- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05439317
Elasticity of the Hoffa's Fat Pad in Patients With Knee Osteoarthritis
February 20, 2023 updated by: Taipei Veterans General Hospital, Taiwan
Knee osteoarthritis (OA) is a common problem in clinical settings.
Knee OA is well known for its association with the wear and tear of the cartilage and osteophyte formation.
Evidence has suggested the importance of the infrapatellar fat pad, known as Hoffa's fat pad, during the development of knee OA.
Some studies have demonstrated the protective role of the infrapatellar fat pad, whereas others have suggested an inflammatory role such as increased fibrosis and proinflammatory cytokine levels.
Ultrasound is exceptionally convenient in the assessment of the musculoskeletal system, and elastography is a tool to evaluate tissue texture.
Therefore, in this study, we investigated the Hoffa's fat pad in knee OA patients by using elastography.
Study Overview
Status
Completed
Conditions
Detailed Description
This was an observation study that included a control group.
We enrolled 20 patients with knee OA, as well as 10 healthy individuals.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Kellgren-Lawrence X-ray grading were employed to determine disease severity.
All the study participants received elastography assessment, including strain and shear wave elastography in the knee extension and flexion position.
The strain elastography contained color mapping that enabled the calculation of the relative texture and strain ratio.
The shear wave elastography revealed the qualitative velocity, which was measured 3 times.
Each patients with knee OA received elastography examination twice: once before hyaluronic acid injection and once 1 month after the injection.
Study Type
Observational
Enrollment (Actual)
33
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan
- Taipei Veterans General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 86 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
individuals with knee osteoarthritis diagnosis is classified as K-L grading I - IV individuals in control group has no knee pain or osteoarthritis history
Description
Inclusion Criteria:
OA group
- Kellgren-Lawrence grading I-IV proved by knee X-ray Healthy group
- No knee pain or received injection during the past 1 year
- No history of knee OA
Exclusion Criteria:
- History of knee surgery, trauma or malignancy
- History of patellar tendinopathy or patellofemoral pain syndrome
- Refused informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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knee osteoarthritis group
individuals being diagnosed with osteoarthritis and classified by K-L grading
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healthy group
individuals without knee pain or diagnosis of knee osteoarthritis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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shear modulus
Time Frame: before and 1-3 months after hyaluronic acid injection
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the absolute quantitative measurement of elasticity (kPa) of Hoffa's fat pad
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before and 1-3 months after hyaluronic acid injection
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strain ratio
Time Frame: before and 1-3 months after hyaluronic acid injection
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the semiquantitative measurement of elasticity of Hoffa's fat pad, a ratio with patellar tendon as reference
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before and 1-3 months after hyaluronic acid injection
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thickness of Hoffa's fat pad
Time Frame: before and 1-3 months after hyaluronic acid injection
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the thickness of Hoffa's fat pad from mid patellar tendon to femur cartilage
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before and 1-3 months after hyaluronic acid injection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ding-Hao Liu, Physical and Rehabilitation Medicine, Veterans General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 3, 2021
Primary Completion (Actual)
April 11, 2022
Study Completion (Actual)
August 5, 2022
Study Registration Dates
First Submitted
May 19, 2022
First Submitted That Met QC Criteria
June 27, 2022
First Posted (Actual)
June 30, 2022
Study Record Updates
Last Update Posted (Estimate)
February 22, 2023
Last Update Submitted That Met QC Criteria
February 20, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-09-013AC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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