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Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
NCT07138898 · NYU Langone Health
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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
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.
Study design
Enrollment target: 80 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-12-12
Estimated completion: 2028-01
Last updated: 2026-07-09
Interventions
Drug: MethotrexateDrug: SulfasalazineDrug: HydroxychloroquineDrug: LeflunomideDrug: AzathioprineDrug: MycophenolateDrug: CyclosporineDrug: TacrolimusDrug: EtanerceptDrug: AdalimumabDrug: GolimumabDrug: CertolizumabDrug: InfliximabBiological: RituximabBiological: BelimumabBiological: TocilizumabBiological: AnakinraBiological: CanakinumabBiological: AbataceptBiological: SecukinumabBiological: IxekizumabBiological: BimekizumabBiological: UstekinumabBiological: GuselkumabBiological: RisankizumabDrug: TofacitinibDrug: Upadacitinib
Primary outcomes
- • Incidence of wound complications (90-day post operation)
- • Incidence of superficial surgical site infections (90-day post operation)
- • Incidence of deep surgical site infections (90-day post operation)
Sponsor
NYU Langone Health · other
Contacts & investigators
ContactThomas Chalothron · contact · Thomas.Chalothron@nyulangone.org · 646-501-7384
ContactVinay Bijoor · contact · Vinay.Bijoor@nyulangone.org · 914-610-6112
InvestigatorJonathan Samuels, MD · principal_investigator, NYU Langone Health
All locations (1)
NYU Langone HealthRecruiting
New York, New York, United States