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Идёт набор NCT05402072

AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip

Фаза I С лечением Hip Arthroscopy Articular Cartilage Defect Microfractures

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: Autologous matrix-induced chondrogenesis (AMIC).
Кому может быть актуально
Состояния в реестре: Hip Arthroscopy, Articular Cartilage Defect, Microfractures. Базовые параметры: 18 лет — 55 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
Канада
Следующий шаг
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Официальное название

Autologous MatRix-Induced ChondrogenEsis ComPared With Microfracture for Focal ArtIcular CaRtilage Damage of the Hip (REPAIR): A Pilot Randomized Controlled Trial

Обзор

This is a pilot multi-centre RCT of 40 patients (ages 18-55 years, inclusive) undergoing primary hip arthroscopy with a focal articular cartilage defect of the acetabulum to compare the effect of using autologous matrix-induced chondrogenesis (AMIC) in comparison to microfracture on hip function, health-related quality of life, hip pain, cartilage regeneration, health utility, and any adverse events at 2 years. Follow-up will occur at 6 weeks, 6 months, 12 months, 18 months, and 24 months post-surgery.

Вмешательства

  • Процедура Autologous matrix-induced chondrogenesis (AMIC)
    AMIC is a novel approach in which the microfracture technique has been enhanced by the use of a type I/III collagen matrix (Chondro-Gide®; Geistlich Pharma AG, Wolhusen, Switzerland). In this single-step procedure, the matrix is placed over the defect to stabilize the fragile blood clot that arises from microfracture and to provide infrastructure for repair tissue formation. Essentially, the matrix covers the defect and serves as a protective shield that contains the cells and minimizes the impa

Первичные конечные точки

  • Hip function and health-related quality of life using the International Hip Outcome Tool (iHOT-33) [Срок оценки: Change from baseline to 24 months post-surgery]
Вторичные конечные точки (4)
  • Hip pain using the Visual Analogue Scale (VAS); 100-point scale [Срок оценки: Change from baseline to 24 months post-surgery]
  • Cartilage repair using the Magnetic Resonance Evaluation of the Repair of Cartilage in the Hip Score (MERCH) (scored from 0-100) [Срок оценки: Change from baseline to 24 months post-surgery]
  • Health utility using the Euro-Qol 5 Dimensions (EQ-5D); index score [Срок оценки: Change from baseline to 24 months post-surgery]
  • Total number of adverse events [Срок оценки: 24 months post-surgery]

Критерии участия

Критерии включения

  • All patients aged 18-55 years
  • Hip pain lasting 6 months or more with no relief from documented non-operative modalities
  • Focal articular cartilage defects of the acetabulum on MRI, confirmed to be full thickness (International Cartilage Regeneration and Joint Preservation Society (ICRS) grade 3 or 4) during arthroscopic examination
  • Focal acetabular articular cartilage lesions measuring between 3 cm2 and 25 cm2 on MRI and confirmed on arthroscopic examination
  • Patient agrees to participate in the study-specific postoperative rehabilitation protocol
  • Patient can speak, read, and understand the language of the site
  • Patient has provided informed consent

Критерии исключения

  • Cartilage defects of the femoral head
  • Previous surgery on the study hip
  • Traumatic chondral injury of the hip from a single event
  • Presence of advanced osteoarthritis (Tonnis grade 3) or any other acute or chronic inflammatory joint disease
  • Known hypersensitivity or allergy to porcine collagen
  • Acute or chronic infection at the surgical site
  • Evidence of hip dysplasia (i.e., lateral centre edge angle < 20˚)
  • Evidence of acetabular over coverage such as coxa profunda or coxa protrusion
  • Immunosuppressive or anti-proliferative medication use
  • Chronic pain syndromes
  • Significant medical co-morbidities (requiring assistance for activities of daily living (ADLs))
  • History of paediatric hip disease
  • Uncontrolled diabetes
  • Contraindications to MRI imaging (e.g. claustrophobia)
  • Patient is involved in ongoing legal or workplace claims
  • Patient is incarcerated
  • Patient is pregnant or breastfeeding
  • Patient who will likely have problems, in the judgement of the investigator, with maintaining follow-up
  • Any other reason(s) the investigator feels is relevant for excluding the patient

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • McMaster University — Hamilton

Идентификаторы

NCT: NCT05402072 · 14981

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗