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

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 is more effective for individuals with severe shoulder arthritis. Total Shoulder Arthroplasty replaces the shoulder joint and uses a special component to address uneven bone. Reverse Shoulder Arthroplasty switches the position of the joint parts. The trial seeks participants aged 65 and older who have tried other treatments for at least six months but continue to experience pain and issues from shoulder arthritis. As an unphased trial, it offers 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 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.

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

Research shows that both Reverse Shoulder Arthroplasty (RSA) and Total Shoulder Arthroplasty (TSA) with an enhanced glenoid component are generally safe options for shoulder surgery.

For RSA, studies have consistently found it reduces pain and improves movement, with long-term success rates remaining high. One study reported that 88% of patients did not need additional surgery within 10 years, indicating RSA is well-tolerated over time.

Regarding TSA, research indicates a low complication rate of 2.6% and an even lower rate of follow-up surgery at 1.9%. This suggests that TSA with an enhanced glenoid component is also a safe and effective option.

Overall, both surgeries have strong safety records, with only a small percentage of patients experiencing complications or needing further surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for shoulder osteoarthritis because they offer innovative approaches to joint replacement. Total Shoulder Arthroplasty with an augmented glenoid component aims to improve joint stability and alignment by using artificial parts to compensate for missing bone, a step beyond standard shoulder replacements. On the other hand, Reverse Shoulder Arthroplasty flips the orientation of the ball and socket, potentially offering improved outcomes for patients whose shoulders are unstable. These techniques could lead to more effective and tailored solutions for those suffering from severe shoulder damage.

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

Research shows that reverse shoulder replacement surgery, one of the treatments studied in this trial, can greatly improve shoulder movement and reduce pain compared to non-surgical treatments. Long-term studies indicate that 88% of patients do not need further surgery 10 years after the procedure. This surgery is especially beneficial for people aged 60 and older with shoulder arthritis.

In contrast, total shoulder replacement with an augmented glenoid component, another treatment option in this trial, also yields good results. Studies have found that this surgery improves shoulder function, with benefits lasting from 6 months to 5 years. Early research shows low rates of complications and the need for additional surgery, making it a promising option for treating shoulder problems. ^{1 3 5 6 7}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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]

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 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]

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. 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 ...

3. 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. ...

4. 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.

5. 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.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT01884077

Total vs. Reverse Shoulder Replacement: Pain Relief Two ... The Reverse Shoulder Arthroplasty has revolutionized the management of complex shoulder pain and dysfunction due to rotator cuff tear arthropathy since its FDA ...