<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/NCT03259906</url>
  </required_header>
  <id_info>
    <org_study_id>ALVERNHE LABATTUT 2016</org_study_id>
    <nct_id>NCT03259906</nct_id>
  </id_info>
  <brief_title>Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate</brief_title>
  <acronym>PAPPO</acronym>
  <official_title>Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      For les intra-articular fractures, plate osteosynthesis is the indicated technique. Despite&#xD;
      the absence of consensus, in recent years, the use of open reduction associated with internal&#xD;
      plate fixation has considerably developed. Indeed, this therapeutic option allows a more&#xD;
      anatomical reduction and stable fixation.&#xD;
&#xD;
      First-generation posterior plates presented complications related to the size of the plate,&#xD;
      notably tendon lesions. Over the last ten years, a new generation of thinner anterior plates&#xD;
      has reduced these complications.&#xD;
&#xD;
      In the literature, few studies have compared these two techniques in terms of functional and&#xD;
      radiological outcomes. The hypothesis of this research is that osteosynthesis using a&#xD;
      posterior plate is more effective than that with an anterior plate in terms of functional&#xD;
      recovery in patients older than 60 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">January 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of functional recovery using the DASH questionnaire</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Distal Intra-articular Radius Fracture With a Dorsal Tilt</condition>
  <arm_group>
    <arm_group_label>Osteosynthesis using a posterior plate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Osteosynthesis using an anterior plate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DASH score</intervention_name>
    <description>Questionnaire asking about Disability of Arm, Shoulder and Hand</description>
    <arm_group_label>Osteosynthesis using a posterior plate</arm_group_label>
    <arm_group_label>Osteosynthesis using an anterior plate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>X-ray</intervention_name>
    <description>postoperative x-rays at 6 weeks, 3, 6 and 12 months</description>
    <arm_group_label>Osteosynthesis using a posterior plate</arm_group_label>
    <arm_group_label>Osteosynthesis using an anterior plate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>posterior osteosynthesis</intervention_name>
    <description>Osteosynthesis using a posterior plate</description>
    <arm_group_label>Osteosynthesis using a posterior plate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anterior osteosynthesis</intervention_name>
    <description>Osteosynthesis using an anterior plate</description>
    <arm_group_label>Osteosynthesis using an anterior plate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have provided written informed consent&#xD;
&#xD;
          -  Patients older than 60 years&#xD;
&#xD;
          -  Patients presenting a closed intra-articular fracture of the distal radius with a&#xD;
             dorsal tilt (stages B2, C1, C2 and C3)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults under guardianship&#xD;
&#xD;
          -  Patients without national health insurance cover&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Patients presenting other injuries in the same upper limb&#xD;
&#xD;
          -  Patients presenting injuries of the wrist or hand (scapholunate injury, fracture of&#xD;
             the carpal bone or fingers)&#xD;
&#xD;
          -  Pre-trauma paralysis of the limb&#xD;
&#xD;
          -  Open fracture&#xD;
&#xD;
          -  Fracture with palmer tilt or extra-articular&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ludovic LABATTUT, MD</last_name>
    <phone>03 80 29 33 74</phone>
    <email>Ludovic.LABATTUT@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ludovic LABATTUT</last_name>
      <phone>03 80 29 33 74</phone>
      <email>Ludovic.LABATTUT@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</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>
  </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/NCT03259906
org study id: ALVERNHE LABATTUT 2016
nct id: NCT03259906
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
For les intra-articular fractures, plate osteosynthesis is the indicated technique. Despite
      the absence of consensus, in recent years, the use of open reduction associated with internal
      plate fixation has considerably developed. Indeed, this therapeutic option allows a more
      anatomical reduction and stable fixation.

      First-generation posterior plates presented complications related to the size of the plate,
      notably tendon lesions. Over the last ten years, a new generation of thinner anterior plates
      has reduced these complications.

      In the literature, few studies have compared these two techniques in terms of functional and
      radiological outcomes. The hypothesis of this research is that osteosynthesis using a
      posterior plate is more effective than that with an anterior plate in terms of functional
      recovery in patients older than 60 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of functional recovery using the DASH questionnaire
time frame: 6 months
arm group label: Osteosynthesis using a posterior plate
arm group type: Active Comparator
arm group label: Osteosynthesis using an anterior plate
arm group type: Active Comparator
intervention type: Other
intervention name: DASH score
description: Questionnaire asking about Disability of Arm, Shoulder and Hand
arm group label: Osteosynthesis using a posterior plate
arm group label: Osteosynthesis using an anterior plate
intervention type: Procedure
intervention name: X-ray
description: postoperative x-rays at 6 weeks, 3, 6 and 12 months
arm group label: Osteosynthesis using a posterior plate
arm group label: Osteosynthesis using an anterior plate
intervention type: Procedure
intervention name: posterior osteosynthesis
description: Osteosynthesis using a posterior plate
arm group label: Osteosynthesis using a posterior plate
intervention type: Procedure
intervention name: Anterior osteosynthesis
description: Osteosynthesis using an anterior plate
arm group label: Osteosynthesis using an anterior plate
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Ludovic LABATTUT, MD
phone: 03 80 29 33 74
email: Ludovic.LABATTUT@chu-dijon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Radius Fractures
sharing ipd: Undecided