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Набор скоро начнётся NCT05983692

Mg Wire for Augmentation of ACL Reconstruction

Без фазы С лечением Anterior Cruciate Ligament Rupture

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: Magnesium based wire.
Кому может быть актуально
Состояния в реестре: Anterior Cruciate Ligament Rupture. Базовые параметры: 18 лет — 40 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
Гонконг
Следующий шаг
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Официальное название

Clinical Translation of Biodegradable Magnesium Wire for Augmentation of Anterior Cruciate Ligament (ACL) Reconstruction From Bench Side to Bedside: A Multicentre, Double-blinded, Randomised Controlled Trial

Обзор

Background: ACLR with autologous tendon graft is commonly used for the treatment of ACL injury. However, as the BTI healing is poor, this can lead to a failure rate of 5% in the first-year post-operation; a long and unpredictable rehabilitation period is expected and 35 % of patients never return to preinjury level of sports. Biological enhancement of BTI healing will help to cut down the medical cost related to poor prognosis. As a biodegradable metal, Mg has been developed as implants in orthopaedics for decades, yet without clinical implants developed for ACLR. Our team has been working on this area in the past 10 years preclinically. Our animal studies showed that supplementation of magnesium wire significantly promotes osteogenesis at BTI and improves mechanical strength in ACLR. Recently, our team developed a highly pure (99.99%) Mg wire (Fig 2) in collaboration with metallic engineers for tendon graft braiding during ACLR and with its improved physical quality and strength, it is suitable for graft braiding and then its degradation in vivo can promote tunnel bone formation and bone tendon interface integration. Objective: To investigate if anterior cruciate ligament (ACL) reconstruction augmented with magnesium (Mg) wire enhances osteogenesis at the bone-tendon interface (BTI), improving post-op rehabilitation and leading to better clinical outcomes. Hypothesis: Patients with ACL reconstruction using Mg wire will experience improved osteogenesis at the BTI, more effective rehabilitation, and superior knee strength and function. Design and Subjects: A multicentre, double-blinded, randomized controlled trial will recruit patients aged 18-30 with unilateral ACL tear for primary ACLR with a hamstring graft at four sites. Instruments: Mg-based wire. Interventions: Participants will receive either 99.99% purity Mg wire or 2-0 vicryl as a control. Main Outcomes: Osteogenesis will be assessed by High-Resolution Peripheral Quantitative Computed Tomography (HR-pQCT), muscle strength via Biodex tests, and functional recovery with International Knee Documentation Committee (IKDC) and Tegner scores at multiple post-op intervals. Knee stability will be checked with KT-1000 arthrometer. Blood samples will be analyzed for inflammatory markers and metabolic effects related to Mg wire. Data Analysis and Expected Results: A repeated-measures ANOVA will be utilized for data analysis. The expectation is that Mg wire augmentation will significantly enhance osteogenesis at the BTI and improve rehabilitation outcomes.

Вмешательства

  • Устройство Magnesium based wire
    Mg wire will be used as a braiding suture to braid tendon graft, which is a standard preparation of graft and is not related to fixation of the tendon graft

Первичные конечные точки

  • Bone shell size [Срок оценки: 2 weeks and 3, 6, 12 and 24 months post-operation.]
Вторичные конечные точки (6)
  • International Knee Documentation Committee [Срок оценки: Pre-operation, 2 weeks and 3, 6, 12 and 24 months post-operation.]
  • Tegner activity score [Срок оценки: Pre-operation, 2 weeks and 3, 6, 12 and 24 months post-operation.]
  • Passive Knee laxity [Срок оценки: 3, 6, 12 and 24 months post-operation.]
  • Isokinetic muscle strength [Срок оценки: 3, 6, 12 and 24 months post-operation]
  • Cytokines assay [Срок оценки: Pre-operation, Day 1, 2 and 6 weeks and 3 months post-operation]
  • Single leg hop distance [Срок оценки: 6, 12 and 24 months post-operation]

Критерии участия

Критерии включения

  • Age 18-40
  • Unilateral ACL tear for primary ACLR (Single bundle, Hamstring) confirmed clinically and radiologically.

Критерии исключения

  • Concomitant multiple ligament injuries requiring additional surgical procedures,
  • Preoperative radiographic signs of arthritis,
  • Revision ACLR
  • Femoral tunnel interference screws
  • Contralateral knee with ACL deficiency or reconstruction
  • Medical co-morbidities
  • Long-term steroid intake
  • Non-compliance to our rehabilitation protocol.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Гонконг · 1 центр
  • The Chinese University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT05983692 · 2021.654

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗