<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/NCT02990052</url>
  </required_header>
  <id_info>
    <org_study_id>Distal Radius Fr. Sirniö</org_study_id>
    <nct_id>NCT02990052</nct_id>
  </id_info>
  <brief_title>Conservative Treatment vs. Volar Plating of Distal Radius Fractures</brief_title>
  <acronym>DRF</acronym>
  <official_title>Conservative Treatment vs. Volar Plating of Distal Radius Fractures in Patients Aged Over 50 Years Old: A Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oulu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oulu</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, randomized controlled single-center trial with 80 patients aged 50 years and&#xD;
      above to compare the functional and radiological results of conservative treatment and volar&#xD;
      fixed-angle plating in the management of distal radius fracture&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Volar plating has became as a standard approach for treating unstable distal radius&#xD;
      fractures. The incidence of surgically treated patients with distal radius fractures has&#xD;
      increased many fold from the beginning of this millennium, owing mostly to increased number&#xD;
      of volar platings. The most striking increase of plate fixations has occurred in older&#xD;
      patient groups, especially in females. With volar fixed-angle plate, very near-anatomic,&#xD;
      stable fixation with relatively low complication rate, can be achieved even in osteoporotic&#xD;
      bone. There are only few randomized, prospective studies comparing results of volar plating&#xD;
      and conservative treatment, comparing patients aged over 65 years. Quite little is known of&#xD;
      the results comparing conservative treatment and volar plating in patients aged below 65&#xD;
      years.&#xD;
&#xD;
      Main goal of our study was to compare the functional and radiological results of conservative&#xD;
      treatment and volar fixed-angle plating in the management of distal radius fracture in&#xD;
      patients aged over 50 years an older.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2008</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Difference of DASH-score between two study groups</measure>
    <time_frame>2 year observation</time_frame>
    <description>Disability of the Arm, Shoulder and Hand -Score assessing the function of the upper extremity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference of radiological parameters between two study groups</measure>
    <time_frame>2 year observation</time_frame>
    <description>Dorsal angulation, ulnar variance and radial inclination of distal radius. Osteoarthritis of radiocarpal joint</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Distal Radius Fractures</condition>
  <arm_group>
    <arm_group_label>Volar plating</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Volar fixed-angle plating for dislocated distal radius fracture after closed reduction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conservative treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Primary conservative treatment (closed reduction and casting) for dislocated distal radius fracture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Volar plating</intervention_name>
    <description>Open reduction and volar fixed-angle plate fixation of distal radius fracture</description>
    <arm_group_label>Volar plating</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conservative treatment</intervention_name>
    <description>Closed reduction &amp; casting of distal radius fracture</description>
    <arm_group_label>Conservative treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients over 50 years-old&#xD;
&#xD;
          -  primary dislocated distal radius fracture (AO/OTA 23 type A2-3 and C1-2)&#xD;
&#xD;
          -  primary reduction of fracture is acceptable considering primary conservative treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bilateral and open fractures and fractures with neurovascular compromise&#xD;
&#xD;
          -  other major concurrent fracture necessitating treatment of any kind&#xD;
&#xD;
          -  patients under 50 years of age&#xD;
&#xD;
          -  previous ipsilateral distal radius fracture&#xD;
&#xD;
          -  inflammatory joint disease&#xD;
&#xD;
          -  significant radiocarpal-joint degeneration&#xD;
&#xD;
          -  patient's bad co-operation or major co-morbidity making an operation contraindicated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>December 9, 2016</last_update_submitted>
  <last_update_submitted_qc>December 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02990052
org study id: Distal Radius Fr. Sirniö
nct id: NCT02990052
lead sponsor: 
has dmc: No
A prospective, randomized controlled single-center trial with 80 patients aged 50 years and
      above to compare the functional and radiological results of conservative treatment and volar
      fixed-angle plating in the management of distal radius fracture
Volar plating has became as a standard approach for treating unstable distal radius
      fractures. The incidence of surgically treated patients with distal radius fractures has
      increased many fold from the beginning of this millennium, owing mostly to increased number
      of volar platings. The most striking increase of plate fixations has occurred in older
      patient groups, especially in females. With volar fixed-angle plate, very near-anatomic,
      stable fixation with relatively low complication rate, can be achieved even in osteoporotic
      bone. There are only few randomized, prospective studies comparing results of volar plating
      and conservative treatment, comparing patients aged over 65 years. Quite little is known of
      the results comparing conservative treatment and volar plating in patients aged below 65
      years.

      Main goal of our study was to compare the functional and radiological results of conservative
      treatment and volar fixed-angle plating in the management of distal radius fracture in
      patients aged over 50 years an older.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Difference of DASH-score between two study groups
time frame: 2 year observation
description: Disability of the Arm, Shoulder and Hand -Score assessing the function of the upper extremity
measure: Difference of radiological parameters between two study groups
time frame: 2 year observation
description: Dorsal angulation, ulnar variance and radial inclination of distal radius. Osteoarthritis of radiocarpal joint
arm group label: Volar plating
arm group type: Active Comparator
description: Volar fixed-angle plating for dislocated distal radius fracture after closed reduction.
arm group label: Conservative treatment
arm group type: Active Comparator
description: Primary conservative treatment (closed reduction and casting) for dislocated distal radius fracture.
intervention type: Procedure
intervention name: Volar plating
description: Open reduction and volar fixed-angle plate fixation of distal radius fracture
arm group label: Volar plating
intervention type: Procedure
intervention name: Conservative treatment
description: Closed reduction & casting of distal radius fracture
arm group label: Conservative treatment
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Radius Fractures
mesh term: Wrist Fractures
sharing ipd: Undecided