Sling vs No Sling After Reverse Total Shoulder Arthroplasty

NCT06092996 | Active Not Recruiting

• 1 other identifier: Pro00113901
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Disease; Rotator Cuff Tear Arthropathy; Shoulder Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Number of participants who develop any kind of postoperative complication

  Incidence of postoperative complications

  6 months primary, Up to the first 2 years following surgery

Secondary Outcomes (2)

• American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score

  6 months primary, Up to the first 2 years following surgery

• Single Assessment Numeric Evaluation (SANE) score

  6 months primary, Up to the first 2 years following surgery

Study Arms (2)

Sling

NO INTERVENTION

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

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

Other: Time of Sling Use

Interventions

Time of Sling Use OTHER

Standard sling worn for only three days post operatively

No Sling

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Study Officials

• Oke A Anakwenze, MD, MBA

  Duke University

  PRINCIPAL INVESTIGATOR

• Christopher Klifto, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: December 7, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)