Subscapularis Repair During Reverse Total Shoulder Arthroplasty

Not Applicable

Withdrawn

• Conditions: Shoulder Osteoarthritis; Arthropathy Shoulder

• Registration Number: NCT05341518
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-22
• Study Start: 2023-01-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Internal Rotator (IR) Strength	up to 12 months post-surgery	IR at the side and supported IR at 90˚ scapation; percent of nonsurgical side
PROMIS Bank v1.1 - Pain Interference	up to 12 months post-surgery	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).
Shoulder Range of Motion	up to 12 months post-surgery	shoulder extension, flexion, internal rotation, abduction, adduction; percent of nonsurgical side

Trial Locations

Locations (2)

Loyola Medicine; 🇺🇸 Maywood, Illinois, United States

Beaumont Health; 🇺🇸 Royal Oak, Michigan, United States