HIP: Hip Imaging Protocol

NCT04126161 | Completed FDA Device

• 1 other identifier: Pro00102976
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Profiling Muscle

Keywords

muscle; ultrasound; CT; MuscleSound

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

CT

ACTIVE COMPARATOR

Patients have standard of care CT prior to primary hip replacement

Procedure: CT

Ultrasound

EXPERIMENTAL

Patients have ultrasound scans together with standard of care CT prior to primary hip replacement

Device: Ultrasound

Interventions

CT PROCEDURE

standard of care CT prior to primary hip replacement

CT

Ultrasound DEVICE

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

Ultrasound

Eligibility Criteria

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

You may qualify if:

• Primary hip replacement

You may not qualify if:

• Revision hip replacement
• Ipsilateral knee replacement

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• David MacLeod

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: November 1, 2019
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)