Clinical trial NCT06092996: Sling vs No Sling After Reverse Total Shoulder Arthroplasty
Official title: Sling vs No Sling After Reverse Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Disease
Rotator Cuff Tear Arthropathy
Shoulder Osteoarthritis
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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. 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.

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 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.

Eligibility 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

Primary outcomes:
measure: Number of participants who develop any kind of postoperative complication
timeFrame: Up to the first 2 years following surgery
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score
timeFrame: Up to the first 2 years following surgery
measure: Single Assessment Numeric Evaluation (SANE) score
timeFrame: Up to the first 2 years following surgery
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Oke A Anakwenze, MD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Christopher Klifto, MD
role: PRINCIPAL_INVESTIGATOR
References: