Subscapularis Repair During Reverse Total Shoulder Arthroplasty

Subscapularis Repair During Reverse Total Shoulder Arthroplasty: a Randomized Control Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Shoulder Osteoarthritis; Arthropathy Shoulder
• Intervention / Treatment: Procedure: Subscapularis repair

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola Medicine
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Primary RSA procedure with repairable (intact) SSc
2. Operation will be performed by a participating surgeon using Zimmer Biomet Comprehensive Reverse Shoulder System implant
3. Diagnosis with imaging of arthropathy with rotator cuff insufficiency
4. Surgical approach: Deltopectoral
5. Fluent English speakers/readers

Exclusion Criteria:

1. Minor (<18 y/o)/vulnerable populations (pregnant women, prisoners, adults unable to consent)
2. Revision surgery
3. Oncologic surgery
4. non-ZB CRSS implants
5. Unrepairable SSc

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subscapularis repair; Patients will undergo standard of care reverse total shoulder arthroplasty with subscapularis repair	Procedure: Subscapularis repair; To complete reverse total shoulder arthroplasty, the surgeon must cut through the subscapularis muscle. In this arm of the study, the muscle will be repaired, rather than left to heal itself.
No Intervention: No repair; Patients will undergo standard of care reverse total shoulder arthroplasty. The subscapularis will not be repaired.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The American Shoulder and Elbow Surgeons (ASES) Shoulder Score	Scored from 0 (worst shoulder condition) to 100 (best shoulder condition)	up to 12 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Internal Rotator (IR) Strength	IR at the side and supported IR at 90˚ scapation; percent of nonsurgical side	up to 12 months post-surgery
PROMIS Bank v1.1 - Pain Interference	PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population).	up to 12 months post-surgery
Shoulder Range of Motion	shoulder extension, flexion, internal rotation, abduction, adduction; percent of nonsurgical side	up to 12 months post-surgery

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Guido Marra, MD, Northwestern University Feinberg School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases
• Other Study ID Numbers: STU00215591

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no participant data to share. No participants were enrolled.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No