气体冷冻疗法对 TKA 后膝关节 ROM 的影响:一项可行性研究
高压气体冷冻疗法对全膝关节置换术后前两天膝关节屈曲活动范围的影响:一项可行性随机对照试验
研究概览
详细说明
背景:全膝关节置换术 (TKA) 后,患者最早可在手术后两天出院。 然而,患者通常在术后第一天无法达到功能性膝关节屈曲范围 (ROM)。 在手术后一小时内和术后几天内对手术膝关节早期应用高压气体冷冻疗法 (HGC) 可能会通过减少炎症、水肿和疼痛来增加 ROM。 然而,目前尚不清楚 HGC 的这种早期应用是否可行。 此外,没有数据可以计算进行随机对照试验所需的样本量,以比较 HGC 与传统冷冻疗法对 TKA 后前两天膝关节屈曲度增加的影响。
目的:探讨在 TKA 后一小时内和术后第二天每天两次应用 HGC 的可行性。 收集术后前两天膝关节屈曲 ROM 变化的数据,以计算大型随机对照试验所需的样本量。 比较 HGC 与传统冷冻疗法对术后前两天膝关节屈曲 ROM 变化的影响。
设计:前瞻性、单盲、随机、对照试验。
地点:一家急症医院的骨科术后病房。
干预:患者被随机分配到高压气体冷冻疗法(干预组)或冰袋冷冻疗法(对照组)。 在每组中,参与者在手术后一小时内(第 0 天)和术后两天(第 1 天和第 2 天)两次接受手术膝关节的特定冷冻疗法干预。
结果测量:可行性测量包括愿意参与的符合条件的患者比例、自然减员、对干预措施的依从性和存在的不良反应。 在术后第 1 天和第 2 天评估主动和被动膝关节屈曲运动范围 (ROM) 和静息时膝关节疼痛强度。评估术后第 1 天到第 2 天主动和被动膝关节屈曲 ROM 和静息时膝关节疼痛强度的变化. 收集住院时间。
研究类型
注册 (实际的)
阶段
- 不适用
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
描述
纳入标准:
- 计划单侧 TKA 在凡尔登医院完成。
- 能够用法语或英语进行交流。
排除标准:
- 手术期间或之后的并发症。
- 因其他疾病无法进行检查。
- 冷冻疗法的禁忌症,如雷诺氏病、冷球蛋白血症、血红蛋白病、与温度敏感性缺陷或对寒冷过敏相关的多发性神经病。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:平行线
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:高压气体冷冻治疗组
使用 Cryoton™ 高压冷冻疗法进行常规康复
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在干预组中,参与者在手术后一小时内接受使用 Cryoton ™ 设备(Cryonic Médical,Salins-les-Bains,France)递送的高压气体冷冻疗法,术后几天每天两次。
喷嘴尖端保持在干燥皮肤上方 10-15 厘米,同时使用缓慢而规律的扫动运动将气态 CO2 喷洒在 5 厘米乘 10 厘米的三个区域(分别为内侧、外侧和后部)约 30 秒在达到 2°C 的皮肤温度后。
其他名称:
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有源比较器:控制冰袋组
冰袋冷冻疗法的常规康复。
将一袋碎冰直接放在膝盖前面。
|
在对照组中,参与者在手术后一小时内接受两次 20 分钟的冷冻疗法,并在术后几天每天接受两次冷冻疗法。
使用直接应用于膝盖前面的冰袋进行冷冻疗法。
冰袋是一个30厘米乘30厘米的方形乳胶袋,里面装满碎冰,用薄枕套包裹。
治疗评估员以标准化方式实施干预,确保膝盖完全伸展,同时用冰袋覆盖手术切口以及膝盖的外侧和内侧。
其他名称:
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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 |
|---|---|---|
|
通过分析测量的主动和被动膝关节屈曲 ROM 的变化。
大体时间:术后第 1 天和第 2 天之间
|
主要结果是从术后第 1 天到第 2 天主动和被动膝关节屈曲 ROM 的变化。
该结果计算为第 2 天和第 1 天之间主动和被动 ROM 的差异
|
术后第 1 天和第 2 天之间
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
使用测角法测量主动和被动膝关节屈曲 ROM。
大体时间:在手术后的前 2 天内。
|
主动和被动膝关节屈曲 ROM 使用具有 360º 和两个 180º 刻度的长臂 (35 cm) 测角仪测量,增量为 1º,读数方向相反(基线 360° 14" 测角仪,Fabrication enterprises Inc.,NY,USA ).
膝关节 ROM 是在坐姿下测量的,因为观察者之间的一致性水平在坐姿时比在仰卧姿时更高。
|
在手术后的前 2 天内。
|
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通过视觉模拟量表测量膝关节疼痛。
大体时间:在手术后的前 2 天内。
|
在尺子上刻度从 0 到 10 厘米,其中 0 代表没有疼痛,10 代表可以想象到的最严重的疼痛。
|
在手术后的前 2 天内。
|
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通过分析第 2 天和第 1 天记录的疼痛数据之间的变化来测量术后第 1 天到第 2 天的疼痛变化(膝关节疼痛通过视觉模拟量表测量)
大体时间:在第 1 天和第 2 天之间。
|
计算为第 2 天和第 1 天之间的疼痛差异。
|
在第 1 天和第 2 天之间。
|
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通过分析是否存在不良反应来评估可行性。
大体时间:参与者将在住院期间接受随访,预计平均为 3 天。
|
确定患者在住院期间是否有不良反应。
|
参与者将在住院期间接受随访,预计平均为 3 天。
|
|
通过坚持干预(损耗)来评估可行性。
大体时间:参与者将在住院期间接受随访,预计平均为 3 天。
|
确定患者是否坚持治疗(下降)。
|
参与者将在住院期间接受随访,预计平均为 3 天。
|
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住院时间的长短以住院治疗的时间长短(以天为单位)来衡量。
大体时间:参与者将在住院期间接受随访,预计平均为 3 天。
|
在医院病房的停留时间。
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参与者将在住院期间接受随访,预计平均为 3 天。
|
合作者和调查者
调查人员
- 首席研究员:David Moreau, MSc、Centre Hospitalier de Verdun
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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