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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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04126161
Enrollment
18
Registered
2019-10-15
Start date
2019-11-01
Completion date
2025-07-10
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Profiling Muscle

Keywords

muscle, ultrasound, CT, MuscleSound

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.

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.

Interventions

PROCEDURECT

standard of care CT prior to primary hip replacement

DEVICEUltrasound

Ultrasound scan together with standard of care CT prior to primary hip replacement

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Primary hip replacement

Exclusion criteria

* Revision hip replacement * Ipsilateral knee replacement

Design outcomes

Primary

MeasureTime frameDescription
Area of Intramuscular Adipose Tissue (IMAT) - CT ScanVisit 1, up to 1 hourAs measured by CT scan and reported in cm\^2. The Short-Axis (Transverse) view is achieved by placing the transducer perpendicular to the muscle fibers and the Long-Axis (Longitudinal) view is achieved by placing the transducer parallel to the muscle fibers.
Area of Intramuscular Adipose Tissue (IMAT) - UltrasoundVisit 1, up to 1 hourAs measured by ultrasound and reported as a percentage. The Short-Axis (Transverse) view is achieved by placing the transducer perpendicular to the muscle fibers and the Long-Axis (Longitudinal) view is achieved by placing the transducer parallel to the muscle fibers.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDavid MacLeod

Duke University

Baseline characteristics

Characteristic
Age, Continuous61.61 years
STANDARD_DEVIATION 15.74
Body Mass Index (BMI)31.05 kg/m^2
STANDARD_DEVIATION 6.03
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
18 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Height172.13 cm
STANDARD_DEVIATION 7.83
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
7 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
11 Participants
Region of Enrollment
United States
18 Participants
Sex: Female, Male
Female
14 Participants
Sex: Female, Male
Male
4 Participants
Weight91.80 kg
STANDARD_DEVIATION 17.35

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 18
other
Total, other adverse events
0 / 18
serious
Total, serious adverse events
0 / 18

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026