Clinical trial NCT04431752: Development of Spin-lock and FSE Acquisitions Based 3D Quantitative Biochemical Imaging for Osteoarthritis
Official title: Development of Spin-lock and FSE Acquisitions Based 3D Quantitative Biochemical Imaging for Osteoarthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis, Knee
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteer and Knee Osteoarthritis Patient groups.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Degree of cartilage wear
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Oxford Knee Score
timeFrame: Through study completion, an average of 1 year
measure: Knee Society Function Score
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Orthopaedics & Traumatology
Study officials:
References: