Status:
RECRUITING
Subscapularis Repair in Reverse Shoulder Arthroplasty
Lead Sponsor:
Arthrex, Inc.
Conditions:
Rotator Cuff Tear Arthropathy
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).
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 scor...
Eligibility Criteria
Inclusion
- Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using the Arthrex ReversTM system.
- 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.
- Patient meets FDA cleared indications for reverse shoulder arthroplasty
- Patient is between 18-100 years old
- Patient agrees to also be enrolled in the Arthrex Total Shoulder Registry Study
- 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
- Patient has a history of ipsilateral shoulder arthroplasty
- A history of shoulder septic arthritis
- A full thickness subscapularis tear
- An acute or malunited proximal humeral fracture
- Chronic locked dislocation
- Rheumatoid arthritis
- Tumors
- Axillary nerve damage
- Non-functioning deltoid muscle
- Glenoid vault deficiency precluding baseplate fixation
- Infection and neuropathic joints
- Known or suspected non-compliance, drug or alcohol abuse
- Patients incapable of judgement or under tutelage
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc.
- The subject is related to investigator as family members, employees, or other dependent persons
- Any prior open anterior shoulder surgery that included takedown of the subscapularis tendon or violation of the subscapularis tendon (i.e. Latarjet, Bristow)
Key Trial Info
Start Date :
November 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 14 2025
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT05438914
Start Date
November 14 2022
End Date
September 14 2025
Last Update
January 30 2024
Active Locations (6)
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1
The University of Arizona/Banner Health
Phoenix, Arizona, United States, 85006
2
Western Orthopaedics, P.C.
Denver, Colorado, United States, 80218
3
Southern Oregon Orthopedics
Medford, Oregon, United States, 97504
4
The Hawkins Foundation
Greenville, South Carolina, United States, 29615