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Набор скоро начнётся NCT07498660

PRP Injection Into the Sacroiliac Joint After Ipsilateral THA: Effects on Early Recovery and Function (SIJ-THA Randomized Trial)

Без фазы С лечением Osteoarthitis Sacro Iliac Joint Pain Hip Arthroplasty, Total Sacro-Iliac Spondylosis

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: PRP injection, Placebo.
Кому может быть актуально
Состояния в реестре: Osteoarthitis, Sacro Iliac Joint Pain, Hip Arthroplasty, Total, Sacro-Iliac Spondylosis. Базовые параметры: от 45 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
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of Platelet-Rich Plasma Injection Into the Sacroiliac Joint After Ipsilateral Total Hip Arthroplasty on Early Rehabilitation and Patient Function: A Randomized Trial (SIJ-THA Trial)

Обзор

The study is an interventional, randomized, open-label (non-blinded), placebo-controlled trial. Preoperatively, patients scheduled for primary total hip arthroplasty (THA) will undergo a clinical examination in the Orthopaedic Department. Clinical tests will be performed to confirm sacroiliac joint (SIJ) dysfunction on the operated side. In addition, low-dose computed tomography (CT) will be used to assess structural changes in the SIJ. All patients will complete patient-reported outcome measures related to the hip joint, including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Harris Hip Score (HHS), as well as SIJ-related assessments, including the Oswestry Disability Index (ODI). Pain intensity will be assessed using the Visual Analogue Scale (VAS). Following THA, patients will be randomly allocated into two groups during their hospital stay. In the intervention group, platelet-rich plasma (PRP) will be injected into the sacroiliac joint, whereas the control group will receive an injection of normal saline. All injections will be performed in the operating theatre. At discharge, patients will be scheduled for follow-up visits at 2, 6, and 12 weeks postoperatively. At each follow-up, patient-reported outcomes will be collected, including WOMAC and HHS for hip function, ODI for SIJ-related disability, and VAS for pain assessment of both the hip and sacroiliac joint.

Вмешательства

  • Процедура PRP injection
    Platelet-rich plasma (PRP) will be prepared from autologous peripheral blood using a standardized centrifugation protocol in accordance with the manufacturer's instructions. The PRP will be obtained intraoperatively under sterile conditions. A single injection will be administered into the sacroiliac joint on the operated side under sterile conditions in the operating theatre. The injection will be performed using anatomical landmarks and/or imaging guidance, according to institutional practice.
  • Другое Placebo
    A single injection of sterile 0.9% sodium chloride (normal saline) will be administered into the sacroiliac joint on the operated side under sterile conditions in the operating theatre. The procedure will be performed using the same technique, anatomical approach, and guidance method as in the experimental (PRP) group. The injection volume, timing, and procedural conditions will be identical to those used in the PRP group to ensure comparability.

Первичные конечные точки

  • Change in hip function measured by the Harris Hip Score (HHS) from baseline to 6 weeks postoperatively. [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

  • primary osteoarthritis of the hip;
  • qualification for elective total hip arthroplasty (THA);
  • age ≥45 years;
  • written informed consent;
  • ability to understand Polish.

Критерии исключения

  • prior surgical treatment of the hip or sacroiliac joint;
  • malignancy;
  • developmental dysplasia of the hip;
  • rheumatologic diseases (rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis);
  • neurological or psychiatric disorders;
  • allergy to local anesthetics.

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

Польша · 1 центр
  • Department of Orthopaedics and Rehabilitation, Medical University of Warsaw — Warsaw

Публикации

  • 1. Ian D Learmonth, Claire Young, Cecil Rorabeck: The operation of the century: total hip replacement. Lancet 2007; 370: 1508-19 Published Online March 29, 2007 DOI:10.1016/S0140- 6736(07)60457. 2. The AJRR 2024 Annual Report 3. AOANJRR AnnualReports 2024 4. The NJR's 21st Annual Report 5. David P Newman 1, Adam T Soto 1: Sacroiliac Joint Dysfunction: Diagnosis and Treatment. Am Fam Physician.

Идентификаторы

NCT: NCT07498660 · SIJ-THA Randomized Trial

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗