Reverse Shoulder Arthroplasty with subscapularis repair for Rotator Cuff Tear Arthropathy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Hawkins Foundation, Greenville, SC
Rotator Cuff Tear Arthropathy+1 More
Repair of the subscapularis - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).

Eligible Conditions

  • Rotator Cuff Tear Arthropathy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Rotator Cuff Tear Arthropathy

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.

Year 1
Return to Work Form
Year 2
American Shoulder and Elbow Surgeons (ASES) subjective survey
Simple Shoulder Test (SST) questionnaire
Single Assessment Numeric Evaluation score (SANE)
Veterans Rand 12 Item Health Survey (VR-12)
Visual Analog Scale (VAS)
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
Year 2
Standard Late Postoperative Form
Year 2
Constant-Murley Shoulder Outcome Score
Collected at the pre-op visit.
Standard Pre-Operative Form
Year 2
Ultrasound

Trial Safety

Safety Progress

1 of 3

Other trials for Rotator Cuff Tear Arthropathy

Trial Design

2 Treatment Groups

Reverse Shoulder Arthroplasty without subscapularis repair
1 of 2
Reverse Shoulder Arthroplasty with subscapularis repair
1 of 2
Active Control
Experimental Treatment

134 Total Participants · 2 Treatment Groups

Primary Treatment: Reverse Shoulder Arthroplasty with subscapularis repair · No Placebo Group · N/A

Reverse Shoulder Arthroplasty with subscapularis repair
Device
Experimental Group · 1 Intervention: Repair of the subscapularis · Intervention Types: Device
Reverse Shoulder Arthroplasty without subscapularis repairNoIntervention Group · 1 Intervention: Reverse Shoulder Arthroplasty without subscapularis repair · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Closest Location: The Hawkins Foundation · Greenville, SC
Photo of Greenville  1Photo of Greenville  2Photo of Greenville  3
2020First Recorded Clinical Trial
1 TrialsResearching Rotator Cuff Tear Arthropathy
1 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between 18 and 100 years old.
Patient agrees to be enrolled in the Arthrex Total Shoulder Registry Study.
Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using the Arthrex ReversTM system.

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.