<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04431752</url>
  </required_header>
  <id_info>
    <org_study_id>2020.115</org_study_id>
    <nct_id>NCT04431752</nct_id>
  </id_info>
  <brief_title>Development of Spin-lock and FSE Acquisitions Based 3D Quantitative Biochemical Imaging for Osteoarthritis</brief_title>
  <official_title>Development of Spin-lock and FSE Acquisitions Based 3D Quantitative Biochemical Imaging for Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Hong Kong, joint diseases are common health problems as identified by the Elderly Health&#xD;
      Service under the Department of Health. It accounts for most of the disability of the elderly&#xD;
      in Hong Kong. In particular, osteoarthritis (OA) is on the rise and the prevalence of OA&#xD;
      increases with age. Women are more likely to have OA in knee and hip joints after menopause.&#xD;
      A study in 2000 reported that among Hong Kong people aged 50 and above, 7 percent of men and&#xD;
      13 percent of women suffered from OA. With an ageing population, it is expected that OA will&#xD;
      become a major public health problem in Hong Kong and worldwide and the socio-economic cost&#xD;
      of supportive care to these patients can become a major burden to Hong Kong society and many&#xD;
      regions in the world. Early diagnosis and prevention of OA and effective technology for&#xD;
      treatment monitoring are very important. At present, the management of OA is not optimal and&#xD;
      standard quality indicators suggest that the majority of persons with the disease do not&#xD;
      receive appropriate care. Over half of the population affected with OA are unaware of the&#xD;
      diagnosis. The research team have developed a quantitative and fully automated non-contrast&#xD;
      MRI application for early detection and monitoring of joint diseases. The whole project was&#xD;
      funded by the Innovation and Technology Fund (ITF) (MRP/001/18X ) started in January 2019.&#xD;
      This clinical trial is part of the quantitative assessment of this developed technology. The&#xD;
      team anticipate this innovation will address both OA diagnosis, surveillance and management.&#xD;
      This can potentially increase diagnostic capabilities with minimum efforts, improving patient&#xD;
      awareness, and improved treatment monitoring of the disease state after the interventions.&#xD;
      Thus, the proposed technology is expected to provide betterment in the quality of life for&#xD;
      the elderly population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 22, 2022</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Degree of cartilage wear</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>All patient will have Xrays and MRI to quantitative assess the degree of cartilage wear.&#xD;
The patient will be categorised based on their Kellgren-Lawrence grading.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Society Function Score</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Clinical Questionnaire Assessment Tool. Score from 100 to -20. The higher the score, the better the knee function outcome.</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteer</arm_group_label>
    <description>10 healthy volunteers to undergo radiographic examinations of the knee joint.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kellgren-Laurence grading I Osteoarthritis Knee</arm_group_label>
    <description>10 patients in Kellgren-Laurence grading I to undergo radiographic examinations of the knee joint.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kellgren-Laurence grading II Osteoarthritis Knee</arm_group_label>
    <description>10 patients in Kellgren-Laurence grading II to undergo radiographic examinations of the knee joint.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kellgren-Laurence grading III Osteoarthritis Knee</arm_group_label>
    <description>10 patients in Kellgren-Laurence grading III to undergo radiographic examinations of the knee joint.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kellgren-Laurence grading IV Osteoarthritis Knee</arm_group_label>
    <description>10 patients in Kellgren-Laurence grading IV to undergo radiographic examinations of the knee joint.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Magnetic Resonance Imaging Scan</intervention_name>
    <description>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.</description>
    <arm_group_label>Healthy Volunteer</arm_group_label>
    <arm_group_label>Kellgren-Laurence grading I Osteoarthritis Knee</arm_group_label>
    <arm_group_label>Kellgren-Laurence grading II Osteoarthritis Knee</arm_group_label>
    <arm_group_label>Kellgren-Laurence grading III Osteoarthritis Knee</arm_group_label>
    <arm_group_label>Kellgren-Laurence grading IV Osteoarthritis Knee</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy Volunteer and Knee Osteoarthritis Patient groups.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All Patients over the age of 18&#xD;
&#xD;
          -  All patients must provide their written consent&#xD;
&#xD;
        In the OA group&#xD;
&#xD;
          -  Patients must be affected by primary osteoarthritis of the knee (according to ACR -&#xD;
             American College of Rheumatology - classification)&#xD;
&#xD;
          -  All patients must have pain symptoms for more than or equal to 2 months&#xD;
&#xD;
          -  Radiological evidence of osteoarthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to MRI&#xD;
&#xD;
          -  Patient with a mental disability&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Inflammatory arthritis&#xD;
&#xD;
          -  Ongoing Pregnancy and breast-feeding&#xD;
&#xD;
          -  Presence of severe diseases like terminal cancers&#xD;
&#xD;
          -  Presence of metalwork in the knee&#xD;
&#xD;
          -  Significant hematological diseases;&#xD;
&#xD;
          -  Non-consenting patients who have not provided the written Informed Consent&#xD;
&#xD;
          -  Gross lower limb deformity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Orthopaedics &amp; Traumatology</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ki Wai Ho, MBChB, MSc, MRCSEd, FRCSEd</last_name>
      <phone>(852) 3505 2715</phone>
      <email>kevinho@cuhk.edu.hk</email>
    </contact>
    <investigator>
      <last_name>Ki Wai Ho, MBChB, MSc, MRCSEd, FRCSEd</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>March 21, 2022</last_update_submitted>
  <last_update_submitted_qc>March 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Ho Ki Wai</investigator_full_name>
    <investigator_title>Clinical Professional Consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04431752
org study id: 2020.115
nct id: NCT04431752
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Control
time perspective: Prospective
measure: Degree of cartilage wear
time frame: Through study completion, an average of 1 year
description: 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.
measure: Oxford Knee Score
time frame: Through study completion, an average of 1 year
description: 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.
measure: Knee Society Function Score
time frame: Through study completion, an average of 1 year
description: Clinical Questionnaire Assessment Tool. Score from 100 to -20. The higher the score, the better the knee function outcome.
arm group label: Healthy Volunteer
description: 10 healthy volunteers to undergo radiographic examinations of the knee joint.
arm group label: Kellgren-Laurence grading I Osteoarthritis Knee
description: 10 patients in Kellgren-Laurence grading I to undergo radiographic examinations of the knee joint.
arm group label: Kellgren-Laurence grading II Osteoarthritis Knee
description: 10 patients in Kellgren-Laurence grading II to undergo radiographic examinations of the knee joint.
arm group label: Kellgren-Laurence grading III Osteoarthritis Knee
description: 10 patients in Kellgren-Laurence grading III to undergo radiographic examinations of the knee joint.
arm group label: Kellgren-Laurence grading IV Osteoarthritis Knee
description: 10 patients in Kellgren-Laurence grading IV to undergo radiographic examinations of the knee joint.
intervention type: Radiation
intervention name: Magnetic Resonance Imaging Scan
description: 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.
arm group label: Healthy Volunteer
arm group label: Kellgren-Laurence grading I Osteoarthritis Knee
arm group label: Kellgren-Laurence grading II Osteoarthritis Knee
arm group label: Kellgren-Laurence grading III Osteoarthritis Knee
arm group label: Kellgren-Laurence grading IV Osteoarthritis Knee
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Dr. Ho Ki Wai
investigator title: Clinical Professional Consultant
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: Undecided