Defining Normal Postoperative Magnetic Resonance Imaging After Total Knee Arthroplasty

NCT04821245 | Completed Results

• 1 other identifier: BRI IRB18-008
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Local Anesthetic Complication; Local Anesthetic Drug Adverse Reaction

Keywords

Myotoxicity; Myositis; Magnetic resonance imaging; Creatine phosphokinase; Aldolase

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Edema

  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 Outcomes (1)

• Postoperative Muscle Enzyme Levels

  Sample was drawn the morning after surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Scheduled for unilateral primary TKA with CACB
• TKA and early recovery was uncomplicated (no evidence of unexpected leg weakness)

You may not qualify if:

• 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

Sponsors & Collaborators

• Benaroya Research Institute: lead
• Washington State Society of Anesthesiologists: collaborator

Study Sites (1)

Benaroya Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (4)

• 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.

  PMID: 27662067 BACKGROUND

• 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.

  PMID: 28419048 BACKGROUND

• 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.

  PMID: 30236244 BACKGROUND

• 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.

  PMID: 34059556 DERIVED

MeSH Terms

Conditions

Myotoxicity; Myositis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Limitations and Caveats

This case series aimed to describe MRI appearance and muscle enzyme levels presented under the same clinical conditions as the 3 sentinel cases of presumed local anesthetic myotoxicity after TKA/CACB. This descriptive design was not intended to sort cause-and-effect (that is, the relative role of surgery, pneumatic tourniquet, local anesthetic, etc.) in causing muscular edema or raising enzyme levels.

Results Point of Contact

• Title: Joseph M. Neal, MD
• Organization: Benaroya Research Institute

Joseph.Neal@virginiamason.org

206-223-6980

Study Officials

• Joseph M Neal, MD

  Benaroya Research Center at Virginia Mason Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliate Investigator

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: December 4, 2018
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: May 25, 2021
• Results First Posted: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: March 2021 through March 2026
• Access Criteria: Upon request

Locations

US (1)