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

Trial Summary

What is the purpose of this trial?

The purpose of this double-blind randomized controlled trial is to compare patient-reported, clinical, and functional outcomes in patients undergoing RTSA with and without subscapularis repair after placement of a modern "lateralized" implant over the course of 24-months postoperative.

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.

What data supports the effectiveness of the treatment RTSA with and without subscapularis repair for shoulder arthritis?

Research suggests that repairing the subscapularis (a shoulder muscle) during reverse total shoulder arthroplasty (RTSA) may influence outcomes like shoulder movement and stability, but its necessity is debated. Some studies indicate that subscapularis repair could reduce the risk of dislocation and improve clinical outcomes, though there is no clear consensus on its overall impact. ^{1 2 3 4 5}

Is subscapularis repair in reverse total shoulder arthroplasty generally safe?

Research suggests that subscapularis repair in reverse total shoulder arthroplasty (rTSA) is generally safe, with studies focusing on outcomes like joint stability and complication rates. While the role of subscapularis repair is debated, no significant safety concerns have been highlighted in the available studies. ^{1 2 3 4 5}

How does the treatment of reverse total shoulder arthroplasty with or without subscapularis repair differ from other treatments for shoulder arthritis?

This treatment is unique because it involves a surgical procedure called reverse total shoulder arthroplasty (RTSA), where the shoulder joint is replaced and the role of repairing the subscapularis tendon (a muscle in the shoulder) is debated. The decision to repair the subscapularis tendon can affect shoulder stability and range of motion, but there is no clear consensus on whether it improves outcomes compared to not repairing it. ^{1 2 3 4 6}

Research Team

Jarret Woodmass

Principal Investigator

Pan Am Clinic

Eligibility Criteria

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 had shoulder replacement surgery before.

I have arthritis caused by a previous infection.

I have a broken upper arm bone near the shoulder.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

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

Patient reported outcomes and ranges of motion after reverse total shoulder arthroplasty with and without subscapularis repair. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Subscapularis repair techniques for reverse total shoulder arthroplasty: A systematic review. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Outcomes and Joint Stability after Lateralized Reverse Total Shoulder Arthroplasty with and without Subscapularis Repair: A Meta-Analysis. [2021]

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

Comparison of reverse total shoulder arthroplasty outcomes with and without subscapularis repair. [2022]

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

Primary reverse total shoulder arthroplasty outcomes in patients with subscapularis repair versus tenotomy. [2022]

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

Role of Subscapularis Tendon Repair in Reverse Total Shoulder Arthroplasty. [2023]