Subscapularis Repair in Reverse Shoulder Arthroplasty for Rotator Cuff Syndrome

Enrolling by invitation at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Encore Medical, L.P.

Must not be taking: Chemotherapy, Radiation, Corticosteroids, others

Disqualifiers: Metal allergies, Active infection, Neuromuscular compromise, others

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

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether repairing the subscapularis muscle improves strength after shoulder implant surgery using the AltiVate Reverse® Shoulder System. The study includes two groups: one with muscle repair and one without, to determine which approach enhances shoulder strength. It targets individuals requiring shoulder surgery due to severe joint issues and a rotator cuff problem affecting daily activities. Participants must have a repairable subscapularis muscle, as determined by an MRI. As an unphased trial, it offers participants the chance to contribute to valuable research that may enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking more than 5mg/day of corticosteroids (like prednisone) within 3 months before surgery, you may not be eligible to participate.

What prior data suggests that this shoulder implant and subscapularis repair are safe?

Research has shown that reverse shoulder replacement surgery, with or without subscapularis muscle repair, is generally safe. Studies indicate that this surgery can improve shoulder movement and reduce pain. Specifically, one study found that patients with repaired subscapularis tendons could turn their shoulders inward more easily.

Overall, patients tolerate the surgery well. However, some research highlights that while improvements occur, functional gains might be moderate, and the risk of complications is higher. Prospective participants should consider these factors when deciding to join a clinical trial for this surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether repairing the subscapularis muscle during reverse shoulder arthroplasty can provide better outcomes for people with rotator cuff syndrome. Standard treatments often involve shoulder implants without focusing on subscapularis repair. This trial specifically investigates if addressing the subscapularis muscle can enhance shoulder stability and function compared to not repairing it. By examining both approaches, researchers hope to determine if subscapularis repair offers significant benefits, potentially leading to improved recovery and joint performance.

What evidence suggests that this trial's treatments could be effective for rotator cuff syndrome?

This trial will compare outcomes between two groups: one where the subscapularis muscle is repaired during reverse total shoulder replacement surgery, and another where it is not. Research has shown that fixing the subscapularis muscle might enhance shoulder stability. In one study, only 0.8% of patients with this muscle repaired experienced instability, compared to 4.2% without the repair. Other studies suggest that while repairing the subscapularis doesn't significantly affect complication rates, it might improve shoulder function and strength. Overall, repairing this muscle could lead to better shoulder performance after surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Jessica Knowlton, MS, CRA

Principal Investigator

DJO Global

Are You a Good Fit for This Trial?

This trial is for individuals over 21 needing reverse shoulder arthroplasty due to severe joint issues with a deficient rotator cuff. They must be able to follow the study plan, have a repairable subscapularis muscle as confirmed by MRI, and not be pregnant or planning pregnancy during the study. Exclusions include metal allergies, active infections near implantation site, high corticosteroid use, nonfunctional deltoid muscle, cognitive impairments affecting participation, recent chemotherapy or radiation treatment, substance abuse issues.

Inclusion Criteria

Subject is likely to be available for evaluation for the duration of the study

I am 21 years old or older.

I am scheduled for a specific shoulder replacement due to severe joint disease and a major rotator cuff issue.

Exclusion Criteria

You have a history of cognitive or mental health issues that could make it difficult for you to participate in the study.

I am currently undergoing or planning to start chemotherapy or radiation.

You are currently using drugs or alcohol excessively, or receiving treatment for substance abuse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo reverse total shoulder arthroplasty with or without subscapularis repair using the AltiVate Reverse® Shoulder System

6 weeks

1 visit (surgical procedure)

Follow-up

Participants are monitored for changes in shoulder functionality, general health, radiographic parameters, and device survivorship

10 years

Multiple visits at 6 weeks, 6 months, and 1, 2, 5, and 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Shoulder implant
• Subscapularis repair

Trial Overview

The trial tests whether repairing the subscapularis muscle improves strength after receiving an AltiVate Reverse® Shoulder System implant in patients undergoing reverse total shoulder arthroplasty. It's a prospective (forward-looking), multi-center study where participants are randomly assigned to either get their subscapularis repaired or not and then compared.

How Is the Trial Designed?

Group I: Group B Experimental Treatment 1 Intervention

The subscapularis is not repaired. Receives device

Group II: Group A Experimental Treatment 2 Interventions

The subscapularis is repaired. Receives device

Who Is Running the Clinical Trial?

Encore Medical, L.P.

Lead Sponsor

Trials

22

Recruited

3,600+

Published Research Related to This Trial

In a study of 145 patients who underwent arthroscopic subscapularis repair, there was a significant reduction in pain scores from an average of 4.8 to 0.9 after surgery, indicating effective pain management post-operation.

Patient-reported outcomes were similar across different types of subscapularis tears and concurrent repairs, suggesting that the size of the tear or additional procedures did not significantly affect overall recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes After Isolated and Combined Arthroscopic Subscapularis Tendon Repairs. Monroe, EJ., Flores, SE., Chambers, CC., 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]

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]

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]

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 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]

Citations

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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.

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

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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 ...

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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 ...

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Subscapularis repair resulted in less instability compared to without subscapularis repair (0.8% vs. 4.2%, P = .04), and there were no significant differences ...

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Reverse shoulder arthroplasty with or without subscapularis repair is a safe and successful method to improve range of motion and reduce pain in patients with ...

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Subscapularis Repair in Reverse Shoulder Arthroplasty

The primary objective of this study is to evaluate pain and function in patients undergoing RSA with or without subscapularis repair. This primary outcome ...

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Outcomes of reverse shoulder arthroplasty following failed ...

RTSA after failed SCR improves pain and FF but is associated with modest functional improvements and high complication rates.

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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 ...