NCT04431752

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
1.8 years until next milestone

Study Start

First participant enrolled

March 22, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 7, 2023

Status Verified

December 1, 2023

Enrollment Period

2.3 years

First QC Date

May 14, 2020

Last Update Submit

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.

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.

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.

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.

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.

Radiation: Magnetic Resonance Imaging Scan

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.

Healthy VolunteerKellgren-Laurence grading I Osteoarthritis KneeKellgren-Laurence grading II Osteoarthritis KneeKellgren-Laurence grading III Osteoarthritis KneeKellgren-Laurence grading IV Osteoarthritis Knee

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

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

Locations