Subscapularis Repair in Reverse Shoulder Arthroplasty

Description

This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).

Conditions

Rotator Cuff Tear Arthropathy

Study Overview

Study Details

Study overview

This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).

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

Subscapularis Repair in Reverse Shoulder Arthroplasty

Condition
Rotator Cuff Tear Arthropathy
Intervention / Treatment

-

Contacts and Locations

Phoenix

The University of Arizona/Banner Health, Phoenix, Arizona, United States, 85006

Denver

Western Orthopaedics, P.C., Denver, Colorado, United States, 80218

Medford

Southern Oregon Orthopedics, Medford, Oregon, United States, 97504

Greenville

The Hawkins Foundation, Greenville, South Carolina, United States, 29615

Collierville

The Campbell Clinic, Collierville, Tennessee, United States, 38017

Norfolk

Jordan Young Institute, Norfolk, Virginia, United States, 23462

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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)

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Arthrex, Inc.,

Study Record Dates

2025-09-14