Sling vs No Sling After Reverse Total Shoulder Arthroplasty

Study Overview
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Brief Summary
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This study involves patients who will be undergoing a reverse total shoulder replacement at Duke University. 100 eligible will be randomly assigned into one of two groups, a sling or no sling group. Patients in the sling group will wear a sling for four weeks after their surgery while the no sling group will only wear a sling three days after their surgery or until their nerve block wears off, whichever comes first. Patients will follow their doctors normal follow up visit schedule after surgery, with visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years.

Detailed Description
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The purpose of this study is to determine whether or not a sling is necessary after the nerve block has worn off postoperatively for patients undergoing reverse total shoulder arthroplasty. Patients who are scheduled for a reverse total shoulder with the participating investigators will be approached for potential participation in the study. Before the surgery, subjects will be randomly assigned to either the Sling (control) group or the No-Sling (investigational) group. The Sling, or control, group will wear a sling through 4 weeks postoperatively. The No Sling (investigational) group, will wear a sling either through 3 days postoperatively or until your nerve block wears off, whichever comes first. Following surgery, patients will be followed at their standard of care visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after their surgical date. The investigators will collect data from these standard of care visits including PROs (including but not limited to ASES, SANE, and SSV), Adverse events data, and physical exam data including range of motion. Patients will be followed through their two-year visit and then taken off study.

Official Title
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Sling vs No Sling After Reverse Total Shoulder Arthroplasty

Conditions
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Shoulder Disease, Rotator Cuff Tear Arthropathy, Shoulder Osteoarthritis

Intervention / Treatment
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* Other: Time of Sling Use


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is scheduled to undergo a primary reverse shoulder arthroplasty procedure Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy at Duke. Patient meets indications for primary reverse shoulder arthroplasty for the following diagnosis Rotator cuff arthropathy Glenohumeral arthritis Patient is between 18-100 years old Patient is English speaking Exclusion Criteria: A history of ipsilateral shoulder arthroplasty A history of shoulder septic arthritis A history of a proximal humeral fracture Chronic locked dislocation Rheumatoid arthritis Tumors Axillary nerve damage Non-functioning deltoid muscle Glenoid vault deficiency precluding baseplate fixation Infection and neuropathic joints Known or suspected non-compliance, drug or alcohol abuse Patients incapable of judgement or under tutelage Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc. The subject is related to investigator as family members, employees, or other dependent persons

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Sling<br>Participants in the sling group will wear a sling according to current standard of care: 4 weeks postoperatively | |
| Experimental: No Sling<br>Participants in the no sling group will only wear a sling for three days postoperatively | Other: Time of Sling Use<br>* Standard sling worn for only three days post operatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who develop any kind of postoperative complication | Incidence of postoperative complications | Up to the first 2 years following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score | The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. Total score ranges from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. | Up to the first 2 years following surgery | 
| Single Assessment Numeric Evaluation (SANE) score | The SANE is a single-question outcome measure that asks patients to rate their function (as it pertains to the area being treated) on a scale of 0 to 100, where a higher score indicates greater function. | Up to the first 2 years following surgery | 
| Subjective Shoulder Value (SSV) | The SSV score is defined as the subjective evaluation by the patient of shoulder function, expressed as a percentage of a normal shoulder. This score ranges from 0 to 100%. | Up to the first 2 years following surgery |