- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04821245
Defining Normal Postoperative Magnetic Resonance Imaging After Total Knee Arthroplasty
May 3, 2021 updated by: 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.
Study Overview
Status
Completed
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.
Study Type
Observational
Enrollment (Actual)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98101
- Benaroya Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1-2 days postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Sample was drawn the morning after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joseph M Neal, MD, Benaroya Research Center at Virginia Mason Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Neal JM, Salinas FV, Choi DS. Local Anesthetic-Induced Myotoxicity After Continuous Adductor Canal Block. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):723-727. doi: 10.1097/AAP.0000000000000466.
- Neal JM, Salinas FV, Choi DS. Reply to Dr Kelly et al. Reg Anesth Pain Med. 2017 May/Jun;42(3):414. doi: 10.1097/AAP.0000000000000574. No abstract available.
- Hussain N, McCartney CJL, Neal JM, Chippor J, Banfield L, Abdallah FW. Local anaesthetic-induced myotoxicity in regional anaesthesia: a systematic review and empirical analysis. Br J Anaesth. 2018 Oct;121(4):822-841. doi: 10.1016/j.bja.2018.05.076. Epub 2018 Aug 8.
- Mahyar L, Neal JM, Blackmore CC, Jackson DW, Hanson NA, MacDonald KM, Warren D, Verdin PJ. MRI and muscle enzymes do not support the diagnosis of local anesthetic myotoxicity: a descriptive case series. Reg Anesth Pain Med. 2021 Aug;46(8):679-682. doi: 10.1136/rapm-2021-102772. Epub 2021 May 31.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 4, 2018
Primary Completion (Actual)
August 2, 2019
Study Completion (Actual)
August 2, 2019
Study Registration Dates
First Submitted
March 25, 2021
First Submitted That Met QC Criteria
March 26, 2021
First Posted (Actual)
March 29, 2021
Study Record Updates
Last Update Posted (Actual)
May 25, 2021
Last Update Submitted That Met QC Criteria
May 3, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRI IRB18-008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified raw data in Excel format may be obtained from Joseph M. Neal, MD upon request.
IPD Sharing Time Frame
March 2021 through March 2026
IPD Sharing Access Criteria
Upon request
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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