Knee OsteoarthritisNCT05439317
Elasticity of the Hoffa's Fat Pad in Patients With Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Elasticity Imaging Techniques, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 86 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Elasticity Imaging Techniques
- How many people
- 33 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Dec 2021to 5 Aug 2022
- 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 20 to 86 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- History of knee surgery, trauma or malignancy
- History of patellar tendinopathy or patellofemoral pain syndrome
- Refused informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Elasticity Imaging Techniques
- Medical subject headings
- Osteoarthritis, Knee
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 |
|---|---|---|
| knee osteoarthritis group | individuals being diagnosed with osteoarthritis and classified by K-L grading | |
| healthy group | individuals without knee pain or diagnosis of knee osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
shear modulus
the absolute quantitative measurement of elasticity (kPa) of Hoffa's fat pad
Measured: before and 1-3 months after hyaluronic acid injection
strain ratio
the semiquantitative measurement of elasticity of Hoffa's fat pad, a ratio with patellar tendon as reference
Measured: before and 1-3 months after hyaluronic acid injection
thickness of Hoffa's fat pad
the thickness of Hoffa's fat pad from mid patellar tendon to femur cartilage
Measured: before and 1-3 months after hyaluronic acid injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start3 Dec 2021
- Primary completion11 Apr 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ding-Hao Liu, Study chair, Physical and Rehabilitation Medicine, Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439317
- Sponsor's protocol ID
- 2021-09-013AC
- Status last verified
- Feb 2023
- First submitted
- 19 May 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elasticity of the Hoffa's Fat Pad in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05439317
- Acronym / sponsor ID
- 2021-09-013AC
- Conditions
- Knee Osteoarthritis, Elasticity Imaging Techniques
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 30 Jun 2022 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| knee osteoarthritis group | – | –individuals being diagnosed with osteoarthritis and classified by K-L grading |
| healthy group | – | –individuals without knee pain or diagnosis of knee osteoarthritis |
Who may qualify
- Ages
- 20 to 86 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- History of knee surgery, trauma or malignancy
- History of patellar tendinopathy or patellofemoral pain syndrome
- Refused informed consent
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
shear modulus
Time frame: before and 1-3 months after hyaluronic acid injection
the absolute quantitative measurement of elasticity (kPa) of Hoffa's fat pad
strain ratio
Time frame: before and 1-3 months after hyaluronic acid injection
the semiquantitative measurement of elasticity of Hoffa's fat pad, a ratio with patellar tendon as reference
thickness of Hoffa's fat pad
Time frame: before and 1-3 months after hyaluronic acid injection
the thickness of Hoffa's fat pad from mid patellar tendon to femur cartilage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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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.
Ding-Hao Liu study chair
Physical and Rehabilitation Medicine, Veterans General Hospital
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 Knee Osteoarthritis and Elasticity Imaging Techniques, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 22 Feb 2023. 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 Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
shear modulus (time frame: before and 1-3 months after hyaluronic acid injection). The study lists 3 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 22 Feb 2023.