Subscapularis Repair in Reverse Shoulder Arthroplasty for Rotator Cuff Syndrome

Recruiting at 3 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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The study is a prospective, multi-center, randomized blinded study to determine how repairing the subscapularis vs. not repairing the subscapularis when subjects are implanted with the AltiVate Reverse® Shoulder System for reverse total shoulder arthroplasty affects isometric and isokinetic internal rotational strength. It is hypothesized that patients in which the subscapularis is repaired will have improved postoperative isometric and isokinetic internal rotational strength.

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 data supports the effectiveness of the treatment Shoulder implant, Subscapularis repair in Reverse Shoulder Arthroplasty for Rotator Cuff Syndrome?

Some studies suggest that repairing the subscapularis tendon during reverse shoulder arthroplasty can improve shoulder stability and range of motion, potentially reducing the risk of dislocation. However, the effectiveness of this repair is still debated, with some evidence indicating it may not significantly impact clinical outcomes. ^{1 2 3 4 5}

Is subscapularis repair in reverse shoulder arthroplasty safe?

Subscapularis repair in reverse shoulder arthroplasty is generally considered safe, with similar complication rates to surgeries without the repair. Studies show no significant difference in shoulder instability rates between patients with or without the repair, suggesting it does not increase risk. ^{1 3 6 7 8}

How does subscapularis repair in reverse shoulder arthroplasty differ from other treatments for rotator cuff syndrome?

Subscapularis repair in reverse shoulder arthroplasty is unique because it focuses on repairing a specific tendon (the subscapularis) to potentially reduce dislocation rates and improve joint stability, which is still debated among experts. This approach is different from other treatments that may not specifically address this tendon during shoulder replacement surgery. ^{1 3 5 9 10}

Research Team

Jessica Knowlton, MS, CRA

Principal Investigator

DJO Global

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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]

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]

References

1. 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]

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

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

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

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

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

Clinical Outcomes After Reverse Shoulder Arthroplasty With and Without Subscapularis Repair: The Importance of Considering Glenosphere Lateralization. [2019]

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

Is subscapularis repair associated with better outcome compared to non-repair in reverse total shoulder arthroplasty? A systematic review of comparative trials. [2020]

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

Patient-Reported Outcomes After Isolated and Combined Arthroscopic Subscapularis Tendon Repairs. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Does shoulder stability differ with or without subscapularis repair after primary reverse total shoulder arthroplasty? A systematic review. [2023]

9. England pubmed.ncbi.nlm.nih.gov

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

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

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