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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05341518
Other study ID # STU00215591
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 2, 2023
Est. completion date August 2025

Study information

Verified date March 2024
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2025
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 88 Years
Eligibility 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


Intervention

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.

Locations

Country Name City State
United States Loyola Medicine Maywood Illinois
United States Beaumont Health Royal Oak Michigan

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Internal Rotator (IR) Strength IR at the side and supported IR at 90° scapation; percent of nonsurgical side up to 12 months post-surgery
Secondary 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
Secondary Shoulder Range of Motion shoulder extension, flexion, internal rotation, abduction, adduction; percent of nonsurgical side up to 12 months post-surgery
See also
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