Osteoarthritis, KneeNCT04431752
Development of Spin-lock and FSE Acquisitions Based 3D Quantitative Biochemical Imaging for Osteoarthritis
An observational study of Osteoarthritis, Knee, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
In Hong Kong, joint diseases are common health problems as identified by the Elderly Health Service under the Department of Health. It accounts for most of the disability of the elderly in Hong Kong. In particular, osteoarthritis (OA) is on the rise and the prevalence of OA increases with age. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Magnetic Resonance Imaging Scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Mar 2022to 31 Dec 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteer and Knee Osteoarthritis Patient groups.
Who may be able to join
- All Patients over the age of 18
- All patients must provide their written consent
- In the OA group
- Patients must be affected by primary osteoarthritis of the knee (according to ACR - American College of Rheumatology - classification)
- All patients must have pain symptoms for more than or equal to 2 months
- Radiological evidence of osteoarthritis
Who cannot join
- Contraindication to MRI
- Patient with a mental disability
- Claustrophobia
- Inflammatory arthritis
- Ongoing Pregnancy and breast-feeding
- Presence of severe diseases like terminal cancers
Show all 10Show fewer
- Presence of metalwork in the knee
- Significant hematological diseases;
- Non-consenting patients who have not provided the written Informed Consent
- Gross lower limb deformity
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Orthopaedics & Traumatology
Hong Kong
Ki Wai Ho, MBChB, MSc, MRCSEd, FRCSEd, (852) 3505 2715, kevinho@cuhk.edu.hk
Ki Wai Ho, MBChB, MSc, MRCSEd, FRCSEd
About this study
In Hong Kong, joint diseases are common health problems as identified by the Elderly Health Service under the Department of Health. It accounts for most of the disability of the elderly in Hong Kong. In particular, osteoarthritis (OA) is on the rise and the prevalence of OA increases with age. Women are more likely to have OA in knee and hip joints after menopause. A study in 2000 reported that among Hong Kong people aged 50 and above, 7 percent of men and 13 percent of women suffered from OA. With an ageing population, it is expected that OA will become a major public health problem in Hong Kong and worldwide and the socio-economic cost of supportive care to these patients can become a major burden to Hong Kong society and many regions in the world. Early diagnosis and prevention of OA and effective technology for treatment monitoring are very important. At present, the management of OA is not optimal and standard quality indicators suggest that the majority of persons with the disease do not receive appropriate care. Over half of the population affected with OA are unaware of the diagnosis. The research team have developed a quantitative and fully automated non-contrast MRI application for early detection and monitoring of joint diseases. The whole project was funded by the Innovation and Technology Fund (ITF) (MRP/001/18X ) started in January 2019. This clinical trial is part of the quantitative assessment of this developed technology. The team anticipate this innovation will address both OA diagnosis, surveillance and management. This can potentially increase diagnostic capabilities with minimum efforts, improving patient awareness, and improved treatment monitoring of the disease state after the interventions. Thus, the proposed technology is expected to provide betterment in the quality of life for the elderly population.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Magnetic Resonance Imaging Scan
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging ScanRadiation
The selection of patients with different level of OA will be made using the existing Kellgren-Laurence grading systems. The recruited patients will receive MRI exams with our enhanced sequencing. The OA level of each patient will be determined objectively through our quantitative OA grading system on MRI, which will be compared to Kellgren-Laurence grading results to evaluate the clinical performance of the MRI.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | 10 healthy volunteers to undergo radiographic examinations of the knee joint. Receives: Radiation: Magnetic Resonance Imaging Scan | |
| Kellgren-Laurence grading I Osteoarthritis Knee | 10 patients in Kellgren-Laurence grading I to undergo radiographic examinations of the knee joint. Receives: Radiation: Magnetic Resonance Imaging Scan | |
| Kellgren-Laurence grading II Osteoarthritis Knee | 10 patients in Kellgren-Laurence grading II to undergo radiographic examinations of the knee joint. Receives: Radiation: Magnetic Resonance Imaging Scan | |
| Kellgren-Laurence grading III Osteoarthritis Knee | 10 patients in Kellgren-Laurence grading III to undergo radiographic examinations of the knee joint. Receives: Radiation: Magnetic Resonance Imaging Scan | |
| Kellgren-Laurence grading IV Osteoarthritis Knee | 10 patients in Kellgren-Laurence grading IV to undergo radiographic examinations of the knee joint. Receives: Radiation: Magnetic Resonance Imaging Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of cartilage wear
All patient will have Xrays and MRI to quantitative assess the degree of cartilage wear.
The patient will be categorised based on their Kellgren-Lawrence grading.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Oxford Knee Score
Clinical Questionnaire Assessment Tool. Subjective patient-reported outcome measurement (Oxford Knee Score) will be performed at the time of recruitment and prior to the MRI. Score 80-100 = Excellent, Score 70-79 = Good, Score 60-69 = Fair, Score below 60 = Poor.
Measured: Through study completion, an average of 1 year
Knee Society Function Score
Clinical Questionnaire Assessment Tool. Score from 100 to -20. The higher the score, the better the knee function outcome.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start22 Mar 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ho Ki Wai, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431752
- Sponsor's protocol ID
- 2020.115
- Status last verified
- Dec 2023
- First submitted
- 14 May 2020
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Spin-lock and FSE Acquisitions Based 3D Quantitative Biochemical Imaging for Osteoarthritis
- ClinicalTrials.gov ID
- NCT04431752
- Acronym / sponsor ID
- 2020.115
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Jun 2020 (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.
In Hong Kong, joint diseases are common health problems as identified by the Elderly Health Service under the Department of Health. It accounts for most of the disability of the elderly in Hong Kong. In particular, osteoarthritis (OA) is on the rise and the prevalence of OA increases with age. Women are more likely to have OA in knee and hip joints after menopause. A study in 2000 reported that among Hong Kong people aged 50 and above, 7 percent of men and 13 percent of women suffered from OA. With an ageing population, it is expected that OA will become a major public health problem in Hong Kong and worldwide and the socio-economic cost of supportive care to these patients can become a major burden to Hong Kong society and many regions in the world. Early diagnosis and prevention of OA and effective technology for treatment monitoring are very important. At present, the management of OA is not optimal and standard quality indicators suggest that the majority of persons with the disease do not receive appropriate care. Over half of the population affected with OA are unaware of the diagnosis. The research team have developed a quantitative and fully automated non-contrast MRI application for early detection and monitoring of joint diseases. The whole project was funded by the Innovation and Technology Fund (ITF) (MRP/001/18X ) started in January 2019. This clinical trial is part of the quantitative assessment of this developed technology. The team anticipate this innovation will address both OA diagnosis, surveillance and management. This can potentially increase diagnostic capabilities with minimum efforts, improving patient awareness, and improved treatment monitoring of the disease state after the interventions. Thus, the proposed technology is expected to provide betterment in the quality of life for the elderly population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | – | Radiation: Magnetic Resonance Imaging Scan10 healthy volunteers to undergo radiographic examinations of the knee joint. |
| Kellgren-Laurence grading I Osteoarthritis Knee | – | Radiation: Magnetic Resonance Imaging Scan10 patients in Kellgren-Laurence grading I to undergo radiographic examinations of the knee joint. |
| Kellgren-Laurence grading II Osteoarthritis Knee | – | Radiation: Magnetic Resonance Imaging Scan10 patients in Kellgren-Laurence grading II to undergo radiographic examinations of the knee joint. |
| Kellgren-Laurence grading III Osteoarthritis Knee | – | Radiation: Magnetic Resonance Imaging Scan10 patients in Kellgren-Laurence grading III to undergo radiographic examinations of the knee joint. |
| Kellgren-Laurence grading IV Osteoarthritis Knee | – | Radiation: Magnetic Resonance Imaging Scan10 patients in Kellgren-Laurence grading IV to undergo radiographic examinations of the knee joint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteer and Knee Osteoarthritis Patient groups.
Key inclusion criteria (6 listed)
- All Patients over the age of 18
- All patients must provide their written consent
- In the OA group
- Patients must be affected by primary osteoarthritis of the knee (according to ACR - American College of Rheumatology - classification)
- All patients must have pain symptoms for more than or equal to 2 months
Key exclusion criteria (10 listed)
- Contraindication to MRI
- Patient with a mental disability
- Claustrophobia
- Inflammatory arthritis
- Ongoing Pregnancy and breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging ScanThe selection of patients with different level of OA will be made using the existing Kellgren-Laurence grading systems. The recruited patients will receive MRI exams with our enhanced sequencing. The OA level of each patient will be determined objectively through our quantitative OA grading system on MRI, which will be compared to Kellgren-Laurence grading results to evaluate the clinical performance of the MRI. | Radiation | Healthy Volunteer, Kellgren-Laurence grading I Osteoarthritis Knee, Kellgren-Laurence grading II Osteoarthritis Knee, Kellgren-Laurence grading III Osteoarthritis Knee, Kellgren-Laurence grading IV Osteoarthritis Knee |
Primary outcome
Degree of cartilage wear
Time frame: Through study completion, an average of 1 year
All patient will have Xrays and MRI to quantitative assess the degree of cartilage wear. The patient will be categorised based on their Kellgren-Lawrence grading.
2 secondary outcomes
Oxford Knee Score
Time frame: Through study completion, an average of 1 year
Knee Society Function Score
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Osteoarthritis, Knee, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 7 Dec 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of cartilage wear (time frame: Through study completion, an average of 1 year). 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 7 Dec 2023.