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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
Sponsor:
Collaborator:
Washington State Society of Anesthesiologists
Information provided by (Responsible Party):
Joseph M. Neal, Benaroya Research Institute

Brief Summary:
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.

Condition or disease
Local Anesthetic Complication Local Anesthetic Drug Adverse Reaction

Detailed Description:
  • 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.

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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • 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
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Washington
Benaroya Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Benaroya Research Institute
Washington State Society of Anesthesiologists
Investigators
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Principal Investigator: Joseph M Neal, MD Benaroya Research Center at Virginia Mason Medical Center
  Study Documents (Full-Text)

Documents provided by Joseph M. Neal, Benaroya Research Institute:
Informed Consent Form  [PDF] April 25, 2019

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joseph M. Neal, Affiliate Investigator, Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT04821245    
Other Study ID Numbers: BRI IRB18-008
First Posted: March 29, 2021    Key Record Dates
Results First Posted: May 25, 2021
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified raw data in Excel format may be obtained from Joseph M. Neal, MD upon request.
Time Frame: March 2021 through March 2026
Access Criteria: Upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Joseph M. Neal, Benaroya Research Institute:
Myotoxicity
Myositis
Magnetic resonance imaging
Creatine phosphokinase
Aldolase
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders