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The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03727490
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Arthropathy Shoulder Other: Repair Other: Standard Treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control
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
No repair will be performed
Experimental: 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.
 Other: Repair
The subscapularis will be repaired.


Outcome Measures
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Primary Outcome Measures :
  1. American Shoulder and Elbow Surgeons Score [ Time Frame: Two Years ]
    Patient Reported Outcome


Secondary Outcome Measures :
  1. Simple Shoulder Test [ Time Frame: Two Years ]
    Patient Reported Outcome


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults undergoing primary reverse shoulder arthroplasty

Exclusion Criteria:

  • Adults without an intact subscapularis
  • Inflammatory arthritis
  • Revision surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727490


Contacts
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Contact: Julianne Sefko, MPH 314-747-2496 sefkoj@wudosis.wustl.edu

Locations
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United States, Missouri
Washington University Department of Orthopaedic Surgery Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Julianne Sefko, MPH    314-747-2496    sefkoj@wudosis.wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Alexander W Aleem, MD Washington University School of Medicine
More Information
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03727490    
Other Study ID Numbers: 201611123
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases