Arthropathy Shoulder, Shoulder Osteoarthritis
Conditions
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.
Interventions
PROCEDURESubscapularis 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.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed