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Набор скоро начнётся NCT07233122

MRI Role in Knee Hemophilic Arthopathy

Наблюдательное MRI Hemophilia Arthropathy Hemophilic Arthropathy of Knee

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: MRI, Hemophilia, Arthropathy Hemophilic, Arthropathy of Knee. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

MRI Vs Conventional Radiography in Assessing Knee Hemophilic Arthropathy : A Scoring Based Approach

Обзор

The aim of this study is to assess role of MRI in detecting synovial, cartilaginous , osseous abnormalities ، bleeding inside knee joint and to use a system for assessing HA as support for therapeutic regimes and for monitoring response to therapy .

Подробное описание

Hemophilia is a mostly inherited genetic disorder caused by a complete or partial deficiency of coagulation factors VIII or IX, which impairs the body's ability to form blood clots-a process necessary to stop bleeding. This results in prolonged bleeding after injury, easy bruising, and an increased risk of internal bleeding, particularly within joints or the brain.

Hemophilic arthropathy (HA), caused by recurrent hemarthrosis, is the most common musculoskeletal manifestation of hemophilia and one of the most disabling complications of the disease. It can lead to severe pain, deformity, destruction of the joint, debilitating arthritis, and permanent joint damage.

Clinical assessment plays only a minor role in detecting the early stages of HA, as early clinical signs are often nonspecific and of limited value in quantifying disease involvement. Conventional radiographs mainly detect bone lesions that appear in advanced HA, but they cannot identify early changes such as synovial hypertrophy or focal cartilage destruction. Computed tomography (CT) is highly sensitive for detecting bone changes, but it provides limited information on soft tissue involvement and requires a relatively high dose of ionizing radiation.

By contrast, magnetic resonance imaging (MRI) offers superior soft tissue contrast, allowing detailed evaluation of hemophilic joints and visualization of synovial and cartilaginous abnormalities.

T1-weighted imaging: evaluates bone marrow, joint anatomy, and subchondral changes.

T2 fat-suppressed imaging: useful for detecting synovitis and joint effusion.

Gradient echo (GRE) or susceptibility-weighted imaging (SWI): detect chronic blood products (hemosiderin), with SWI being more sensitive and able to identify earlier blood deposits.

Several scoring systems exist for the assessment of hemophilic arthropathy, including the European scoring system and the International Prophylaxis Study Group (IPSG) MRI scale. The IPSG system provides more detailed scoring and greater sensitivity for early disease, including subtle synovial changes. For radiographs, the most widely used system is the Pettersson radiographic scoring system.

In this study, the investigators will use the IPSG MRI scoring system and the Pettersson X-ray scoring system to evaluate hemophilic arthropathy, with the aim of improving grading, management, and follow-up.

Первичные конечные точки

  • International Prophylaxis Study Group (IPSG) MRI Score for Hemophilic Arthropathy [Срок оценки: After completion of MRI scanning session (within the same study visit). Overall Study Duration: 2 years (for recruitment, imaging, and data analysis).]
Вторичные конечные точки (2)
  • Pettersson X-ray Score for Hemophilic Arthropathy [Срок оценки: After completion of X-ray scanning session (within the same study visit). Overall Study Duration: 2 years (including recruitment, imaging, and data analysis).]
  • Agreement Between MRI and X-ray Scoring Systems in Hemophilic Arthropathy [Срок оценки: After completion of MRI and X-ray scanning sessions (within the same study visit). Overall study duration: 2 years (including recruitment, imaging, and data analysis).]

Критерии участия

Критерии включения

  • Adult patient ( more than 18 years old ) diagnosed as Haemophilia with history of bleeding in knee joint more than once

Критерии исключения

  • \*contraindications for MRI such as claustrophobia , metallic foriegn body carriers , cardiac pacemaker
  • patient refused the exam
  • Pregnant female patients

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Ibad HA, de Cesar Netto C, Shakoor D, Sisniega A, Liu SZ, Siewerdsen JH, Carrino JA, Zbijewski W, Demehri S. Computed Tomography: State-of-the-Art Advancements in Musculoskeletal Imaging. Invest Radiol. 2023 Jan 1;58(1):99-110. doi: 10.1097/RLI.0000000000000908. Epub 2022 Aug 16. PMID 35976763
  • Foppen W, van der Schaaf IC, Beek FJA, Mali WPTM, Fischer K. MRI predicts 5-year joint bleeding and development of arthropathy on radiographs in hemophilia. Blood Adv. 2020 Jan 14;4(1):113-121. doi: 10.1182/bloodadvances.2019001238. PMID 31917842
  • Lundin B, Manco-Johnson ML, Ignas DM, Moineddin R, Blanchette VS, Dunn AL, Gibikote SV, Keshava SN, Ljung R, Manco-Johnson MJ, Miller SF, Rivard GE, Doria AS; International Prophylaxis Study Group. An MRI scale for assessment of haemophilic arthropathy from the International Prophylaxis Study Group. Haemophilia. 2012 Nov;18(6):962-70. doi: 10.1111/j.1365-2516.2012.02883.x. Epub 2012 Jul 5. PMID 22765835
  • Haacke EM, Mittal S, Wu Z, Neelavalli J, Cheng YC. Susceptibility-weighted imaging: technical aspects and clinical applications, part 1. AJNR Am J Neuroradiol. 2009 Jan;30(1):19-30. doi: 10.3174/ajnr.A1400. Epub 2008 Nov 27. PMID 19039041
  • Kim HK, Zbojniewicz AM, Merrow AC, Cheon JE, Kim IO, Emery KH. MR findings of synovial disease in children and young adults: Part 1. Pediatr Radiol. 2011 Apr;41(4):495-511; quiz 545-6. doi: 10.1007/s00247-011-1971-0. Epub 2011 Feb 22. PMID 21337125

Идентификаторы

NCT: NCT07233122 · MRI in Hemophilic Arthopathy

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗