<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/NCT03240471</url>
  </required_header>
  <id_info>
    <org_study_id>NL 59217.091.17</org_study_id>
    <nct_id>NCT03240471</nct_id>
  </id_info>
  <brief_title>Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization</brief_title>
  <acronym>Cast-OFF</acronym>
  <official_title>Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization for Non-reduced Distal Radius Fractures: A Randomized Clinical Trial - A Feasibility Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Distal radius fracture (DRF) is a common fracture of which the incidence appears to be&#xD;
      increasing worldwide. On average, a total of 17% of all diagnosed fractures are DRF's.&#xD;
&#xD;
      In the Dutch guideline for DRF the treatment advice for DRF, without reduction, is treatment&#xD;
      with plaster cast or brace for one-three weeks. Despite the advice in the guideline and&#xD;
      despite several studies from the 90's showing that plaster cast treatment of a stable DRF for&#xD;
      one week is safe, the usual length of plaster cast treatment for stable DRF is four-six&#xD;
      weeks. In addition, recent studies have also shown that a long period of immobilization can&#xD;
      lead to more post traumatic pain by increasing disuse and kinesiophobia.&#xD;
&#xD;
      This evidence suggests that the usual duration (4-6 weeks) of plaster cast treatment for DRF&#xD;
      is unnecessary.&#xD;
&#xD;
      The aim of this feasibility study is to define whether one week of plaster cast treatment is&#xD;
      possible and can lead to better functional results, with at least the same patient&#xD;
      satisfaction and complications. In addition, this feasibility study will be used to define&#xD;
      the sample size of the future RCT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 14, 2020</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>
    <intervention_model_description>Randomized clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in patient-rated wrist evaluation (PRWE) questionnaire score</measure>
    <time_frame>Week 6, month 3, month 6 and month 12</time_frame>
    <description>Patient rated wrist evaluation score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in disability of the Arm, Shoulder and Hand (DASH) questionnaire score</measure>
    <time_frame>Week 6, month 3, month 6 and month 12</time_frame>
    <description>In addition to the PRWE questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Short-Form 36 questionnaire score</measure>
    <time_frame>Week 6, month 3, month 6 and month 12</time_frame>
    <description>In addition to the PRWE questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Duration of study (12 months)</time_frame>
    <description>The number of participants who experienced treatment related complications scored with a checklist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain after DRF</measure>
    <time_frame>Baseline, week 6, month 3, month 6, month 12</time_frame>
    <description>Pain will be assessed by a visual analog scale (VAS). Participants rate their pain level in a scale from 0 to 10; 0 representing &quot;no pain&quot; and 10 representing &quot;the worst pain imaginable&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Distal Radius Fracture</condition>
  <arm_group>
    <arm_group_label>One week of plaster cast</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One week of plaster cast after a non-reduced distal radius fracture.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control; four-five weeks of plaster cast</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Four-five weeks of plaster cast after a non-reduced distal radius fracture, usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>One week of plaster cast</intervention_name>
    <description>One week of plaster cast as treatment for a non-reduced distal radius fracture.</description>
    <arm_group_label>One week of plaster cast</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Four-Five weeks of plaster cast</intervention_name>
    <description>Four-Five weeks of plaster cast as treatment for a non-reduced distal radius fracture.</description>
    <arm_group_label>Control; four-five weeks of plaster cast</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 75 years&#xD;
&#xD;
          -  Isolated acute distal radius fracture&#xD;
&#xD;
          -  Closed reduction is not performed&#xD;
&#xD;
          -  Non-operative treatment with cast immobilisation&#xD;
&#xD;
          -  Understanding of Dutch language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under the age of 18 or older than 75 years&#xD;
&#xD;
          -  Multiple injured patient&#xD;
&#xD;
          -  Reduction is indicated/performed&#xD;
&#xD;
          -  Operative treatment&#xD;
&#xD;
          -  Not understanding of Dutch language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JP Frolke, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rijnstate hospital</name>
      <address>
        <city>Arnhem</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Gelderse Vallei</name>
      <address>
        <city>Ede</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboudumc</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>January 19, 2021</last_update_submitted>
  <last_update_submitted_qc>January 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Distal radius fracture</keyword>
  <keyword>Conservative treatment</keyword>
  <keyword>Patient rated outcome (PRO)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Radius Fractures</mesh_term>
    <mesh_term>Wrist Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calpastatin</mesh_term>
  </intervention_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/NCT03240471
org study id: NL 59217.091.17
nct id: NCT03240471
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Distal radius fracture (DRF) is a common fracture of which the incidence appears to be
      increasing worldwide. On average, a total of 17% of all diagnosed fractures are DRF's.

      In the Dutch guideline for DRF the treatment advice for DRF, without reduction, is treatment
      with plaster cast or brace for one-three weeks. Despite the advice in the guideline and
      despite several studies from the 90's showing that plaster cast treatment of a stable DRF for
      one week is safe, the usual length of plaster cast treatment for stable DRF is four-six
      weeks. In addition, recent studies have also shown that a long period of immobilization can
      lead to more post traumatic pain by increasing disuse and kinesiophobia.

      This evidence suggests that the usual duration (4-6 weeks) of plaster cast treatment for DRF
      is unnecessary.

      The aim of this feasibility study is to define whether one week of plaster cast treatment is
      possible and can lead to better functional results, with at least the same patient
      satisfaction and complications. In addition, this feasibility study will be used to define
      the sample size of the future RCT.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized clinical trial
primary purpose: Treatment
masking: None (Open Label)
measure: Change in patient-rated wrist evaluation (PRWE) questionnaire score
time frame: Week 6, month 3, month 6 and month 12
description: Patient rated wrist evaluation score
measure: Change in disability of the Arm, Shoulder and Hand (DASH) questionnaire score
time frame: Week 6, month 3, month 6 and month 12
description: In addition to the PRWE questionnaire.
measure: Change in Short-Form 36 questionnaire score
time frame: Week 6, month 3, month 6 and month 12
description: In addition to the PRWE questionnaire.
measure: Complications
time frame: Duration of study (12 months)
description: The number of participants who experienced treatment related complications scored with a checklist.
measure: Pain after DRF
time frame: Baseline, week 6, month 3, month 6, month 12
description: Pain will be assessed by a visual analog scale (VAS). Participants rate their pain level in a scale from 0 to 10; 0 representing "no pain" and 10 representing "the worst pain imaginable".
arm group label: One week of plaster cast
arm group type: Experimental
description: One week of plaster cast after a non-reduced distal radius fracture.
arm group label: Control; four-five weeks of plaster cast
arm group type: Other
description: Four-five weeks of plaster cast after a non-reduced distal radius fracture, usual care.
intervention type: Procedure
intervention name: One week of plaster cast
description: One week of plaster cast as treatment for a non-reduced distal radius fracture.
arm group label: One week of plaster cast
intervention type: Procedure
intervention name: Four-Five weeks of plaster cast
description: Four-Five weeks of plaster cast as treatment for a non-reduced distal radius fracture.
arm group label: Control; four-five weeks of plaster cast
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: JP Frolke, Dr.
role: Principal Investigator
affiliation: Radboud University Medical Center
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Radius Fractures
mesh term: Wrist Fractures
mesh term: Calpastatin
sharing ipd: No