon after the operation. Patients often report feeling better and experiencing less pain. After two years, many patients notice significant improvement in shoulder function and express high satisfaction with the results.

Reverse total shoulder replacements also lead to long-term improvements in shoulder function and pain relief. However, some studies have noted serious complications in certain cases. Despite this, the implants demonstrate durability, with over 90% not needing replacement for several years.

Both treatments have a strong history of success and are FDA-approved, indicating thorough testing and safety for patients with shoulder arthritis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about anatomic and reverse total shoulder replacements for shoulder osteoarthritis because they offer innovative approaches to joint replacement. Anatomic total shoulder replacement mimics the natural anatomy by replacing the humeral head with a metal ball and the glenoid socket with a polyethylene component, closely resembling a healthy shoulder. On the other hand, reverse total shoulder replacement switches the positions of these components, placing the polyethylene socket on the humeral side and the glenosphere on the glenoid side, which can provide better stability and function, especially for patients with damaged rotator cuffs. These treatments promise enhanced mobility and pain relief, potentially offering better outcomes for patients who struggle with traditional shoulder replacement methods.

What evidence suggests that this trial's treatments could be effective for shoulder osteoarthritis?

This trial will compare anatomic total shoulder replacement with reverse total shoulder replacement for treating shoulder arthritis. Research has shown that both treatments are effective. Participants in the anatomic total shoulder replacement arm may experience good patient satisfaction, with studies reporting improvements in shoulder function scores from 58.3 to 113.7 points two years after surgery. In contrast, participants in the reverse total shoulder replacement arm may see long-term improvements in shoulder movement and pain relief, with studies showing shoulder function scores increasing from 35.4 to 57.8 points after the procedure. Both treatments offer benefits, and the choice between them usually depends on the specific needs and conditions of the patient. ^{1 2 3 6 7}

Who Is on the Research Team?

Christopher Joyce, M.D.

Principal Investigator

University of Utah Orthopaedics

Are You a Good Fit for This Trial?

This trial is for individuals with glenohumeral osteoarthritis, which affects the shoulder joint. Participants should not have rotator cuff tears or significant backward tilting of the socket part of their shoulder joint. The study is looking for people who can undergo surgery using a specific incision technique.

Inclusion Criteria

I am between 60 and 85 years old.

My shoulder bone is intact without significant loss.

Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion Criteria

Known or suspected non-compliance, drug or alcohol abuse

I have a tumor.

I have damage to the nerve in my armpit area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either anatomic or reverse total shoulder arthroplasty

Surgery and immediate recovery

1 visit (in-person for surgery)

Follow-up

Participants are monitored for functional outcomes and complications

24 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Anatomic total shoulder replacement
• Reverse total shoulder replacement

Trial Overview The study compares two types of shoulder replacement surgeries: reverse total shoulder arthroplasty (RTSA) and anatomic total shoulder arthroplasty (TSA). It aims to see if RTSA is at least as effective as TSA or even better, and whether it leads to fewer complications post-surgery.

How Is the Trial Designed?

Group I: Reverse total shoulder replacement Experimental Treatment 1 Intervention

Reverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side.

Group II: Anatomic total shoulder replacement Experimental Treatment 1 Intervention

Anatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1. bmj.com bmj.com/content/385/bmj-2023-077939

Reverse total shoulder replacement versus anatomical ... This study's findings provide reassurance that RTSR is an acceptable alternative to TSR for patients aged 60 years or older with osteoarthritis and intact ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666638325002981

Anatomical total shoulder arthroplasty for osteoarthritis in ... We found low short-term revision rates and good patient-reported outcomes for both older and middle-aged patients treated for osteoarthritis ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12227341/

Promising short-term results after anatomical total shoulder ... There was an overall clinical improvement 2 years postoperatively. The aCS increased from 58.3 ± 17.7 to 113.7 ± 15.6 points (p < 0.0001). The ...

4. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746%2824%2900194-0/fulltext

an analysis of data from the National Joint Registry TSA resulted in superior OSSs at 6 months in patients with osteoarthritis. The median OSS improved from 6 months to 5 years following TSA; however, there was a ...

5. eor.bioscientifica.com eor.bioscientifica.com/view/journals/eor/10/6/EOR-2025-0052.xml

Shoulder replacement in the under 55's is anatomical or ... ASA consistently emerges as the superior choice for younger patients with well-preserved rotator cuffs and minimal anatomical compromise.

6. jsesinternational.org jsesinternational.org/article/S2666-6383(22)00104-9/fulltext

The recovery curve of anatomic total shoulder arthroplasty ... Patients undergoing anatomic TSA for primary GHOA showed excellent improvement in PROs and satisfaction in the first year, and these results were maintained ...

7. jsesreviewsreportstech.org jsesreviewsreportstech.org/article/S2666-6391(23)00022-6/fulltext

Outcomes of anatomic and reverse total shoulder ... Both ATSA and RTSA implant survivorship was reported to range from 93.1% to 98.9% at 5- and 8-year follow-up, respectively. Patient mortality ...