Subscapularis Repair During Reverse Total Shoulder Arthroplasty

Northwestern University

Status: Withdrawn

Conditions: Shoulder Osteoarthritis; Arthropathy Shoulder

Treatments: Procedure: Subscapularis repair

Study type: Interventional

Funder types: Other

Identifiers

NCT05341518

STU00215591

Details and patient eligibility

About

This multi-site study involving Northwestern Medicine, Beaumont Health, and Loyola Medicine seeks to answer the following question: do patients who undergo subscapularis (SSc) repair during reverse total shoulder arthroplasty (RSA) have better post-operative outcomes than patients who do not undergo SSc repair during RSA? The investigators hypothesize that patients who do not undergo SSc repair during RSA have better post-operative outcomes than patients who undergo SSc repair during RSA. This study will address the controversy surrounding SSc repair during RSA via a multi-institutional randomized controlled trial that will compare clinical outcomes of patients who receive SSc repair during RSA to those who do not.

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Primary RSA procedure with repairable (intact) SSc
2. Operation will be performed by a participating surgeon using Zimmer Biomet Comprehensive Reverse Shoulder System implant
3. Diagnosis with imaging of arthropathy with rotator cuff insufficiency
4. Surgical approach: Deltopectoral
5. Fluent English speakers/readers

Exclusion criteria

1. Minor (<18 y/o)/vulnerable populations (pregnant women, prisoners, adults unable to consent)
2. Revision surgery
3. Oncologic surgery
4. non-ZB CRSS implants
5. Unrepairable SSc

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Subscapularis repair

Experimental group

Description:

Patients will undergo standard of care reverse total shoulder arthroplasty with subscapularis repair

Treatment:

Procedure: Subscapularis repair

No repair

No Intervention group

Description:

Patients will undergo standard of care reverse total shoulder arthroplasty. The subscapularis will not be repaired.