Subscapularis Repair in Shoulder Replacement for Shoulder Arthritis

Overseen By Derek McLennan, BSc

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Panam Clinic

Disqualifiers: Previous shoulder arthroplasty, Avascular necrosis, Inflammatory arthritis, others

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

Compensation: Varies

Number of Visits: 1

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of shoulder replacement surgery with and without repairing the subscapularis muscle. Researchers will compare patient outcomes in terms of feeling and function over two years. Participants will be divided into two groups: one will undergo RTSA with subscapularis repair, and the other will undergo RTSA without it. The trial seeks individuals with shoulder arthritis or related issues who are planning their first shoulder replacement surgery. Those whose shoulder conditions match these criteria and can attend follow-up visits may find this trial suitable. As an Early Phase 1 trial, this research focuses on understanding the surgical approach in people, offering participants a chance to contribute to pioneering medical insights.

Will I have to stop taking my current medications?

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.

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

Research has shown that repairing the subscapularis muscle during reverse total shoulder replacement surgery is safe. Several studies confirm its safety, though it may not offer additional clinical or functional benefits. Specifically, patients who underwent this repair demonstrated improved shoulder movement, particularly in internal rotation, after 12 months.

In early trials, safety remains a key concern. Testing this treatment in humans has indicated it is safe enough to proceed. However, early trials provide limited information on long-term effects or rare issues. It is important to consider both the potential benefits and risks before deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the technique of subscapularis repair in shoulder replacement for shoulder arthritis because it could potentially enhance the stability and function of the shoulder joint post-surgery. Most current treatments for shoulder arthritis, like standard reverse total shoulder arthroplasty (RTSA), often do not include subscapularis repair, which may limit shoulder strength and mobility. By incorporating subscapularis repair, this method aims to improve outcomes by restoring a more natural muscle function, possibly leading to better shoulder movement and patient satisfaction.

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

This trial will compare two approaches to reverse total shoulder arthroplasty (RTSA) for shoulder arthritis: RTSA with subscapularis repair and RTSA without it. Research has shown that RTSA generally improves shoulder movement, provides better results, and reduces pain for individuals with shoulder arthritis. However, studies have found that adding subscapularis repair to RTSA does not offer additional benefits. For instance, shoulder strength, including movements like lifting the arm or rotating it inwards or outwards, remains the same whether the subscapularis is repaired or not. Additionally, complication rates are similar for both methods, with only a small difference in dislocation rates. Overall, while RTSA alone is effective, repairing the subscapularis muscle does not enhance its effectiveness. ^{1 2 6 7 8}

Who Is on the Research Team?

Jarret Woodmass

Principal Investigator

Pan Am Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with shoulder arthritis or similar conditions who need their first RTSA implant and have a low-grade fatty infiltration in the subscapularis muscle. It's not for those who've had previous shoulder replacements, suffer from inflammatory arthritis, can't communicate in English, or won't be able to attend follow-up visits for 2 years.

Inclusion Criteria

I do not have cancer at the site being treated.

I have shoulder joint issues and have decided with my surgeon to undergo a specific shoulder replacement.

Subscapularis with fatty infiltration (Goutallier ≥ 3)

Exclusion Criteria

I have arthritis caused by a previous infection.

I have had shoulder replacement surgery before.

I have a broken upper arm bone near the shoulder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo RTSA with or without subscapularis repair

1 day

1 visit (in-person)

Postoperative Follow-up

Participants are monitored for clinical and functional outcomes, including PROMs, shoulder function, and surgical complications

24 months

Regular visits (in-person)

Long-term Follow-up

Participants continue to be monitored for long-term outcomes and any late complications

Additional 12 months

What Are the Treatments Tested in This Trial?

Interventions

• RTSA without subscapularis repair
• RTSA with subscapularis repair

Trial Overview The study is testing two approaches to shoulder replacement surgery (RTSA): one includes repairing the subscapularis muscle while the other does not. The outcomes of patients will be compared over a period of 24 months to see which method is more effective.

How Is the Trial Designed?

Group I: RTSA with subscapularis repair Experimental Treatment 1 Intervention

Group II: RTSA without subscapularis repair Active Control 1 Intervention

RTSA without subscapularis repair is already approved in European Union, United States for the following indications:

Approved in European Union as Reverse Total Shoulder Arthroplasty for:

• Rotator cuff arthropathy
• Shoulder pseudoparalysis
• Massive rotator cuff tear
• Fracture
• Tumor
• Instability
• Revision arthroplasty

Approved in United States as Reverse Total Shoulder Arthroplasty for:

• Rotator cuff arthropathy
• Shoulder pseudoparalysis
• Massive rotator cuff tear
• Fracture
• Tumor
• Instability
• Revision arthroplasty

Who Is Running the Clinical Trial?

Panam Clinic

Lead Sponsor

Trials

17

Recruited

1,500+

University of Manitoba

Collaborator

Trials

628

Recruited

209,000+

Published Research Related to This Trial

In a study of 202 patients who underwent primary reverse total shoulder arthroplasty (RTSA), there were no significant differences in clinical outcomes, range of motion, or strength between those who had their subscapularis repaired and those who did not, after an average follow-up of over 3 years.

The rates of complications, including dislocations, were also similar, with 0 dislocations in the subscapularis repair group compared to 3 (2.6%) in the no-repair group, indicating that subscapularis repair may not be necessary for optimal outcomes in RTSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary reverse total shoulder arthroplasty outcomes in patients with subscapularis repair versus tenotomy. Vourazeris, JD., Wright, TW., Struk, AM., et al.[2022]

In a meta-analysis of four studies involving 978 patients, repairing the subscapularis tendon during reverse total shoulder arthroplasty led to significantly better functional outcomes, as measured by Constant and ASES scores.

While the repair did not affect dislocation rates or range of motion in certain movements, patients without subscapularis repair showed increased abduction, suggesting that repairing the tendon is beneficial when the tissue is healthy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes and Joint Stability after Lateralized Reverse Total Shoulder Arthroplasty with and without Subscapularis Repair: A Meta-Analysis. Corona, K., Cerciello, S., Ciolli, G., et al.[2021]

The role of subscapularis repair in reverse total shoulder arthroplasty (TSA) is still debated, with some studies suggesting it improves stability and range of motion, while others find it unnecessary for clinical outcomes.

This review will evaluate existing literature on subscapularis repair in reverse TSA and consider how different prosthesis designs (medialized vs. lateralized) may influence the effectiveness of tendon repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Subscapularis Tendon Repair in Reverse Total Shoulder Arthroplasty. Jawa, A., Colliton, EM.[2023]

In a study of 143 patients who underwent reverse total shoulder arthroplasty (rTSA), repairing the subscapularis did not significantly impact postoperative shoulder motion, strength, or patient-reported outcomes after 2 years.

Increased glenoid lateralization was found to improve internal rotation and patient-reported scores, suggesting that this surgical technique may enhance functional outcomes in rTSA, regardless of subscapularis repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported outcomes and ranges of motion after reverse total shoulder arthroplasty with and without subscapularis repair. Oak, SR., Kobayashi, E., Gagnier, J., et al.[2022]

A systematic review of seven studies involving 367 patients showed that various subscapularis repair techniques during reverse total shoulder arthroplasty (rTSA) lead to significant improvements in clinical outcomes, including pain and shoulder function.

The most common technique was tendon-tendon repair, which was associated with positive results, although variations in outcomes were noted among different repair methods, indicating a need for further high-quality studies to determine the optimal approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subscapularis repair techniques for reverse total shoulder arthroplasty: A systematic review. Lachance, AD., Peebles, AM., McBride, T., et al.[2022]

In a study of 591 patients undergoing reverse total shoulder arthroplasty (rTSA), both those with and without subscapularis repair showed significant improvements in pain and function, indicating that rTSA is effective regardless of whether the subscapularis is repaired.

Patients who had their subscapularis repaired experienced better postoperative scores in four out of five clinical metrics, while those without repair had better active abduction and passive external rotation, suggesting that both approaches have their benefits without a significant difference in complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of reverse total shoulder arthroplasty outcomes with and without subscapularis repair. Friedman, RJ., Flurin, PH., Wright, TW., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6784593/

Is subscapularis repair associated with better outcome ... Although subscapularis repair was proven safe and effective for the augmentation of RTSA, it did not offer any additional clinical or functional benefit.

2. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/23083-is-subscapularis-repair-associated-with-better-outcome-compared-to-non-repair-in-reverse-total-shoulder-arthroplasty-a-systematic-review-of-comparati.pdf

Non-commercial use only - Orthopedic Reviews We aimed to investigate whether com- bined reverse total shoulder arthroplasty. (RTSA) and subscapularis repair leads to improved clinical and functional ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666639121001140

Shoulder strength outcomes after reverse total ... Conclusion. There were no differences in abduction, internal rotation, or external rotation strength after rTSA with or without subscapularis repair. The ...

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

Long-Term Outcomes Following Reverse Total Shoulder ... Conclusion: RTSA appears to provide substantial long-term improvements in shoulder function, clinical outcomes, and pain relief, albeit with ...

5. researchgate.net researchgate.net/publication/309516593_Comparison_of_reverse_total_shoulder_arthroplasty_outcomes_with_and_without_subscapularis_repair

(PDF) Comparison of reverse total shoulder arthroplasty ... The complication rate was 7.4% (0% dislocations) for the subscapularis-repaired cohort and 6.8% (1.2% dislocations) for the non-subscapularis-repaired cohort.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9886633/

Results after primary reverse shoulder arthroplasty with ... Patients with a refixation of the SSC-tendon and primary rTSA had improved internal rotation [40° (20°–60°) vs. 32° (20°–45°); p = 0.03] at 12 months of follow ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2059775422000530

Subscapularis repair techniques for reverse total shoulder ... Several studies have found subscapularis repair to be safe and effective for the augmentation of reverse total shoulder arthroplasty. •. Reported benefits ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058274624005494

Journal of Shoulder and Elbow Surgery Conclusion. Although SCR requires a longer rehabilitation period, it provides similar outcomes to rTSA after two years for non-osteoarthritic, irreparable cuff ...