Subscapularis Repair During Reverse Total Shoulder Arthroplasty

Not Applicable

Withdrawn

• Conditions: Shoulder Osteoarthritis; Arthropathy Shoulder
• Interventions: Procedure: Subscapularis repair

• 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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
Subscapularis repair	Subscapularis repair	Patients will undergo standard of care reverse total shoulder arthroplasty with subscapularis repair

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