Sling vs No Sling After Reverse Total Shoulder Arthroplasty

Duke University

Status: Enrolling

Conditions: Shoulder Osteoarthritis; Shoulder Disease; Rotator Cuff Tear Arthropathy

Treatments: Other: Time of Sling Use

Study type: Interventional

Funder types: Other

Identifiers

NCT06092996

Pro00113901

Details and patient eligibility

About

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 three weeks after their surgery while the no sling group will only wear a sling three days after their surgery. 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.

Full 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 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 3 weeks postoperatively. The No Sling (investigational) group, will wear a sling either through 3 days postoperatively.

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 and SANE), 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Sling

No Intervention group

Description:

Participants in the sling group will wear a sling according to current standard of care: 3 weeks postoperatively (2 weeks all the time, 3rd week at night and while in the community)

No Sling

Experimental group

Description:

Participants in the no sling group will only wear a sling for three days postoperatively

Treatment:

Other: Time of Sling Use