<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/NCT03297047</url>
  </required_header>
  <id_info>
    <org_study_id>Forearm combi cast 2016</org_study_id>
    <nct_id>NCT03297047</nct_id>
  </id_info>
  <brief_title>Comparing Forearm and Upper Arm Combi Cast for Distal Forearm Fractures in Children</brief_title>
  <official_title>Randomized Controlled Trial Comparing Forearm and Upper Arm Combi Cast for Immobilization After Closed Reduced Distal Forearm Fractures in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Children's Hospital, Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Children's Hospital, Zurich</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The standard treatment for children with closed reduction of displaced distal forearm&#xD;
      fractures is an immobilization with an upper arm combicast. The hypothesis is that an forearm&#xD;
      immobilization with combicast in children 4-16 years might be sufficient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children with distal radial or forearm fractures needing closed reduction are eligible for&#xD;
      this study. By drawing lots either an immobilization with an upper arm or forearm combicast&#xD;
      will be performed. Regular controls after 5, 10, 28 days, 4 weeks and 7 weeks will be&#xD;
      performed to check the rate of displacement, consolidation time, wearing comfort and movement&#xD;
      of the elbow joint after taking off the cast.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">August 29, 2019</completion_date>
  <primary_completion_date type="Actual">August 29, 2019</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>one Group with upper arm cast one Group with forearm cast</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>secondary displacement of the fracture</measure>
    <time_frame>Significant difference of secondary displaced fractures 28 days after closed reduction of fracture</time_frame>
    <description>radiological evaluation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wearing comfort of the two different casts</measure>
    <time_frame>5, 10, 28 days, 4 weeks, 7 weeks after closed reduction of fracture</time_frame>
    <description>help in daily life in hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobilisation of elbow joint after cast removal</measure>
    <time_frame>4 weeks and 7 weeks after closed reduction of fracture</time_frame>
    <description>Mobility of the elbow joint in degrees (flection and extension measurement)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Salter-Harris Type I</condition>
  <condition>Salter-Harris Type 2</condition>
  <condition>Radius Fractures</condition>
  <condition>Forearm Fracture</condition>
  <arm_group>
    <arm_group_label>upper arm combi cast</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>standardized treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>forearm combi cast</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with a forearm combi cast should be a sufficient immobilization</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>combi cast</intervention_name>
    <description>upper arm or forearm combi cast</description>
    <arm_group_label>forearm combi cast</arm_group_label>
    <arm_group_label>upper arm combi cast</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  open growth Zone&#xD;
&#xD;
          -  displaced metaphyseal radial or forearm fractures including Salter harris fracture 1&#xD;
             and 2 which require closed reduction&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  intraarticular fractures&#xD;
&#xD;
          -  open fractures&#xD;
&#xD;
          -  unstable fractures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Georg Staubli, Dr. med</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emergency department, University Children's Hospital Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital</name>
      <address>
        <city>Zurich</city>
        <zip>8032</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Paneru SR, Rijal R, Shrestha BP, Nepal P, Khanal GP, Karn NK, Singh MP, Rai P. Randomized controlled trial comparing above- and below-elbow plaster casts for distal forearm fractures in children. J Child Orthop. 2010 Jun;4(3):233-7. doi: 10.1007/s11832-010-0250-1. Epub 2010 Mar 17.</citation>
    <PMID>21629372</PMID>
  </reference>
  <reference>
    <citation>Webb GR, Galpin RD, Armstrong DG. Comparison of short and long arm plaster casts for displaced fractures in the distal third of the forearm in children. J Bone Joint Surg Am. 2006 Jan;88(1):9-17. doi: 10.2106/JBJS.E.00131.</citation>
    <PMID>16391244</PMID>
  </reference>
  <reference>
    <citation>Boyer BA, Overton B, Schrader W, Riley P, Fleissner P. Position of immobilization for pediatric forearm fractures. J Pediatr Orthop. 2002 Mar-Apr;22(2):185-7.</citation>
    <PMID>11856927</PMID>
  </reference>
  <reference>
    <citation>Bhatia M, Housden PH. Re-displacement of paediatric forearm fractures: role of plaster moulding and padding. Injury. 2006 Mar;37(3):259-68. doi: 10.1016/j.injury.2005.10.002. Epub 2006 Jan 18. Erratum In: Injury. 2006 Aug;37(8):801.</citation>
    <PMID>16414049</PMID>
  </reference>
  <reference>
    <citation>Katz K, Weigl D, Becker T, Attias J, Bar-On E. Short-term after-effect of forearm cast removal in children. J Orthop Sci. 2011 May;16(3):283-5. doi: 10.1007/s00776-011-0054-2. Epub 2011 Mar 29.</citation>
    <PMID>21590522</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 16, 2019</last_update_submitted>
  <last_update_submitted_qc>September 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Children's Hospital, Zurich</investigator_affiliation>
    <investigator_full_name>Georg Staubli</investigator_full_name>
    <investigator_title>Dr. med.</investigator_title>
  </responsible_party>
  <keyword>cast, fracture, immobilization, displacement, child</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>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/NCT03297047
org study id: Forearm combi cast 2016
nct id: NCT03297047
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The standard treatment for children with closed reduction of displaced distal forearm
      fractures is an immobilization with an upper arm combicast. The hypothesis is that an forearm
      immobilization with combicast in children 4-16 years might be sufficient.
Children with distal radial or forearm fractures needing closed reduction are eligible for
      this study. By drawing lots either an immobilization with an upper arm or forearm combicast
      will be performed. Regular controls after 5, 10, 28 days, 4 weeks and 7 weeks will be
      performed to check the rate of displacement, consolidation time, wearing comfort and movement
      of the elbow joint after taking off the cast.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: one Group with upper arm cast one Group with forearm cast
primary purpose: Treatment
masking: None (Open Label)
measure: secondary displacement of the fracture
time frame: Significant difference of secondary displaced fractures 28 days after closed reduction of fracture
description: radiological evaluation
measure: Wearing comfort of the two different casts
time frame: 5, 10, 28 days, 4 weeks, 7 weeks after closed reduction of fracture
description: help in daily life in hours
measure: Mobilisation of elbow joint after cast removal
time frame: 4 weeks and 7 weeks after closed reduction of fracture
description: Mobility of the elbow joint in degrees (flection and extension measurement)
arm group label: upper arm combi cast
arm group type: Active Comparator
description: standardized treatment
arm group label: forearm combi cast
arm group type: Experimental
description: Treatment with a forearm combi cast should be a sufficient immobilization
intervention type: Device
intervention name: combi cast
description: upper arm or forearm combi cast
arm group label: forearm combi cast
arm group label: upper arm combi cast
criteria: 
gender: All
minimum age: 4 Years
maximum age: 16 Years
healthy volunteers: No
last name: Georg Staubli, Dr. med
role: Principal Investigator
affiliation: Emergency department, University Children's Hospital Zurich
facility: 
country: Switzerland
citation: Paneru SR, Rijal R, Shrestha BP, Nepal P, Khanal GP, Karn NK, Singh MP, Rai P. Randomized controlled trial comparing above- and below-elbow plaster casts for distal forearm fractures in children. J Child Orthop. 2010 Jun;4(3):233-7. doi: 10.1007/s11832-010-0250-1. Epub 2010 Mar 17.
PMID: 21629372
citation: Webb GR, Galpin RD, Armstrong DG. Comparison of short and long arm plaster casts for displaced fractures in the distal third of the forearm in children. J Bone Joint Surg Am. 2006 Jan;88(1):9-17. doi: 10.2106/JBJS.E.00131.
PMID: 16391244
citation: Boyer BA, Overton B, Schrader W, Riley P, Fleissner P. Position of immobilization for pediatric forearm fractures. J Pediatr Orthop. 2002 Mar-Apr;22(2):185-7.
PMID: 11856927
citation: Bhatia M, Housden PH. Re-displacement of paediatric forearm fractures: role of plaster moulding and padding. Injury. 2006 Mar;37(3):259-68. doi: 10.1016/j.injury.2005.10.002. Epub 2006 Jan 18. Erratum In: Injury. 2006 Aug;37(8):801.
PMID: 16414049
citation: Katz K, Weigl D, Becker T, Attias J, Bar-On E. Short-term after-effect of forearm cast removal in children. J Orthop Sci. 2011 May;16(3):283-5. doi: 10.1007/s00776-011-0054-2. Epub 2011 Mar 29.
PMID: 21590522
responsible party type: Principal Investigator
investigator affiliation: University Children's Hospital, Zurich
investigator full name: Georg Staubli
investigator title: Dr. med.
mesh term: Fractures, Bone
mesh term: Radius Fractures
sharing ipd: No