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Recruiting NCT07138898

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Phase II Interventional Rheumatic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Methotrexate, Sulfasalazine, Hydroxychloroquine, Leflunomide.
Who it may be relevant to
Registry conditions: Rheumatic Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug Methotrexate
    Continue throughout perioperative period
  • Drug Sulfasalazine
    Continue throughout perioperative period
  • Drug Hydroxychloroquine
    Continue throughout perioperative period
  • Drug Leflunomide
    Continue throughout perioperative period
  • Drug Azathioprine
    Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
  • Drug Mycophenolate
    Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
  • Drug Cyclosporine
    Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
  • Drug Tacrolimus
    Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
  • Drug Etanercept
    Control group: Schedule surgery 2 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose
  • Drug Adalimumab
    Control group: Schedule surgery 3 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose

Primary outcome measures

  • Incidence of wound complications [Time frame: 90-day post operation]
  • Incidence of superficial surgical site infections [Time frame: 90-day post operation]
  • Incidence of deep surgical site infections [Time frame: 90-day post operation]
  • Incidence of return trips to the operating room [Time frame: 90-day post operation]
  • Incidence of rheumatologic disease flares [Time frame: 90-day post operation]
Secondary outcome measures (12)
  • Length of hospital stay [Time frame: From admission to discharge (on average 2 days)]
  • Postoperative pain score as assessed by the VAS for Pain [Time frame: Week 2]
  • Postoperative pain score as assessed by the VAS for Pain [Time frame: Week 6]
  • Postoperative pain score as assessed by the VAS for Pain [Time frame: Month 3]
  • Change in Range of motion (ROM) - active forward elevation (AFE) [Time frame: Week 2, Month 3]
  • Change in Range of motion (ROM) - external rotation (ER) [Time frame: Week 2, Month 3]
  • Change in Range of motion (ROM) - internal rotation (IR) [Time frame: Week 2, Month 3]
  • Change in PROMIS - Physical Function (PF) - Short Form 10a [Time frame: Week 2, Month 3]
  • Change in PROMIS - Pain Interference - Short Form 6a [Time frame: Week 2, Month 3]
  • Change in American Shoulder and Elbow Surgeons (ASES) score [Time frame: Week 2, Month 3]
  • Change in Disabilities of the Arm, Shoulder and Hand (DASH) score [Time frame: Week 2, Month 3]
  • Proportion of participants who used rescue medications or corticosteroid bursts [Time frame: Month 3]

Eligibility criteria

Inclusion criteria

  • 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;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07138898 · 25-00380

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗