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HIP: Hip Imaging Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04126161
Recruitment Status : Suspended (COVID-19 Restrictions)
First Posted : October 15, 2019
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Metabolic Profiling Muscle Procedure: CT Device: Ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: HIP: Hip Imaging Protocol: the Comparison of Muscle Ultrasound-derived Parameters With CT Imaging-derived Parameters in Primary Total Hip Arthroplasty Patients.
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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




Primary Outcome Measures :
  1. All IMAT [ Time Frame: visit 1, up to 1 hour ]
    CT-derived area of intramuscular adipose tissue in cm2

  2. %IMAT [ Time Frame: visit 1, up to 1 hour ]
    Ultrasound-derived area of intramuscular adipose tissue in %



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary hip replacement

Exclusion Criteria:

  • Revision hip replacement
  • Ipsilateral knee replacement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126161


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: David MacLeod Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04126161    
Other Study ID Numbers: Pro00102976
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Duke University:
muscle
ultrasound
CT