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NCT06092996 | RECRUITING | Shoulder Disease

Sling vs No Sling After Reverse Total Shoulder Arthroplasty
Sponsor:

Duke University

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.

Condition or disease

Shoulder Disease

Rotator Cuff Tear Arthropathy

Shoulder Osteoarthritis

Intervention/treatment

Time of Sling Use

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Sling vs No Sling After Reverse Total Shoulder Arthroplasty
Actual Study Start Date : 2023-12-07
Estimated Primary Completion Date : 2027-12
Estimated Study Completion Date : 2028-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Sling vs No Sling After Reverse Total Shoulder Arthroplasty

Location Details

NCT06092996

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Locations

RECRUITING

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27708