- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04061499
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21201
- Baltimore VA Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Hip OA
Individuals with diagnosed hip osteoarthritis
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Control
Individuals without diagnosed hip osteoarthritis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1
|
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.
|
Day 1
|
Intramuscular fat infiltration (IMAT)
Time Frame: Day 1
|
Assessed from CT images, and measured in Hounsfield units or HU
|
Day 1
|
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.
|
Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance
Time Frame: Day 1
|
Balance assessed with Four-square step test
|
Day 1
|
Strength
Time Frame: Day 1
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Muscle strength assessed with Biodex
|
Day 1
|
Mobility
Time Frame: Day 1
|
Mobility assessed with Short Physical Performance Battery (SPPB)
|
Day 1
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Mobility
Time Frame: Day 1
|
Mobility assessed with 30-sec chair stand test
|
Day 1
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Patient self-reported pain and disability: Hip Disability and Osteoarthritis Outcome Score (HOOS)
Time Frame: Day 1
|
Hip 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. |
Day 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Christa Nelson, DPT, PhD, University of Maryland, Baltimore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00087080
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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