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Ultrasound and CT to Measure Muscle in Hip OA

A Combination of Ultrasound and CT for Investigation of Muscle and Functional Changes in Hip OA Across the Disease Spectrum

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04061499
Enrollment
0
Registered
2019-08-19
Start date
2019-12-04
Completion date
2021-04-29
Last updated
2021-05-04

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

Conditions

Hip Osteoarthritis

Keywords

muscle, ultrasound, hip

Brief summary

This study will examine alterations in muscle in individuals with hip osteoarthritis compared to individuals without hip arthritis. All individuals will receive imaging of their hip and low back muscles in order to compare differences between groups. The investigators hypothesize that there will be differences between groups and that these differences will be related to strength, functional, and balance impairments which will also be measured in all individuals.

Detailed description

Hip osteoarthritis (OA) is one of the most common causes of disability in older adults, with pain, stiffness, and weakness the most frequently reported symptoms. Weakness is a major concern as decreased lower extremity strength is a contributor to balance and other mobility limitations that increase fall risk in the aging population. Weakness in the primary hip muscles in particular have been shown to contribute to gait variability and altered mechanics of stepping when recovering from a balance perturbation. Contributing factors for these strength deficits are multifactorial and may include decreased muscle mass/size, changes in muscle composition, and/or a decreased ability to activate the muscle. Intramuscular fat infiltration (IMAT), has been reported in several conditions affecting older adults, and has been shown to be more modifiable at lower levels, suggesting that earlier detection and intervention may be important. CT and MRI are both commonly used to measure these relevant muscle properties, but ultrasound imaging may be valid alternative, and has the advantage of being more accessible to clinicians in many settings. The investigators hypothesize that cross-sectional area (CSA) and IMAT of the hip and lumbar musculature will be significantly altered in individuals with hip OA (affected limb) compared to that seen in similar-aged control participants, and that larger differences in CSA and IMAT will be positively correlated with OA severity, increased impairment, pain, and disability.

Interventions

None listed

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* Age \>=60 and \<= 85 * Hip OA group ONLY: Diagnosed unilateral OA of the hip as determined by Kellgren/Lawrence (K/L) or similar grades of 2, 3, or 4 from standard hip series A-P radiographs. * CONTROL GROUP ONLY: No significant OA of either hip joint as determined by K/L grades or similar of 0 or 1 from standard hip series A-P radiographs.

Exclusion criteria

* BMI\>35 * Other significant orthopedic conditions of the hip, pelvis or lumbar spine, including prior trauma or significant surgical procedures (examples: lumbar fusion, fractures with surgical management, hip joint replacement, etc.) * Diagnosis of any other arthritic conditions other than osteoarthritis (e.g. psoriatic arthritis or rheumatoid arthritis, ankylosing spondylitis/spondylosis). * Any known neurological disorders, including multiple sclerosis, stroke, spinal cord injury or any serious medical condition that may affect muscle quality. * Inability to undergo CT testing for any reason * Significant cardiovascular conditions that would make the participant unsafe for any testing procedures (for example uncontrolled hypertension (BP\>160/100 at rest), uncontrolled arrhythmia, uncontrolled diabetes, etc.)

Design outcomes

Primary

MeasureTime frameDescription
Echo intensity (EI)Day 1A measure of muscle quality, assessed as the brightness of the ultrasound image using histogram function for each pixel on scale from 0 to 255.
Muscle cross-sectional areaDay 1Muscle CSA will be assessed from CT images and will be reported in units of area, for example square centimeters.
Muscle thicknessDay 1Muscle thickness will be assessed from ultrasound images and will be reported in units of length, for example centimeters.
Intramuscular fat infiltration (IMAT)Day 1Assessed from CT images, and measured in Hounsfield units or HU

Secondary

MeasureTime frameDescription
BalanceDay 1Balance assessed with Four-square step test
StrengthDay 1Muscle strength assessed with Biodex
MobilityDay 1Mobility assessed with Short Physical Performance Battery (SPPB)
Patient self-reported pain and disability: Hip Disability and Osteoarthritis Outcome Score (HOOS)Day 1Hip Disability and Osteoarthritis Outcome Score (HOOS) The HOOS is a 40-question questionnaire with five subsections: Pain (10 items) Symptoms (5 items) Activities of Daily Living (ADLs - 17 items) Sports and recreations (4 items) Hip-related quality of life (4 items) Scoring: Scoring for each question ranges from 0 (never) to extreme (4). A normalized score is calculated for each subscale with 0 representing extreme symptoms and 100 representing no symptoms.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026