<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/NCT03009890</url>
  </required_header>
  <id_info>
    <org_study_id>NL56858.100.16</org_study_id>
    <nct_id>NCT03009890</nct_id>
  </id_info>
  <brief_title>Surgery vs. Casting for Displaced Articular Radius Fractures in Elderly</brief_title>
  <acronym>DART</acronym>
  <official_title>The Effectiveness of Surgery Versus Casting for Elderly Patients With Displaced Distal Intra-Articular Radius Fractures: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JointResearch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maasstad Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Deventer Ziekenhuis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>JointResearch</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>
      Objective: to compare the functional outcome after open reduction and internal fixation with&#xD;
      non-operative cast treatment for elderly patients with displaced intra-articular distal&#xD;
      radius fractures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: there is no consensus about the optimal treatment of displaced intra-articular&#xD;
      distal radius fractures in elderly patients. To ensure optimal functional outcome there is a&#xD;
      tendency to operate. However, there is no evidence that supports the surgical treatment of&#xD;
      patients aged 65 years or older and in the absence of clinical trials it stays unclear how&#xD;
      elderly patients with intra-articular fractures should be treated.&#xD;
&#xD;
      Study design: multi-center randomized controlled trial with a non-inferiority design.&#xD;
      Economic evaluation alongside a randomized controlled multi-center trial.&#xD;
&#xD;
      Study population: all consecutive patients aged between 65 years and older with displaced&#xD;
      intra-articular (AO Type C) distal radius fractures, with a not acceptable reduction within 3&#xD;
      weeks following trauma.&#xD;
&#xD;
      Intervention: patients will be randomized between open reduction and internal fixation&#xD;
      (intervention group) and plaster immobilization (control group).&#xD;
&#xD;
      Main study parameters: the primary outcome will be evaluated after 1 year with the&#xD;
      Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes comprise other patient&#xD;
      reported outcome measures (PROM) including the Disability of the Arm, Shoulder and Hand&#xD;
      (DASH), Quality of life (EQ-5D) and Pain Catastrophizing Scale (PCS). Further outcome&#xD;
      measurements comprise a costs evaluation questionnaire, range of motion (ROM), grip strength,&#xD;
      radiographic parameters and Complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">November 1, 2022</completion_date>
  <primary_completion_date type="Actual">November 1, 2022</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>PRWE</measure>
    <time_frame>12 months</time_frame>
    <description>Patient-Rated Wrist Evaluation score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DASH</measure>
    <time_frame>12 months</time_frame>
    <description>Disability of the Arm, Shoulder and Hand</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ/5D</measure>
    <time_frame>12 months</time_frame>
    <description>Quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCS</measure>
    <time_frame>12 months</time_frame>
    <description>Pain Catastrophizing Scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>ROM</measure>
    <time_frame>12 months</time_frame>
    <description>range of motion</description>
  </other_outcome>
  <other_outcome>
    <measure>grip strength</measure>
    <time_frame>12 months</time_frame>
    <description>grip strength of both wrists</description>
  </other_outcome>
  <other_outcome>
    <measure>Radiographic parameters</measure>
    <time_frame>6 months</time_frame>
    <description>Radial inclination, volar/dorsal tilt, ulnar variance, gap, step off and radial length</description>
  </other_outcome>
  <other_outcome>
    <measure>Complications</measure>
    <time_frame>12 months</time_frame>
    <description>Complications of either treatment arm</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Radius Distal Fracture</condition>
  <arm_group>
    <arm_group_label>Open reduction internal fixation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surgical open reduction internal fixation (ORIF)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plaster immobilization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard local hospital protocol for cast treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery (Open Reduction Internal Fixation)</intervention_name>
    <description>Either volar of dorsal plating or both</description>
    <arm_group_label>Open reduction internal fixation</arm_group_label>
    <other_name>ORIF Open Reduction Internal Fixation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cast treatment</intervention_name>
    <description>Hospitals may use their preferred protocol</description>
    <arm_group_label>Plaster immobilization</arm_group_label>
    <other_name>Plaster</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 65 years at time of trauma&#xD;
&#xD;
          -  Intra-articular distal radius fracture (AO type C*)&#xD;
&#xD;
          -  One or more of the following fracture characteristics within 3 weeks post-trauma&#xD;
             (including secondary dislocation):&#xD;
&#xD;
             ≤15° inclination &lt;5 mm radial length &gt;15° dorsal tilt &gt;20° volar tilt intra-articular&#xD;
             gap or step-off &gt;2 mm&#xD;
&#xD;
          -  &lt; 3 weeks post trauma&#xD;
&#xD;
          -  Living independent&#xD;
&#xD;
          -  Fit for surgery&#xD;
&#xD;
          -  Mentally competent&#xD;
&#xD;
          -  Dutch fluency and literacy&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Open fractures&#xD;
&#xD;
          -  Neurovascular damage&#xD;
&#xD;
          -  Multiple-trauma patients (ISS &gt;16)&#xD;
&#xD;
          -  Other fractures in the injured extremity other than ulnar styloid process fractures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rudolf W Poolman, Prof. MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OLVG, Amsterdam, the Netherlands</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Onze Lieve Vrouwe Gasthuis</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord Holland</state>
        <zip>1090 HM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 16, 2023</last_update_submitted>
  <last_update_submitted_qc>January 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>elderly</keyword>
  <keyword>intra articular</keyword>
  <keyword>RCT</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>
  </condition_browse>
  <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/NCT03009890
org study id: NL56858.100.16
nct id: NCT03009890
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective: to compare the functional outcome after open reduction and internal fixation with
      non-operative cast treatment for elderly patients with displaced intra-articular distal
      radius fractures.
Rationale: there is no consensus about the optimal treatment of displaced intra-articular
      distal radius fractures in elderly patients. To ensure optimal functional outcome there is a
      tendency to operate. However, there is no evidence that supports the surgical treatment of
      patients aged 65 years or older and in the absence of clinical trials it stays unclear how
      elderly patients with intra-articular fractures should be treated.

      Study design: multi-center randomized controlled trial with a non-inferiority design.
      Economic evaluation alongside a randomized controlled multi-center trial.

      Study population: all consecutive patients aged between 65 years and older with displaced
      intra-articular (AO Type C) distal radius fractures, with a not acceptable reduction within 3
      weeks following trauma.

      Intervention: patients will be randomized between open reduction and internal fixation
      (intervention group) and plaster immobilization (control group).

      Main study parameters: the primary outcome will be evaluated after 1 year with the
      Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes comprise other patient
      reported outcome measures (PROM) including the Disability of the Arm, Shoulder and Hand
      (DASH), Quality of life (EQ-5D) and Pain Catastrophizing Scale (PCS). Further outcome
      measurements comprise a costs evaluation questionnaire, range of motion (ROM), grip strength,
      radiographic parameters and Complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PRWE
time frame: 12 months
description: Patient-Rated Wrist Evaluation score
measure: DASH
time frame: 12 months
description: Disability of the Arm, Shoulder and Hand
measure: EQ/5D
time frame: 12 months
description: Quality of life
measure: PCS
time frame: 12 months
description: Pain Catastrophizing Scale
measure: ROM
time frame: 12 months
description: range of motion
measure: grip strength
time frame: 12 months
description: grip strength of both wrists
measure: Radiographic parameters
time frame: 6 months
description: Radial inclination, volar/dorsal tilt, ulnar variance, gap, step off and radial length
measure: Complications
time frame: 12 months
description: Complications of either treatment arm
arm group label: Open reduction internal fixation
arm group type: Experimental
description: Surgical open reduction internal fixation (ORIF)
arm group label: Plaster immobilization
arm group type: Active Comparator
description: Standard local hospital protocol for cast treatment
intervention type: Procedure
intervention name: Surgery (Open Reduction Internal Fixation)
description: Either volar of dorsal plating or both
arm group label: Open reduction internal fixation
other name: ORIF Open Reduction Internal Fixation
intervention type: Procedure
intervention name: Cast treatment
description: Hospitals may use their preferred protocol
arm group label: Plaster immobilization
other name: Plaster
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Rudolf W Poolman, Prof. MD PhD
role: Principal Investigator
affiliation: OLVG, Amsterdam, the Netherlands
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Radius Fractures
sharing ipd: Yes