Subscapularis Repair in Reverse Shoulder Arthroplasty

Launched by ARTHREX, INC. · Jun 28, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at whether repairing a muscle called the subscapularis during a specific shoulder surgery, known as reverse shoulder arthroplasty (RSA), is better than not repairing it. This surgery is often needed for people with severe shoulder problems, like rotator cuff tear arthropathy, a condition where the shoulder’s tendons are damaged. The study is currently recruiting participants aged 18 to 100 who are planning to have this surgery using a particular system made by Arthrex. To join, patients must be able to agree to the study, complete follow-up visits, and attend physical therapy after the surgery.

If you decide to participate, you will help researchers understand the benefits of repairing the subscapularis muscle during your surgery. It’s important to note that some people may not be eligible to join, especially those with certain shoulder injuries or conditions, such as previous shoulder surgeries or specific health issues. Participants will also be part of the Arthrex Total Shoulder Registry Study, which helps track shoulder surgeries over time. This trial aims to improve shoulder surgery outcomes, so your involvement could contribute to better care for future patients.

Gender

ALL

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)