Subscapularis Repair During Reverse Total Shoulder Arthroplasty
Primary Purpose
Shoulder Osteoarthritis, Arthropathy Shoulder
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Subscapularis repair
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Minor (<18 y/o)/vulnerable populations (pregnant women, prisoners, adults unable to consent)
- Revision surgery
- Oncologic surgery
- non-ZB CRSS implants
- Unrepairable SSc
Sites / Locations
- Loyola Medicine
- Beaumont Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Subscapularis repair
No repair
Arm Description
Patients will undergo standard of care reverse total shoulder arthroplasty with subscapularis repair
Patients will undergo standard of care reverse total shoulder arthroplasty. The subscapularis will not be repaired.
Outcomes
Primary Outcome Measures
The American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Scored from 0 (worst shoulder condition) to 100 (best shoulder condition)
Secondary Outcome Measures
Internal Rotator (IR) Strength
IR at the side and supported IR at 90˚ scapation; percent of nonsurgical side
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).
Shoulder Range of Motion
shoulder extension, flexion, internal rotation, abduction, adduction; percent of nonsurgical side
Full Information
NCT ID
NCT05341518
First Posted
April 18, 2022
Last Updated
January 24, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT05341518
Brief Title
Subscapularis Repair During Reverse Total Shoulder Arthroplasty
Official Title
Subscapularis Repair During Reverse Total Shoulder Arthroplasty: a Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Osteoarthritis, Arthropathy Shoulder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Subscapularis repair
Arm Type
Experimental
Arm Description
Patients will undergo standard of care reverse total shoulder arthroplasty with subscapularis repair
Arm Title
No repair
Arm Type
No Intervention
Arm Description
Patients will undergo standard of care reverse total shoulder arthroplasty. The subscapularis will not be repaired.
Intervention Type
Procedure
Intervention Name(s)
Subscapularis repair
Intervention Description
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.
Primary Outcome Measure Information:
Title
The American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Description
Scored from 0 (worst shoulder condition) to 100 (best shoulder condition)
Time Frame
up to 12 months post-surgery
Secondary Outcome Measure Information:
Title
Internal Rotator (IR) Strength
Description
IR at the side and supported IR at 90˚ scapation; percent of nonsurgical side
Time Frame
up to 12 months post-surgery
Title
PROMIS Bank v1.1 - Pain Interference
Description
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).
Time Frame
up to 12 months post-surgery
Title
Shoulder Range of Motion
Description
shoulder extension, flexion, internal rotation, abduction, adduction; percent of nonsurgical side
Time Frame
up to 12 months post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Minor (<18 y/o)/vulnerable populations (pregnant women, prisoners, adults unable to consent)
Revision surgery
Oncologic surgery
non-ZB CRSS implants
Unrepairable SSc
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Marra, MD
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola Medicine
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Beaumont Health
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Subscapularis Repair During Reverse Total Shoulder Arthroplasty
We'll reach out to this number within 24 hrs