Subscapularis Repair During Reverse Total Shoulder Arthroplasty

NCT05341518 | Withdrawn

• 1 other identifier: STU00215591
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Shoulder Osteoarthritis; Arthropathy Shoulder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Internal Rotator (IR) Strength

  up to 12 months post-surgery

• PROMIS Bank v1.1 - Pain Interference

  up to 12 months post-surgery

• Shoulder Range of Motion

  up to 12 months post-surgery

Study Arms (2)

Subscapularis repair

EXPERIMENTAL

Patients will undergo standard of care reverse total shoulder arthroplasty with subscapularis repair

Procedure: Subscapularis repair

No repair

NO INTERVENTION

Patients will undergo standard of care reverse total shoulder arthroplasty. The subscapularis will not be repaired.

Interventions

Subscapularis repair PROCEDURE

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.

Subscapularis repair

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Minor (\<18 y/o)/vulnerable populations (pregnant women, prisoners, adults unable to consent)
• Revision surgery
• Oncologic surgery
• non-ZB CRSS implants
• Unrepairable SSc

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (2)

Loyola Medicine

Maywood, Illinois, 60153, United States

Location

Beaumont Health

Royal Oak, Michigan, 48073, United States

Location

Study Officials

• Guido Marra, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 22, 2022
• Study Start: January 2, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)