Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

Qualifiers

Adults aged 18 years and older at the time of informed consent;

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;

On active immunosuppression for at least 3 months prior to scheduled surgery;

Scheduled for elective total shoulder arthroplasty;

Disqualifiers

Patients with active infections or malignancies;

Patients undergoing shoulder arthroplasty for fracture or tumor;

Pregnancy or breastfeeding;

Unable to provide informed consent;

Trial design

Treatments tested in this trial

  • Methotrexate
  • Sulfasalazine
  • Hydroxychloroquine
  • Leflunomide
  • Azathioprine
  • Mycophenolate
  • Cyclosporine
  • Tacrolimus
  • Etanercept
  • Adalimumab
  • Golimumab
  • Certolizumab
  • Infliximab
  • Rituximab
  • Belimumab
  • Tocilizumab
  • Anakinra
  • Canakinumab
  • Abatacept
  • Secukinumab
  • Ixekizumab
  • Bimekizumab
  • Ustekinumab
  • Guselkumab
  • Risankizumab
  • Tofacitinib
  • Upadacitinib

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators