<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/NCT03010605</url>
  </required_header>
  <id_info>
    <org_study_id>MED</org_study_id>
    <nct_id>NCT03010605</nct_id>
  </id_info>
  <brief_title>Measuring Every Day (MED) Study</brief_title>
  <acronym>MED</acronym>
  <official_title>Evaluation of the Measuring Every Day, Patient Incentive Device, as an Adjunct to Conventional Physical Therapy in the Acceleration of Flexion and Extension Capability in the Post-Operative Total Knee Arthroplasty Patient: A Prospective, Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Christ Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Christ Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Achieving adequate range of motion post Total Knee Arthroplasty(TKA) is an important goal for&#xD;
      return to optimum function. Traditionally, adequate range of motion has been achieved by a&#xD;
      combination of in-home and outpatient physical therapy. While physical therapy is successful,&#xD;
      it has the limitation of cost and availability. As copayments rise, patients may decide that&#xD;
      they cannot afford physical therapy, potentially compromising the outcome of their surgery&#xD;
      and successful return to function.&#xD;
&#xD;
      It is assumed that having an easy and fun to use, patient administered, incentive device that&#xD;
      provides accurate, quantitative flexion and extension measurements may accelerate patient&#xD;
      mobility and return to function after TKA. The Measuring Every Day (MED) portable goniometer&#xD;
      is commercially available and provides objective, consistent range of motion measurements&#xD;
      that are recorded and can be sent electronically to the clinician's office potentially&#xD;
      enabling earlier clinical or therapy adjustments or modifications to the prescribed therapy.&#xD;
&#xD;
      Goniometry is a commonly used tool to measure and document range of motion (ROM) during&#xD;
      clinical evaluation or a physical therapy examination. The technique is used to assess the&#xD;
      limitations of a patient's joint and provide information to the clinician that may help&#xD;
      determine further treatment.&#xD;
&#xD;
      The study is designed to compare range of motion measurement data for 6 weeks in patients&#xD;
      that have been randomized to receive either traditional physical therapy or the MED device.&#xD;
      The hypothesis is that patients who use the MED device achieve equivalent range of motion at&#xD;
      six weeks as compared to patients participating in traditional standard of care physical&#xD;
      therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The MED is a commercially available, digital range of motion monitoring device for patients&#xD;
      recovering from knee surgery. It displays both flexion and extension measurements and has the&#xD;
      option of connecting to an Apple or Android device to send data to the clinician's office for&#xD;
      review. Patients will have the capability to log on to the Measuring Every Day website with&#xD;
      an assigned username and a password which they create. This will allow them to view their&#xD;
      progress and send messages to the study team. Study team members will also have access to&#xD;
      this website for review and the ability to send and receive messages. All shared files will&#xD;
      reside on an Amazon HIPAA compliant platform.&#xD;
&#xD;
      This is a prospective, randomized, unblinded, single-center study to compare the MED device&#xD;
      to traditional physical therapy. The study will include 46 patients who have undergone&#xD;
      successful, unilateral total knee arthroplasty. All patients will receive a minimum of 2&#xD;
      physical therapy sessions prior to hospital discharge and also be instructed to flex and&#xD;
      extend their operative knee 10 times every 15 minutes while awake as per standard of care&#xD;
      after discharge. Patients will be randomized in a 1:1 ratio prior to discharge from the&#xD;
      hospital to either: 1) total knee arthroplasty standard of care rehab which consists of 2&#xD;
      weeks of in-home physical therapy consisting of 3 sessions per week starting within 48 hours&#xD;
      of hospital discharge, followed by 4 weeks of out-patient therapy three times weekly, or 2)&#xD;
      ten repetitions with the MED device three times daily at 8:00am, 2:00pm and 8:00pm. Patients&#xD;
      will transmit the 10th measurement of each time point to the clinician's office. Patients&#xD;
      randomized to the MED device will be trained on the use of the device prior to hospital&#xD;
      discharge.&#xD;
&#xD;
      All enrolled subjects will return to the surgeon's office at Week 2 to have their index knee&#xD;
      range of motion measured by the PI or study coordinators with the MED device. If subjects&#xD;
      enrolled in the MED device arm do not have a minimum flexion of 90 degrees and extension of&#xD;
      -25 degrees, they will be considered screen failures and return to traditional physical&#xD;
      therapy.&#xD;
&#xD;
      All enrolled subjects will return to the surgeon's office at Week 6 to have their index knee&#xD;
      range of motion measured by the PI or study coordinators using the MED device with the goal&#xD;
      of achieving a minimum flexion of 120 degrees and an extension of 0 degrees.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">August 2018</completion_date>
  <primary_completion_date type="Actual">June 14, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Index Knee Flexion of 90 degrees</measure>
    <time_frame>2 weeks post-op</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Index Knee Extension of -25 degrees</measure>
    <time_frame>2 weeks post-op</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Index Knee Flexion of 120 degrees</measure>
    <time_frame>6 weeks post-op</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Index Knee Extension of 0 degrees</measure>
    <time_frame>6 weeks post-op</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Standard of care physical therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive 2 weeks of in-home physical therapy consisting of 3 sessions per week followed by 4 weeks of outpatient physical therapy three times weekly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MED Device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will perform 10 repetitions with the MED device 3 times daily at 8am, 2pm, and 8pm and will transmit the 10th measurement of each time point to the clinicians office.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Measuring Every Day Device</intervention_name>
    <arm_group_label>MED Device</arm_group_label>
    <other_name>MED Device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Therapy</intervention_name>
    <arm_group_label>Standard of care physical therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is able to provide written informed consent.&#xD;
&#xD;
          2. Age 18 - 64 years of age&#xD;
&#xD;
          3. Subject has undergone successful unilateral total knee arthroplasty for degenerative&#xD;
             joint disease&#xD;
&#xD;
          4. Subject has access to an Apple device with Bluetooth capability&#xD;
&#xD;
          5. Subject is able to demonstrate the capability of setting up and using an Apple&#xD;
             application for remote data collection and transmission&#xD;
&#xD;
          6. Subject is able to demonstrate capability of correctly using the MED device&#xD;
&#xD;
          7. Subject is able to comply with post-operative visits and evaluations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is scheduled for an index knee revision surgery&#xD;
&#xD;
          2. Subject has pre-operative flexion range of motion less than 110 degrees&#xD;
&#xD;
          3. Subject has a pre-operative flexion contracture greater than 15 degrees.&#xD;
&#xD;
          4. Subject has additional joint replacement surgery scheduled within the six week study&#xD;
             period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Christ Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>July 16, 2018</last_update_submitted>
  <last_update_submitted_qc>July 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Christ Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Michael Swank</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>physical therapy post total knee replacement</keyword>
  <keyword>range of motion</keyword>
  <keyword>goniometry</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 15, 2018</submitted>
    <returned>December 10, 2018</returned>
  </pending_results>
  <!-- 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/NCT03010605
org study id: MED
nct id: NCT03010605
lead sponsor: 
has dmc: No
Achieving adequate range of motion post Total Knee Arthroplasty(TKA) is an important goal for
      return to optimum function. Traditionally, adequate range of motion has been achieved by a
      combination of in-home and outpatient physical therapy. While physical therapy is successful,
      it has the limitation of cost and availability. As copayments rise, patients may decide that
      they cannot afford physical therapy, potentially compromising the outcome of their surgery
      and successful return to function.

      It is assumed that having an easy and fun to use, patient administered, incentive device that
      provides accurate, quantitative flexion and extension measurements may accelerate patient
      mobility and return to function after TKA. The Measuring Every Day (MED) portable goniometer
      is commercially available and provides objective, consistent range of motion measurements
      that are recorded and can be sent electronically to the clinician's office potentially
      enabling earlier clinical or therapy adjustments or modifications to the prescribed therapy.

      Goniometry is a commonly used tool to measure and document range of motion (ROM) during
      clinical evaluation or a physical therapy examination. The technique is used to assess the
      limitations of a patient's joint and provide information to the clinician that may help
      determine further treatment.

      The study is designed to compare range of motion measurement data for 6 weeks in patients
      that have been randomized to receive either traditional physical therapy or the MED device.
      The hypothesis is that patients who use the MED device achieve equivalent range of motion at
      six weeks as compared to patients participating in traditional standard of care physical
      therapy.
The MED is a commercially available, digital range of motion monitoring device for patients
      recovering from knee surgery. It displays both flexion and extension measurements and has the
      option of connecting to an Apple or Android device to send data to the clinician's office for
      review. Patients will have the capability to log on to the Measuring Every Day website with
      an assigned username and a password which they create. This will allow them to view their
      progress and send messages to the study team. Study team members will also have access to
      this website for review and the ability to send and receive messages. All shared files will
      reside on an Amazon HIPAA compliant platform.

      This is a prospective, randomized, unblinded, single-center study to compare the MED device
      to traditional physical therapy. The study will include 46 patients who have undergone
      successful, unilateral total knee arthroplasty. All patients will receive a minimum of 2
      physical therapy sessions prior to hospital discharge and also be instructed to flex and
      extend their operative knee 10 times every 15 minutes while awake as per standard of care
      after discharge. Patients will be randomized in a 1:1 ratio prior to discharge from the
      hospital to either: 1) total knee arthroplasty standard of care rehab which consists of 2
      weeks of in-home physical therapy consisting of 3 sessions per week starting within 48 hours
      of hospital discharge, followed by 4 weeks of out-patient therapy three times weekly, or 2)
      ten repetitions with the MED device three times daily at 8:00am, 2:00pm and 8:00pm. Patients
      will transmit the 10th measurement of each time point to the clinician's office. Patients
      randomized to the MED device will be trained on the use of the device prior to hospital
      discharge.

      All enrolled subjects will return to the surgeon's office at Week 2 to have their index knee
      range of motion measured by the PI or study coordinators with the MED device. If subjects
      enrolled in the MED device arm do not have a minimum flexion of 90 degrees and extension of
      -25 degrees, they will be considered screen failures and return to traditional physical
      therapy.

      All enrolled subjects will return to the surgeon's office at Week 6 to have their index knee
      range of motion measured by the PI or study coordinators using the MED device with the goal
      of achieving a minimum flexion of 120 degrees and an extension of 0 degrees.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Index Knee Flexion of 90 degrees
time frame: 2 weeks post-op
measure: Index Knee Extension of -25 degrees
time frame: 2 weeks post-op
measure: Index Knee Flexion of 120 degrees
time frame: 6 weeks post-op
measure: Index Knee Extension of 0 degrees
time frame: 6 weeks post-op
arm group label: Standard of care physical therapy
arm group type: Active Comparator
description: Patients will receive 2 weeks of in-home physical therapy consisting of 3 sessions per week followed by 4 weeks of outpatient physical therapy three times weekly.
arm group label: MED Device
arm group type: Active Comparator
description: Patients will perform 10 repetitions with the MED device 3 times daily at 8am, 2pm, and 8pm and will transmit the 10th measurement of each time point to the clinicians office.
intervention type: Device
intervention name: Measuring Every Day Device
arm group label: MED Device
other name: MED Device
intervention type: Other
intervention name: Physical Therapy
arm group label: Standard of care physical therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Christ Hospital
investigator full name: Dr. Michael Swank
investigator title: Principal Investigator
sharing ipd: Undecided
submitted: November 15, 2018
returned: December 10, 2018