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临床试验/NCT04431752
NCT04431752招募中不适用

Development of Spin-lock and FSE Acquisitions Based 3D Quantitative Biochemical Imaging for Osteoarthritis

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Degree of cartilage wear

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Degree of cartilage wear

时间窗: 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.

次要结局

  • Knee Society Function Score(Through study completion, an average of 1 year)
  • Oxford Knee Score(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Ho Ki Wai

Clinical Professional Consultant

Chinese University of Hong Kong

研究点 (1)

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