ROM Outcomes in Patients Undergoing a Primary TKA
2021年9月14日 更新者：Arthur Malkani、University of Louisville
Will Visual Affirmation of Knee Range of Motion (ROM) Affect Patient Outcomes in Patients Undergoing a Primary Total Knee Arthroplasty (TKA)? A Prospective, Randomized Study.
The goal of this prospective, randomized study is to compare the outcomes of patients undergoing primary TKA after photographing final knee range of motion immediately post-operatively and sharing these photographs with patients at their first follow-up appointment versus a group that does not see a photograph.
研究概览
地位
完全的
条件
详细说明
The goal of this prospective, randomized study is to compare the outcomes of patients undergoing primary total knee arthroplasty (TKA) after photographing final knee range of motion immediately postoperatively and sharing these photographs with patients at their first follow-up appointment versus a group that does not see a photograph.
The knee will be photographed in maximum flexion and extension.
The primary objectives will be to compare the range of motion of the operative knee at 2 weeks and 6 weeks postoperatively.
In the investigator's institution, patients who have failed to achieve 90 degrees of flexion at a postoperative period of 6 weeks undergo manipulation of the knee under anesthesia (MUA).
The investigators will also measure how many patients require MUA in the photograph group and non-photograph group.
MUA will be performed if patients fail to achieve 90 degrees of flexion at 6 weeks post-op.
研究类型
介入性
注册 (实际的)
158
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
-
-
Kentucky
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Louisville、Kentucky、美国、40202
- Jewish Hospital
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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
22年 至 89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
Inclusion Criteria:
- Patient is between the age of 22-89
- Patient is scheduled to undergo a unilateral, cementless primary TKA, secondary to osteoarthritis
- Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization documents
- Patient is able to read and speak English.
Exclusion Criteria:
- Patient is under the age of 22 or over the age of 89
- Patient has preoperative stiffness/contracture of the knee secondary to post-traumatic arthritis
- Patient is scheduled to undergo a bilateral TKA surgery
- Patient is unable to read and speak English
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：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：A - will be shown their photograph at 2 weeks post-operative.
40-50 arms: patients undergoing a unilateral, cementless primary TKA, secondary to osteoarthritis will be shown a photograph of their knee, photographed in maximum flexion and extension, at 2 weeks postoperatively.
|
Patients who undergo primary TKA surgery will then be shown a photograph of their knee at 2 weeks postoperative.
|
|
有源比较器：B - will not be shown their photograph
40-50 arms: patients undergoing a unilateral, cementless primary TKA, secondary to osteoarthritis will not be shown a photograph of their knee, photographed in maximum flexion and extension, at 2 weeks postoperatively.
|
Patients who undergo primary TKA surgery will not be shown a photograph of their knee at 2 weeks postoperative.
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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 |
|---|---|---|
|
膝关节协会评分
大体时间：结果测量将在术前进行（手术日期前 4-6 周）
|
膝关节协会评分。
分数范围为 0-100。
更高的值代表更好的结果。
|
结果测量将在术前进行（手术日期前 4-6 周）
|
|
膝关节协会评分
大体时间：术后 6 周（± 2 周）进行结果测量
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膝关节协会评分。
分数范围为 0-100。
更高的值代表更好的结果。
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术后 6 周（± 2 周）进行结果测量
|
|
主动活动范围 (ROM)
大体时间：结果测量将在术前进行（手术日期前 4-6 周）
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由测角仪测量的活动 ROM（运动范围）（范围为 0-135 度）
|
结果测量将在术前进行（手术日期前 4-6 周）
|
|
主动活动范围 (ROM)
大体时间：术后 6 周（± 2 周）进行结果测量
|
由测角仪测量的活动 ROM（运动范围）（范围为 0-135 度）
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术后 6 周（± 2 周）进行结果测量
|
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总住院时间
大体时间：结果测量将在术后 2 周进行
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从手术之日到出院之日的总住院天数
|
结果测量将在术后 2 周进行
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手术时间
大体时间：结果测量将在术后 2 周进行
|
以分钟为单位定义的总操作时间
|
结果测量将在术后 2 周进行
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估计失血量 (EBL)
大体时间：结果测量将在术后 2 周进行
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估计失血量定义为以立方厘米 (cc) 为单位测量的术中失血量。
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结果测量将在术后 2 周进行
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WOMAC Score
大体时间：outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
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WOMAC score.
The score is on a scale from 0-100.
In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome
|
outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
|
|
WOMAC Score
大体时间：outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
|
WOMAC score.
The score is on a scale from 0-100.
In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome
|
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
|
|
Incidence of loss of knee motion requiring an MUA (manipulation under anesthesia)
大体时间：outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
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Loss of knee motion is defined as failure to achieve greater than 100 degrees of active flexion.
Manipulation under anesthesia is an outpatient procedure performed by orthopedic surgeon to help improve patient's range-of-motion.
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outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
|
|
Tourniquet time
大体时间：outcome measure will be taken at 2 weeks postoperatively
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Total Tourniquet Time is the number of minutes that the tourniquet is inflated, as defined in minutes.
|
outcome measure will be taken at 2 weeks postoperatively
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants with postoperative complications
大体时间：outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
|
Number of Participants with postoperative complications.
A postoperative complication is defined as any diagnosis or condition that necessitates a re-operation or procedure on the surgical knee
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outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
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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。
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)
2020年2月4日
初级完成 (实际的)
2020年9月21日
研究完成 (实际的)
2021年5月31日
研究注册日期
首次提交
2019年12月30日
首先提交符合 QC 标准的
2019年12月30日
首次发布 (实际的)
2020年1月3日
研究记录更新
最后更新发布 (实际的)
2021年9月16日
上次提交的符合 QC 标准的更新
2021年9月14日
最后验证
2021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.