RECRUITING

Subscapularis Repair in Reverse Shoulder Arthroplasty

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-11-14

Study Completion:2025-09-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05438914

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.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)

Inclusion Criteria

Exclusion 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)

Contacts and Locations

Study Contact

Kelly A Ganz

CONTACT

1 (800) 933-7001

kelly.ganz@arthrex.com

Samantha Martino

CONTACT

1 (800) 933-7001

samantha.martino@arthrex.com

Study Locations (Sites)

The University of Arizona/Banner Health

Phoenix, Arizona, 85006

United States

Western Orthopaedics, P.C.

Denver, Colorado, 80218

United States

Southern Oregon Orthopedics

Medford, Oregon, 97504

United States

The Hawkins Foundation

Greenville, South Carolina, 29615

United States

The Campbell Clinic

Collierville, Tennessee, 38017

United States

Jordan Young Institute

Norfolk, Virginia, 23462

United States

Collaborators and Investigators

Sponsor: Arthrex, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-14

Study Completion Date2025-09-14

Study Record Updates

Study Start Date2022-11-14

Study Completion Date2025-09-14

Terms related to this study

Additional Relevant MeSH Terms

Rotator Cuff Tear Arthropathy