Subscapularis Repair for Rotator Cuff Tears

(Subscap Trial)

Recruiting at 5 trial locations

Overseen By Samantha Martino

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arthrex, Inc.

Disqualifiers: Rheumatoid arthritis, Tumors, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

134 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether repairing the subscapularis muscle during reverse shoulder replacement surgery benefits patients more than leaving it unrepaired. The goal is to determine if fixing this muscle enhances recovery and shoulder function. Patients undergoing reverse shoulder replacement without a history of certain shoulder issues may be suitable candidates. The trial will compare patients who have the muscle repaired with those who do not, to identify the more effective approach. As an unphased trial, this study provides patients the chance to contribute to innovative research that could improve future shoulder surgeries.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that subscapularis repair is safe during reverse shoulder arthroplasty?

Research shows that repairing the subscapularis muscle in the shoulder is generally safe during reverse total shoulder replacement surgery. Studies have found that this repair is well-tolerated and safely enhances the surgery. Although fixing this muscle doesn't offer additional benefits for recovery or outcomes, it doesn't pose significant safety issues either. Overall, current evidence considers it a safe procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the subscapularis repair technique for rotator cuff tears because it offers a potentially more effective way to restore shoulder function. Unlike typical treatments that may not repair the subscapularis muscle, this approach uses a "suture through bone and prosthesis holes" technique to directly repair the subscapularis. This could lead to improved stability and strength in the shoulder, addressing issues that standard reverse shoulder arthroplasty alone might not fully resolve. By focusing on repairing this specific muscle, the technique aims to enhance recovery and outcomes for patients with rotator cuff tears.

What evidence suggests that subscapularis repair might be an effective treatment for rotator cuff tears?

This trial will compare reverse shoulder arthroplasty with and without subscapularis repair. Research has shown that fixing the subscapularis muscle during reverse shoulder replacement surgery is safe and effective. However, studies have found no additional benefits compared to not repairing it. Occasionally, repairing this muscle can aid shoulder movement post-surgery, but overall, results show no significant differences a few years later. Thus, while the repair method is effective, it may not enhance the surgery's success compared to skipping the repair. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-100 who need reverse shoulder arthroplasty using the Arthrex system and can follow post-op care, including physical therapy. They must be able to participate in another related registry study. Excluded are those with prior surgeries affecting the subscapularis tendon, previous shoulder replacements, substance abuse issues, or conditions like rheumatoid arthritis that could interfere with the study.

Inclusion Criteria

I've had a CT scan within the last 6 months for Arthrex VIP planning.

I agree to join the study and can follow the study plan, including filling out questionnaires and attending follow-up visits.

Patient meets FDA cleared indications for reverse shoulder arthroplasty

Exclusion Criteria

I have had shoulder surgery that involved altering the subscapularis tendon.

I have had a shoulder infection.

I am unable to make decisions for myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants complete pre-operative assessments and questionnaires

1-2 weeks

1 visit (in-person)

Surgery and Initial Recovery

Participants undergo reverse shoulder arthroplasty with or without subscapularis repair

1 week

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for recovery and outcomes at various timepoints

2 years

Multiple visits at 9 weeks, 26 weeks, 1 year, and 2 years (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Repair of the subscapularis

Trial Overview The study is examining if repairing the subscapularis muscle during a type of shoulder replacement surgery (reverse shoulder arthroplasty) has better outcomes than not repairing it. Participants will either receive a repair or no repair as part of their surgical procedure.

How Is the Trial Designed?

Group I: Reverse Shoulder Arthroplasty with subscapularis repair Experimental Treatment 1 Intervention

The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.

Group II: Reverse Shoulder Arthroplasty without subscapularis repair Active Control 1 Intervention

The subscapularis will not be repaired.

Repair of the subscapularis is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Subscapularis repair for:

• Shoulder instability
• Rotator cuff tears
• Shoulder arthropathy

Approved in United States as Subscapularis repair for:

• Shoulder instability
• Rotator cuff tears
• Shoulder arthropathy
• Reverse shoulder arthroplasty

Approved in Canada as Subscapularis repair for:

• Shoulder instability
• Rotator cuff tears
• Shoulder arthropathy

Who Is Running the Clinical Trial?

Arthrex, Inc.

Lead Sponsor

Trials

48

Recruited

30,200+

Published Research Related to This Trial

The subscapularis muscle is crucial for rotator cuff function, and repairing it can significantly improve the ability to repair massive supraspinatus tears.

The presented technique utilizes double-row anchors in a knotless and tension-free manner, making it applicable for both partial and full-thickness tears of the upper subscapularis, which may enhance surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Repair of Massive Subscapularis and Supraspinatus Tear by Double-Row Knotless Technique. Chernchujit, B., Sharma, PN.[2020]

Repairing a torn subscapularis tendon is crucial for restoring shoulder anatomy and improving functional outcomes, despite it being less emphasized than other rotator cuff tears.

A systematic arthroscopic approach can effectively address various types of subscapularis tears, including partial, full-thickness, and retracted tears, using tailored repair techniques based on the specific injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic recognition and repair of the torn subscapularis tendon. Denard, PJ., Burkhart, SS.[2022]

In a study using eight human cadaveric shoulders, it was found that larger subscapularis tendon tears resulted in a significant decrease in the range of external rotation and horizontal abduction after surgical repair, particularly with large tears.

The research highlights that as the size of the tendon tear increases, the passive range of motion in the glenohumeral joint decreases, indicating that surgical outcomes may vary based on the size of the tear, which is important for post-operative rehabilitation planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glenohumeral joint motion after subscapularis tendon repair: an analysis of cadaver shoulder models. Sano, T., Aoki, M., Tanaka, Y., et al.[2021]

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 study of 65 patients undergoing reverse shoulder arthroplasty, repairing the subscapularis tendon did not significantly improve range of motion, strength, or functional outcomes compared to cases where the tendon was not repaired.

At a mean follow-up of 36 months, only 40% of the repaired tendons were still intact, indicating that the repair may not be crucial for achieving good clinical results after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of subscapularis tendon reattachment on range of motion in reversed shoulder arthroplasty: a clinical study. de Boer, FA., van Kampen, PM., Huijsmans, PE.[2022]

Repairing subscapularis tendon tears during shoulder arthroscopy can significantly improve functional outcomes and reduce the risk of retear, especially in patients with large rotator cuff tears.

The paper introduces a straightforward arthroscopic technique using a Clever Hook and Lasso Loop stitch, which aims to simplify the repair of both high-grade partial and full-thickness subscapularis tendon tears, addressing the challenges in diagnosis and surgical execution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Subscapularis Repair Using a Clever Hook and Lasso Loop Technique in the Beach Chair Position: A Simple and Reproducible Guide. Howlett, N., Parisien, RL., Son, SJ., et al.[2021]

Surgical treatment of single-tendon tears, particularly in the supraspinatus, can lead to good outcomes when the tendon is carefully mobilized and securely repaired.

For subscapularis tears, accurate diagnosis through clinical evaluation and imaging (CT or MR) is crucial, and performing an acute repair typically results in satisfactory outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-tendon tears of the rotator cuff. Evaluation and treatment of subscapularis tears and principles of treatment for supraspinatus tears. Ticker, JB., Warner, JJ.[2022]

Subscapularis tendon tears are increasingly recognized and often occur alongside posterosuperior rotator cuff tears, highlighting the importance of addressing both during surgical repair.

Repairing the subscapularis tendon first enhances the security and ease of repairing the posterosuperior rotator cuff, suggesting that neglecting the subscapularis can compromise overall shoulder function and repair integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why repair the subscapularis? A logical rationale. Ticker, JB., Burkhart, SS.[2022]

In a study of 40 patients with reverse shoulder arthroplasty, reattaching the subscapularis tendon showed no significant clinical benefits in terms of shoulder function or strength after an average follow-up of 89 months.

Despite one-third of the reattached tendons remaining intact at follow-up, there were no differences in outcomes like the Constant Murley Score or Oxford Shoulder Score between groups, indicating that subscapularis reattachment may not be necessary for optimal recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of subscapularis tendon reattachment after reverse shoulder arthroplasty: clinical findings and ultrasonographic evaluation of the subscapularis at 89 months mean follow-up. de Boer, FA., Pasma, JH., Huijsmans, PE., et al.[2023]

Restoring the function of the subscapularis tendon is crucial for achieving long-term success in treating both traumatic and nontraumatic rotator cuff tears.

The surgical technique described, which uses a combination of interlocking stitches and mattress sutures with a double-loaded suture anchor, effectively reduces tendon retraction and provides strong fixation to promote healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Subscapularis Interlocking Stitch for the Arthroscopic Treatment of Subscapularis Tendon Tears at the Shoulder. Kircher, J., Schwalba, K., Hedtmann, A.[2020]

Isolated tears of the subscapularis tendon, the largest muscle of the rotator cuff, often require surgical intervention due to their tendency for early retraction and fatty infiltration, which can compromise shoulder function.

Arthroscopic suture-anchor repair of the subscapularis tendon effectively restores shoulder mobility and strength, reduces pain, and leads to high patient satisfaction, demonstrating its efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Repair of Subscapularis Tendon Tears. Plath, JE., Henderson, DJH., Coquay, J., et al.[2020]

Citations

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

Is subscapularis repair associated with better outcome ... Although subscapularis repair was proven safe and effective for the augmentation of RTSA, it did not offer any additional clinical or functional benefit.

2. 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.

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 Although subscapularis repair was proven safe and effective for the augmenta- tion of RTSA, it did not offer any additional clinical or functional benefit in ...

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 ... Various clinical outcomes have been reported following subscapularis repair in RSA. Previous studies reported that subscapularis repair can ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38759837/

Does the subscapularis repair affect the clinical outcome ... Conclusions: Although the subscapularis repair affects the postoperative internal rotation positively, there were no differences in midterm follow-up concerning ...

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

Subscapularis in Reverse Total Shoulder Arthroplasty - PMC This review provides an overview of the current literature, which suggests that the subscapularis may have a more important role in RSA than originally thought.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2059775422000530

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. •. Reported benefits ...

8. momayamd.com momayamd.com/pdf/outcomes-for-subscapularis-management-techniques-in-shoulder-arthroplasty-a-systematic-review-18.pdf

outcomes-for-subscapularis-management-techniques-in- ... Background: This systematic review aims to synthesize published data for the most common subscapu- laris takedown and repair to compare outcomes in the ...