<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/NCT02982785</url>
  </required_header>
  <id_info>
    <org_study_id>FYS002</org_study_id>
    <nct_id>NCT02982785</nct_id>
  </id_info>
  <brief_title>Knee Replacement Outcome Predicted by Physiotherapists</brief_title>
  <official_title>Knee Replacement Outcome Predicted by Physiotherapists: A Prospective Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marius Henriksen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Frederiksberg University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim is to assess if physiotherapists attending inpatients at elective orthopaedic wards&#xD;
      can predict the future course (post hospitalisation) of recovery of patients undergoing KA.&#xD;
      The prediction is made at hospital discharge using a 1-10 numerical rating scale (1=poor&#xD;
      prognosis; 10=best prognosis).&#xD;
&#xD;
      To identify candidate prognostic factors, the therapist are asked to qualify their prognosis&#xD;
      narratively, by listing at least 3-5 factors that they consider important for their projected&#xD;
      prognosis score. There will be no maximum number of factors the physiotherapist can list.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Oxford Knee Score</measure>
    <time_frame>6 months after surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxford Knee Score</measure>
    <time_frame>12 months after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Acceptable Symptom State</measure>
    <time_frame>6 and 12 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQoL questionnaire</measure>
    <time_frame>6 and 12 months after surgery</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Questionnaire regarding postoperative rehabilitation</measure>
    <time_frame>6 and 12 months after surgery</time_frame>
    <description>This is a questionnaire that includes questions regarding the postoperative rehabilitation (i.e., setting, participation, type, duration, frequency, and degree of supervision). Details from post-operative rehabilitation provided at one of the investigational sites will be obtained from the patients' hospital records</description>
  </other_outcome>
  <other_outcome>
    <measure>Transition ratings of global perceived effect</measure>
    <time_frame>6 and 12 months after surgery</time_frame>
    <description>This is a transition questionnaire on which the participants initially answers if their current state is &quot;unchanged, worse&quot; or &quot;better&quot; compared to pre-surgery. An &quot;unchanged&quot; equals a transition score of 0. If the participant answers &quot;worse&quot;, the participant is asked to rate the degree of worsening on a 7 point Likert scale, and the corresponding scores range from -1 to -7. Correspondingly, if a participant answers &quot;better&quot;, the participant is asked to rate the degree of improvement on a 7 point Likert scale, and the corresponding scores range from 1 to 7. Thus the global perceived effect score range from -7 (worsening) to 7 (improvement), with the mid-point - 0 - representing no change.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse events</measure>
    <time_frame>6 and 12 months after surgery</time_frame>
    <description>Survey of the participants for events that patients have experienced during the observation period. These events will be self-reported using a questionnaire with ample space for free text. An event will be defined as causing limitations in daily activities, Sports/Recreational activities or work limitations together with symptoms causing participants to seek medical care. The events may be unrelated to the knee (such as development or exacerbation of comorbidities) and the events are not necessarily causally linked to the knee surgery</description>
  </other_outcome>
  <enrollment type="Actual">364</enrollment>
  <condition>Total Knee Replacement</condition>
  <condition>Osteoarthritis</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard post-operative rehabilitation</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing primary total knee arthroplasty (TKA) for treatment of knee&#xD;
        osteoarthritis. All patients from december 2016 to december 2017 will be invited to&#xD;
        participate.&#xD;
&#xD;
        If it is not possible to reach the set sample size within the set timeframe, recruitment&#xD;
        will continue until the numbers specified in the a priori sample size calculation are&#xD;
        reached. Should the set sample size be reached ahead of time, recruitment will stop.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Received primary knee replacement surgery for knee OA&#xD;
&#xD;
          2. Age ≥ 18 years&#xD;
&#xD;
          3. Reads and speaks Danish&#xD;
&#xD;
          4. Has an email address&#xD;
&#xD;
          5. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cognitive impairments that preclude reliable answers to online questionnaires (e.g.&#xD;
             dementia)&#xD;
&#xD;
          2. Revision surgery&#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>Marius Henriksen, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bispebjerg Hospital, Department of Physical and Occupational Therapy</name>
      <address>
        <city>Copenhagen</city>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gentofte Hospital, Department of Physical Therapy</name>
      <address>
        <city>Copenhagen</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Frederiksberg University Hospital</investigator_affiliation>
    <investigator_full_name>Marius Henriksen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Upon finalisation of the prespecified analyses we will share the IPD to other researchers based on an email inquiry.</ipd_description>
  </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/NCT02982785
org study id: FYS002
nct id: NCT02982785
lead sponsor: 
has dmc: No
The aim is to assess if physiotherapists attending inpatients at elective orthopaedic wards
      can predict the future course (post hospitalisation) of recovery of patients undergoing KA.
      The prediction is made at hospital discharge using a 1-10 numerical rating scale (1=poor
      prognosis; 10=best prognosis).

      To identify candidate prognostic factors, the therapist are asked to qualify their prognosis
      narratively, by listing at least 3-5 factors that they consider important for their projected
      prognosis score. There will be no maximum number of factors the physiotherapist can list.
observational model: Cohort
time perspective: Prospective
measure: Oxford Knee Score
time frame: 6 months after surgery
measure: Oxford Knee Score
time frame: 12 months after surgery
measure: Patient Acceptable Symptom State
time frame: 6 and 12 months after surgery
measure: EuroQoL questionnaire
time frame: 6 and 12 months after surgery
measure: Questionnaire regarding postoperative rehabilitation
time frame: 6 and 12 months after surgery
description: This is a questionnaire that includes questions regarding the postoperative rehabilitation (i.e., setting, participation, type, duration, frequency, and degree of supervision). Details from post-operative rehabilitation provided at one of the investigational sites will be obtained from the patients' hospital records
measure: Transition ratings of global perceived effect
time frame: 6 and 12 months after surgery
description: This is a transition questionnaire on which the participants initially answers if their current state is "unchanged, worse" or "better" compared to pre-surgery. An "unchanged" equals a transition score of 0. If the participant answers "worse", the participant is asked to rate the degree of worsening on a 7 point Likert scale, and the corresponding scores range from -1 to -7. Correspondingly, if a participant answers "better", the participant is asked to rate the degree of improvement on a 7 point Likert scale, and the corresponding scores range from 1 to 7. Thus the global perceived effect score range from -7 (worsening) to 7 (improvement), with the mid-point - 0 - representing no change.
measure: Adverse events
time frame: 6 and 12 months after surgery
description: Survey of the participants for events that patients have experienced during the observation period. These events will be self-reported using a questionnaire with ample space for free text. An event will be defined as causing limitations in daily activities, Sports/Recreational activities or work limitations together with symptoms causing participants to seek medical care. The events may be unrelated to the knee (such as development or exacerbation of comorbidities) and the events are not necessarily causally linked to the knee surgery
intervention type: Behavioral
intervention name: Standard post-operative rehabilitation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marius Henriksen, PT, PhD
role: Principal Investigator
affiliation: Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg Hospital
facility: 
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Frederiksberg University Hospital
investigator full name: Marius Henriksen
investigator title: Professor
mesh term: Osteoarthritis
sharing ipd: Yes
ipd description: Upon finalisation of the prespecified analyses we will share the IPD to other researchers based on an email inquiry.