Subscapularis Repair in Reverse Shoulder Arthroplasty
Status unconfirmed · Not applicable
Conditions studied: Rotator Cuff Tear Arthropathy
In brief
This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).
Key facts
- Study ID
- NCT05438914
- Run by
- Arthrex, Inc.
- People needed
- 134
- Starts
- 2022-11-14
- Expected to finish
- 2025-09-14
- Last updated by the study team
- 2024-01-30
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- The University of Arizona/Banner Health — Phoenix, Arizona, United States (enrolling)
- Southern Oregon Orthopedics — Medford, Oregon, United States (enrolling)
- The Hawkins Foundation — Greenville, South Carolina, United States (enrolling)
- The Campbell Clinic — Collierville, Tennessee, United States (enrolling)
- Jordan Young Institute — Norfolk, Virginia, United States (enrolling)
- Western Orthopaedics, P.C. — Denver, Colorado, United States
Full record on ClinicalTrials.gov
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