ACTIVE_NOT_RECRUITING

Sling vs No Sling After Reverse Total Shoulder Arthroplasty

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Conditions

Shoulder DiseaseRotator Cuff Tear ArthropathyShoulder Osteoarthritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Sling vs No Sling After Reverse Total Shoulder Arthroplasty

Quick Facts

Study Start:2023-12-07
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06092996

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient is scheduled to undergo a primary reverse shoulder arthroplasty procedure
  2. * 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
  3. * Patient meets indications for primary reverse shoulder arthroplasty for the following diagnosis
  4. * Rotator cuff arthropathy
  5. * Glenohumeral arthritis
  6. * Patient is between 18-100 years old
  7. * Patient is English speaking
  1. * A history of ipsilateral shoulder arthroplasty
  2. * A history of shoulder septic arthritis
  3. * A history of a proximal humeral fracture
  4. * Chronic locked dislocation
  5. * Rheumatoid arthritis
  6. * Tumors
  7. * Axillary nerve damage
  8. * Non-functioning deltoid muscle
  9. * Glenoid vault deficiency precluding baseplate fixation
  10. * Infection and neuropathic joints
  11. * Known or suspected non-compliance, drug or alcohol abuse
  12. * Patients incapable of judgement or under tutelage
  13. * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc.
  14. * The subject is related to investigator as family members, employees, or other dependent persons

Contacts and Locations

Principal Investigator

Oke A Anakwenze, MD, MBA
PRINCIPAL_INVESTIGATOR
Duke University
Christopher Klifto, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke University
Durham, North Carolina, 27708
United States

Collaborators and Investigators

Sponsor: Duke University

  • Oke A Anakwenze, MD, MBA, PRINCIPAL_INVESTIGATOR, Duke University
  • Christopher Klifto, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-07
Study Completion Date2028-12

Study Record Updates

Study Start Date2023-12-07
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

  • Shoulder Disease
  • Rotator Cuff Tear Arthropathy
  • Shoulder Osteoarthritis