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NCT05438914 | RECRUITING | Rotator Cuff Tear Arthropathy

Subscapularis Repair in Reverse Shoulder Arthroplasty
Sponsor:

Arthrex, Inc.

Brief Summary:

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

Condition or disease

Rotator Cuff Tear Arthropathy

Intervention/treatment

Repair of the subscapularis

Phase

NA

Detailed Description:

The primary objective of this study is to evaluate pain and function in patients undergoing RSA with or without subscapularis repair. This primary outcome will be measured by analysis of Constant scores at two years post-operative. Secondary objectives are to evaluate pain, function and imaging, between the two groups at each applicable time point.

Study Type : INTERVENTIONAL
Estimated Enrollment : 134 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : Subscapularis Repair in Reverse Shoulder Arthroplasty: a Randomized, Controlled, Multicenter, Prospective Study
Actual Study Start Date : 2022-11-14
Estimated Primary Completion Date : 2025-09-14
Estimated Study Completion Date : 2025-09-14

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
Subscapularis Repair in Reverse Shoulder Arthroplasty

Location Details

NCT05438914

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

The University of Arizona/Banner Health

Phoenix, arizona, United States, 85006

NOT YET RECRUITING

United States, Colorado

Western Orthopaedics, P.C.

Denver, Colorado, United States, 80218

RECRUITING

United States, Oregon

Southern Oregon Orthopedics

Medford, Oregon, United States, 97504

RECRUITING

United States, South Carolina

The Hawkins Foundation

Greenville, South Carolina, United States, 29615

RECRUITING

United States, Tennessee

The Campbell Clinic

Collierville, Tennessee, United States, 38017

RECRUITING

United States, Virginia

Jordan Young Institute

Norfolk, Virginia, United States, 23462