<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/NCT03039907</url>
  </required_header>
  <id_info>
    <org_study_id>TKAUnder65-001</org_study_id>
    <nct_id>NCT03039907</nct_id>
  </id_info>
  <brief_title>Return to Physical Activities After Total Knee Arthroplasty</brief_title>
  <official_title>A Critical Assessment of the Factors That Promote or Limit the Return to Recreational, Work, and Physical Fitness Activities After Primary Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cincinnati Sportsmedicine Research and Education Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cincinnati Sportsmedicine Research and Education Foundation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to examine the factors that allow patients that undergo&#xD;
      total knee arthroplasty to return to recreational sports and/or work activities, and to&#xD;
      achieve recommended physical activity levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are three purposes of this study. The first purpose is to examine the factors that&#xD;
      allow patients that underwent total knee arthroplasty with the Journey II to return to&#xD;
      recreational sports and/or work activities, and to achieve recommended physical activity&#xD;
      levels (defined by the American Heart Association and the American College of Sports&#xD;
      Medicine).&#xD;
&#xD;
      The second purpose is to examine the factors that limit the ability of patients to resume&#xD;
      sports, work, and physical fitness training, including comorbidities, general health,&#xD;
      complications, and other factors.&#xD;
&#xD;
      The third purpose is to use advanced sports medicine rehabilitation principles that involve&#xD;
      staged progressive protocols to safely prepare patients for sports, work, and physical&#xD;
      fitness training. Objective measurements of muscle strength, endurance, balance, and&#xD;
      neuromuscular control will be used to determine when patients may be cleared to participate&#xD;
      in these activities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 23, 2017</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Analysis of Number of Participants That Return to Recreational and Fitness Activities</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>Participants will complete a questionnaire that determines the type of physical activities they routinely participate in (for instance, swimming, bicycling, hiking, golf). Patients will also complete two questions regarding their general fitness level in accordance with current standards of the American Heart Association. These questions are contained in the study patient registry.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of Effect of Charlson Comorbidity Index on Return to Recreational and Physical Activities</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>Patient comorbidities will be documented by the surgeon using the weighted Charlson Comorbidity Index. An analysis will be conducted to determine if the index score has a deleterious effect on recreational activities or general fitness activities at follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Postoperative Complications on Return to Recreational and Physical Activities</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>All postoperative complications will be documented in the study patient registry with a list related specifically to TKA from the AKS and a second general list that was generated from complications recorded by the Centers for Medicare and Medicaid Services (2015 update). An analysis will be conducted to determine if complications have a deleterious effect on recreational activities or general fitness activities patients return to after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Effect of Preoperative Body Mass Index on Return to Recreational and Physical Activities</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>Patient body mass index will be collected before surgery and will be designated as either obese, over weight, or within normal limits according to WHO classification of obesity. Determination will be made of the effect of BMI on return to recreational or general fitness activities at follow-up.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Arthroplasty, Replacement, Knee</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total Knee Arthroplasty</intervention_name>
    <description>Total knee arthroplasty</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients 65 years of age and younger who undergo total knee arthroplasty who desire to&#xD;
        return to recreational (sports) and/or work activities postoperatively.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women 65 years of age or younger.&#xD;
&#xD;
          -  Patient indicates before surgery the desire to return to recreational (sports) and/or&#xD;
             work activities postoperatively&#xD;
&#xD;
          -  Patient provides informed consent.&#xD;
&#xD;
          -  Patient complies with postoperative rehabilitation program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient did not desire to return to recreational and/or work activities after TKA&#xD;
&#xD;
          -  History of alcohol or drug abuse within 3 years of the operation.&#xD;
&#xD;
          -  Disabling or widespread osteoarthritis or other joint disease in any other joint.&#xD;
&#xD;
          -  Presence of a significant connective tissue disease, autoimmune disease, HIV-positive,&#xD;
             or immune deficiency syndrome.&#xD;
&#xD;
          -  Any other contraindications that in the opinion of the principal investigator would&#xD;
             interfere with the conduct of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank R Noyes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cincinnati Sportsmedicine and Orthopaedic Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Frank R Noyes, MD</last_name>
    <phone>513-347-9999</phone>
    <email>frnoyes@gmaili.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cassie Fleckenstein, MS</last_name>
    <phone>513-792-3232</phone>
    <email>cfleckenstein@csmref.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cincinnati Sportsmedicine and Orthopaedic Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cassie Fleckenstein, M.S.</last_name>
      <phone>513-794-8466</phone>
      <email>cfleckenstein@csmref.org</email>
    </contact>
    <investigator>
      <last_name>Frank Noyes, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>April 11, 2016</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cincinnati Sportsmedicine Research and Education Foundation</investigator_affiliation>
    <investigator_full_name>Sue Barber-Westin</investigator_full_name>
    <investigator_title>Director Clinical Studies</investigator_title>
  </responsible_party>
  <keyword>Knee</keyword>
  <keyword>Replacement</keyword>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03039907
org study id: TKAUnder65-001
nct id: NCT03039907
lead sponsor: 
has dmc: Yes
The main purpose of this study is to examine the factors that allow patients that undergo
      total knee arthroplasty to return to recreational sports and/or work activities, and to
      achieve recommended physical activity levels.
There are three purposes of this study. The first purpose is to examine the factors that
      allow patients that underwent total knee arthroplasty with the Journey II to return to
      recreational sports and/or work activities, and to achieve recommended physical activity
      levels (defined by the American Heart Association and the American College of Sports
      Medicine).

      The second purpose is to examine the factors that limit the ability of patients to resume
      sports, work, and physical fitness training, including comorbidities, general health,
      complications, and other factors.

      The third purpose is to use advanced sports medicine rehabilitation principles that involve
      staged progressive protocols to safely prepare patients for sports, work, and physical
      fitness training. Objective measurements of muscle strength, endurance, balance, and
      neuromuscular control will be used to determine when patients may be cleared to participate
      in these activities.
observational model: Cohort
time perspective: Prospective
measure: Analysis of Number of Participants That Return to Recreational and Fitness Activities
time frame: 2 years postoperatively
description: Participants will complete a questionnaire that determines the type of physical activities they routinely participate in (for instance, swimming, bicycling, hiking, golf). Patients will also complete two questions regarding their general fitness level in accordance with current standards of the American Heart Association. These questions are contained in the study patient registry.
measure: Assessment of Effect of Charlson Comorbidity Index on Return to Recreational and Physical Activities
time frame: 2 years postoperatively
description: Patient comorbidities will be documented by the surgeon using the weighted Charlson Comorbidity Index. An analysis will be conducted to determine if the index score has a deleterious effect on recreational activities or general fitness activities at follow-up.
measure: Assessment of Postoperative Complications on Return to Recreational and Physical Activities
time frame: 2 years postoperatively
description: All postoperative complications will be documented in the study patient registry with a list related specifically to TKA from the AKS and a second general list that was generated from complications recorded by the Centers for Medicare and Medicaid Services (2015 update). An analysis will be conducted to determine if complications have a deleterious effect on recreational activities or general fitness activities patients return to after surgery.
measure: Assessment of Effect of Preoperative Body Mass Index on Return to Recreational and Physical Activities
time frame: 2 years postoperatively
description: Patient body mass index will be collected before surgery and will be designated as either obese, over weight, or within normal limits according to WHO classification of obesity. Determination will be made of the effect of BMI on return to recreational or general fitness activities at follow-up.
intervention type: Procedure
intervention name: Total Knee Arthroplasty
description: Total knee arthroplasty
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Frank R Noyes, MD
role: Principal Investigator
affiliation: Cincinnati Sportsmedicine and Orthopaedic Center
last name: Frank R Noyes, MD
phone: 513-347-9999
email: frnoyes@gmaili.com
last name: Cassie Fleckenstein, MS
phone: 513-792-3232
email: cfleckenstein@csmref.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cincinnati Sportsmedicine Research and Education Foundation
investigator full name: Sue Barber-Westin
investigator title: Director Clinical Studies
sharing ipd: Yes