Defining Normal Postoperative Magnetic Resonance Imaging After Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT04821245|
Recruitment Status : Completed
First Posted : March 29, 2021
Results First Posted : May 25, 2021
Last Update Posted : May 25, 2021
|Condition or disease|
|Local Anesthetic Complication Local Anesthetic Drug Adverse Reaction|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||36 participants|
|Official Title:||Defining Normal Postoperative Magnetic Resonance Imaging and Muscle Enzyme Levels After Total Knee Arthroplasty Associated With Continuous Adductor Canal Block|
|Actual Study Start Date :||December 4, 2018|
|Actual Primary Completion Date :||August 2, 2019|
|Actual Study Completion Date :||August 2, 2019|
- Number of Participants With Edema [ Time Frame: 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.
- Postoperative Muscle Enzyme Levels [ Time Frame: Sample was drawn the morning after surgery ]Participants with Postoperative Creatine Phosphokinase (CPK) or Aldolase levels above the upper limit of normal
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04821245
|United States, Washington|
|Benaroya Research Institute|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Joseph M Neal, MD||Benaroya Research Center at Virginia Mason Medical Center|