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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether repairing the subscapularis tendon during reverse shoulder replacement surgery improves outcomes or addresses shoulder dislocation concerns. The trial compares two approaches: repairing the tendon and not repairing it. This research could influence future shoulder surgery practices. Individuals undergoing reverse shoulder arthroplasty (a type of shoulder replacement) with a healthy subscapularis tendon might be suitable candidates for this trial. As an unphased trial, it offers participants the opportunity to contribute to pioneering research that could enhance surgical techniques and outcomes.

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 prior data suggests that these rotator cuff repair techniques are safe for shoulder injuries?

Studies have shown that both subscapularis tenotomy and repair are generally well-tolerated, though each has specific outcomes. For subscapularis tenotomy, research indicates a failure rate of about 3.3%, with some studies reporting a 6.2% failure rate over longer follow-ups. While generally safe, there is a small chance of complications over time.

Subscapularis repair is considered safe and effective for improving outcomes in reverse shoulder replacement surgery. It can enhance shoulder movement and strength, but results may vary depending on the techniques used.

Both treatments have their pros and cons, but overall, they are considered safe for shoulder surgeries. Participants should consult their healthcare provider to understand which option might be best for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the rotator cuff repair techniques being explored in this trial because they offer new approaches to treating shoulder injuries. Subscap Tenotomy is unique because it involves not repairing the subscapularis tendon, which could lead to quicker recovery times and less invasive procedures compared to traditional repair methods. On the other hand, Subscap Repair focuses on restoring the tendon, potentially offering improved strength and stability for patients. These techniques could provide tailored solutions depending on the specific needs of the shoulder injury, offering more personalized treatment options than the current standard of care.

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

This trial will compare two techniques for rotator cuff repair: Subscap Repair and Subscap Tenotomy. Research has shown that fixing the subscapularis tendon during reverse shoulder replacement surgery doesn't significantly affect the risk of complications like dislocation. Some studies have found a slight difference, with 1.5% dislocation rates for those who had the tendon repaired compared to 2.3% for those who didn't. However, no clear evidence shows that repairing the tendon improves shoulder function or reduces pain. Conversely, not repairing the tendon, a method called tenotomy, might be simpler and avoids some cosmetic issues. Current data suggests that the decision to repair or not depends on individual situations, as both options appear equally safe and effective. Participants in this trial will be assigned to either the Subscap Repair or Subscap Tenotomy arm to further evaluate these techniques. ^{2 6 7 8 9}

Who Is on the Research Team?

Mohit Gilotra, MD

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

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

I have had a shoulder bone fracture.

My Subscapularis Tendon cannot be repaired.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666638324000707

Clinical outcomes of over-the-top subscapularis repair in ... This study compares the clinical outcomes of patients undergoing RSA with over-the-top subscapularis repair (OTTR) to patients without repair.

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

Is subscapularis repair associated with better outcome ... All studies concluded that the repair of subscapularis did not affect the complications' rate of patients who were treated with RTSA. The mean dislocations' ...

3. 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 Comparison of reverse total shoulder arthroplasty outcomes with and without subscapularis repair. J Shoulder Elbow. Surg 2017;26:662-8. 19. Liberati A ...

4. frontiersin.org frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2023.1229646/full

Effect of subscapularis repair on joint contact forces based ... The findings of this study can help clinician decide whether to repair the rotator cuff during RSA to enhance joint stability. 1 Introduction.

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

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

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8282168/

Subscapularis in Reverse Total Shoulder Arthroplasty - PMC Patients with subscapularis repair and lateralization showed much lower ASES score improvements than patients with subscapularis repair without lateralization.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666638322000032

Outcomes of reverse shoulder arthroplasty following failed ... We found that RTSA after failed SCR improves pain and FF but is associated with modest functional improvements and high complication rates. Considering that SCR ...

8. link.springer.com link.springer.com/article/10.1007/s00402-021-04024-6

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 ...

9. jisakos.com jisakos.com/article/S2059-7754(22)00053-0/fulltext

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. •.