Меню
Идёт набор NCT07138898

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Фаза II С лечением Rheumatic Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Methotrexate, Sulfasalazine, Hydroxychloroquine, Leflunomide.
Кому может быть актуально
Состояния в реестре: Rheumatic Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • NYU Langone Health — New York

Идентификаторы

NCT: NCT07138898 · 25-00380

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗