评估膝骨关节炎患者实施客观参数可行性的试点试验 (SMILE)
2019年9月27日 更新者：River Pharma S.r.l.
试点、开放的非对照试验，以评估在受膝骨关节炎影响的患者的临床试验中实施客观参数作为主要终点的可行性
试点、开放的非对照试验，以评估在膝骨关节炎患者的临床试验中将客观参数作为主要终点的可行性。
研究概览
详细说明
• 评估实施超声检查和运动范围(ROM) 作为客观测量的可行性，以将膝关节活动度的改善与假定含有HA 的保健品的患者受影响膝关节的疼痛减轻联系起来。
试验的次要目标是：
- 评估实施 Actigraphy 作为客观测量的可行性，以将膝关节活动度的改善与疼痛减轻相关联（可选）。
- 1个月评估招生范围。
该试验的探索性目标是：
• 受试产品功效的初步数据
研究类型
介入性
注册 (实际的)
8
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Timis
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Timişoara、Timis、罗马尼亚、300209
- Opera Contract Research Organization S.r.l.
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 50 至 70 岁的任何性别和年龄
- 入组前至少 6 个月有症状的膝关节骨关节炎 (OA)，并伴有轻度关节不适，并遵循 ACR 标准以及病史和体格检查 (1)。 被诊断患有双侧膝关节 OA 的受试者将被要求指定基线时受影响最严重的膝关节，并且将在整个研究期间评估该膝关节。
- 在评估的膝关节 (2) 可用的确认性 X 射线（在过去 6 个月内进行）诊断（Kellgren/Lawrence 评分 2）。
- 在研究开始前的 30 天中，受试者至少经历了 15 天的疼痛。
排除标准：
- 患有任何炎症性关节炎病症（不同于膝关节 OA）、纤维肌痛、多发性硬化症或自身免疫性疾病的受试者。
- 筛选前 4 周内接受口服皮质类固醇治疗。
- 筛选前 3 个月内在目标关节关节内注射 HA 或皮质类固醇。
- 选择前2周用抗炎或软骨保护药物（硫酸软骨素、氨基葡萄糖、甲磺酰甲烷、HA、双醋瑞因）治疗。
- 研究前一个月使用含 HA 的营养补充剂或化妆品。
- 既往膝关节手术治疗或其必要性；住院和手术治疗所需的并发症。
- 在筛选前的过去 6 个月内目标关节有严重损伤（根据病史确定）。
- 遵循能量限制饮食以减轻体重的受试者。
- 未使用适当避孕方法的孕妇、哺乳期母亲或女性（仅限有生育能力的女性）。
- 患有心血管、肝脏、肾脏、呼吸系统或血液系统疾病，或研究者认为会影响参与或可能导致在研究过程中住院的其他医学或精神疾病的受试者。
- 在过去 30 天内参加过一项介入性临床研究。
- 存在任何由研究者判断为排除患者被纳入研究的具有临床意义的医学状况。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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其他：含透明质酸的营养品
服用含 HA 的保健品患者患膝关节疼痛减轻
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服用含 HA 的保健品患者患膝关节疼痛减轻
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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滑液积液减少
大体时间：第 4 周和第 8 周
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VAS（静止时）减少与超声检查参数之间的相关性
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第 4 周和第 8 周
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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减轻疼痛
大体时间：第 4 周和第 8 周
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VAS 减少（静止时；移动时；按压时）和 Actigraphy 参数之间的相关性。
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第 4 周和第 8 周
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Bogdan Andor, MD、MEDICALI'S
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Yang CC, Hsu YL. A review of accelerometry-based wearable motion detectors for physical activity monitoring. Sensors (Basel). 2010;10(8):7772-88. doi: 10.3390/s100807772. Epub 2010 Aug 20.
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- Voelker R. Few adults with knee osteoarthritis meet national guidelines for physical activity. JAMA. 2011 Oct 5;306(13):1428, 1430. doi: 10.1001/jama.2011.1388. No abstract available.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年3月19日
初级完成 (实际的)
2018年4月15日
研究完成 (实际的)
2018年5月14日
研究注册日期
首次提交
2018年1月29日
首先提交符合 QC 标准的
2018年1月29日
首次发布 (实际的)
2018年2月5日
研究记录更新
最后更新发布 (实际的)
2019年10月1日
上次提交的符合 QC 标准的更新
2019年9月27日
最后验证
2019年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
膝骨性关节炎的临床试验
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The Hong Kong Polytechnic UniversityChinese University of Hong Kong; Zhujiang Hospital尚未招聘膝关节骨性关节炎 (Knee OA)
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Universitas SriwijayaPT Bifarma Adiluhung尚未招聘
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First Affiliated Hospital of Wenzhou Medical University尚未招聘
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Ankara Etlik City Hospital主动，不招人