The Role of Subscapularis Repair in Reverse Shoulder Arth... | NCT03727490

Studies
The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty

NCT03727490

Sponsor

Washington University School of Medicine

Status

Completed

Last Update Posted

Dec 31, 2025Actual

Enrollment

102Actual

Phase

Not Applicable

Conditions

Arthropathy Shoulder

Interventions

Repair
Standard Treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2018Actual

Primary Completion Date

Jan 1, 2025Actual

Completion Date

May 31, 2025Actual

First Submitted Date

Oct 30, 2018

First Submission Date that Met QC Criteria

Oct 30, 2018

First Posted Date

Nov 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2025

Last Update Posted Date

Dec 31, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	This group will have the subscapularis left un-repaired, which is the standard of care for our institution for reverse shoulder arthroplasty.	Other: Standard Treatment
Study	Experimental	This group will have the subscapularis tendon repaired through a bone to bone repair that will add approximately 5 minutes to the surgical procedure.	Other: Repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Repair	Other	The subscapularis will be repaired.	Study
Standard Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
American Shoulder and Elbow Surgeons Score	Patient Reported Outcome	Two Years

Secondary Outcomes

Measure	Description	Time Frame
Simple Shoulder Test	Patient Reported Outcome	Two Years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults undergoing primary reverse shoulder arthroplasty

Exclusion Criteria:

Adults without an intact subscapularis
Inflammatory arthritis
Revision surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexander W Aleem, MD	Washington University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington University Department of Orthopaedic Surgery		St Louis	Missouri	63110	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014945	Wound Healing

Ancestor Terms

ID	Term
D012038	Regeneration
D001686	Biological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided