基底关节关节炎前瞻性 (BJAM)
拇指基底关节关节炎的多中心前瞻性研究
该研究假设,对于某些患有拇指基底关节炎的患者群体,存在有效的非手术和手术治疗方法。 还存在一种功能优越、成本效益高且风险低的非手术或微创手术治疗方案,以减轻疾病晚期患者的疼痛并减缓疾病进展。 同样,使用目前实践中的一种流行手术通过手术治疗晚期基底关节关节炎具有显着的功能、健康效用和经济优势。
拇指根部的关节炎是一种常见病症,会给患者带来相当大的不适。 已经描述了许多非手术和手术治疗,但很少有涉及多个中心比较这些治疗的前瞻性研究。 通过从关节炎治疗开始就跟踪患者并使用问卷调查和放射照片评估他们在特定时间点的进展,研究人员相信患者的结果和满意度可以提高。 这项研究将包括接受非手术和手术治疗的患者,并且不会改变患者的护理标准。 通过建立标准化的结果测量并前瞻性地收集从最初出现到所有治疗干预的数据,将有可能直接比较拇指基底关节炎的保守治疗和手术治疗期间的治疗。 这项多中心研究将确定那些最有可能在后续重点和精心设计的随机对照试验中进行研究的特定程序或保守治疗。
研究概览
地位
条件
详细说明
拇指基底关节关节炎是一种常见病症,发病率相当高。 已经描述了许多非手术和手术治疗,但很少进行比较标准治疗的多中心前瞻性循证试验。 这种对最佳临床实践共识的持续探索已经在对基底关节关节炎手术治疗的全面荟萃分析中得到了回顾。 通过系统收集有关患者特定特征、治疗干预和纵向功能结果测量的数据,研究人员认为,通过阐明疾病进展的风险因素以及治疗方式的时机和选择,可以改善患者的结果和满意度,无论是保守的或手术,针对任何特定患者。 多中心临床登记的建立将极大地促进这些目标的实现。 通过建立标准化的结果测量并前瞻性地收集从最初出现到所有治疗干预的数据,将有可能直接比较拇指基底关节炎的保守治疗和手术治疗期间的治疗。 这个拟议的多中心注册将确定那些最有可能在随后的重点和精心设计的随机对照试验中进行研究的特定程序或保守治疗。
骨关节炎是最常见的关节炎形式,也是北美长期残疾的第二大最常见原因。 拇指基底关节的骨关节炎是一种影响大部分成年人的衰弱性疾病,尽管在美国尚未对基底关节关节炎的患病率进行大规模的流行病学研究。
骨关节炎的发病机制仍然是多因素的,但大多数研究人员认为它是一种退化过程,由机械、生化和遗传因素引起,破坏了关节软骨和软骨下骨降解和合成的正常平衡。
尽管有一些采用随机、前瞻性设计的优秀研究显示了几种手术技术的良好效果,但仍不清楚哪种手术最适合特定患者以实现最佳功能结果和长期成功且手术创伤最小。 最佳固定类型和持续时间也未知。 掌指关节过度伸展对长期结果的影响以及该相邻关节的最佳治疗方法也是未知的。 这项拟议的研究将允许从全国多个机构收集前瞻性数据,并聘请公认的专家,所有这些专家都使用不同的临床方案治疗基础关节关节炎。
在美国,数百万人患有或将患上基底关节骨关节炎,这是上肢最常受影响的关节,需要手术干预。 对这种致残性疾病的手术和非手术治疗的更有效和成本效益形式的需求是相当大的。 从众多可用的治疗方式中确定安全有效的治疗方法可能会显着改善这一人群中很大一部分人的生活质量。 如果未来的研究表明较少涉及的重建,例如单独的斜方肌切除术,与更复杂的带肌腱介入的韧带重建一样有效,那么许多患者可能会受益于这种不太复杂的手术。 该试验将提高临床医生和患者对有效治疗方案的认识和信心。
本研究假设对于某些患有拇指基底关节关节炎的患者群体,存在有效的非手术和手术治疗方法。 还存在一种功能优越、成本效益高且风险低的非手术或微创手术治疗方案,以减轻疾病晚期患者的疼痛并减缓疾病进展。 同样,使用目前实践中的一种流行手术通过手术治疗晚期拇指基底关节关节炎具有显着的功能、健康效用和经济优势。
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:John W Karl, MD, MPH
- 电话号码:212-305-3912
- 邮箱:jwk2115@columbia.edu
学习地点
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New York
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New York、New York、美国、10032
- 招聘中
- Columbia University/NY Presbyterian Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
纳入标准:
- 患有症状性基底关节炎的患者。
- 能够提供知情同意的患者
排除标准:
- 入组时年龄小于 18 岁的患者
- 影响手术手的神经肌肉疾病患者,不是由 CMC 手术引起的
- 患有已知炎症性关节炎病症的患者,例如类风湿性关节炎或银屑病性关节炎
- 患手有基底关节感染病史或目前感染的患者。
- 痴呆或无法提供知情同意的患者。
- 无法遵守研究指南的患者。
- 不排除患有掌指关节过度伸展的患者。 将对这些患者进行随访,如果他们在进行基底关节置换术的同时在 MCPJ 接受了关节囊固定术或其他手术,这将记录在他们的数据记录中。
学习计划
研究是如何设计的?
设计细节
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 |
---|---|---|
缓解疼痛
大体时间:最初,最多 1 年
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受试者可能在第一年后进行年度评估。
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最初,最多 1 年
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功能强度-灵活性
大体时间:最初,最多 1 年
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受试者可能在第一年后进行年度评估。
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最初,最多 1 年
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
成本效益
大体时间:最初,最多 1 年
|
受试者可能在第一年后进行年度评估。
|
最初,最多 1 年
|
患者满意度
大体时间:最初,最多 1 年
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受试者可能在第一年后进行年度评估。
|
最初,最多 1 年
|
合作者和调查者
出版物和有用的链接
一般刊物
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