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Clinical Trials/NCT04061499
NCT04061499
Withdrawn
Not Applicable

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

University of Maryland, Baltimore1 site in 1 countryDecember 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Osteoarthritis
Sponsor
University of Maryland, Baltimore
Locations
1
Primary Endpoint
Intramuscular fat infiltration (IMAT)
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 4, 2019
End Date
April 29, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christa Nelson

Assistant Professor

University of Maryland, Baltimore

Eligibility Criteria

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

  • 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.)

Outcomes

Primary Outcomes

Intramuscular fat infiltration (IMAT)

Time Frame: Day 1

Assessed from CT images, and measured in Hounsfield units or HU

Muscle cross-sectional area

Time Frame: Day 1

Muscle CSA will be assessed from CT images and will be reported in units of area, for example square centimeters.

Echo intensity (EI)

Time Frame: Day 1

A 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 thickness

Time Frame: Day 1

Muscle thickness will be assessed from ultrasound images and will be reported in units of length, for example centimeters.

Secondary Outcomes

  • Strength(Day 1)
  • Mobility(Day 1)
  • Balance(Day 1)
  • Patient self-reported pain and disability: Hip Disability and Osteoarthritis Outcome Score (HOOS)(Day 1)

Study Sites (1)

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