Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
ConditionRheumatic Disease
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Methotrexate
DrugContinue throughout perioperative period
Sulfasalazine
DrugContinue throughout perioperative period
Hydroxychloroquine
DrugContinue throughout perioperative period
Leflunomide
DrugContinue throughout perioperative period
Azathioprine
DrugControl group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
Mycophenolate
DrugControl group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
Cyclosporine
DrugControl group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
Tacrolimus
DrugControl group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
Etanercept
DrugControl group: Schedule surgery 2 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose
Adalimumab
DrugControl group: Schedule surgery 3 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose
Golimumab
DrugControl group: Schedule surgery 5 weeks after last administered 4-week subcutaneous dose or 9 weeks after last administered 8-week intravenous dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week subcutaneous dose or 4 weeks after last administered 8-week intravenous dose.
Certolizumab
DrugControl group: Schedule surgery 5 weeks after last administered dose. Intervention group: Schedule surgery 2 weeks after last administered dose.
Infliximab
DrugControl group: Schedule surgery 9 weeks after last administered intravenous dose. Intervention group: Schedule surgery 4 weeks after last administered dose.
Rituximab
Biological/VaccineControl: Schedule 7 months after last administered dose. Intervention group: Schedule 3 months after last administered dose.
Belimumab
Biological/VaccineControl group: Schedule surgery 2 weeks after last administered subcutaneous weekly dose or 5 weeks after last administered 4-week intravenous dose. Intervention group: Schedule surgery 1 week after last administered weekly dose or 2 weeks after last administered 4-week dose.
Tocilizumab
Biological/VaccineControl group: Schedule surgery 2 weeks after last administered subcutaneous weekly dose or 5 weeks after last administered 4-week intravenous dose. Intervention group: Schedule surgery 1 week after last administered weekly dose or 2 weeks after last administered 4-week dose.
Anakinra
Biological/VaccineControl group: Schedule surgery 2 days after last administered daily dose. Experimental group: Schedule surgery 1 day after last administered daily dose.
Canakinumab
Biological/VaccineControl group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.
Abatacept
Biological/VaccineControl group: Schedule surgery 2 weeks after last administered weekly subcutaneous dose or 5 weeks after last administered monthly intravenous dose. Intervention group: Schedule surgery 1 week after last administered weekly subcutaneous dose or 2 weeks after last administered monthly intravenous dose.
Secukinumab
Biological/VaccineControl group: Schedule surgery 5 weeks after last administered subcutaneous dose. Intervention group: Schedule surgery 2 weeks after last administered subcutaneous dose.
Ixekizumab
Biological/VaccineControl group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.
Bimekizumab
Biological/VaccineControl group: Schedule surgery 9 weeks after last administered 8-week dose. Intervention group: Schedule surgery 4 weeks after last administered 8-week dose
Ustekinumab
Biological/VaccineControl group: Schedule surgery 13 weeks after last administered 12-week dose. Intervention group: Schedule surgery 6 weeks after last administered 12-week dose.
Guselkumab
Biological/VaccineControl group: Schedule surgery 9 weeks after last administered 8-week dose. Intervention group: Schedule surgery 4.5 weeks after last administered 8-week dose.
Risankizumab
Biological/VaccineControl group: Schedule surgery 13 weeks after last administered 12-week dose. Intervention group: Schedule surgery 6-7 weeks after last administered 12-week dose.
Tofacitinib
DrugControl group: Schedule surgery 4 days after last administered daily dose. Intervention group: Schedule surgery 2 days after last administered daily dose.
Upadacitinib
DrugControl group: Withhold 4 days prior to surgery Intervention group: Withhold 2 days prior to surgery
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Standard holdActive comparator 27 interventions
Group B: Shorter holdExperimental treatment 27 interventions
Trial outcomes
Primary outcomes
1
Incidence of wound complications
Time frame
90-day post operation2
Incidence of superficial surgical site infections
Time frame
90-day post operation3
Incidence of deep surgical site infections
Time frame
90-day post operation4
Incidence of return trips to the operating room
Time frame
90-day post operationSecondary outcomes
1
Length of hospital stay
Time frame
From admission to discharge (on average 2 days)2
Postoperative pain score as assessed by the VAS for Pain
Visual Analogue Scale (VAS) for Pain is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Time frame
Week 23
Postoperative pain score as assessed by the VAS for Pain
Visual Analogue Scale (VAS) for Pain is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Time frame
Week 64
Postoperative pain score as assessed by the VAS for Pain
Visual Analogue Scale (VAS) for Pain is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Time frame
Month 3Sponsors and contacts
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Source ClinicalTrials.gov