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Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

RecruitingPhase 2Ages 18 Years - anyAllNYU Langone Health
NCT07138898 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to assess the incidence of rheumatologic flares, changes in pain scores (VAS), changes in functional outcomes (PROMIS), wound complications, surgical site infections, and return trips to the operating room for rheumatology patients following shoulder replacements, comparing those who stop their immunosuppressants preoperatively for the same amount of time as suggested in the literature for hip and knee arthroplasty versus those who hold the medications for a shorter period of time preoperatively.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adults aged 18 years and older at the time of informed consent; 2. Diagnosis of rheumatic disease: rheumatoid arthritis (RA), psoriatic arthritis (PA) , ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), spondyloarthritis, polymyalgia rheumatica, giant cell arteritis, vasculitis, granulomatosis with polyangiitis, dermatomyositis, polymyositis, and inflammatory bowel disease-associated arthritis; 3. On active immunosuppression for at least 3 months prior to scheduled surgery; 4. Scheduled for elective total shoulder arthroplasty; 5. Able and willing to provide written informed consent prior to any study specific procedures. Exclusion Criteria: * Patients with active infections or malignancies; * Patients undergoing shoulder arthroplasty for fracture or tumor; * Pregnancy or breastfeeding; * Unable to provide informed consent; * Patients with severe SLE with marked activity - as they should be offered enrollment in the observational arm. All such patients should remain on treatment to avoid worsening of disease activity; * Unable or without capacity to provide written informed consent prior to any study specific procedures.
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What it tests

  • Methotrexate
  • Sulfasalazine
  • Hydroxychloroquine
  • Leflunomide
  • Azathioprine
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Where

1 site
NYU Langone Health
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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