<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/NCT04497129</url>
  </required_header>
  <id_info>
    <org_study_id>ROMTECH-0002</org_study_id>
    <nct_id>NCT04497129</nct_id>
  </id_info>
  <brief_title>ROMTECH PortableConnect Rehabilitation Device Usage Post Unilateral Total Knee Arthroplasty (TKA)</brief_title>
  <official_title>Randomized Multicenter Comparative Trial Evaluating the Impact of the ROMTECH PortableConnect Rehabilitation Device on Time to Recovery and Comprehensive Rehabilitation Outcomes Post Unilateral Total Knee Arthroplasty (TKA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ROM Technologies, INC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ROM Technologies, INC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      ROMTech is focused on transforming the healthcare market by delivering lower extremity&#xD;
      rehabilitation systems that are effective, efficient for patient use, cost-effective, and&#xD;
      provide better patient outcomes while simultaneously decreasing rehabilitation and overall&#xD;
      recovery times.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patented technology of the ROMTech PortableConnect can improve the rehabilitation&#xD;
      protocol for lower extremities in shorter time periods. The focus of this study is to compare&#xD;
      the effectiveness of the ROMTech PortableConncect device only rehabilitation program&#xD;
      following total knee arthroplasty to an active comparator group of continuous passive motion&#xD;
      with a standard of care combination HHPT and OPPT rehabilitation program. The technology used&#xD;
      to develop the ROMTech PortableConnect device has been reported in a pilot study to tend to&#xD;
      be highly effective in decreasing the recovery time of patients post TKA, as discussed in the&#xD;
      findings from the pilot study with the ROMTech Pro Cycle. The expedited recovery resulting&#xD;
      from use of the ROMTech rehabilitation technology is noted to be contributed to the ability&#xD;
      of the ROMTech technology to achieve a more rapid range of motion in this patient population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>Screening</time_frame>
    <description>Knee Flexion and Extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>Baseline</time_frame>
    <description>Knee Flexion and Extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>Week 1</time_frame>
    <description>Knee Flexion and Extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>Week 2</time_frame>
    <description>Knee Flexion and Extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>Week 3</time_frame>
    <description>Knee Flexion and Extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>Week 4</time_frame>
    <description>Knee Flexion and Extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>Week 5</time_frame>
    <description>Knee Flexion and Extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>Week 6</time_frame>
    <description>Knee Flexion and Extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>Week 7 (End of Treatment)</time_frame>
    <description>Knee Flexion and Extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>Week 9 (Follow-up)</time_frame>
    <description>Knee Flexion and Extension</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Timed up and go (TUG) performance</measure>
    <time_frame>Screening</time_frame>
    <description>Assessment performed by study team</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed up and go (TUG) performance</measure>
    <time_frame>Week 4</time_frame>
    <description>Assessment performed by study team</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed up and go (TUG) performance</measure>
    <time_frame>Week 7 (End of Treatment)</time_frame>
    <description>Assessment performed by study team</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed up and go (TUG) performance</measure>
    <time_frame>Week 9 (Follow-UP)</time_frame>
    <description>Assessment performed by study team</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee pain as measured on a 10-point pain scale</measure>
    <time_frame>Screening</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee pain as measured on a 10-point pain scale</measure>
    <time_frame>Baseline</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee pain as measured on a 10-point pain scale</measure>
    <time_frame>Week 1</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee pain as measured on a 10-point pain scale</measure>
    <time_frame>Week 2</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee pain as measured on a 10-point pain scale</measure>
    <time_frame>Week 3</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee pain as measured on a 10-point pain scale</measure>
    <time_frame>Week 4</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee pain as measured on a 10-point pain scale</measure>
    <time_frame>Week 5</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee pain as measured on a 10-point pain scale</measure>
    <time_frame>Week 6</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee pain as measured on a 10-point pain scale</measure>
    <time_frame>Week 7 (End of Treatment)</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee pain as measured on a 10-point pain scale</measure>
    <time_frame>Week 9 (Follow-up)</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee swelling</measure>
    <time_frame>Screening</time_frame>
    <description>measured using a tape measure to obtain the circumference of the knee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee swelling</measure>
    <time_frame>Baseline</time_frame>
    <description>measured using a tape measure to obtain the circumference of the knee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee swelling</measure>
    <time_frame>Week 1</time_frame>
    <description>measured using a tape measure to obtain the circumference of the knee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee swelling</measure>
    <time_frame>Week 2</time_frame>
    <description>measured using a tape measure to obtain the circumference of the knee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee swelling</measure>
    <time_frame>Week 3</time_frame>
    <description>measured using a tape measure to obtain the circumference of the knee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee swelling</measure>
    <time_frame>Week 4</time_frame>
    <description>measured using a tape measure to obtain the circumference of the knee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee swelling</measure>
    <time_frame>Week 5</time_frame>
    <description>measured using a tape measure to obtain the circumference of the knee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee swelling</measure>
    <time_frame>Week 6</time_frame>
    <description>measured using a tape measure to obtain the circumference of the knee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee swelling</measure>
    <time_frame>Week 7 (End of Treatment)</time_frame>
    <description>measured using a tape measure to obtain the circumference of the knee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee swelling</measure>
    <time_frame>Week 9 (Follow-up)</time_frame>
    <description>measured using a tape measure to obtain the circumference of the knee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)</measure>
    <time_frame>Screening</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)</measure>
    <time_frame>Week 1</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)</measure>
    <time_frame>Week 2</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)</measure>
    <time_frame>Week 3</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)</measure>
    <time_frame>Week 4</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)</measure>
    <time_frame>Week 5</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)</measure>
    <time_frame>Week 6</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)</measure>
    <time_frame>Week 7 (End of Treatment)</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)</measure>
    <time_frame>Week 9 (Follow-up)</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambulation using the 6 Minute Walk Test (6MWT)</measure>
    <time_frame>Screening, Baseline</time_frame>
    <description>Assessment performed by study team</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambulation using the 6 Minute Walk Test (6MWT)</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessment performed by study team</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambulation using the 6 Minute Walk Test (6MWT)</measure>
    <time_frame>Week 4</time_frame>
    <description>Assessment performed by study team</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambulation using the 6 Minute Walk Test (6MWT)</measure>
    <time_frame>Week 7 (End of Treatment)</time_frame>
    <description>Assessment performed by study team</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambulation using the 6 Minute Walk Test (6MWT)</measure>
    <time_frame>Week 9 (Follow-up)</time_frame>
    <description>Assessment performed by study team</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to ambulate without assistive devices and/or assistance</measure>
    <time_frame>Screening</time_frame>
    <description>Obtained via single response question</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to ambulate without assistive devices and/or assistance</measure>
    <time_frame>Baseline</time_frame>
    <description>Obtained via single response question</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to ambulate without assistive devices and/or assistance</measure>
    <time_frame>Week 1</time_frame>
    <description>Obtained via single response question</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to ambulate without assistive devices and/or assistance</measure>
    <time_frame>Week 2</time_frame>
    <description>Obtained via single response question</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to ambulate without assistive devices and/or assistance</measure>
    <time_frame>Week 3</time_frame>
    <description>Obtained via single response question</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to ambulate without assistive devices and/or assistance</measure>
    <time_frame>Week 4</time_frame>
    <description>Obtained via single response question</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to ambulate without assistive devices and/or assistance</measure>
    <time_frame>Week 5</time_frame>
    <description>Obtained via single response question</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to ambulate without assistive devices and/or assistance</measure>
    <time_frame>Week 6</time_frame>
    <description>Obtained via single response question</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to ambulate without assistive devices and/or assistance</measure>
    <time_frame>Week 7 (End of Treatment)</time_frame>
    <description>Obtained via single response question</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to ambulate without assistive devices and/or assistance</measure>
    <time_frame>Week 9 (Follow-up)</time_frame>
    <description>Obtained via single response question</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to return to activities of daily living</measure>
    <time_frame>Screening</time_frame>
    <description>Obtained via patient interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to return to activities of daily living</measure>
    <time_frame>Baseline</time_frame>
    <description>Obtained via patient interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to return to activities of daily living</measure>
    <time_frame>Week 1</time_frame>
    <description>Obtained via patient interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to return to activities of daily living</measure>
    <time_frame>Week 2</time_frame>
    <description>Obtained via patient interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to return to activities of daily living</measure>
    <time_frame>Week 3</time_frame>
    <description>Obtained via patient interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to return to activities of daily living</measure>
    <time_frame>Week 4</time_frame>
    <description>Obtained via patient interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to return to activities of daily living</measure>
    <time_frame>Week 5</time_frame>
    <description>Obtained via patient interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to return to activities of daily living</measure>
    <time_frame>Week 6</time_frame>
    <description>Obtained via patient interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to return to activities of daily living</measure>
    <time_frame>Week 7 (End of Treatment)</time_frame>
    <description>Obtained via patient interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to return to activities of daily living</measure>
    <time_frame>Week 9 (Follow-up)</time_frame>
    <description>Obtained via patient interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid usage</measure>
    <time_frame>Screening</time_frame>
    <description>Compared to baseline opioid use by concomitant medication tracking at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid usage</measure>
    <time_frame>Baseline</time_frame>
    <description>Compared to baseline opioid use by concomitant medication tracking at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid usage</measure>
    <time_frame>Week 1</time_frame>
    <description>Compared to baseline opioid use by concomitant medication tracking at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid usage</measure>
    <time_frame>Week 2</time_frame>
    <description>Compared to baseline opioid use by concomitant medication tracking at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid usage</measure>
    <time_frame>Week 3</time_frame>
    <description>Compared to baseline opioid use by concomitant medication tracking at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid usage</measure>
    <time_frame>Week 4</time_frame>
    <description>Compared to baseline opioid use by concomitant medication tracking at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid usage</measure>
    <time_frame>Week 5</time_frame>
    <description>Compared to baseline opioid use by concomitant medication tracking at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid usage</measure>
    <time_frame>Week 6</time_frame>
    <description>Compared to baseline opioid use by concomitant medication tracking at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid usage</measure>
    <time_frame>Week 7 (End of Treatment)</time_frame>
    <description>Compared to baseline opioid use by concomitant medication tracking at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid usage</measure>
    <time_frame>Week 9 (Follow-up)</time_frame>
    <description>Compared to baseline opioid use by concomitant medication tracking at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Screening</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Week 1</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Week 2</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Week 3</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Week 4</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Week 5</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Week 6</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Week 7 (End of Treatment)</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Week 9 (Follow-up)</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score (OKS)</measure>
    <time_frame>Screening</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score (OKS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score (OKS)</measure>
    <time_frame>Week 1</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score (OKS)</measure>
    <time_frame>Week 2</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score (OKS)</measure>
    <time_frame>Week 3</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score (OKS)</measure>
    <time_frame>Week 4</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score (OKS)</measure>
    <time_frame>Week 5</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score (OKS)</measure>
    <time_frame>Week 6</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score (OKS)</measure>
    <time_frame>Week 7 (End of Treatment)</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score (OKS)</measure>
    <time_frame>Week 9 (Follow-up)</time_frame>
    <description>Patient reported outcome</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient Satisfaction Questionnaire via 4-point scale</measure>
    <time_frame>Week 1</time_frame>
    <description>Patient Reported Outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Satisfaction Questionnaire via 4-point scale</measure>
    <time_frame>Week 2</time_frame>
    <description>Patient Reported Outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Satisfaction Questionnaire via 4-point scale</measure>
    <time_frame>Week 3</time_frame>
    <description>Patient Reported Outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Satisfaction Questionnaire via 4-point scale</measure>
    <time_frame>Week 4</time_frame>
    <description>Patient Reported Outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Satisfaction Questionnaire via 4-point scale</measure>
    <time_frame>Week 5</time_frame>
    <description>Patient Reported Outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Satisfaction Questionnaire via 4-point scale</measure>
    <time_frame>Week 6</time_frame>
    <description>Patient Reported Outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Satisfaction Questionnaire via 4-point scale</measure>
    <time_frame>Week 7 (End of Treatment)</time_frame>
    <description>Patient Reported Outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Satisfaction Questionnaire via 4-point scale</measure>
    <time_frame>Week 9 (Follow-up)</time_frame>
    <description>Patient Reported Outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Manipulation under anesthesia</measure>
    <time_frame>Baseline</time_frame>
    <description>By patient questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Manipulation under anesthesia</measure>
    <time_frame>Week 1</time_frame>
    <description>By patient questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Manipulation under anesthesia</measure>
    <time_frame>Week 2</time_frame>
    <description>By patient questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Manipulation under anesthesia</measure>
    <time_frame>Week 3</time_frame>
    <description>By patient questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Manipulation under anesthesia</measure>
    <time_frame>Week 4</time_frame>
    <description>By patient questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Manipulation under anesthesia</measure>
    <time_frame>Week 5</time_frame>
    <description>By patient questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Manipulation under anesthesia</measure>
    <time_frame>Week 6</time_frame>
    <description>By patient questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Manipulation under anesthesia</measure>
    <time_frame>Week 7 (End of Treatment)</time_frame>
    <description>By patient questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Manipulation under anesthesia</measure>
    <time_frame>Week 9 (Follow-up)</time_frame>
    <description>By patient questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Total number of physical therapy sessions completed</measure>
    <time_frame>Baseline</time_frame>
    <description>A sum of all physical therapy sessions outpatient and home health visits</description>
  </other_outcome>
  <other_outcome>
    <measure>Total number of physical therapy sessions completed</measure>
    <time_frame>Week 1</time_frame>
    <description>A sum of all physical therapy sessions outpatient and home health visits</description>
  </other_outcome>
  <other_outcome>
    <measure>Total number of physical therapy sessions completed</measure>
    <time_frame>Week 2</time_frame>
    <description>A sum of all physical therapy sessions outpatient and home health visits</description>
  </other_outcome>
  <other_outcome>
    <measure>Total number of physical therapy sessions completed</measure>
    <time_frame>Week 3</time_frame>
    <description>A sum of all physical therapy sessions outpatient and home health visits</description>
  </other_outcome>
  <other_outcome>
    <measure>Total number of physical therapy sessions completed</measure>
    <time_frame>Week 4</time_frame>
    <description>A sum of all physical therapy sessions outpatient and home health visits</description>
  </other_outcome>
  <other_outcome>
    <measure>Total number of physical therapy sessions completed</measure>
    <time_frame>Week 5</time_frame>
    <description>A sum of all physical therapy sessions outpatient and home health visits</description>
  </other_outcome>
  <other_outcome>
    <measure>Total number of physical therapy sessions completed</measure>
    <time_frame>Week 6</time_frame>
    <description>A sum of all physical therapy sessions outpatient and home health visits</description>
  </other_outcome>
  <other_outcome>
    <measure>Total number of physical therapy sessions completed</measure>
    <time_frame>Week 7 (End of Treatment)</time_frame>
    <description>A sum of all physical therapy sessions outpatient and home health visits</description>
  </other_outcome>
  <other_outcome>
    <measure>Total number of physical therapy sessions completed</measure>
    <time_frame>Week 9 (Follow-up)</time_frame>
    <description>A sum of all physical therapy sessions outpatient and home health visits</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Knee Arthritis</condition>
  <condition>Knee Pain Chronic</condition>
  <condition>Knee Disease</condition>
  <condition>Joint Pain</condition>
  <condition>Osteo Arthritis Knee</condition>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>ROMTech PortableConnect</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rehabilitation Using the ROMTech PortableConnect Device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Rehabilitation &amp; Continuous Passive Motion Device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Combination of OPPT and HHPT in conjunction with CPM device usage</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ROMTech PortableConnect</intervention_name>
    <description>ROMTech PortableConnect (ROMTechPC) therapy will be completed four to five times per day for 6 minutes duration for 6 weeks. The intervention will be administered using the portable rehabilitation unit.</description>
    <arm_group_label>ROMTech PortableConnect</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Traditional Rehabilitation and CPM Device</intervention_name>
    <description>Continuous passive motion (CPM) with standard of care HHPT and OPPT rehabilitation program (CPM with SOC). Therapy with the CPM will be completed daily from day 0 through week 3 for a total of 6 to 8 hours per day. The HHPT and OPPT rehabilitation program will be a 6-week program based on SOC goals.</description>
    <arm_group_label>Traditional Rehabilitation &amp; Continuous Passive Motion Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female ≥18 years of age at screening visit.&#xD;
&#xD;
          -  Documentation of a definitive diagnosis of osteoarthritis of the knee requiring total&#xD;
             knee arthroplasty.&#xD;
&#xD;
          -  Scheduled or willing to schedule TKA procedure within the timelines consistent with&#xD;
             the study enrollment period. This includes up to a 28-day screening window prior to&#xD;
             the scheduled surgery.&#xD;
&#xD;
          -  Willing to consent to outpatient, home-based physical therapy, CPM, or the ROMTech&#xD;
             protocol&#xD;
&#xD;
          -  Able to provide written informed consent.&#xD;
&#xD;
          -  Willing and able to participate in and complete all study assessments, questionnaires,&#xD;
             and procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent.&#xD;
&#xD;
          -  Inability to understand and complete study related assessments and procedures.&#xD;
&#xD;
          -  Other scheduled surgical knee procedures in addition to the TKA.&#xD;
&#xD;
          -  Presence of a condition or abnormality that in the opinion of the investigator would&#xD;
             compromise the safety of the subject or the quality of the data.&#xD;
&#xD;
          -  History of musculoskeletal or neurological disorders that limit physical function&#xD;
             including but not limited to severe spine OA, contralateral leg issues limiting&#xD;
             mobility, and other disorders as identified by the investigator&#xD;
&#xD;
          -  Planned additional knee joint surgery within 3 months of the primary scheduled TKA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ryan Nunley, MD</last_name>
    <role>Study Director</role>
    <affiliation>ROM Tech</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Katelyn Rokenbach</last_name>
    <phone>203-663-3202</phone>
    <email>katelyn.rokenbach@romtech.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Janel Shelton</last_name>
    <phone>203-663-3202</phone>
    <email>janel.shelton@romtech.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>OrthoArizona</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dameon Hahn</last_name>
      <email>dameon.hahn@romtech.com</email>
    </contact>
    <contact_backup>
      <last_name>David Scheck</last_name>
      <email>david.scheck@romtech.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Aventura Orthopaedics</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kourtney Trainor</last_name>
      <email>kourtney.trainor@romtech.com</email>
    </contact>
    <contact_backup>
      <last_name>David Scheck, DPT</last_name>
      <email>david.scheck@romtech.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Orthopaedic Associates of West Florida</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michelle MacMillian</last_name>
      <email>michelle.macmillan@romtech.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institute of Orthopedic Research and Innovation</name>
      <address>
        <city>Coeur d'Alene</city>
        <state>Idaho</state>
        <zip>83814</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Research</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>OrthoSouth</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shane Tripod</last_name>
      <email>shane.tripod@romtech.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>May 22, 2021</last_update_submitted>
  <last_update_submitted_qc>May 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ROMTech</keyword>
  <keyword>PortableConnect</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>Remote monitoring</keyword>
  <keyword>Home Health Physical Therapy</keyword>
  <keyword>Outpatient Physical Therapy</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Physical Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Arthralgia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04497129
org study id: ROMTECH-0002
nct id: NCT04497129
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
ROMTech is focused on transforming the healthcare market by delivering lower extremity
      rehabilitation systems that are effective, efficient for patient use, cost-effective, and
      provide better patient outcomes while simultaneously decreasing rehabilitation and overall
      recovery times.
The patented technology of the ROMTech PortableConnect can improve the rehabilitation
      protocol for lower extremities in shorter time periods. The focus of this study is to compare
      the effectiveness of the ROMTech PortableConncect device only rehabilitation program
      following total knee arthroplasty to an active comparator group of continuous passive motion
      with a standard of care combination HHPT and OPPT rehabilitation program. The technology used
      to develop the ROMTech PortableConnect device has been reported in a pilot study to tend to
      be highly effective in decreasing the recovery time of patients post TKA, as discussed in the
      findings from the pilot study with the ROMTech Pro Cycle. The expedited recovery resulting
      from use of the ROMTech rehabilitation technology is noted to be contributed to the ability
      of the ROMTech technology to achieve a more rapid range of motion in this patient population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Range of Motion
time frame: Screening
description: Knee Flexion and Extension
measure: Range of Motion
time frame: Baseline
description: Knee Flexion and Extension
measure: Range of Motion
time frame: Week 1
description: Knee Flexion and Extension
measure: Range of Motion
time frame: Week 2
description: Knee Flexion and Extension
measure: Range of Motion
time frame: Week 3
description: Knee Flexion and Extension
measure: Range of Motion
time frame: Week 4
description: Knee Flexion and Extension
measure: Range of Motion
time frame: Week 5
description: Knee Flexion and Extension
measure: Range of Motion
time frame: Week 6
description: Knee Flexion and Extension
measure: Range of Motion
time frame: Week 7 (End of Treatment)
description: Knee Flexion and Extension
measure: Range of Motion
time frame: Week 9 (Follow-up)
description: Knee Flexion and Extension
measure: Timed up and go (TUG) performance
time frame: Screening
description: Assessment performed by study team
measure: Timed up and go (TUG) performance
time frame: Week 4
description: Assessment performed by study team
measure: Timed up and go (TUG) performance
time frame: Week 7 (End of Treatment)
description: Assessment performed by study team
measure: Timed up and go (TUG) performance
time frame: Week 9 (Follow-UP)
description: Assessment performed by study team
measure: Knee pain as measured on a 10-point pain scale
time frame: Screening
description: Patient reported outcome
measure: Knee pain as measured on a 10-point pain scale
time frame: Baseline
description: Patient reported outcome
measure: Knee pain as measured on a 10-point pain scale
time frame: Week 1
description: Patient reported outcome
measure: Knee pain as measured on a 10-point pain scale
time frame: Week 2
description: Patient reported outcome
measure: Knee pain as measured on a 10-point pain scale
time frame: Week 3
description: Patient reported outcome
measure: Knee pain as measured on a 10-point pain scale
time frame: Week 4
description: Patient reported outcome
measure: Knee pain as measured on a 10-point pain scale
time frame: Week 5
description: Patient reported outcome
measure: Knee pain as measured on a 10-point pain scale
time frame: Week 6
description: Patient reported outcome
measure: Knee pain as measured on a 10-point pain scale
time frame: Week 7 (End of Treatment)
description: Patient reported outcome
measure: Knee pain as measured on a 10-point pain scale
time frame: Week 9 (Follow-up)
description: Patient reported outcome
measure: Knee swelling
time frame: Screening
description: measured using a tape measure to obtain the circumference of the knee
measure: Knee swelling
time frame: Baseline
description: measured using a tape measure to obtain the circumference of the knee
measure: Knee swelling
time frame: Week 1
description: measured using a tape measure to obtain the circumference of the knee
measure: Knee swelling
time frame: Week 2
description: measured using a tape measure to obtain the circumference of the knee
measure: Knee swelling
time frame: Week 3
description: measured using a tape measure to obtain the circumference of the knee
measure: Knee swelling
time frame: Week 4
description: measured using a tape measure to obtain the circumference of the knee
measure: Knee swelling
time frame: Week 5
description: measured using a tape measure to obtain the circumference of the knee
measure: Knee swelling
time frame: Week 6
description: measured using a tape measure to obtain the circumference of the knee
measure: Knee swelling
time frame: Week 7 (End of Treatment)
description: measured using a tape measure to obtain the circumference of the knee
measure: Knee swelling
time frame: Week 9 (Follow-up)
description: measured using a tape measure to obtain the circumference of the knee
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
time frame: Screening
description: Patient reported outcome
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
time frame: Baseline
description: Patient reported outcome
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
time frame: Week 1
description: Patient reported outcome
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
time frame: Week 2
description: Patient reported outcome
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
time frame: Week 3
description: Patient reported outcome
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
time frame: Week 4
description: Patient reported outcome
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
time frame: Week 5
description: Patient reported outcome
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
time frame: Week 6
description: Patient reported outcome
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
time frame: Week 7 (End of Treatment)
description: Patient reported outcome
measure: Lower extremity functionality as measured using the Lower Extremity Functionality Scale (LEFS)
time frame: Week 9 (Follow-up)
description: Patient reported outcome
measure: Ambulation using the 6 Minute Walk Test (6MWT)
time frame: Screening, Baseline
description: Assessment performed by study team
measure: Ambulation using the 6 Minute Walk Test (6MWT)
time frame: Baseline
description: Assessment performed by study team
measure: Ambulation using the 6 Minute Walk Test (6MWT)
time frame: Week 4
description: Assessment performed by study team
measure: Ambulation using the 6 Minute Walk Test (6MWT)
time frame: Week 7 (End of Treatment)
description: Assessment performed by study team
measure: Ambulation using the 6 Minute Walk Test (6MWT)
time frame: Week 9 (Follow-up)
description: Assessment performed by study team
measure: Days to ambulate without assistive devices and/or assistance
time frame: Screening
description: Obtained via single response question
measure: Days to ambulate without assistive devices and/or assistance
time frame: Baseline
description: Obtained via single response question
measure: Days to ambulate without assistive devices and/or assistance
time frame: Week 1
description: Obtained via single response question
measure: Days to ambulate without assistive devices and/or assistance
time frame: Week 2
description: Obtained via single response question
measure: Days to ambulate without assistive devices and/or assistance
time frame: Week 3
description: Obtained via single response question
measure: Days to ambulate without assistive devices and/or assistance
time frame: Week 4
description: Obtained via single response question
measure: Days to ambulate without assistive devices and/or assistance
time frame: Week 5
description: Obtained via single response question
measure: Days to ambulate without assistive devices and/or assistance
time frame: Week 6
description: Obtained via single response question
measure: Days to ambulate without assistive devices and/or assistance
time frame: Week 7 (End of Treatment)
description: Obtained via single response question
measure: Days to ambulate without assistive devices and/or assistance
time frame: Week 9 (Follow-up)
description: Obtained via single response question
measure: Days to return to activities of daily living
time frame: Screening
description: Obtained via patient interview
measure: Days to return to activities of daily living
time frame: Baseline
description: Obtained via patient interview
measure: Days to return to activities of daily living
time frame: Week 1
description: Obtained via patient interview
measure: Days to return to activities of daily living
time frame: Week 2
description: Obtained via patient interview
measure: Days to return to activities of daily living
time frame: Week 3
description: Obtained via patient interview
measure: Days to return to activities of daily living
time frame: Week 4
description: Obtained via patient interview
measure: Days to return to activities of daily living
time frame: Week 5
description: Obtained via patient interview
measure: Days to return to activities of daily living
time frame: Week 6
description: Obtained via patient interview
measure: Days to return to activities of daily living
time frame: Week 7 (End of Treatment)
description: Obtained via patient interview
measure: Days to return to activities of daily living
time frame: Week 9 (Follow-up)
description: Obtained via patient interview
measure: Opioid usage
time frame: Screening
description: Compared to baseline opioid use by concomitant medication tracking at each visit
measure: Opioid usage
time frame: Baseline
description: Compared to baseline opioid use by concomitant medication tracking at each visit
measure: Opioid usage
time frame: Week 1
description: Compared to baseline opioid use by concomitant medication tracking at each visit
measure: Opioid usage
time frame: Week 2
description: Compared to baseline opioid use by concomitant medication tracking at each visit
measure: Opioid usage
time frame: Week 3
description: Compared to baseline opioid use by concomitant medication tracking at each visit
measure: Opioid usage
time frame: Week 4
description: Compared to baseline opioid use by concomitant medication tracking at each visit
measure: Opioid usage
time frame: Week 5
description: Compared to baseline opioid use by concomitant medication tracking at each visit
measure: Opioid usage
time frame: Week 6
description: Compared to baseline opioid use by concomitant medication tracking at each visit
measure: Opioid usage
time frame: Week 7 (End of Treatment)
description: Compared to baseline opioid use by concomitant medication tracking at each visit
measure: Opioid usage
time frame: Week 9 (Follow-up)
description: Compared to baseline opioid use by concomitant medication tracking at each visit
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: Screening
description: Patient reported outcome
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: Baseline
description: Patient reported outcome
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: Week 1
description: Patient reported outcome
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: Week 2
description: Patient reported outcome
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: Week 3
description: Patient reported outcome
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: Week 4
description: Patient reported outcome
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: Week 5
description: Patient reported outcome
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: Week 6
description: Patient reported outcome
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: Week 7 (End of Treatment)
description: Patient reported outcome
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: Week 9 (Follow-up)
description: Patient reported outcome
measure: Oxford Knee Score (OKS)
time frame: Screening
description: Patient reported outcome
measure: Oxford Knee Score (OKS)
time frame: Baseline
description: Patient reported outcome
measure: Oxford Knee Score (OKS)
time frame: Week 1
description: Patient reported outcome
measure: Oxford Knee Score (OKS)
time frame: Week 2
description: Patient reported outcome
measure: Oxford Knee Score (OKS)
time frame: Week 3
description: Patient reported outcome
measure: Oxford Knee Score (OKS)
time frame: Week 4
description: Patient reported outcome
measure: Oxford Knee Score (OKS)
time frame: Week 5
description: Patient reported outcome
measure: Oxford Knee Score (OKS)
time frame: Week 6
description: Patient reported outcome
measure: Oxford Knee Score (OKS)
time frame: Week 7 (End of Treatment)
description: Patient reported outcome
measure: Oxford Knee Score (OKS)
time frame: Week 9 (Follow-up)
description: Patient reported outcome
measure: Patient Satisfaction Questionnaire via 4-point scale
time frame: Week 1
description: Patient Reported Outcome
measure: Patient Satisfaction Questionnaire via 4-point scale
time frame: Week 2
description: Patient Reported Outcome
measure: Patient Satisfaction Questionnaire via 4-point scale
time frame: Week 3
description: Patient Reported Outcome
measure: Patient Satisfaction Questionnaire via 4-point scale
time frame: Week 4
description: Patient Reported Outcome
measure: Patient Satisfaction Questionnaire via 4-point scale
time frame: Week 5
description: Patient Reported Outcome
measure: Patient Satisfaction Questionnaire via 4-point scale
time frame: Week 6
description: Patient Reported Outcome
measure: Patient Satisfaction Questionnaire via 4-point scale
time frame: Week 7 (End of Treatment)
description: Patient Reported Outcome
measure: Patient Satisfaction Questionnaire via 4-point scale
time frame: Week 9 (Follow-up)
description: Patient Reported Outcome
measure: Manipulation under anesthesia
time frame: Baseline
description: By patient questionnaires
measure: Manipulation under anesthesia
time frame: Week 1
description: By patient questionnaires
measure: Manipulation under anesthesia
time frame: Week 2
description: By patient questionnaires
measure: Manipulation under anesthesia
time frame: Week 3
description: By patient questionnaires
measure: Manipulation under anesthesia
time frame: Week 4
description: By patient questionnaires
measure: Manipulation under anesthesia
time frame: Week 5
description: By patient questionnaires
measure: Manipulation under anesthesia
time frame: Week 6
description: By patient questionnaires
measure: Manipulation under anesthesia
time frame: Week 7 (End of Treatment)
description: By patient questionnaires
measure: Manipulation under anesthesia
time frame: Week 9 (Follow-up)
description: By patient questionnaires
measure: Total number of physical therapy sessions completed
time frame: Baseline
description: A sum of all physical therapy sessions outpatient and home health visits
measure: Total number of physical therapy sessions completed
time frame: Week 1
description: A sum of all physical therapy sessions outpatient and home health visits
measure: Total number of physical therapy sessions completed
time frame: Week 2
description: A sum of all physical therapy sessions outpatient and home health visits
measure: Total number of physical therapy sessions completed
time frame: Week 3
description: A sum of all physical therapy sessions outpatient and home health visits
measure: Total number of physical therapy sessions completed
time frame: Week 4
description: A sum of all physical therapy sessions outpatient and home health visits
measure: Total number of physical therapy sessions completed
time frame: Week 5
description: A sum of all physical therapy sessions outpatient and home health visits
measure: Total number of physical therapy sessions completed
time frame: Week 6
description: A sum of all physical therapy sessions outpatient and home health visits
measure: Total number of physical therapy sessions completed
time frame: Week 7 (End of Treatment)
description: A sum of all physical therapy sessions outpatient and home health visits
measure: Total number of physical therapy sessions completed
time frame: Week 9 (Follow-up)
description: A sum of all physical therapy sessions outpatient and home health visits
arm group label: ROMTech PortableConnect
arm group type: Experimental
description: Rehabilitation Using the ROMTech PortableConnect Device
arm group label: Traditional Rehabilitation & Continuous Passive Motion Device
arm group type: Active Comparator
description: Combination of OPPT and HHPT in conjunction with CPM device usage
intervention type: Device
intervention name: ROMTech PortableConnect
description: ROMTech PortableConnect (ROMTechPC) therapy will be completed four to five times per day for 6 minutes duration for 6 weeks. The intervention will be administered using the portable rehabilitation unit.
arm group label: ROMTech PortableConnect
intervention type: Device
intervention name: Traditional Rehabilitation and CPM Device
description: Continuous passive motion (CPM) with standard of care HHPT and OPPT rehabilitation program (CPM with SOC). Therapy with the CPM will be completed daily from day 0 through week 3 for a total of 6 to 8 hours per day. The HHPT and OPPT rehabilitation program will be a 6-week program based on SOC goals.
arm group label: Traditional Rehabilitation & Continuous Passive Motion Device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ryan Nunley, MD
role: Study Director
affiliation: ROM Tech
last name: Katelyn Rokenbach
phone: 203-663-3202
email: katelyn.rokenbach@romtech.com
last name: Janel Shelton
phone: 203-663-3202
email: janel.shelton@romtech.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Arthralgia
sharing ipd: No