Total vs Reverse Shoulder Arthroplasty for Shoulder Osteoarthritis

(SERVASA Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen by Peter Lapner, MD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Infection, Rotator cuff arthropathy, Paralysis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will compare total shoulder arthroplasty (TSA) reverse shoulder arthroplasty (RSA) procedures, in the context of a prospective, randomized-controlled trial to determine the optimal treatment in patients 65 years of age and older, and equal to or less than 15 degrees of glenoid retroversion, who have glenohumeral osteoarthritis.

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.

What data supports the effectiveness of the treatment Reverse Shoulder Arthroplasty (RSA) for shoulder osteoarthritis?

Research shows that Reverse Shoulder Arthroplasty (RSA) is increasingly used for shoulder osteoarthritis and is known for its stability, especially in cases with severe joint wear. It is also popular among older patients due to its high success rates and less reliance on shoulder muscles. ^{1 2 3 4 5}

Is shoulder arthroplasty safe for humans?

Both reverse shoulder arthroplasty (RSA) and total shoulder arthroplasty (TSA) are generally considered safe, but they can have complications such as glenoid loosening (when the shoulder socket becomes unstable) and other mechanical issues. RSA is often chosen for its stability, especially in cases with severe wear, and has high survivorship rates, particularly in older patients. ^{1 4 5 6 7}

How does the treatment of reverse shoulder arthroplasty differ from other treatments for shoulder osteoarthritis?

Reverse shoulder arthroplasty (RSA) is unique because it is often used for complex shoulder problems and can be more effective in certain cases, especially in older patients or those with specific shoulder conditions, compared to traditional total shoulder arthroplasty (TSA). RSA changes the mechanics of the shoulder joint, which can provide better stability and function when the rotator cuff muscles are damaged or weak. ^{1 2 8 9 10}

Research Team

Peter Lapner, MD

Principal Investigator

The Ottawa Hospital

Eligibility Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• Reverse Shoulder Arthroplasty (N/A)
• Total Shoulder Arthroplasty (N/A)
• Total Shoulder Arthroplasty + Augmented Glenoid Implantation (N/A)

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. Kathleen Gartke

Ottawa Hospital Research Institute

Chief Medical Officer

MD, University of Ottawa

Dr. Rebecca Auer

Ottawa Hospital Research Institute

Chief Executive Officer

MD, Memorial Sloan-Kettering Cancer Centre

Findings from Research

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Speed of recovery after shoulder arthroplasty: a comparison of reverse and anatomic total shoulder arthroplasty. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes After Anatomic and Reverse Shoulder Arthroplasty for the Treatment of Glenohumeral Osteoarthritis: A Propensity Score-Matched Analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Survivorship of a Medialized Glenoid and Lateralized Onlay Humerus Reverse Shoulder Arthroplasty Is High at Midterm Follow-up. [2022]

4. France pubmed.ncbi.nlm.nih.gov

Complications of shoulder arthroplasty for osteoarthritis with posterior glenoid wear. [2018]

5. United States 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. [2021]

6. France pubmed.ncbi.nlm.nih.gov

Trends in outcomes following aseptic revision shoulder arthroplasty. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Glenoid loosening and failure in anatomical total shoulder arthroplasty: is revision with a reverse shoulder arthroplasty a reliable option? [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Short-stem uncemented anatomical shoulder replacement for osteoarthritis in patients older than 70 years: is it appropriate? [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Reverse total shoulder arthroplasty: a review of results according to etiology. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of acquired glenoid bone defects on surgical technique and clinical outcomes in reverse shoulder arthroplasty. [2022]