Shoulder Replacement Techniques for Shoulder Arthritis

(SOAR Trial)

Overseen By Xavier C Gendry

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Rotator cuff insufficiency, Severe glenoid deformity, others

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

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of shoulder replacement surgeries to determine which one better alleviates symptoms of shoulder arthritis after a year. The surgeries under comparison are anatomic total shoulder arthroplasty (aTSA) and reverse total shoulder arthroplasty (rTSA), both designed to reduce pain and enhance shoulder function. Individuals with shoulder arthritis and an intact rotator cuff may be suitable candidates. The trial aims to identify which surgery provides better outcomes for patients. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance future treatment options.

Do I have to stop taking my current medications for the trial?

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 techniques are safe?

Studies have shown that both anatomic total shoulder arthroplasty (aTSA) and reverse total shoulder arthroplasty (rTSA) have strong safety records.

For aTSA, research has found that the implants last between 93.1% and 98.9% of the time over 5 to 8 years, indicating that most implants function well for several years. Additionally, studies have noted that aTSA is generally well-tolerated by patients, including those over 60 years old.

Similarly, rTSA has demonstrated high safety and effectiveness. One study found that 96% of the artificial joints remained effective in patients with rheumatoid arthritis. Other research has shown that the implants last between 91% and 98% of the time at 5 years and remain high at 10 years.

Overall, both procedures are considered safe with a low chance of serious complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the shoulder replacement techniques being studied for shoulder arthritis because these methods aim to improve surgical outcomes and patient recovery. Unlike traditional shoulder replacement options, reverse total shoulder arthroplasty (rTSA) alters the mechanics by reversing the ball-and-socket structure, which may provide better stability and function for patients with severe rotator cuff damage. Anatomic total shoulder arthroplasty (aTSA), on the other hand, seeks to more closely mimic the natural anatomy of the shoulder, which could lead to more natural movement and reduced wear over time. These techniques could potentially offer improved pain relief and enhanced mobility compared to existing methods.

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

This trial will compare two shoulder replacement techniques for shoulder arthritis: anatomic total shoulder arthroplasty (aTSA) and reverse total shoulder arthroplasty (rTSA). Studies have shown that aTSA effectively treats shoulder arthritis, improving shoulder function and movement, especially in patients with healthy rotator cuffs. Research indicates that aTSA successfully relieves pain and enhances movement in individuals over 60 years old. In contrast, rTSA also offers long-term improvements in shoulder function and pain relief, particularly for those with complex shoulder issues, such as severe rotator cuff damage. Both aTSA and rTSA improve patient outcomes, though aTSA might provide better movement in some cases. ^{3 6 7 8 9}

Who Is on the Research Team?

Jonathan D. Barlow, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for people with shoulder arthritis who still have a healthy, intact rotator cuff and less than 25° of glenoid retroversion (a specific shoulder bone angle).

Inclusion Criteria

I have arthritis in my shoulder.

My rotator cuff is not torn or damaged.

My shoulder socket is tilted less than 25 degrees backward.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either anatomic total shoulder arthroplasty (aTSA) or reverse total shoulder arthroplasty (rTSA)

6 weeks

Baseline, 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

24 months

3 months, 6 months, 12 months, 24 months

What Are the Treatments Tested in This Trial?

Interventions

• aTSA
• rTSA

Trial Overview

The study compares two types of shoulder replacement surgeries: anatomic total shoulder arthroplasty (aTSA) and reverse total shoulder arthroplasty (rTSA), to see which gives better results after one year.

How Is the Trial Designed?

Group I: Reverse total shoulder arthroplasty (rTSA) Experimental Treatment 1 Intervention

Group II: Anatomic total shoulder arthroplasty (aTSA) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10825258/

Comparison between Anatomic Total Shoulder Arthroplasty ...

The purpose of this study was to compare the clinical outcomes of anatomic TSA and reverse shoulder arthroplasty (RSA) in patients aged over 70 years with ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666638325002981

Anatomic total shoulder arthroplasty for osteoarthritis in ...

Anatomic total shoulder arthroplasty (aTSA) has been proven effective in the treatment of painful end-stage osteoarthritis in patients with intact rotator ...

3.

jsesarthroplasty.org

jsesarthroplasty.org/article/S1045-4527(23)00159-1/abstract

a decision-analytic Markov model-based cost-utility analysis

Anatomic total shoulder arthroplasty is cost-effective in patients over 67 years of age with glenohumeral osteoarthritis and an intact rotator ...

4.

jshoulderelbow.org

jshoulderelbow.org/article/S1058-2746(25)00749-9/abstract

Anatomic total shoulder arthroplasty indications, outcomes, ...

In young patients under the age of 50 years, aTSA is a reliable option for restoring shoulder function and range of motion with low revision ...

5.

cureus.com

cureus.com/articles/424054-functional-outcomes-of-anatomic-total-shoulder-arthroplasty-in-patients-over-60-years-old-a-retrospective-study-2019-2024

Functional Outcomes of Anatomic Total Shoulder ...

In this study, we report the outcomes of aTSA in a cohort of patients over 60 years old with intact rotator cuffs treated for glenohumeral ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12925865/

Anatomic total shoulder arthroplasty for osteoarthritis in ... - PMC

We hypothesized that revision rates and patient-reported outcomes were similar for patients aged 55-74 years and 75 years or older. Methods.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1045452725001233

Efficacy and safety of the new Mirror anatomic total ...

This proof-of-concept study reports on the safety and clinical efficacy of this novel Mirror anatomic total shoulder arthroplasty (Mirror aTSA) with preliminary ...

8.

mdpi.com

mdpi.com/2076-3417/11/21/10112

Anatomic Total Shoulder Arthroplasty versus ...

Both anatomic total shoulder arthroplasty (TSA) and shoulder hemiarthroplasty (SHA) are used for the management of end-stage glenohumeral osteoarthritis (GHOA).

9.

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 ...