Sling vs No Sling After Reverse Total Shoulder Arthroplasty

Last updated: October 8, 2024
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Time of Sling Use

Clinical Study ID

NCT06092996
Pro00113901
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andphysical ability to participate in the study, fill out subjective questionnaires,return for follow-up visits, and comply with prescribed post-operative physicaltherapy

  • Patient meets indications for primary reverse shoulder arthroplasty for thefollowing diagnosis

  • Rotator cuff arthropathy

  • Glenohumeral arthritis

  • Patient is between 18-100 years old

  • Patient is English speaking

Exclusion

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 otherdependent persons

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Time of Sling Use
Phase:
Study Start date:
December 07, 2023
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Duke University

    Durham, North Carolina 27708
    United States

    Active - Recruiting

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