Subscapularis Repair in Reverse Shoulder Arthroplasty

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05438914
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Arthrex, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rotator Cuff Tear Arthropathy

Additional Details

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.

Arms & Interventions

Arms

Experimental: Reverse Shoulder Arthroplasty with subscapularis repair

The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.

No Intervention: Reverse Shoulder Arthroplasty without subscapularis repair

The subscapularis will not be repaired.

Interventions

Device: - Repair of the subscapularis

The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

The University of Arizona/Banner Health, Phoenix, Arizona

Status

Recruiting

Address

The University of Arizona/Banner Health

Phoenix, Arizona, 85006

Site Contact

Saleh Ahmed

[email protected]

1 (800) 933-7001

Western Orthopaedics, P.C., Denver, Colorado

Status