NCT04821245

Defining Normal Postoperative Magnetic Resonance Imaging After Total Knee Arthroplasty

Completed Results posted Last updated 25 May 2021

What this trial tests

trial in Local Anesthetic Complication in 36 participants. Completed in 2 August 2019.

Timeline

4 December 2018

Primary endpoint
2 August 2019

2 August 2019

Quick facts

Lead sponsor	Benaroya Research Institute
Status	Completed
Study type	OBSERVATIONAL
Enrollment	36
Start date	4 December 2018
Primary completion	2 August 2019
Estimated completion	2 August 2019
Sites	1 location across United States

Conditions studied

• Local Anesthetic Complication — all drugs for Local Anesthetic Complication →
• Local Anesthetic Drug Adverse Reaction — all drugs for Local Anesthetic Drug Adverse Reaction →

Sponsor

Benaroya Research Institute

Who can join

Eligibility, any sex, with Local Anesthetic Complication or Local Anesthetic Drug Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Edema Primary · 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.

Group	Value	95% CI
Participants Undergoing MRI	12

Postoperative Muscle Enzyme Levels Secondary · Sample was drawn the morning after surgery

Participants with Postoperative Creatine Phosphokinase (CPK) or Aldolase levels above the upper limit of normal

Group	Value	95% CI
CPK Analysis	5
Aldolase Analysis	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 10 days. Participant was evaluated at the time of the incident and twice during the 10 days thereafter.. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MRI Appearance

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (1 terms — click to expand)

Reaction	System	MRI Appearance
Warmth around adductor canal catheter during MRI	Musculoskeletal and connective tissue disorders	—

Data from ClinicalTrials.gov NCT04821245 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. MRI and muscle enzymes do not support the diagnosis of local anesthetic myotoxicity: a descriptive case series.
   Mahyar L, Neal JM, Blackmore CC, Jackson DW, et al · · 2021 · PMID 34059556 · DOI 10.1136/rapm-2021-102772