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The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty

Primary Purpose

Arthropathy Shoulder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repair
Standard Treatment
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy Shoulder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults undergoing primary reverse shoulder arthroplasty

Exclusion Criteria:

  • Adults without an intact subscapularis
  • Inflammatory arthritis
  • Revision surgery

Sites / Locations

  • Washington University Department of Orthopaedic Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Study

Arm Description

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

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

Outcomes

Primary Outcome Measures

American Shoulder and Elbow Surgeons Score
Patient Reported Outcome

Secondary Outcome Measures

Simple Shoulder Test
Patient Reported Outcome

Full Information

First Posted
October 30, 2018
Last Updated
March 22, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03727490
Brief Title
The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty
Official Title
The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy Shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
This group will have the subscapularis left un-repaired, which is the standard of care for our institution for reverse shoulder arthroplasty.
Arm Title
Study
Arm Type
Experimental
Arm Description
This group will have the subscapularis tendon repaired through a bone to bone repair that will add approximately 5 minutes to the surgical procedure.
Intervention Type
Other
Intervention Name(s)
Repair
Intervention Description
The subscapularis will be repaired.
Intervention Type
Other
Intervention Name(s)
Standard Treatment
Intervention Description
No repair will be performed
Primary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons Score
Description
Patient Reported Outcome
Time Frame
Two Years
Secondary Outcome Measure Information:
Title
Simple Shoulder Test
Description
Patient Reported Outcome
Time Frame
Two Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults undergoing primary reverse shoulder arthroplasty Exclusion Criteria: Adults without an intact subscapularis Inflammatory arthritis Revision surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander W Aleem, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University Department of Orthopaedic Surgery
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty

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