Hip OsteoarthritisNCT04061499
Ultrasound and CT to Measure Muscle in Hip OA
An observational study of Hip Osteoarthritis, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2019to 29 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Older adults with and without hip osteoarthritis
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center
Baltimore, Maryland, 21201
About this study
Official title: A Combination of Ultrasound and CT for Investigation of Muscle and Functional Changes in Hip OA Across the Disease Spectrum
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.
Read the 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.
- Conditions
- Hip Osteoarthritis
- Keywords
- muscle, ultrasound, hip
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hip OA | Individuals with diagnosed hip osteoarthritis | |
| Control | Individuals without diagnosed hip osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle cross-sectional area
Muscle CSA will be assessed from CT images and will be reported in units of area, for example square centimeters.
Measured: Day 1
Muscle thickness
Muscle thickness will be assessed from ultrasound images and will be reported in units of length, for example centimeters.
Measured: Day 1
Intramuscular fat infiltration (IMAT)
Assessed from CT images, and measured in Hounsfield units or HU
Measured: Day 1
Echo intensity (EI)
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.
Measured: Day 1
Secondary outcomes (5)
Balance
Balance assessed with Four-square step test
Measured: Day 1
Strength
Muscle strength assessed with Biodex
Measured: Day 1
Mobility
Mobility assessed with Short Physical Performance Battery (SPPB)
Measured: Day 1
Mobility
Mobility assessed with 30-sec chair stand test
Measured: Day 1
Patient self-reported pain and disability: Hip Disability and Osteoarthritis Outcome Score (HOOS)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start4 Dec 2019
- Primary completion29 Apr 2021
- Study completion29 Apr 2021
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christa Nelson, University of Maryland, Baltimore
- Investigators
- Christa Nelson, DPT, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061499
- Sponsor's protocol ID
- HP-00087080
- Status last verified
- Apr 2021
- First submitted
- 14 Aug 2019
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination of Ultrasound and CT for Investigation of Muscle and Functional Changes in Hip OA Across the Disease Spectrum
- ClinicalTrials.gov ID
- NCT04061499
- Acronym / sponsor ID
- HP-00087080
- Conditions
- Hip Osteoarthritis
- Keywords
- muscle, ultrasound, hip
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip OA | – | –Individuals with diagnosed hip osteoarthritis |
| Control | – | –Individuals without diagnosed hip osteoarthritis |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Older adults with and without hip osteoarthritis
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Intramuscular fat infiltration (IMAT)
Time frame: Day 1
Assessed from CT images, and measured in Hounsfield units or HU
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.
5 secondary outcomes
Balance
Time frame: Day 1
Strength
Time frame: Day 1
Mobility
Time frame: Day 1
Mobility
Time frame: Day 1
Patient self-reported pain and disability: Hip Disability and Osteoarthritis Outcome Score (HOOS)
Time frame: Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: No
Related trials for Hip Osteoarthritis
Active, not recruiting
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
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PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christa Nelson, DPT, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Osteoarthritis, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle cross-sectional area (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.