NCT03727490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

6.1 years

First QC Date

October 30, 2018

Last Update Submit

December 23, 2025

Conditions

Arthropathy Shoulder

Outcome Measures

Primary Outcomes (1)

  • American Shoulder and Elbow Surgeons Score

    Patient Reported Outcome

    Two Years

Secondary Outcomes (1)

  • Simple Shoulder Test

    Two Years

Study Arms (2)

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

RepairOTHER

The subscapularis will be repaired.

Study
Standard TreatmentOTHER

No repair will be performed

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults undergoing primary reverse shoulder arthroplasty

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University Department of Orthopaedic Surgery

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Interventions

Wound Healing

Intervention Hierarchy (Ancestors)

RegenerationBiological Phenomena

Study Officials

  • Alexander W Aleem, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2018

First Posted

November 1, 2018

Study Start

December 1, 2018

Primary Completion

January 1, 2025

Study Completion

May 31, 2025

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)