Rotator Cuff Repair Techniques for Shoulder Injuries

Overseen By Mohit Gilotra, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Irreparable subscapularis, Proximal humerus fracture, others

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

Compensation: Varies

Number of Visits: 3

118 Participants Needed

Trial Summary

What is the purpose of this trial?

The subscapularis is part of the rotator cuff and is release as part of a reverse shoulder replacement. The decision to repair this tendon is controversial. This research is being done to help determine if rotator cuff repair improves or hinders shoulder replacement. A worrisome but rare complication after shoulder replacement is dislocation. Rotator cuff repair may help reduce this risk. The repair may hinder some of the range of motion afterwards or could help with internal rotation strength. There is a chance that the repair doesn't matter at all. The goal of this study is to delineate outcomes after reverse shoulder arthroplasty with the respect to management of the subscapularis tendon. Further information about rotator cuff repair after reverse shoulder replacement can help define complications, potentially decrease OR time, and improve functional outcomes. A total of 148 patients will be enrolled and the duration of the study will be 5 years. All patients will be required to follow-up at 2¬-week, 6-week, 3-month, 6-month, 1-year, and 2-year post-operative marks. Any time information is collected for a study there is a small risk of breach of confidentiality. There are no monetary costs or payments associated with this study. You may or may not benefit by taking part in this study. There is no guarantee that you will receive direct benefit from your participation in this study. To be clear, participation in this study is completely voluntary.

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 Subscap Repair, Reverse Shoulder Arthroplasty, RTSA, Subscapularis Repair in Reverse Shoulder Replacement, Subscap Tenotomy, Subscapularis Tenotomy, Subscap Tenotomy for shoulder injuries?

Research suggests that repairing the subscapularis (a shoulder muscle) during reverse total shoulder arthroplasty (a type of shoulder surgery) can influence outcomes like shoulder movement and stability, although the best repair technique is still debated. ^{1 2 3 4 5}

Is subscapularis repair during reverse total shoulder arthroplasty safe?

Research on subscapularis repair during reverse total shoulder arthroplasty (RTSA) shows that it is generally safe, but there is ongoing debate about its impact on outcomes like joint stability and dislocation risk. Studies have not reached a consensus on the best repair technique, but they do not indicate significant safety concerns. ^{1 4 5 6 7}

How does the rotator cuff repair technique differ from other treatments for shoulder injuries?

The rotator cuff repair technique for shoulder injuries is unique because it focuses on repairing the subscapularis tendon, which is a key component in reverse total shoulder arthroplasty (a type of shoulder replacement surgery). This approach is debated for its potential to reduce dislocation rates and improve joint stability, setting it apart from other treatments that may not address this specific tendon. ^{1 4 5 8 9}

Research Team

Mohit Gilotra, MD

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

This trial is for individuals aged 18 to 95 who are undergoing reverse shoulder arthroplasty, which could include revision surgery. Candidates must have an intact subscapularis tendon with minimal fatty infiltration and no history of proximal humerus fracture or bone loss.

Inclusion Criteria

I am having or have had a reverse shoulder replacement surgery.

I am between 18 and 95 years old.

Exclusion Criteria

I've had shoulder surgery that resulted in bone loss in my upper arm.

My Subscapularis Tendon cannot be repaired.

I have had a shoulder bone fracture.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo reverse shoulder arthroplasty with or without subscapularis tendon repair

2 weeks

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for recovery and functional outcomes at various intervals

2 years

Visits at 2-week, 6-week, 3-month, 6-month, 1-year, and 2-year post-operative marks

Long-term Follow-up

Participants are assessed for long-term outcomes and complications

3 years

Treatment Details

Interventions

• Subscap Repair
• Subscap Tenotomy

Trial Overview The study compares outcomes of reverse shoulder arthroplasty with two different approaches to the subscapularis tendon: one group will have the tendon released (Subscap Tenotomy), while another will have it repaired (Subscap Repair). The aim is to see if repair affects dislocation risk, range of motion, or internal rotation strength.

Participant Groups

Group I: Subscap Tenotomy Experimental Treatment 1 Intervention

The subscapularis tendon is not repaired.

Group II: Subscap Repair Experimental Treatment 1 Intervention

The subscapularis tendon is repaired.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Findings from Research

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 43 patients who underwent reverse shoulder arthroplasty (RSA), the integrity of the subscapularis tendon did not significantly affect overall functional outcomes as measured by standard shoulder scores.

However, patients with an intact or mildly attenuated subscapularis tendon demonstrated significantly better internal rotation ability compared to those with an absent tendon, highlighting the importance of tendon integrity for specific shoulder functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sonographic assessment of the subscapularis after reverse shoulder arthroplasty: impact of tendon integrity on shoulder function. Dedy, NJ., Gouk, CJ., Taylor, FJ., et al.[2018]

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]

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]

In a study of 48 patients who underwent reverse total shoulder arthroplasty (RTSA), a novel through-implant double-row suture technique for subscapularis repair resulted in an 83.3% healing rate of the tendon as confirmed by ultrasound after an average follow-up of 13.8 months.

Despite the high healing rate, the integrity of the subscapularis tendon did not significantly influence clinical outcomes or range of motion, indicating that the repair technique may be effective regardless of tendon status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subscapularis Repair During Reverse Total Shoulder Arthroplasty Using a Stem-Based Double-Row Repair: Sonographic and Clinical Outcomes. Erickson, BJ., Shishani, Y., Bishop, ME., et al.[2022]

Repairing the subscapularis tendon during reverse total shoulder arthroplasty significantly reduces dislocation rates, with an odds ratio of 0.19, based on a meta-analysis of 1306 patients from 7 studies.

In cases where the subscapularis tendon is not repaired, using a lateralized center of rotation (COR) design also leads to lower dislocation rates compared to a medialized COR, with an odds ratio of 0.24.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of subscapularis repair on dislocation rates in reverse shoulder arthroplasty: a meta-analysis and systematic review. Matthewson, G., Kooner, S., Kwapisz, A., et al.[2019]

Rotator cuff repair during reverse total shoulder arthroplasty (RTSA) can increase deltoid force and joint load, particularly when combined with glenosphere lateralization, which may lead to undesirable effects on shoulder mechanics.

The study suggests that humeral lateralization may be a better alternative to rotator cuff repair, as it improves joint compression and deltoid function without the complications associated with cuff repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The rotator cuff muscles are antagonists after reverse total shoulder arthroplasty. Giles, JW., Langohr, GD., Johnson, JA., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Sonographic assessment of the subscapularis after reverse shoulder arthroplasty: impact of tendon integrity on shoulder function. [2018]

3. 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]

4. 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]

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

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

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

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

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

Subscapularis Repair During Reverse Total Shoulder Arthroplasty Using a Stem-Based Double-Row Repair: Sonographic and Clinical Outcomes. [2022]

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

The effect of subscapularis repair on dislocation rates in reverse shoulder arthroplasty: a meta-analysis and systematic review. [2019]

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

The rotator cuff muscles are antagonists after reverse total shoulder arthroplasty. [2018]