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The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty

NCT ID: NCT03727490

Last Updated: 2025-12-31

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2025-05-31

Brief Summary

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The overall goal of the study is to determine if repairing the subscapularis tendon during primary reverse shoulder arthroplasty effects short-term patient outcomes. The study is a patient blinded randomized controlled trial that is currently enrolling.

Detailed Description

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Conditions

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Arthropathy Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

This group will have the subscapularis left un-repaired, which is the standard of care for our institution for reverse shoulder arthroplasty.

Group Type ACTIVE_COMPARATOR

Standard Treatment

Intervention Type OTHER

No repair will be performed

Study

This group will have the subscapularis tendon repaired through a bone to bone repair that will add approximately 5 minutes to the surgical procedure.

Group Type EXPERIMENTAL

Repair

Intervention Type OTHER

The subscapularis will be repaired.

Interventions

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Repair

The subscapularis will be repaired.

Intervention Type OTHER

Standard Treatment

No repair will be performed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults undergoing primary reverse shoulder arthroplasty

Exclusion Criteria

* Adults without an intact subscapularis
* Inflammatory arthritis
* Revision surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander W Aleem, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University Department of Orthopaedic Surgery

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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201611123

Identifier Type: -

Identifier Source: org_study_id