Subscapularis Repair in Shoulder Replacement for Shoulder Arthropathy

No longer recruiting at 1 trial location

Overseen By Julianne Sefko, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Inflammatory arthritis, Revision surgery, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether repairing the subscapularis tendon during a specific type of shoulder replacement surgery affects recovery. It compares two groups: one undergoes standard surgery without tendon repair, while the other includes tendon repair. The trial targets individuals needing this shoulder surgery with an intact subscapularis tendon. Those with shoulder arthritis considering surgery might find this trial suitable. As an unphased trial, it provides a unique opportunity to contribute to medical knowledge and potentially enhance surgical outcomes for future patients.

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 this repair technique is safe for shoulder arthropathy?

Research has shown that repairing the subscapularis tendon during shoulder surgery is generally well-tolerated. In one study, patients who had their subscapularis tendons repaired experienced significantly less shoulder instability compared to those without the repair. Specifically, only 1 out of 161 patients with repairs had instability, while 14 out of 123 without repairs did.

Another study found that different methods of managing the subscapularis tendon resulted in similar outcomes, indicating that repairing it does not lead to more complications. Additionally, certain techniques for tendon repair proved very successful, with about 93.1% of tendons remaining intact after surgery.

Overall, these findings suggest that subscapularis tendon repair is safe and effective, with a low risk of serious problems after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard approach for shoulder arthropathy, which leaves the subscapularis tendon unrepaired during reverse shoulder arthroplasty, the experimental treatment involves repairing the tendon with a bone-to-bone technique. This adds just about 5 minutes to the surgery but could significantly enhance shoulder stability and function. Researchers are excited because this repair could potentially improve patient outcomes by providing better joint mechanics and reducing the risk of complications associated with tendon non-repair.

What evidence suggests that repairing the subscapularis tendon during shoulder replacement could be effective for shoulder arthropathy?

This trial will compare two approaches in reverse shoulder replacement surgery for shoulder arthropathy. One group will have the subscapularis tendon repaired, which research has shown can lower the chance of shoulder joint dislocation. However, some studies suggest that repairing the tendon doesn't always improve shoulder function or patient satisfaction compared to not repairing it. The other group will follow the standard treatment, leaving the subscapularis unrepaired. While fixing the tendon can reduce dislocation risks, it might not significantly impact other areas like shoulder function. ^{3 6 7 8 9}

Who Is on the Research Team?

Alexander W Aleem, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults who are about to have their first reverse shoulder arthroplasty, a type of shoulder replacement surgery. It's not open to those without an intact subscapularis tendon, those with inflammatory arthritis, or anyone needing revision surgery.

Inclusion Criteria

I am having my first reverse shoulder replacement surgery.

Exclusion Criteria

I have inflammatory arthritis.

I am an adult scheduled for a corrective surgery.

My subscapularis (shoulder muscle) is not intact.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo reverse shoulder arthroplasty with or without subscapularis tendon repair

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

104 weeks

Regular follow-up visits over two years

What Are the Treatments Tested in This Trial?

Interventions

• Repair
• Standard Treatment

Trial Overview The study is testing whether repairing the subscapularis tendon during the initial reverse shoulder arthroplasty improves short-term patient outcomes compared to standard treatment without repair. Participants won't know which group they're in.

How Is the Trial Designed?

Group I: Study Experimental Treatment 1 Intervention

This group will have the subscapularis tendon repaired through a bone to bone repair that will add approximately 5 minutes to the surgical procedure.

Group II: Control Active Control 1 Intervention

This group will have the subscapularis left un-repaired, which is the standard of care for our institution for reverse shoulder arthroplasty.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40536679/

Evaluating the incidence and associated factors of ... Subscapularis tenotomy had a failure rate of 3.3%. Studies with follow-up periods longer than five years reported a combined 6.2% failure rate ...

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

outcomes-for-subscapularis-management-techniques-in- ... Shoulder arthroplasty for the treatment of arthritis has been shown to produce effective and reliable outcomes.7 Dissec- tion through the deltopectoral interval ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30827833/

The effect of subscapularis repair on dislocation rates in ... The results of our meta-analysis of the available data demonstrated a decrease in dislocation risk when the subscapularis tendon was repaired in medialized ...

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

Subscapularis in Reverse Total Shoulder Arthroplasty - PMC Patients with subscapularis tendon insufficiency at surgery had a rate of instability of 12% (14/123) while only 1 out of 161 patients suffered instability ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058274617304743

Outcomes for subscapularis management techniques in ... The data suggest no significant differences exist for postoperative musculotendinous integrity or clinical outcomes among the subscapularis management ...

8. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(17)30474-3/abstract

Outcomes for subscapularis management techniques in ... The data suggest no significant differences exist for postoperative musculotendinous integrity or clinical outcomes among the subscapularis ...

9. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(23)00200-1/fulltext

Subscapularis Repair Augmentation With the Long Head ... Augmenting the subscapularis repair, particularly in at-risk patients, may provide a more robust construct and prevent subscapularis failure.