Trial Outcomes & Findings for Defining Normal Postoperative Magnetic Resonance Imaging After Total Knee Arthroplasty (NCT NCT04821245)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

36 participants

Primary outcome timeframe

1-2 days postoperative

Results posted on

2021-05-25

Participant Flow

* Tertiary care medical center * December 2018 through August 2019 * Potential volunteers were contacted by the principal investigator at least 24 hours prior to their surgery. Informed consent was obtained at this point. * Volunteers could decline to proceed at any point from initial informed consent through MRI scan or final blood draw

-Volunteer patients only entered the study if they showed no signs of unexpected ipsilateral upper leg weakness prior to drawing blood samples or obtaining MRI scans

Participant milestones

Participant milestones
Measure	Single Cohort All volunteer patients
Overall Study STARTED	36
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Cohort All volunteer patients
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	1
Overall Study Protocol Violation	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=27 Participants All enrolled subjects
Age, Continuous	62 years n=27 Participants
Sex: Female, Male Female	18 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=27 Participants
Weight	89 kg n=27 Participants

PRIMARY outcome

Timeframe: 1-2 days postoperative

Population: Participants that underwent postoperative MRI scan of operated leg

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.

Outcome measures

Outcome measures
Measure	Participants Undergoing MRI n=12 Participants Number of Participants with Edema	Aldolase Analysis Aldolase Levels Above High Normal
Number of Participants With Edema	12 participants	—

SECONDARY outcome

Timeframe: Sample was drawn the morning after surgery

Population: Participants with CPK levels 12% to 111%, and aldolase levels, in excess of high normal values

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

Outcome measures

Outcome measures
Measure	Participants Undergoing MRI n=19 Participants Number of Participants with Edema	Aldolase Analysis n=19 Participants Aldolase Levels Above High Normal
Postoperative Muscle Enzyme Levels	5 Participants	0 Participants

Adverse Events

MRI Appearance

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MRI Appearance n=13 participants at risk Volunteers undergoing MRI examination
Musculoskeletal and connective tissue disorders Warmth around adductor canal catheter during MRI	7.7% 1/13 • Number of events 1 • 10 days. Participant was evaluated at the time of the incident and twice during the 10 days thereafter.

Additional Information

Joseph M. Neal, MD

Benaroya Research Institute

Phone: 206-223-6980

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place