Sling vs No Sling After Reverse Total Shoulder Arthroplasty (NCT06092996) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Sling vs No Sling After Reverse Total Shoulder Arthroplasty
United States100 participantsStarted 2023-12-07
Plain-language 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. 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants who develop any kind of postoperative complication
Timeframe: 6 months primary, Up to the first 2 years following surgery