Shoulder Replacement Surgeries for Shoulder Osteoarthritis

(SERVASA15 Trial)

Overseen By Katie McIlquham

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Infection, Muscle paralysis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: Surgical procedure with immediate post-operative care

108 Participants Needed

Trial Summary

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 study involves surgical procedures, 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 for shoulder osteoarthritis?

Research shows that reverse shoulder arthroplasty (RSA) can improve shoulder function in patients with complex shoulder problems and has good early results for shoulder osteoarthritis, with these benefits enduring over time. ^{1 2 3 4 5}

Is shoulder replacement surgery generally safe for humans?

Research shows that reverse shoulder arthroplasty (RSA) is generally safe, with high survivorship and good outcomes, even in older patients. However, there are concerns about higher complication rates, such as instability and infection, compared to other types of shoulder surgeries. ^{2 3 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 when there is severe shoulder damage or when the rotator cuff (a group of muscles and tendons that stabilize the shoulder) is not functioning properly. Unlike traditional shoulder replacements, RSA provides more stability and is less likely to have complications like glenoid loosening, making it a preferred option for complex shoulder issues. ^{1 2 8 9 10}

What is the purpose of this trial?

This study will compare total shoulder arthroplasty (TSA) with an augmented glenoid component and reverse shoulder arthroplasty (RSA) procedures, in participants with advanced glenohumeral osteoarthritis aged 65 years and older, who also present with greater than 15 degrees of glenoid retroversion, in the context of a prospective, randomized controlled trial to determine the optimal treatment in this patient population.

Research Team

Peter Lapner, MD

Principal Investigator

The Ottawa Hospital

Eligibility Criteria

This trial is for people aged 65 and older with advanced shoulder osteoarthritis and a specific bone condition (over 15 degrees of glenoid retroversion). They must have tried standard treatments like painkillers, physiotherapy, and lifestyle changes for at least six months without success. Those who've had previous shoulder surgery or suffer from certain other conditions can't join.

Inclusion Criteria

I have been diagnosed with shoulder arthritis of unknown cause.

My shoulder joint shows advanced cartilage loss.

I am 65 years old or older.

Exclusion Criteria

Pregnancy

I have shoulder joint damage due to rotator cuff issues.

I currently have an infection in my joints or throughout my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Total Shoulder Arthroplasty (TSA) with an augmented glenoid component or Reverse Shoulder Arthroplasty (RSA) procedure

Surgical procedure with immediate post-operative care

1 visit (in-person for surgery)

Follow-up

Participants are monitored for safety, effectiveness, and quality of life outcomes post-surgery

5 years

Regular visits for assessments and CT scans

Long-term Follow-up

Participants' long-term outcomes are assessed, including quality of life and component survivorship

5 years

Treatment Details

Interventions

• Reverse Shoulder Arthroplasty
• Total Shoulder Arthroplasty + augmented glenoid component

Trial Overview The study is comparing two surgical procedures for severe shoulder arthritis: Total Shoulder Arthroplasty with an augmented component versus Reverse Shoulder Arthroplasty. It's designed to find out which surgery works better for patients with the specified bone condition in their shoulders.

Participant Groups

Group I: Total Shoulder Arthroplasty (anatomic) + augmented glenoid component Active Control 1 Intervention

TSA procedure involves replacing the worn-out ball and socket joint with prosthetic components. An additional surgical technique, "augmented glenoid component" implantation is performed when there is missing bone in the shoulder and is currently being done as standard of care. This technique is used particularly when a large amount of instability within the shoulder joint is present. This technique attempts to realign and restore balance to the shoulder joint using artificial 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+

Findings from Research

Patients undergoing reverse shoulder arthroplasty (RSA) for revision had significantly lower shoulder function scores compared to those who had primary RSA, indicating that primary procedures generally yield better outcomes.

The complication rate was higher in the revision RSA group (35.7%) compared to the primary RSA group (17.8%), suggesting that while revision RSA can improve function, it carries a greater risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is reverse shoulder arthroplasty a reasonable alternative for revision arthroplasty? Austin, L., Zmistowski, B., Chang, ES., 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]

Reverse shoulder arthroplasty (RSA) significantly improved shoulder function in patients with primary glenohumeral osteoarthritis and severe glenoid retroversion, with the Constant score increasing from 30 to 68 points over a minimum follow-up of 5 years.

Despite some cases of scapular notching and partial resorption of bone grafts, these factors did not negatively impact the overall clinical outcomes, indicating that RSA is a reliable treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mid-term results of reverse shoulder arthroplasty for glenohumeral osteoarthritis with posterior glenoid deficiency and humeral subluxation. Collin, P., Hervé, A., Walch, G., et al.[2019]

In reverse shoulder arthroplasty for osteoarthritic shoulders with severe glenoid retroversion, the best range of motion (ROM) is achieved with a 10-mm lateralized baseplate and a glenoid component positioned at neutral to 5° retroversion.

The study found that a humeral implant with a varus inclination angle of 135° maximizes internal rotation and flexion, while greater lateralization of the glenoid component significantly improves adduction, abduction, external rotation, extension, and flexion motions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing reverse shoulder arthroplasty component position in the setting of advanced arthritis with posterior glenoid erosion: a computer-enhanced range of motion analysis. Keener, JD., Patterson, BM., Orvets, N., et al.[2018]

In a study of 137 patients who underwent reverse total shoulder arthroplasty (RSA) with at least 2 years of follow-up, prior shoulder surgery was identified as a significant risk factor for poor clinical improvement and overall outcomes after the procedure.

Patients with a history of previous shoulder surgeries had a 2.46 times higher chance of poor improvement and a 4.92 times higher chance of poor outcomes, highlighting the importance of considering past surgeries in treatment planning for shoulder conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of unsatisfactory patient outcomes in primary reverse total shoulder arthroplasty. Carducci, MP., Zimmer, ZR., Jawa, A.[2020]

In a study of 242 patients aged over 80 who underwent reverse shoulder arthroplasty (RSA), the procedure demonstrated a high survivorship rate free from revision surgery at 98.9% at two years and 98.3% at five years, indicating its long-term effectiveness.

The study found a low rate of complications, with only 3% experiencing medical complications and 12% surgical complications, suggesting that RSA is a safe option for elderly patients, although careful assessment of comorbidities is essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary reverse shoulder arthroplasty in patients older than 80 years of age: survival and outcomes. Clark, NJ., Samuelsen, BT., Alentorn-Geli, E., et al.[2020]

In a study of 284 patients undergoing reverse shoulder arthroplasty (RSA), the rate of instability was similar between primary (5%) and revision (8%) surgeries, while infection rates were higher in the revision group (7%) compared to the primary group (1%).

Patients with an irreparable subscapularis tendon had a significantly higher rate of instability (12%) compared to those with a repairable tendon (less than 1%), indicating that certain diagnoses can influence complication rates after RSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the instability and infection rates after reverse shoulder arthroplasty? Trappey, GJ., O'Connor, DP., Edwards, TB.[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]

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]

Anatomic total shoulder arthroplasty (aTSA) can be a suitable treatment for patients with osteoarthritis and a prior successful rotator cuff repair, as it shows no significant difference in strength or range of motion post-surgery.

However, performing a rotator cuff repair concurrently with aTSA may lead to higher complication rates, such as re-tear and loosening, particularly in patients with larger tears, indicating careful consideration is needed when planning the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomic Shoulder Arthroplasty in the Setting of Concurrent or Prior Rotator Cuff Repair: A Systematic Review. Gorica, Z., McFarland, K., O'Neill, CN., et al.[2023]

References

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

Is reverse shoulder arthroplasty a reasonable alternative for revision arthroplasty? [2022]

2. 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]

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

Mid-term results of reverse shoulder arthroplasty for glenohumeral osteoarthritis with posterior glenoid deficiency and humeral subluxation. [2019]

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

Optimizing reverse shoulder arthroplasty component position in the setting of advanced arthritis with posterior glenoid erosion: a computer-enhanced range of motion analysis. [2018]

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

Predictors of unsatisfactory patient outcomes in primary reverse total shoulder arthroplasty. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Primary reverse shoulder arthroplasty in patients older than 80 years of age: survival and outcomes. [2020]

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

What are the instability and infection rates after reverse shoulder arthroplasty? [2022]

8. 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]

9. France pubmed.ncbi.nlm.nih.gov

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

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

Anatomic Shoulder Arthroplasty in the Setting of Concurrent or Prior Rotator Cuff Repair: A Systematic Review. [2023]