Development of Spin-lock and FSE Acquisitions Based 3D Quantitative Biochemical Imaging for Osteoarthritis
1 other identifier
observational
50
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
March 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedDecember 7, 2023
December 1, 2023
2.3 years
May 14, 2020
December 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Through study completion, an average of 1 year
Secondary Outcomes (2)
Oxford Knee Score
Through study completion, an average of 1 year
Knee Society Function Score
Through study completion, an average of 1 year
Study Arms (5)
Healthy Volunteer
10 healthy volunteers to undergo radiographic examinations of the knee joint.
Kellgren-Laurence grading I Osteoarthritis Knee
10 patients in Kellgren-Laurence grading I to undergo radiographic examinations of the knee joint.
Kellgren-Laurence grading II Osteoarthritis Knee
10 patients in Kellgren-Laurence grading II to undergo radiographic examinations of the knee joint.
Kellgren-Laurence grading III Osteoarthritis Knee
10 patients in Kellgren-Laurence grading III to undergo radiographic examinations of the knee joint.
Kellgren-Laurence grading IV Osteoarthritis Knee
10 patients in Kellgren-Laurence grading IV to undergo radiographic examinations of the knee joint.
Interventions
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.
Eligibility Criteria
Healthy Volunteer and Knee Osteoarthritis Patient groups.
You may qualify if:
- 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
You may not qualify if:
- Contraindication to MRI
- Patient with a mental disability
- Claustrophobia
- Inflammatory arthritis
- Ongoing Pregnancy and breast-feeding
- Presence of severe diseases like terminal cancers
- Presence of metalwork in the knee
- Significant hematological diseases;
- Non-consenting patients who have not provided the written Informed Consent
- Gross lower limb deformity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthopaedics & Traumatology
Hong Kong, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professional Consultant
Study Record Dates
First Submitted
May 14, 2020
First Posted
June 16, 2020
Study Start
March 22, 2022
Primary Completion
July 1, 2024
Study Completion
December 31, 2024
Last Updated
December 7, 2023
Record last verified: 2023-12