Comparing sling use after reverse shoulder replacement surgery
Sling vs No Sling After Reverse Total Shoulder Arthroplasty
This study is testing if wearing a sling for three weeks after shoulder surgery helps patients recover better than wearing it for just three days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06092996 on ClinicalTrials.gov |
What this trial studies
This study evaluates the necessity of wearing a sling after reverse total shoulder arthroplasty by randomly assigning 100 patients to either a sling group, which will wear a sling for three weeks post-surgery, or a no-sling group, which will wear a sling for only three days. The aim is to determine if prolonged sling use impacts recovery outcomes. Patients will be monitored through standard follow-up visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years post-surgery, with data collected on patient-reported outcomes and physical examinations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-100 scheduled for primary reverse shoulder arthroplasty due to conditions like rotator cuff arthropathy or glenohumeral arthritis.
Not a fit: Patients with a history of shoulder arthroplasty, septic arthritis, or other specified shoulder conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help optimize post-operative care and recovery for patients undergoing shoulder replacement surgery.
How similar studies have performed: While similar studies have explored post-operative care in shoulder surgeries, this specific comparison of sling duration is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Oke A Anakwenze, MD, MBA — Duke University
- Study coordinator: Caroline Questell, BSN
- Email: caroline.darragh@duke.edu
- Phone: 919-613-3670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.