Subscapularis repair for Arthrosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Loyola Medicine, Maywood, IL
Arthrosis+3 More
Subscapularis repair - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This multi-site study involving Northwestern Medicine, Beaumont Health, and Loyola Medicine seeks to answer the following question: do patients who undergo subscapularis (SSc) repair during reverse total shoulder arthroplasty (RSA) have better post-operative outcomes than patients who do not undergo SSc repair during RSA? The investigators hypothesize that patients who do not undergo SSc repair during RSA have better post-operative outcomes than patients who undergo SSc repair during RSA. This study will address the controversy surrounding SSc repair during RSA via a multi-institutional randomized controlled trial that will compare clinical outcomes of patients who receive SSc repair during RSA to those who do not.

Eligible Conditions

  • Arthrosis
  • Osteoarthritis of the Shoulder
  • Shoulder Arthropathy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: up to 12 months post-surgery

Month 12
Internal Rotator (IR) Strength
PROMIS Bank v1.1 - Pain Interference
Shoulder Range of Motion
The American Shoulder and Elbow Surgeons (ASES) Shoulder Score

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

No repair
1 of 2
Subscapularis repair
1 of 2
Active Control
Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Subscapularis repair · No Placebo Group · N/A

Subscapularis repair
Procedure
Experimental Group · 1 Intervention: Subscapularis repair · Intervention Types: Procedure
No repairNoIntervention Group · 1 Intervention: No repair · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months post-surgery

Trial Background

Prof. Guido Marra, Professor of Orthopaedic Surgery
Principal Investigator
Northwestern University
Closest Location: Loyola Medicine · Maywood, IL
N/AFirst Recorded Clinical Trial
0 TrialsResearching Arthrosis
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The operation will be performed by a participating surgeon using Zimmer Biomet Comprehensive Reverse Shoulder System implant.
Imaging of arthropathy with rotator cuff insufficiency.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.