HIP: Hip Imaging Protocol

HIP: Hip Imaging Protocol: the Comparison of Muscle Ultrasound-derived Parameters With CT Imaging-derived Parameters in Primary Total Hip Arthroplasty Patients.

Objective measures of skeletal muscle features have previously been used to assess skeletal muscle quality. In certain clinical populations, such as intensive care (ICU) patients, specific features of the psoas muscle measured by abdominal CT have been used to assess the nutritional status of the patient. Abdominal CT is not performed routinely as it exposes the patient to ionizing radiation (X-rays) and can only be performed intermittently.

The measurement of the thigh muscles (rectus femoris muscle, part of the quadriceps muscle) by handheld musculoskeletal (MSK) ultrasound is a simple, safe (no ionizing radiation) and repeatable (can be easily performed on a daily basis) technique. A correlation has been shown between muscle parameters of the psoas muscle (abdominal CT) and the rectus femoris muscle (MSK). A direct comparison between muscle parameters of the same skeletal muscle measured with both CT and MSK has not been done.

Intramuscular adipose tissue (IMAT) is a measure of the extent of adipose tissue deposited within the muscle. It is a biomarker of muscle quality. The study objective is to compare muscle area and intramuscular adipose tissue (IMAT) content of rectus femoris muscle, measured by standard CT imaging with point of care handheld musculoskeletal (MSK) ultrasound in patients presenting for primary total hip arthroplasty. This patient group is chosen because they will have hip CT performed as standard of care prior to surgery.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Profiling Muscle
• Intervention / Treatment: Procedure: CT; Device: Ultrasound

Detailed Description

In our institution, all primary total hip arthroplasty patients receive abdominal CT that encompasses their hip as part of the standard clinical evaluation for hip surgery. This provides an opportunity to perform an MSK ultrasound at the same time.

Both CT and MSK have established imaging techniques of soft tissue. Both techniques provide a 2D digital slice representation. Although the image is black and white, there are a large number of intervals, up to 255, between the two extremes of black and white, termed grayscale. The application of an algorithm based upon the grayscale is used to define the different characteristics of the muscle, e.g. striated muscle versus fat infiltration. The algorithms used to measure muscle characteristics are entirely dependent on the originating imaging source. This means that an estimate of adipose using the CT algorithm is entirely independent of the algorithm applied to the MSK estimation of adipose.

This study, therefore, aims to determine how well the two imaging techniques correlate with each other when IMAT is measured by the two separate techniques.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeroen Molinger; Phone Number: 9196816437; Email: jeroen.molinger@duke.edu
• Study Contact Backup: Name: Ashley Burke; Phone Number: 9196816437; Email: ashley.burke@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
      • Contact: Jeroen Molinger; Phone Number: 9196816437; Email: jeroen.molinger@duke.edu
      • Contact: Ashley Burke; Phone Number: 919-681-6437; Email: ashley.burke@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary hip replacement

Exclusion Criteria:

• Revision hip replacement
• Ipsilateral knee replacement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CT; Patients have standard of care CT prior to primary hip replacement	Procedure: CT; standard of care CT prior to primary hip replacement
Experimental: Ultrasound; Patients have ultrasound scans together with standard of care CT prior to primary hip replacement	Device: Ultrasound; Ultrasound scan together with standard of care CT prior to primary hip replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All IMAT	CT-derived area of intramuscular adipose tissue in cm2	visit 1, up to 1 hour
%IMAT	Ultrasound-derived area of intramuscular adipose tissue in %	visit 1, up to 1 hour

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: David MacLeod, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: ultrasound; muscle; CT; MuscleSound
• Other Study ID Numbers: Pro00102976

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No