<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/NCT03035435</url>
  </required_header>
  <id_info>
    <org_study_id>Fast Track Rehab</org_study_id>
    <nct_id>NCT03035435</nct_id>
  </id_info>
  <brief_title>Fast-track Rehabilitation After Total Knee or Hip Arthroplasty</brief_title>
  <official_title>Fast-track Rehabilitation After Total Knee or Hip Arthroplasty: an Observational Prospective Case-control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione Don Carlo Gnocchi Onlus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione Don Carlo Gnocchi Onlus</source>
  <brief_summary>
    <textblock>
      In the last years, a lot of surgical fast track programs (SFTP) have been created and&#xD;
      developed. This is due to the steady growing number of interventions on knee and hip; after&#xD;
      the surgical treatment, a period of physical rehabilitation (PR) is established to be useful&#xD;
      and effective, it usually takes 2-3 weeks. The recovery of strength, range of motion (ROM),&#xD;
      independence, the reduction of pain and disability are the aims of PR. With the SFTP and a&#xD;
      specific rehabilitation program named fast track rehabilitation (FTR) these times can be&#xD;
      reduced. First of all because the length of stay (LOS) it's also caused by organizational&#xD;
      problems of the hospitals, not only for the factors related to the patient. It's already been&#xD;
      demonstrated that an early mobilization decreases the risk of thromboembolic complications&#xD;
      and of pain, furthermore an early rehabilitation increase the patient autonomy and reduces&#xD;
      the lost of residual abilities. Moreover a PR program studied for fast track patient will&#xD;
      reduce minimum by a 50% the LOS in hospital, decreasing so the sanitary efforts that are&#xD;
      always a problem for all the countries. The aim of this study is therefore to propose a fast&#xD;
      track rehabilitation program based on an 8 days program for hip and knee arthroplasty being&#xD;
      operated with an SFTP.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>International Knee Society Score</measure>
    <time_frame>Change from Baseline fast-track rehabilitation at 8th and 15th day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Merle D'Aubigne' scale</measure>
    <time_frame>Change from Baseline fast-track rehabilitation at 8th and 15th day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Barthel Index</measure>
    <time_frame>Change from Baseline fast-track rehabilitation at 8th and 15th day</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">58</enrollment>
  <condition>Knee Arthroplasty</condition>
  <condition>Hip Arthroplasty</condition>
  <arm_group>
    <arm_group_label>study group</arm_group_label>
    <description>fast-track rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>standard care rehabilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fast-track rehabilitation</intervention_name>
    <arm_group_label>study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard care rehabilitation</intervention_name>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The recruitment will take place to Rehabilitation Unit of Don Gnocchi Foundation of Rovato&#xD;
        (Brescia, Italy), from January 2016 to August 2016. An informed consent will be signed by&#xD;
        each participant in agreement with Helsinki Declaration. The study is approved by the local&#xD;
        Ethical Committee.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult people (&gt;18 years), both sex, admitted for elective total knee or hip&#xD;
             arthroplasty, with a clinical stability (Hb&gt;9 g/l).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the presence of pain measured with NRS (NRS&gt;4)&#xD;
&#xD;
          -  rheumatoid arthritis, past surgery&#xD;
&#xD;
          -  cancer&#xD;
&#xD;
          -  neurological and psychiatric disorders&#xD;
&#xD;
          -  dementia with Minimental Test&lt;24&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  participation in the other clinical studies.&#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>Chiara Arienti, PhD(s)</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Don Gnocchi Foundation</affiliation>
  </overall_official>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fondazione Don Carlo Gnocchi Onlus</investigator_affiliation>
    <investigator_full_name>Chiara Arienti</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>fast-track rehabilitation</keyword>
  <keyword>fast-track surgery</keyword>
  <!-- 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/NCT03035435
org study id: Fast Track Rehab
nct id: NCT03035435
lead sponsor: 
In the last years, a lot of surgical fast track programs (SFTP) have been created and
      developed. This is due to the steady growing number of interventions on knee and hip; after
      the surgical treatment, a period of physical rehabilitation (PR) is established to be useful
      and effective, it usually takes 2-3 weeks. The recovery of strength, range of motion (ROM),
      independence, the reduction of pain and disability are the aims of PR. With the SFTP and a
      specific rehabilitation program named fast track rehabilitation (FTR) these times can be
      reduced. First of all because the length of stay (LOS) it's also caused by organizational
      problems of the hospitals, not only for the factors related to the patient. It's already been
      demonstrated that an early mobilization decreases the risk of thromboembolic complications
      and of pain, furthermore an early rehabilitation increase the patient autonomy and reduces
      the lost of residual abilities. Moreover a PR program studied for fast track patient will
      reduce minimum by a 50% the LOS in hospital, decreasing so the sanitary efforts that are
      always a problem for all the countries. The aim of this study is therefore to propose a fast
      track rehabilitation program based on an 8 days program for hip and knee arthroplasty being
      operated with an SFTP.
observational model: Case-Control
time perspective: Prospective
measure: International Knee Society Score
time frame: Change from Baseline fast-track rehabilitation at 8th and 15th day
measure: Merle D'Aubigne' scale
time frame: Change from Baseline fast-track rehabilitation at 8th and 15th day
measure: Barthel Index
time frame: Change from Baseline fast-track rehabilitation at 8th and 15th day
arm group label: study group
description: fast-track rehabilitation
arm group label: control group
description: standard care rehabilitation
intervention type: Other
intervention name: fast-track rehabilitation
arm group label: study group
intervention type: Other
intervention name: standard care rehabilitation
arm group label: control group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chiara Arienti, PhD(s)
role: Principal Investigator
affiliation: IRCCS Don Gnocchi Foundation
responsible party type: Principal Investigator
investigator affiliation: Fondazione Don Carlo Gnocchi Onlus
investigator full name: Chiara Arienti
investigator title: PhD