{"title":"多中心、前瞻性、随机、对照试验比较用栓塞微球和皮质类固醇注射栓塞治疗症状性膝骨关节炎：运动研究方案总结。","authors":"Clare Bent, Craig J McAsey, Sandeep Bagla","doi":"10.1007/s00270-025-03994-z","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Corticosteroid injections are commonly used to treat symptomatic knee osteoarthritis; however, pain relief is usually transient. Genicular artery embolization (GAE) has shown promise as an effective minimally invasive intervention to alleviate symptomatic knee osteoarthritis. The MOTION study is being conducted to compare outcomes following GAE versus corticosteroid injection.</p><p><strong>Materials and methods: </strong>This is an international, multicenter, randomized controlled investigational device exemption (IDE) study enrolling adults (≥ 21 years old) with symptomatic knee osteoarthritis (Kellgren-Lawrence grades 1-4) across ≥ 45 centers worldwide. Patients will be randomized 1:1 to receive GAE with Embosphere® Microspheres (Merit Medical Systems, Inc.) or corticosteroid injections. The primary efficacy measure is clinical success at 6 months, defined as ≥ 50% improvement in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale. The primary safety measure is the proportion of patients free from treatment-related safety event(s) through 6-month post-index procedure (GAE or corticosteroid injection). Following the 6-month visit, patients in either cohort who do not achieve clinical success may crossover to the other study arm. Additional study measures will assess safety and efficacy outcomes throughout the 24-month follow-up period. The target sample size is 264 (132 per arm) and is based on the number of patients needed to confirm superior efficacy of GAE versus corticosteroid injections and non-inferiority with respect to safety. 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The primary safety measure is the proportion of patients free from treatment-related safety event(s) through 6-month post-index procedure (GAE or corticosteroid injection). Following the 6-month visit, patients in either cohort who do not achieve clinical success may crossover to the other study arm. Additional study measures will assess safety and efficacy outcomes throughout the 24-month follow-up period. The target sample size is 264 (132 per arm) and is based on the number of patients needed to confirm superior efficacy of GAE versus corticosteroid injections and non-inferiority with respect to safety. 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引用次数: 0
摘要
目的：皮质类固醇注射常用于治疗症状性膝骨关节炎；然而，疼痛缓解通常是短暂的。膝动脉栓塞术（GAE）作为一种有效的微创介入治疗缓解症状性膝骨关节炎已被证明是有希望的。MOTION研究正在进行，以比较GAE和皮质类固醇注射后的结果。材料和方法：这是一项国际、多中心、随机对照研究器械豁免（IDE）研究，纳入全球≥45个中心的有症状膝骨关节炎（kelgren - lawrence分级1-4）的成人（≥21岁）。患者将以1:1的比例随机接受含有Embosphere®微球（Merit Medical Systems, Inc.）或皮质类固醇注射的GAE。主要疗效指标是6个月时的临床成功，定义为西安大略省和麦克马斯特大学骨关节炎指数（WOMAC）疼痛量表改善≥50%。主要的安全性指标是通过6个月后手术（GAE或皮质类固醇注射）无治疗相关安全事件的患者比例。随访6个月后，任何一个队列中未取得临床成功的患者可转入另一个研究组。额外的研究措施将评估整个24个月随访期间的安全性和有效性结果。目标样本量为264例（每组132例），基于确认GAE优于皮质类固醇注射的疗效和安全性方面的非劣效性所需的患者数量。整体学习能力为80%。讨论：MOTION研究的结果有望提供关于24个月内GAE与标准护理相关的治疗获益程度的信息。试验注册：NCT05818150。
Multicenter, PrOspective, Randomized, Controlled Trial Comparing GenIcular Artery EmbOlization Using Embosphere Microspheres to Corticosteroid iNjections for the Treatment of Symptomatic Knee Osteoarthritis: MOTION Study Protocol Summary.
Purpose: Corticosteroid injections are commonly used to treat symptomatic knee osteoarthritis; however, pain relief is usually transient. Genicular artery embolization (GAE) has shown promise as an effective minimally invasive intervention to alleviate symptomatic knee osteoarthritis. The MOTION study is being conducted to compare outcomes following GAE versus corticosteroid injection.
Materials and methods: This is an international, multicenter, randomized controlled investigational device exemption (IDE) study enrolling adults (≥ 21 years old) with symptomatic knee osteoarthritis (Kellgren-Lawrence grades 1-4) across ≥ 45 centers worldwide. Patients will be randomized 1:1 to receive GAE with Embosphere® Microspheres (Merit Medical Systems, Inc.) or corticosteroid injections. The primary efficacy measure is clinical success at 6 months, defined as ≥ 50% improvement in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale. The primary safety measure is the proportion of patients free from treatment-related safety event(s) through 6-month post-index procedure (GAE or corticosteroid injection). Following the 6-month visit, patients in either cohort who do not achieve clinical success may crossover to the other study arm. Additional study measures will assess safety and efficacy outcomes throughout the 24-month follow-up period. The target sample size is 264 (132 per arm) and is based on the number of patients needed to confirm superior efficacy of GAE versus corticosteroid injections and non-inferiority with respect to safety. The overall study power is > 80%.
Discussion: Findings from the MOTION study are expected to provide information on the magnitude of the therapeutic benefits associated with GAE versus standard of care over 24 months.
期刊介绍：
CardioVascular and Interventional Radiology (CVIR) is the official journal of the Cardiovascular and Interventional Radiological Society of Europe, and is also the official organ of a number of additional distinguished national and international interventional radiological societies. CVIR publishes double blinded peer-reviewed original research work including clinical and laboratory investigations, technical notes, case reports, works in progress, and letters to the editor, as well as review articles, pictorial essays, editorials, and special invited submissions in the field of vascular and interventional radiology. Beside the communication of the latest research results in this field, it is also the aim of CVIR to support continuous medical education. Articles that are accepted for publication are done so with the understanding that they, or their substantive contents, have not been and will not be submitted to any other publication.
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