Trial Outcomes & Findings for HIP: Hip Imaging Protocol (NCT NCT04126161)

NCT ID: NCT04126161

Last Updated: 2026-08-28

Results Overview

As 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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

Visit 1, up to 1 hour

Results posted on

2026-08-28

Participant Flow

Participant milestones

Participant milestones
Measure
Ultrasound and Standard of Care Computed Tomography (CT) Scan
Patients have ultrasound scans together with standard of care CT prior to primary hip replacement Ultrasound: Ultrasound scan together with standard of care CT prior to primary hip replacement
Overall Study
STARTED
18
Overall Study
COMPLETED
18
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HIP: Hip Imaging Protocol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ultrasound and Standard of Care Computed Tomography (CT) Scan
n=18 Participants
Patients have ultrasound scans together with standard of care CT prior to primary hip replacement Ultrasound: Ultrasound scan together with standard of care CT prior to primary hip replacement
Age, Continuous
61.61 years
STANDARD_DEVIATION 15.74 • n=31 Participants
Sex: Female, Male
Female
14 Participants
n=31 Participants
Sex: Female, Male
Male
4 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
18 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=31 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=31 Participants
Race (NIH/OMB)
Asian
0 Participants
n=31 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=31 Participants
Race (NIH/OMB)
Black or African American
7 Participants
n=31 Participants
Race (NIH/OMB)
White
11 Participants
n=31 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=31 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=31 Participants
Region of Enrollment
United States
18 Participants
n=31 Participants
Height
172.13 cm
STANDARD_DEVIATION 7.83 • n=31 Participants
Weight
91.80 kg
STANDARD_DEVIATION 17.35 • n=31 Participants
Body Mass Index (BMI)
31.05 kg/m^2
STANDARD_DEVIATION 6.03 • n=31 Participants

PRIMARY outcome

Timeframe: Visit 1, up to 1 hour

Population: Participants with both ultrasound and CT scan data available.

As 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.

Outcome measures

Outcome measures
Measure
Ultrasound and CT Scan
n=14 Participants
Patients have ultrasound scans together with standard of care CT prior to primary hip replacement Ultrasound: Ultrasound scan together with standard of care CT prior to primary hip replacement
Area of Intramuscular Adipose Tissue (IMAT) - CT Scan
Short-Axis (Transverse)
8.37 cm^2
Standard Deviation 3.75
Area of Intramuscular Adipose Tissue (IMAT) - CT Scan
Long-Axis (Longitudinal)
9.71 cm^2
Standard Deviation 5.44

PRIMARY outcome

Timeframe: Visit 1, up to 1 hour

Population: Participants with both ultrasound and CT scan data available.

As 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.

Outcome measures

Outcome measures
Measure
Ultrasound and CT Scan
n=14 Participants
Patients have ultrasound scans together with standard of care CT prior to primary hip replacement Ultrasound: Ultrasound scan together with standard of care CT prior to primary hip replacement
Area of Intramuscular Adipose Tissue (IMAT) - Ultrasound
Short-Axis (Transverse)
20.42 percentage of muscle tissue
Standard Deviation 7.65
Area of Intramuscular Adipose Tissue (IMAT) - Ultrasound
Long-Axis (Longitudinal)
20.20 percentage of muscle tissue
Standard Deviation 9.09

Adverse Events

Ultrasound and Standard of Care Computed Tomography (CT) Scan

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David MacLeod, M.B.

Duke University

Phone: (919) 681-6437

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place