Evaluating subscapularis repair during reverse shoulder surgery

Subscapularis Repair in Reverse Shoulder Arthroplasty: a Randomized, Controlled, Multicenter, Prospective Study

This study is testing if repairing a specific shoulder muscle during reverse shoulder surgery helps patients feel less pain and move better compared to those who don't have the repair done.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 134 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Arthrex, Inc. (industry)
• Locations: 6 sites (Phoenix, Arizona and 5 other locations)
• Trial ID: NCT05438914 on ClinicalTrials.gov

What this trial studies

This study aims to compare the outcomes of patients undergoing reverse shoulder arthroplasty (RSA) with and without the repair of the subscapularis muscle. The primary focus is on assessing pain and functional improvement, measured by Constant scores at two years post-surgery. Secondary objectives include evaluating pain, function, and imaging results at various time points throughout the study. Participants will be required to complete subjective questionnaires and attend follow-up visits to ensure compliance with the study protocol.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-100 scheduled for reverse shoulder arthroplasty who can provide informed consent and comply with study requirements.

Not a fit: Patients with a history of shoulder arthroplasty, septic arthritis, or specific shoulder injuries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management and functional outcomes for patients undergoing reverse shoulder arthroplasty.

How similar studies have performed: While there have been studies on shoulder arthroplasty, the specific focus on subscapularis repair in this context is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using the Arthrex ReversTM system.
2. Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
3. Patient meets FDA cleared indications for reverse shoulder arthroplasty
4. Patient is between 18-100 years old
5. Patient agrees to also be enrolled in the Arthrex Total Shoulder Registry Study
6. Patient has a standard of care pre-operative CT taken within 6 months that has been submitted for Arthrex Virtual Implant Positioning TM (VIP) planning

Exclusion Criteria:

1. Patient has a history of ipsilateral shoulder arthroplasty
2. A history of shoulder septic arthritis
3. A full thickness subscapularis tear
4. An acute or malunited proximal humeral fracture
5. Chronic locked dislocation
6. Rheumatoid arthritis
7. Tumors
8. Axillary nerve damage
9. Non-functioning deltoid muscle
10. Glenoid vault deficiency precluding baseplate fixation
11. Infection and neuropathic joints
12. Known or suspected non-compliance, drug or alcohol abuse
13. Patients incapable of judgement or under tutelage
14. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc.
15. The subject is related to investigator as family members, employees, or other dependent persons
16. Any prior open anterior shoulder surgery that included takedown of the subscapularis tendon or violation of the subscapularis tendon (i.e. Latarjet, Bristow)

Where this trial is running

Phoenix, Arizona and 5 other locations

• The University of Arizona/Banner Health — Phoenix, Arizona, United States (RECRUITING)
• Western Orthopaedics, P.C. — Denver, Colorado, United States (NOT_YET_RECRUITING)
• Southern Oregon Orthopedics — Medford, Oregon, United States (RECRUITING)
• The Hawkins Foundation — Greenville, South Carolina, United States (RECRUITING)
• The Campbell Clinic — Collierville, Tennessee, United States (RECRUITING)
• Jordan Young Institute — Norfolk, Virginia, United States (RECRUITING)

Study contacts

• Study coordinator: Kelly A Ganz

Conditions: Rotator Cuff Tear Arthropathy