xml: <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/NCT06011122</url>
    </required_header>
    <id_info>
      <org_study_id>29BRC21.0084 - REDIRA</org_study_id>
      <nct_id>NCT06011122</nct_id>
    </id_info>
    <brief_title>Analysis of Implant Placement in Patients With Distal Radius Fractures in Western Brittany (REDIRA)</brief_title>
    <acronym>REDIRA</acronym>
    <official_title>Analysis of Implant Placement of Patients With Distal Radius Fractures in Western Britain,</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Brest</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Brest</source>
    <oversight_info>
      <has_dmc>No</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>
        The purpose of this study was to determine the impact of design on plate position at the&#xD;
        level of the distal radius. Six anterior wrist plates design were analyzed relative to the&#xD;
        watershed line using the Soong classification. A total of 2723 anterior locking plate&#xD;
        fixation cases were analyzed and divided into six groups: Zimmer Biomet, Newclip Technics,&#xD;
        Stryker, Synthes, Medartis and Medartis Footprint. The number of plates recorded as Soong&#xD;
        grade 0+1 was determined for each design, then compared using the Marascuilo procedure. The&#xD;
        Zimmer Biomet and Newclip plates were proximal to the Watershed line significantly more often&#xD;
        than those by Synthes and Medartis Footprint. Plate position with the Medartis design was&#xD;
        significantly more proximal to the Watershed line compared to its companion design, the&#xD;
        Medartis Footprint plate. Plate design is a deciding factor when treating distal radial&#xD;
        fractures, to avoid impingement when implant removal is not routinely planned.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a retrospective multicenter study involving several orthopedic surgeons with a trauma&#xD;
        surgery practice within the public hospital centers of the department of Finistère. These&#xD;
        include the CHU de Brest - Brest University Hospital Center (La Cavale Blanche), the HIA&#xD;
        Clermont-Tonnerre military hospital (Hôpital d'Instruction des Armées - Armed Forces Teaching&#xD;
        Hospital), the CH des Pays de Morlaix, the CH de Landerneau Ferdinand Grall, the CH de&#xD;
        Carhaix and the CH de Cornouaille Quimper Concarneau. This study was approved by the local&#xD;
        ethics committee. Among the cited hospital centers, the CHU de Brest is a level 1 trauma&#xD;
        center, the CH des pays de Morlaix, the HIA military hospital and the CH de Cornouaille are&#xD;
        level 2 trauma centers and the CH de Landerneau and Carhaix are level 3 trauma centers.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2022</start_date>
    <completion_date type="Actual">April 4, 2022</completion_date>
    <primary_completion_date type="Actual">April 1, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Influence of plate design on positioning</measure>
      <time_frame>Retrospective study on Xray during 45 days</time_frame>
      <description>The primary aim of this study was to compare six different VLPs meant to be positioned proximal to the watershed line, using the Soong classification.&#xD;
  We will assess the rate of plates positioned &quot;Soong 0+1&quot; for each plate design</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Epidemiology</measure>
      <time_frame>Retrospective study on Xray during 45 days</time_frame>
      <description>to study the epidemiology of VLP fixation, per year, as recorded by the department of Finistère (northwestern France).&#xD;
  We will assess for every year between 2009 and 2020 the prevalence of distal fracture treated by the use of a volar plate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Impact of fracture type on plate positioning</measure>
      <time_frame>Retrospective study on Xray during 45 days</time_frame>
      <description>determine whether the type of fracture has an impact on plate position as defined by the Soong classification. We will assess the rates of different types of fractures according to AO classification and the rate of plates &quot;Soong 0+1&quot; for each fracture type</description>
    </secondary_outcome>
    <number_of_groups>6</number_of_groups>
    <enrollment type="Actual">2723</enrollment>
    <condition>Distal Radius Fracture</condition>
    <arm_group>
      <arm_group_label>Zimmer Biomet</arm_group_label>
      <description>Patients who were operated with a Zimmer Biomet plate</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Newclip Technics</arm_group_label>
      <description>Patients who were operated with a Newclip Technics plate</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Stryker</arm_group_label>
      <description>Patients who were operated with a Stryker plate</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Medartis</arm_group_label>
      <description>Patients who were operated with a Medartis plate</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Medartis Footprint</arm_group_label>
      <description>Patients who were operated with a Medartis Footprint plate</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Synthes</arm_group_label>
      <description>Patients who were operated with a Synthes plate</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Distal radius fracture ORIF with a specific volar plate</intervention_name>
      <description>Patients who had a distal radius fracture were treated surgically : an ORIF was realised with a volar plate</description>
      <arm_group_label>Medartis</arm_group_label>
      <arm_group_label>Medartis Footprint</arm_group_label>
      <arm_group_label>Newclip Technics</arm_group_label>
      <arm_group_label>Stryker</arm_group_label>
      <arm_group_label>Synthes</arm_group_label>
      <arm_group_label>Zimmer Biomet</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          We included all patients with an intra-articular or extra-articular distal radial fracture&#xD;
          managed by Volar Locking Plate fixation.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          To be included, patients had to have a digital radiographic file that could be used for the&#xD;
          Soong classification. Among the volar plate fixation cases retrieved from the databases, we&#xD;
          excluded patients that were not treated with a locking plate and those with a lateral x-ray&#xD;
          that could not be interpreted. The inclusion criteria for lateral radiographs were&#xD;
          alignment of the radius, lunate, capitate and third metacarpal bones, combined with&#xD;
          radial-ulnar overlap (the ulnar styloid process projecting into the middle of the ulnar&#xD;
          head).&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
          Patient refusal No postoperative radiograph N=40 Poor quality radiograph N=214&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>102 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hoel Letissier, MD MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Brest UH</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>HIA Brest</name>
        <address>
          <city>Brest</city>
          <zip>29600</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>CHRU de brest</name>
        <address>
          <city>Brest</city>
          <zip>29609</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>CH de Landerneau</name>
        <address>
          <city>Landerneau</city>
          <zip>29</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>CH des pays de Morlaix</name>
        <address>
          <city>Morlaix</city>
          <zip>29249</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>CHIC de Quimper</name>
        <address>
          <city>Quimper</city>
          <zip>29000</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <link>
      <url>https://doi.org/10.1186/s12891-017-1596-z</url>
      <description>Jerrhag D, Englund M, Karlsson MK, Rosengren BE. Epidemiology and time trends of distal forearm fractures in adults - a study of 11.2 million person-years in Sweden. BMC Musculoskelet Disord</description>
    </link>
    <link>
      <url>https://doi.org/10.1097/BOT.0000000000000312</url>
      <description>The Epidemiology of Upper Extremity Fractures in the United States, 2009. J Orthop Trauma 2015;29:e242-244</description>
    </link>
    <link>
      <url>https://doi.org/10.2106/JBJS.G.01569</url>
      <description>Corsino CB, Reeves RA, Sieg RN. Distal Radius Fractures. StatPearls, Treasure Island (FL)</description>
    </link>
    <link>
      <url>https://doi.org/10.2106/JBJS.M.00860</url>
      <description>Fractures of the distal part of the radius. The evolution of practice over time. Where's the evidence?</description>
    </link>
    <link>
      <url>https://doi.org/10.1016/j.injury.2017.10.010</url>
      <description>Brehmer JL, Husband JB. Accelerated rehabilitation compared with a standard protocol after distal radial fractures treated with volar open reduction and internal fixation: a prospective, randomized, controlled study</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>January 7, 2022</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Distal Radius fracture</keyword>
    <keyword>Volar plate</keyword>
    <keyword>Plate design</keyword>
    <keyword>Watershed line</keyword>
    <keyword>Plate positioning</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>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All collected data that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Data will be available beginning 6 months and ending five years following the publication</ipd_time_frame>
      <ipd_access_criteria>Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011122
  org study id: 29BRC21.0084 - REDIRA
  nct id: NCT06011122
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study was to determine the impact of design on plate position at the
        level of the distal radius. Six anterior wrist plates design were analyzed relative to the
        watershed line using the Soong classification. A total of 2723 anterior locking plate
        fixation cases were analyzed and divided into six groups: Zimmer Biomet, Newclip Technics,
        Stryker, Synthes, Medartis and Medartis Footprint. The number of plates recorded as Soong
        grade 0+1 was determined for each design, then compared using the Marascuilo procedure. The
        Zimmer Biomet and Newclip plates were proximal to the Watershed line significantly more often
        than those by Synthes and Medartis Footprint. Plate position with the Medartis design was
        significantly more proximal to the Watershed line compared to its companion design, the
        Medartis Footprint plate. Plate design is a deciding factor when treating distal radial
        fractures, to avoid impingement when implant removal is not routinely planned.
  This is a retrospective multicenter study involving several orthopedic surgeons with a trauma
        surgery practice within the public hospital centers of the department of Finistère. These
        include the CHU de Brest - Brest University Hospital Center (La Cavale Blanche), the HIA
        Clermont-Tonnerre military hospital (Hôpital d'Instruction des Armées - Armed Forces Teaching
        Hospital), the CH des Pays de Morlaix, the CH de Landerneau Ferdinand Grall, the CH de
        Carhaix and the CH de Cornouaille Quimper Concarneau. This study was approved by the local
        ethics committee. Among the cited hospital centers, the CHU de Brest is a level 1 trauma
        center, the CH des pays de Morlaix, the HIA military hospital and the CH de Cornouaille are
        level 2 trauma centers and the CH de Landerneau and Carhaix are level 3 trauma centers.
  observational model: Cohort
  time perspective: Retrospective
  measure: Influence of plate design on positioning
  time frame: Retrospective study on Xray during 45 days
  description: The primary aim of this study was to compare six different VLPs meant to be positioned proximal to the watershed line, using the Soong classification.
  We will assess the rate of plates positioned "Soong 0+1" for each plate design
  measure: Epidemiology
  time frame: Retrospective study on Xray during 45 days
  description: to study the epidemiology of VLP fixation, per year, as recorded by the department of Finistère (northwestern France).
  We will assess for every year between 2009 and 2020 the prevalence of distal fracture treated by the use of a volar plate.
  measure: Impact of fracture type on plate positioning
  time frame: Retrospective study on Xray during 45 days
  description: determine whether the type of fracture has an impact on plate position as defined by the Soong classification. We will assess the rates of different types of fractures according to AO classification and the rate of plates "Soong 0+1" for each fracture type
  arm group label: Zimmer Biomet
  description: Patients who were operated with a Zimmer Biomet plate
  arm group label: Newclip Technics
  description: Patients who were operated with a Newclip Technics plate
  arm group label: Stryker
  description: Patients who were operated with a Stryker plate
  arm group label: Medartis
  description: Patients who were operated with a Medartis plate
  arm group label: Medartis Footprint
  description: Patients who were operated with a Medartis Footprint plate
  arm group label: Synthes
  description: Patients who were operated with a Synthes plate
  intervention type: Procedure
  intervention name: Distal radius fracture ORIF with a specific volar plate
  description: Patients who had a distal radius fracture were treated surgically : an ORIF was realised with a volar plate
  arm group label: Medartis
  arm group label: Medartis Footprint
  arm group label: Newclip Technics
  arm group label: Stryker
  arm group label: Synthes
  arm group label: Zimmer Biomet
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 102 Years
  healthy volunteers: No
  last name: Hoel Letissier, MD MSc
  role: Principal Investigator
  affiliation: Brest UH
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: France
  url: https://doi.org/10.1186/s12891-017-1596-z
  description: Jerrhag D, Englund M, Karlsson MK, Rosengren BE. Epidemiology and time trends of distal forearm fractures in adults - a study of 11.2 million person-years in Sweden. BMC Musculoskelet Disord
  url: https://doi.org/10.1097/BOT.0000000000000312
  description: The Epidemiology of Upper Extremity Fractures in the United States, 2009. J Orthop Trauma 2015;29:e242-244
  url: https://doi.org/10.2106/JBJS.G.01569
  description: Corsino CB, Reeves RA, Sieg RN. Distal Radius Fractures. StatPearls, Treasure Island (FL)
  url: https://doi.org/10.2106/JBJS.M.00860
  description: Fractures of the distal part of the radius. The evolution of practice over time. Where's the evidence?
  url: https://doi.org/10.1016/j.injury.2017.10.010
  description: Brehmer JL, Husband JB. Accelerated rehabilitation compared with a standard protocol after distal radial fractures treated with volar open reduction and internal fixation: a prospective, randomized, controlled study
  responsible party type: Sponsor
  mesh term: Fractures, Bone
  mesh term: Radius Fractures
  mesh term: Wrist Fractures
  sharing ipd: Yes
  ipd description: All collected data that underlie results in a publication
  ipd info type: Study Protocol
  ipd time frame: Data will be available beginning 6 months and ending five years following the publication
  ipd access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.