Status:
ACTIVE_NOT_RECRUITING
Sling vs No Sling After Reverse Total Shoulder Arthroplasty
Lead Sponsor:
Duke University
Conditions:
Shoulder Disease
Rotator Cuff Tear Arthropathy
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
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. P...
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
December 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06092996
Start Date
December 7 2023
End Date
December 1 2028
Last Update
January 8 2026
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27708