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Defining Normal Postoperative Magnetic Resonance Imaging After Total Knee Arthroplasty

2021年5月3日更新者：Joseph M. Neal、Benaroya Research Institute

Defining Normal Postoperative Magnetic Resonance Imaging and Muscle Enzyme Levels After Total Knee Arthroplasty Associated With Continuous Adductor Canal Block

The aim of this study was to describe the postoperative "baseline" magnetic resonance imaging (MRI) appearance of the ipsilateral thigh musculature after total knee arthroplasty (TKA). The secondary aim was to describe baseline muscle enzyme levels under the same clinical scenario. Neither of these measures have been reported previously.

研究概览

地位

完全的

条件

详细说明

In 2016, 3 sentinel cases of presumed local anesthetic-induced myotoxicity were reported after TKA with associated continuous adductor canal block (CACB) analgesia. The diagnosis was made based on its consistency with animal and human descriptions of local anesthetic myotoxicity, including: a) exposure to local anesthetic, b) delayed symptom onset after a period of normal recovery, c) rapid development of profound muscle flaccidity, and d) complete to partial recovery of motor function after weeks to months. MRIs obtained in these patients showed diffuse intra- and inter-muscular edema (inflammation) of the ipsilateral thigh, which was believed to support the presumptive diagnosis. However, because baseline MRI appearance of upper leg muscles has never been described for this clinical scenario, it is possible that the MRI scans represented "normal, baseline" appearance.
This case series intended to prospectively describe postoperative MRI appearance in a cohort of asymptomatic volunteer patients that underwent uncomplicated TKA/CACB. In addition, because obtaining biomarkers of muscle injury might also be a reasonable diagnostic step, we sought to measure preoperative and postoperative creatine phosphokinase (CPK) and aldolase levels.
MRI scans were read by 5 board-certified musculoskeletal radiologists masked to the study's purpose. Grading was done using a standard grid that facilitated systematic evaluation of various regions within the upper leg. At least 3 of 5 radiologists were required to declare edema as present within a given region of the leg.
Only those volunteer patients that presented a normal postoperative course, i.e., had no unexpected leg muscle weakness, were entered into the study. As such, the MRI and muscle enzyme analysis results had no impact on the volunteer patients' clinical outcome or management. This was a prospective, observational/descriptive case series. There was no control group and we did not intend to investigate issues of cause-and-effect.

研究类型

观察性的

注册 (实际的)

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

美国
- Washington
  - Seattle、Washington、美国、98101
    - Benaroya Research Institute

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

孩子
成人
年长者

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Volunteer patients of various age and sex
Number of volunteers and diagnostic studies determined by available grant monies
Volunteers were drawn from a population presenting for unilateral primary TKA performed by 1 of 2 orthopedic surgeons in a single institution

描述

Inclusion Criteria:

Scheduled for unilateral primary TKA with CACB
TKA and early recovery was uncomplicated (no evidence of unexpected leg weakness)

Exclusion Criteria:

Contraindication to spinal anesthesia or adductor canal-based analgesia
History of muscle wasting or related disease
History of autoimmune disorders that may affect muscles
History of neurologic condition affecting the lower extremities
Contraindications to MRI

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

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
Number of Participants With Edema 大体时间：1-2 days postoperative	Regions of the ipsilateral thigh were defined by muscle group, neuromuscular bundle, subcutaneous tissue, or inter-muscular fascial layers. Five board-certified musculoskeletal radiologists analyzed the scans for presence of edema. Edema was considered present if judged to be so by at least 3 of the 5 radiologists.	1-2 days postoperative

次要结果测量

结果测量	措施说明	大体时间
Postoperative Muscle Enzyme Levels 大体时间：Sample was drawn the morning after surgery	Participants with Postoperative Creatine Phosphokinase (CPK) or Aldolase levels above the upper limit of normal	Sample was drawn the morning after surgery

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。

赞助

Benaroya Research Institute

合作者

Washington State Society of Anesthesiologists

调查人员

首席研究员：Joseph M Neal, MD、Benaroya Research Center at Virginia Mason Medical Center

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

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12月4日

初级完成 (实际的)

2019年8月2日

研究完成 (实际的)

2019年8月2日

研究注册日期

首次提交

2021年3月25日

首先提交符合 QC 标准的

2021年3月26日

首次发布 (实际的)

2021年3月29日

研究记录更新

最后更新发布 (实际的)

2021年5月25日

上次提交的符合 QC 标准的更新

2021年5月3日

最后验证

2021年5月1日