Total vs Reverse Shoulder Arthroplasty for Shoulder Osteoarthritis

(SERVASA Trial)

Recruiting at 5 trial locations

Overseen By Peter Lapner Lapner, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Infection, Rotator cuff arthropathy, Paralysis, others

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

Compensation: Varies

Number of Visits: 25

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to identify the best surgical option for individuals with shoulder osteoarthritis by comparing total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA). TSA replaces the shoulder's worn-out joint with artificial parts, while RSA switches the positions of the joint's ball and socket. The trial seeks participants who have had shoulder osteoarthritis for over six months, have not found relief with medications or therapy, and experience significant pain and disability. As an unphased trial, it offers participants the chance to contribute to valuable research that may enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves surgery, it's best to discuss your medications with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both Reverse Shoulder Arthroplasty (RSA) and Total Shoulder Arthroplasty (TSA) are generally safe and effective. Studies have found that RSA significantly improves shoulder movement and reduces pain. Serious complications within the first 90 days are rare, and patients often experience better movement and less pain over time.

For TSA, patients can expect good long-term results. Research indicates that most implants last a long time, with a survival rate of 84%. TSA also typically leads to improved shoulder function and pain relief.

Both procedures have been thoroughly reviewed and compared. While each offers benefits, both are viable options for individuals with shoulder osteoarthritis. Safety data suggests that most patients tolerate these treatments well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these shoulder arthroplasty treatments because they offer innovative approaches to address shoulder osteoarthritis. Total Shoulder Arthroplasty (TSA) replaces the worn-out ball and socket joint with prosthetic components, providing a more natural joint movement. In contrast, Reverse Shoulder Arthroplasty (RSA) changes the orientation of the joint, potentially improving stability and function for patients with damaged rotator cuffs. Additionally, the use of an augmented glenoid implantation in TSA aims to enhance joint support and longevity, potentially offering better outcomes for patients with severe joint erosion. These advancements could lead to improved range of motion and reduced pain compared to traditional shoulder replacement options.

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

Research has shown that both reverse shoulder replacement (RSA) and total shoulder replacement (TSA) effectively treat shoulder arthritis. In this trial, participants will receive either the RSA or TSA treatment. RSA significantly improves shoulder movement and reduces pain compared to no surgery, with 88% of patients avoiding another surgery for at least 10 years. For TSA, studies indicate that patients experience better shoulder function after six months, with improvements lasting for years. Both surgeries offer good options, with RSA being particularly suitable for older adults. The best choice depends on each person's specific needs and health conditions. ^{1 3 6 7 8}

Who Is on the Research Team?

Peter Lapner, MD

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

This trial is for people over 65 with severe shoulder osteoarthritis who haven't improved after 6 months of non-surgical treatments like physiotherapy and painkillers. It's not for those with a life expectancy under a year, high surgery risk, psychiatric conditions affecting consent, pregnancy, or previous shoulder surgeries on the affected side.

Inclusion Criteria

I am undergoing physiotherapy with exercises and treatments like ultrasound.

I am 65 years old or older.

My shoulder joint shows advanced cartilage loss.

Exclusion Criteria

I do not have a major illness that would give me less than a year to live.

Pregnancy

Unwilling to be followed for the duration of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo either Total Shoulder Arthroplasty (TSA) or Reverse Shoulder Arthroplasty (RSA) procedures

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for functional outcomes and quality of life improvements using various assessment tools

24 months

Multiple visits (in-person and virtual) over 24 months

Long-term Follow-up

Participants are assessed for long-term outcomes, including survivorship of components and adverse events

5 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Reverse Shoulder Arthroplasty
• Total Shoulder Arthroplasty
• Total Shoulder Arthroplasty + Augmented Glenoid Implantation

Trial Overview The study is comparing two types of shoulder replacement surgeries: Total Shoulder Arthroplasty (TSA) and Reverse Shoulder Arthroplasty (RSA). Participants will be randomly assigned to one of these surgical options to see which is better for treating advanced glenohumeral osteoarthritis in seniors.

How Is the Trial Designed?

Group I: Total Shoulder Arthroplasty (anatomic) Active Control 1 Intervention

TSA procedure involves replacing the worn-out ball and socket joint with prosthetic components.

Group II: Reverse Shoulder Arthroplasty Active Control 1 Intervention

RSA procedure is similar to a TSA, however the orientation of the ball and socket joint is placed in the reverse position

Reverse Shoulder Arthroplasty is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Reverse Shoulder Arthroplasty for:

• Massive rotator cuff tears
• Irreparable rotator cuff tears
• Severe shoulder arthritis

Approved in United States as Reverse Shoulder Arthroplasty for:

• Massive rotator cuff tears
• Irreparable rotator cuff tears
• Severe shoulder arthritis
• Failed rotator cuff repair

Approved in Canada as Reverse Shoulder Arthroplasty for:

• Massive rotator cuff tears
• Irreparable rotator cuff tears
• Severe shoulder arthritis

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

The study found a high revision-free survivorship rate of 93% at 5 years for patients who underwent reverse shoulder arthroplasty (RSA) using a medialized glenoid and lateralized onlay-type humerus implant, based on a review of 526 surgeries with an average follow-up of 4.83 years.

Instability was identified as the most common reason for revision surgeries (1.9%), and patients who had prior shoulder surgeries were more likely to require revisions after RSA, indicating that previous surgeries may increase the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship of a Medialized Glenoid and Lateralized Onlay Humerus Reverse Shoulder Arthroplasty Is High at Midterm Follow-up. Rauck, RC., Eck, EP., Chang, B., et al.[2022]

In a study of 166 revision shoulder arthroplasty cases with an average follow-up of 1 year, it was found that revisions of reverse shoulder arthroplasty (RSA) to another RSA had the highest repeat revision rate at 32%, indicating a higher risk of complications compared to other types of revisions.

Despite a notable long-term complication rate, the immediate perioperative outcomes for revision surgeries were similar to those of primary shoulder arthroplasties, suggesting that revisions can be performed safely and may be considered in future healthcare models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in outcomes following aseptic revision shoulder arthroplasty. Stauffer, TP., Goltz, DE., Wickman, JR., et al.[2023]

In a study of 216 shoulders undergoing reverse total shoulder arthroplasty, glenoid bone defects were managed effectively with modified surgical techniques, including the use of bone grafts in 22 cases, demonstrating that these defects do not prevent successful surgery.

Both groups, those with normal and abnormal glenoids, showed significant improvement in clinical outcomes post-surgery, with no significant differences in American Shoulder and Elbow Surgeons scores, indicating that reverse shoulder arthroplasty is effective regardless of glenoid morphology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of acquired glenoid bone defects on surgical technique and clinical outcomes in reverse shoulder arthroplasty. Klein, SM., Dunning, P., Mulieri, P., et al.[2022]

Both reverse shoulder arthroplasty (RSA) and total shoulder arthroplasty (TSA) are effective for patients over 70 years old, showing significant improvements in pain and function, with no major differences in outcomes between younger and older patients in each group.

TSA had a lower revision rate (3.9%) compared to RSA (8.1%), suggesting that TSA may be a more reliable option for elderly patients with primary osteoarthritis and an intact rotator cuff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomic and reverse shoulder arthroplasty in patients 70 years of age and older: a comparison cohort at early to midterm follow-up. Poondla, RK., Sheth, MM., Heldt, BL., et al.[2021]

In a study of 32 patients over 70 years old who underwent uncemented short-stem total shoulder arthroplasty (TSA), significant improvements in range of motion and clinical scores were observed, with a Constant score of 73 and a subjective shoulder value of 90%.

The TSA group showed better postoperative range of motion and subjective outcomes compared to a matched group receiving reverse shoulder arthroplasty (RSA), suggesting that TSA can be a viable option for elderly patients with primary osteoarthritis and intact rotator cuffs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-stem uncemented anatomical shoulder replacement for osteoarthritis in patients older than 70 years: is it appropriate? Barret, H., Bonnevialle, N., Azoulay, V., et al.[2022]

In a study of 23 patients with glenohumeral osteoarthritis and significant posterior glenoid wear, both total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA) showed similar functional outcomes, with Constant Scores of 65 for both procedures.

However, TSA had a higher complication rate, with 52% of patients showing complete radiolucent lines and 11% experiencing recurrence of posterior subluxation, suggesting that RSA may be a safer alternative for patients with severe glenoid retroversion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of shoulder arthroplasty for osteoarthritis with posterior glenoid wear. Gallusser, N., Farron, A.[2018]

In a study of 240 reverse total shoulder arthroplasties performed on patients averaging 72.7 years old, significant clinical improvement was observed, with average Constant scores rising from 23 to 60 points post-surgery, and 173 out of 186 patients reporting satisfaction with the results.

Patients with primary rotator cuff tear arthropathy and primary osteoarthritis with a rotator cuff tear experienced better outcomes compared to those with posttraumatic arthritis or those undergoing revision arthroplasty, who had higher complication rates and less improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reverse total shoulder arthroplasty: a review of results according to etiology. Wall, B., Nové-Josserand, L., O'Connor, DP., et al.[2022]

In a study of 134 patients with primary osteoarthritis, both reverse shoulder arthroplasty (RSA) and anatomic total shoulder arthroplasty (TSA) showed similar short-term patient-reported outcomes after a follow-up of about 30 months.

However, TSA resulted in significantly better postoperative range of motion compared to RSA, indicating that while both surgeries are effective, TSA may provide superior functional improvements in shoulder movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes After Anatomic and Reverse Shoulder Arthroplasty for the Treatment of Glenohumeral Osteoarthritis: A Propensity Score-Matched Analysis. Kirsch, JM., Puzzitiello, RN., Swanson, D., et al.[2022]

Patients undergoing total shoulder arthroplasty (TSA) experience a more consistent and effective recovery in pain and function compared to those receiving reverse shoulder arthroplasty (RSA), with TSA patients reaching a plateau in improvement by 6 months.

Both TSA and RSA provide rapid pain relief, but TSA patients achieve 90% to 100% of functional improvement by 6 months, while RSA patients only reach 72% to 91%, indicating TSA may be the preferred option for quicker recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speed of recovery after shoulder arthroplasty: a comparison of reverse and anatomic total shoulder arthroplasty. Levy, JC., Everding, NG., Gil, CC., et al.[2022]

In a study of 37 patients who underwent revision from anatomical total shoulder arthroplasty to reverse shoulder arthroplasty due to aseptic glenoid loosening, 86% reported satisfaction, and significant improvements were observed in shoulder function, with Constant scores increasing from 24 to 55 points.

While reverse shoulder arthroplasty effectively addressed complications like rotator cuff tears and prosthetic instability, 21% of patients experienced postoperative complications requiring further surgery, highlighting the need for careful surgical technique and patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glenoid loosening and failure in anatomical total shoulder arthroplasty: is revision with a reverse shoulder arthroplasty a reliable option? Melis, B., Bonnevialle, N., Neyton, L., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12039979/

Long-Term Outcomes Following Reverse Total Shoulder ... RTSA can provide satisfactory improvement of pain and function at long-term follow-up mean revision-free survivorship of 88% after 10 years.

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2059775423005801

Short- to medium-term outcomes and future direction of ... Reverse shoulder arthroplasty is associated with significant improvements in shoulder function and pain reduction compared to non-surgical treatments.

4. 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 ... Reverse shoulder replacement can be a viable solution for younger patients with severe shoulder pathology when anatomic TSA is not an option. ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38218404/

Outcomes after reverse shoulder arthroplasty for the ... RSA is a successful surgical treatment for GHOA regardless of age. Aside from greater postoperative FE in younger patients, there were no other differences.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9998887/

Clinical outcomes after reverse shoulder arthroplasty in ... Early published results of RTSA in elderly, low demand patients with cuff tear arthropathy noted reliable improvements in pain, range of motion, and overall ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9371544/

Total shoulder arthroplasty versus reverse ... This study aimed to compare TSA and RSA in OA patients with or without rotator cuff damage to better guide clinical decision making.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0972978X25003757

A systematic review and meta-analysis Our meta-analysis indicates that, for shoulder degenerative diseases, aTSA generally offers superior postoperative efficacy compared with rTSA.