<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/NCT03789630</url>
  </required_header>
  <id_info>
    <org_study_id>CT002</org_study_id>
    <nct_id>NCT03789630</nct_id>
  </id_info>
  <brief_title>Continuous Monitoring of Physiology and Self-reported Pain Score Amongst Post-surgical Knee Patients</brief_title>
  <acronym>ObservePAIN</acronym>
  <official_title>Observation of In-home Continuous Monitoring of Human Physiology and Self-reported Pain Score Among Knee Replacement, Anterior Cruciate Ligament (ACL), Knee Arthroscopy &amp; Foot &amp; Ankle Related Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biofourmis Singapore Pte Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mundipharma Research Limited</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Biofourmis Singapore Pte Ltd.</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this observational study is to assess whether patient reported pain levels&#xD;
      correlate with a Pain Index derived from deviations in multivariate physiology biomarkers&#xD;
      captured in real-world setting. This study will be conducted using a clinical-grade wearable&#xD;
      sensor to continuously monitor patient's physiology (pain related biomarkers) and allow&#xD;
      subject participant to actively report their pain score, symptoms and quality of life using a&#xD;
      mobile-based application.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The designated clinical-grade wearable sensor used in this study is the Biovotion Everion MD&#xD;
      (See Annex for product description), a Bluetooth-compatible device that will automatically&#xD;
      sync with the mobile application used in this study.&#xD;
&#xD;
      This study will recruit 55 patients aged 21 to 80 years who will be undergoing knee&#xD;
      replacement, Anterior Cruciate Ligament(ACL), Knee Arthroscopy and Foot &amp; Ankle related&#xD;
      surgery. All study participants will be followed for an estimated total of 30 days(+6/-2&#xD;
      days, if visit schedule is fall on weekend), beginning four days before surgery, the entire&#xD;
      period as an in-patient (four to five days), and 20-days post-discharge.&#xD;
&#xD;
      The changes in multivariate physiological biomarkers will be used to generate a Pain Index,&#xD;
      and the Pain Index will be assessed against patient reported Numerical Rating Scale (NRS)&#xD;
      pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2019</start_date>
  <completion_date type="Actual">August 17, 2020</completion_date>
  <primary_completion_date type="Actual">August 17, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Correlation (using binary pain classification)</measure>
    <time_frame>30 days</time_frame>
    <description>Agreement between patient-reported NRS pain (classified into None-Mild and Moderate-Severe) and Pain Index, measured using Kappa statistic.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Correlation in Opioid Medication Subgroup</measure>
    <time_frame>30 days</time_frame>
    <description>Agreement between patient-reported NRS pain and Pain Index in patients using opioid medication for post-surgical pain relief, measured using Kappa statistic.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Correlation (3 pain categories)</measure>
    <time_frame>30 days</time_frame>
    <description>Agreement between patient-reported NRS pain (classified into None-Mild, Moderate and Severe) and Pain Index, measured using Kappa statistic.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">55</enrollment>
  <condition>Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Monitoring arm</arm_group_label>
    <description>Monitoring subjects undergoing total knee replacement surgery using the wearable biosensor to continuously monitor physiology biomarkers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous physiology monitoring in ambulatory setting pre and post surgery</intervention_name>
    <description>This study will recruit 55 patients aged 21 to 80 years who will be undergoing total knee replacement surgery. All study participants undergoing total knee replacement surgery will be monitored using the wearable biosensor to continuously monitor physiology biomarkers. Participants will be followed for an estimated total of 39 days, beginning four days before surgery, the entire period during in-patient recovery (four to five days), and 30-days post-discharge at-home.</description>
    <arm_group_label>Monitoring arm</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        55 study participants, aged between 21 to 80 years, regardless of gender, who is undergoing&#xD;
        total knee replacement surgery will be enrolled for the study upon receiving informed&#xD;
        consent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 21 to 80 years&#xD;
&#xD;
          -  Patients undergoing knee replacement surgery ( Total Knee Replacement (TKR),&#xD;
             Unicompartmental Knee arthroplasty (UKA), Bilateral knee replacemenent,&#xD;
             Patello-Femoral-Joint (PFJ) Knee replacement), Anterior Cruciate Ligament(ACL), Knee&#xD;
             Arthroscopy and Foot &amp; Ankle related surgery such as bunions, hammer toes, metatarsal,&#xD;
             ankle fusion, triple fusion, ankle replacement, achilles tendon &amp; tibialis posterior&#xD;
             disorder&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  Able to commit to using the app and inputting data as needed during the study duration&#xD;
&#xD;
          -  Has access to an iPhone (minimum requirement iPhone 5S)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous myocardial infarction (MI)&#xD;
&#xD;
          -  Known coronary artery disease - prior coronary revascularization&#xD;
&#xD;
          -  Previous stroke. Stroke is defined as new focal neurological deficit perspective more&#xD;
             than 24 hours.&#xD;
&#xD;
          -  More than ongoing use of 2 or more anti-hypertensive agents.&#xD;
&#xD;
          -  Expected life expectancy less than 1 year.&#xD;
&#xD;
          -  Asthma or chronic lung disease requiring long-term medications or oxygen&#xD;
&#xD;
          -  Mental illness that in the clinical judgment of the investigator will affect&#xD;
             participation in the study e.g. dementia&#xD;
&#xD;
          -  Inability to comply with the study protocol&#xD;
&#xD;
          -  Any other acute or chronic medical or physical condition deemed by the investigator to&#xD;
             affect study outcomes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Singapore General Hospital (SGH)</name>
      <address>
        <city>Singapore</city>
        <zip>169865</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Knee Replacement</keyword>
  <keyword>Wearable</keyword>
  <keyword>Pain Score Quantification</keyword>
  <!-- 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/NCT03789630
org study id: CT002
nct id: NCT03789630
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of this observational study is to assess whether patient reported pain levels
      correlate with a Pain Index derived from deviations in multivariate physiology biomarkers
      captured in real-world setting. This study will be conducted using a clinical-grade wearable
      sensor to continuously monitor patient's physiology (pain related biomarkers) and allow
      subject participant to actively report their pain score, symptoms and quality of life using a
      mobile-based application.
The designated clinical-grade wearable sensor used in this study is the Biovotion Everion MD
      (See Annex for product description), a Bluetooth-compatible device that will automatically
      sync with the mobile application used in this study.

      This study will recruit 55 patients aged 21 to 80 years who will be undergoing knee
      replacement, Anterior Cruciate Ligament(ACL), Knee Arthroscopy and Foot & Ankle related
      surgery. All study participants will be followed for an estimated total of 30 days(+6/-2
      days, if visit schedule is fall on weekend), beginning four days before surgery, the entire
      period as an in-patient (four to five days), and 20-days post-discharge.

      The changes in multivariate physiological biomarkers will be used to generate a Pain Index,
      and the Pain Index will be assessed against patient reported Numerical Rating Scale (NRS)
      pain.
observational model: Cohort
time perspective: Prospective
measure: Pain Correlation (using binary pain classification)
time frame: 30 days
description: Agreement between patient-reported NRS pain (classified into None-Mild and Moderate-Severe) and Pain Index, measured using Kappa statistic.
measure: Pain Correlation in Opioid Medication Subgroup
time frame: 30 days
description: Agreement between patient-reported NRS pain and Pain Index in patients using opioid medication for post-surgical pain relief, measured using Kappa statistic.
measure: Pain Correlation (3 pain categories)
time frame: 30 days
description: Agreement between patient-reported NRS pain (classified into None-Mild, Moderate and Severe) and Pain Index, measured using Kappa statistic.
arm group label: Monitoring arm
description: Monitoring subjects undergoing total knee replacement surgery using the wearable biosensor to continuously monitor physiology biomarkers.
intervention type: Device
intervention name: Continuous physiology monitoring in ambulatory setting pre and post surgery
description: This study will recruit 55 patients aged 21 to 80 years who will be undergoing total knee replacement surgery. All study participants undergoing total knee replacement surgery will be monitored using the wearable biosensor to continuously monitor physiology biomarkers. Participants will be followed for an estimated total of 39 days, beginning four days before surgery, the entire period during in-patient recovery (four to five days), and 30-days post-discharge at-home.
arm group label: Monitoring arm
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Singapore
responsible party type: Sponsor