Subscapularis Repair During Reverse Total Shoulder Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-02

Study Completion Date

2025-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Subscapularis Repair in Reverse Shoulder Arthroplasty

NCT05438914

Rotator Cuff Tear Arthropathy

RECRUITING NA

Subscap Reverse Shoulder Arthroplasty

NCT05344898

Shoulder Injuries Rotator Cuff Injuries

RECRUITING NA

The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty

NCT03727490

Arthropathy Shoulder

COMPLETED NA

The Influence of Repairing the Sub-scapularis on Outcomes After Reverse Arthroplasty

NCT03711175

Severe Arthropathy With a Grossly Deficient Rotator Cuff

ENROLLING_BY_INVITATION NA

Reverse Total Shoulder Arthroplasty: A Data Analysis on Patients Undergoing Reverse Total Shoulder Arthroplasty

NCT03617107

Osteo Arthritis Shoulders Proximal Humeral Fracture Rotator Cuff Tear +1 more

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Shoulder Osteoarthritis Arthropathy Shoulder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Subscapularis repair

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

Group Type EXPERIMENTAL

Subscapularis repair

Intervention Type PROCEDURE

To complete reverse total shoulder arthroplasty, the surgeon must cut through the subscapularis muscle. In this arm of the study, the muscle will be repaired, rather than left to heal itself.

No repair

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Subscapularis repair

To complete reverse total shoulder arthroplasty, the surgeon must cut through the subscapularis muscle. In this arm of the study, the muscle will be repaired, rather than left to heal itself.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No