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Active, Not Recruiting

NCT Number: NCT06092996

Sling vs No Sling After Reverse Total Shoulder Arthroplasty

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27708, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time of Sling Use

Other

Standard sling worn for only three days post operatively

Primary outcomes

  1. Number of participants who develop any kind of postoperative complication

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

    Incidence of postoperative complications

Secondary outcomes

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

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

    The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. Total score ranges from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.

  2. Single Assessment Numeric Evaluation (SANE) score

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

    The SANE is a single-question outcome measure that asks patients to rate their function (as it pertains to the area being treated) on a scale of 0 to 100, where a higher score indicates greater function.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 23, 2023
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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