<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/NCT04492462</url>
  </required_header>
  <id_info>
    <org_study_id>Pro20140001090</org_study_id>
    <nct_id>NCT04492462</nct_id>
  </id_info>
  <brief_title>The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery</brief_title>
  <official_title>The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</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>
      This study will look to determine two different types of physical therapy regimens in&#xD;
      patients who undergo anterior total hip replacement. We will compare the results of two&#xD;
      groups. The first group, the &quot;Formal Physical Therapy&quot; group, will undergo standard physical&#xD;
      therapy following their surgery. They will see a physical therapist in a physical therapy&#xD;
      office after their surgery. Here, the therapist will work with the patient to strengthen&#xD;
      muscles and improve their walking. The second group, the &quot;Self-directed Physical Therapy&quot;&#xD;
      group, will undergo physical therapy in the comfort of their own home using common household&#xD;
      items (chairs, steps, etc). These patients will be given a list of exercises and stretches to&#xD;
      perform on their own. It is our goal to prove that formal physical therapy is not needed&#xD;
      after anterior hip replacements.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 22, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change inHarris Hip Score (HHS)</measure>
    <time_frame>assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery</time_frame>
    <description>elf-administered health survey that assesses pain, function, absence of deformity, and range of motion of the hip through 10 questions. HHS measures dysfunction, so a higher score indicates a better, higher functional outcome. Less than 70 is poor result, 70-80 ia fair result, 80-90 is good result, 90-100 is excellent result</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in timed up and go test</measure>
    <time_frame>assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery</time_frame>
    <description>Patients will be assessed the amount of time it takes for them rise from a standard arm chair, walk 10 feet on the floor at normal pace, and then return and site down in same standard arm chair. Duration to complete task will be recorded in seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visual Analog Scale for Pain</measure>
    <time_frame>assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery</time_frame>
    <description>Patients will rate their pain on a scale form 0-10 at a given time point with 0 being no pain and 10 being unbearable pain. The higher the number, the more pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) form</measure>
    <time_frame>assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery</time_frame>
    <description>Self-administered health survey that assesses pain, stiffness, and function of arthritis of the hip or knee. WOMAC form assesses activities of daily living, functional mobility, gait, general health, pain, and quality of life. WOMAC questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). A total score of 0 to 96 is possible, with a lower score indicating less pain or disability.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Hip Arthritis</condition>
  <condition>Total Hip Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Formal Physical Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-directed Physical Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Formal Physical Therapy</intervention_name>
    <description>Patients will undergo standard physical therapy following their surgery with a physical therapist in an office</description>
    <arm_group_label>Formal Physical Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-directed Physical Therapy</intervention_name>
    <description>Patients will undergo self-directed physical therapy in the comfort of their own home by completing a list of exercises and stretches without the direct supervision of a physical therapist in a physical therapist office</description>
    <arm_group_label>Self-directed Physical Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged between 18 and 80 years of age&#xD;
&#xD;
          -  Patients undergoing primary anterior total hip arthroplasty for the diagnosis of&#xD;
             osteoarthritis&#xD;
&#xD;
          -  Patients with no previous invasive hip surgery (such as a previous hip replacement)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking persons will be excluded in our study.&#xD;
&#xD;
          -  Patients with a recent history (&lt;1 year) of heart attack, stroke, and lung clots.&#xD;
&#xD;
          -  Previous invasive surgery on the hip undergoing replacement&#xD;
&#xD;
          -  Patients with dementia, Parkinson's, or other neurological disorders&#xD;
&#xD;
          -  Non-ambulatory patients&#xD;
&#xD;
          -  Patients with impaired ability to consent, whether because of mental illness or&#xD;
             otherwise&#xD;
&#xD;
          -  Patients being discharged to a rehabilitation center&#xD;
&#xD;
          -  Patients that experience intra-operative complications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen T Kayiaros, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rutgers University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel C Mascarenhas, MD</last_name>
    <phone>732-235-7869</phone>
    <email>daniel.mascarenhas@rutgers.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Orthopaedic Associates</name>
      <address>
        <city>Somerset</city>
        <state>New Jersey</state>
        <zip>08873</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephen Kayiaros, MD</last_name>
      <phone>732-537-0909</phone>
    </contact>
    <investigator>
      <last_name>Stephen Kayiaros, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Robert Wood Johnson Somerset Hospital</name>
      <address>
        <city>Somerville</city>
        <state>New Jersey</state>
        <zip>08876</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel C Mascarenhas, MD</last_name>
      <phone>732-235-7869</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>September 14, 2021</last_update_submitted>
  <last_update_submitted_qc>September 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
    <investigator_full_name>Stephen Kayiaros MD</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Total Hip Arthroplasty</keyword>
  <keyword>Anterior Approach</keyword>
  <keyword>Physical Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT04492462
org study id: Pro20140001090
nct id: NCT04492462
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will look to determine two different types of physical therapy regimens in
      patients who undergo anterior total hip replacement. We will compare the results of two
      groups. The first group, the "Formal Physical Therapy" group, will undergo standard physical
      therapy following their surgery. They will see a physical therapist in a physical therapy
      office after their surgery. Here, the therapist will work with the patient to strengthen
      muscles and improve their walking. The second group, the "Self-directed Physical Therapy"
      group, will undergo physical therapy in the comfort of their own home using common household
      items (chairs, steps, etc). These patients will be given a list of exercises and stretches to
      perform on their own. It is our goal to prove that formal physical therapy is not needed
      after anterior hip replacements.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change inHarris Hip Score (HHS)
time frame: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
description: elf-administered health survey that assesses pain, function, absence of deformity, and range of motion of the hip through 10 questions. HHS measures dysfunction, so a higher score indicates a better, higher functional outcome. Less than 70 is poor result, 70-80 ia fair result, 80-90 is good result, 90-100 is excellent result
measure: Change in timed up and go test
time frame: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
description: Patients will be assessed the amount of time it takes for them rise from a standard arm chair, walk 10 feet on the floor at normal pace, and then return and site down in same standard arm chair. Duration to complete task will be recorded in seconds
measure: Change in Visual Analog Scale for Pain
time frame: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
description: Patients will rate their pain on a scale form 0-10 at a given time point with 0 being no pain and 10 being unbearable pain. The higher the number, the more pain
measure: Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) form
time frame: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
description: Self-administered health survey that assesses pain, stiffness, and function of arthritis of the hip or knee. WOMAC form assesses activities of daily living, functional mobility, gait, general health, pain, and quality of life. WOMAC questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). A total score of 0 to 96 is possible, with a lower score indicating less pain or disability.
arm group label: Formal Physical Therapy
arm group type: Experimental
arm group label: Self-directed Physical Therapy
arm group type: Experimental
intervention type: Other
intervention name: Formal Physical Therapy
description: Patients will undergo standard physical therapy following their surgery with a physical therapist in an office
arm group label: Formal Physical Therapy
intervention type: Other
intervention name: Self-directed Physical Therapy
description: Patients will undergo self-directed physical therapy in the comfort of their own home by completing a list of exercises and stretches without the direct supervision of a physical therapist in a physical therapist office
arm group label: Self-directed Physical Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen T Kayiaros, MD
role: Principal Investigator
affiliation: Rutgers University
last name: Daniel C Mascarenhas, MD
phone: 732-235-7869
email: daniel.mascarenhas@rutgers.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rutgers, The State University of New Jersey
investigator full name: Stephen Kayiaros MD
investigator title: Principal Investigator, Clinical Assistant Professor
mesh term: Arthritis
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)