Last updated: January 29, 2024
Sponsor: Arthrex, Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
Repair of the subscapularis
Clinical Study ID
NCT05438914
AIRR-00608-20
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using theArthrex ReversTM system.
- Patient voluntarily consents to participate in the study and has the mental andphysical ability to participate in the study, fill out subjective questionnaires,return for follow-up visits, and comply with prescribed post-operative physicaltherapy.
- 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 beensubmitted for Arthrex Virtual Implant Positioning TM (VIP) planning
Exclusion
Exclusion Criteria:
- 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 otherdependent persons
- Any prior open anterior shoulder surgery that included takedown of the subscapularistendon or violation of the subscapularis tendon (i.e. Latarjet, Bristow)
Study Design
Total Participants: 134
Treatment Group(s): 1
Primary Treatment: Repair of the subscapularis
Phase:
Study Start date:
November 14, 2022
Estimated Completion Date:
September 14, 2025
Study Description
Connect with a study center
The University of Arizona/Banner Health
Phoenix, Arizona 85006
United StatesActive - Recruiting
Western Orthopaedics, P.C.
Denver, Colorado 80218
United StatesSite Not Available
Southern Oregon Orthopedics
Medford, Oregon 97504
United StatesActive - Recruiting
The Hawkins Foundation
Greenville, South Carolina 29615
United StatesActive - Recruiting
The Campbell Clinic
Collierville, Tennessee 38017
United StatesActive - Recruiting
Jordan Young Institute
Norfolk, Virginia 23462
United StatesActive - Recruiting
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