Microfracture With Platelet Rich Plasma Gel Injection for Osteochondral Lesion of the Talus

Официальное название

Clinical Efficacy of Arthroscopic Microfracture Combined With Local Injection of Platelet Rich Plasma Gel in Treatment of Osteochondral Lesion of the Talus: A Randomized Control Trial

Обзор

The goal of this clinical trial is to learn if combined local injection of platelet rich plasma (PRP) gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus (OLT). The interface integration of the injured area will also be assessed via radiographic follow-up. The main questions it aims to answer are: * Does arthroscopic microfracture combined with PRP gel injection improve ankle function of participants based on American Orthopedic Foot and Ankle Society (AOFAS) Score? * Does arthroscopic microfracture combined with PRP gel injection improve interface integration of the injured cartilage on magnetic resonance imaging (MRI)? Researchers will compare arthroscopic microfracture with concomitant local injection of PRP gel to isolated microfracture to see if intraoperative PRP gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of OLT. Participants will: * Undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of PRP gel * Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment * Take MRI preoperatively and 6, 12 and 24 months after surgery

Вмешательства

• Процедура Arthroscopic microfracture with intraoperative local PRP gel injection
  Arthroscopic microfracture: An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion. PRP preparation and local
• Процедура Isolated microfracture
  Arthroscopic microfracture: An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion.

Первичные конечные точки

• American Orthopedic Foot and Ankle Society Score (AOFAS) [Срок оценки: Pre-surgery and 3, 6, 12 and 24 months after surgery]

Вторичные конечные точки (7)

• Foot and Ankle Outcome Score (FAOS) [Срок оценки: Pre-surgery and 3, 6, 12 and 24 months after surgery]
• Ankle Activity Score (AAS) [Срок оценки: Pre-surgery and 3, 6, 12 and 24 months after surgery]
• Visual Analogue Scale (VAS) [Срок оценки: Pre-surgery and 3, 6, 12 and 24 months after surgery]
• Patient Satisfaction [Срок оценки: Final follow-up (24 months after surgery)]
• Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) [Срок оценки: Twelve and 24 months after surgery]
• Return-to-Sport Rate [Срок оценки: Final follow-up (24 months after surgery)]
• Complications [Срок оценки: Final follow-up (24 months after surgery)]

Критерии участия

Критерии включения

• Chronic ankle pain, diagnosed as osteochondral lesion of the talus;
• Lesion size ≤ 1.5 cm2 or the diameter of the lesion ≤ 1.5 cm;
• Conservative treatment of at least 3 months fails to relieve symptoms;
• Willingness to voluntarily participate in the trial and to sign informed consent.

Критерии исключения

• Varus or valgus deformity of the ankle of more than 5 degrees;
• Grade III injury of the lateral collateral ligament of ankle;
• Chronic synovitis (rheumatoid arthritis, pigmented villous nodular synovitis, etc.);
• Joint fibrosis, stiffness, and significantly restricted range of motion;
• Evidence of moderate to severe knee osteoarthritis on plain radiographs;
• Failure to complete the rehabilitation protocol as required;
• Patient medically not fit for surgery, radiographs or MRI;
• For women, pregnant, planning to be pregnant or lactating.

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

Китай · 1 центр

• Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT06358807 · M2023438

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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