<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/NCT03835065</url>
  </required_header>
  <id_info>
    <org_study_id>2017-1930</org_study_id>
    <nct_id>NCT03835065</nct_id>
  </id_info>
  <brief_title>Long Arm Vs Short Arm Fiberglass Cast for Treatment of Displaced Distal Radius Fractures</brief_title>
  <official_title>Long Arm Vs Short Arm Fiberglass Cast for Treatment of Displaced Distal Radius Fractures: A Multi-Center Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</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 aim of the study is to determine by multicenter randomized controlled trial whether short&#xD;
      arm fiberglass casts are as effective as long arm casts for immobilizing displaced pediatric&#xD;
      distal third forearm fractures that have undergone closed reduction.&#xD;
&#xD;
      The primary outcome is loss of reduction requiring cast wedging, recasting, repeat reduction,&#xD;
      or surgical intervention.&#xD;
&#xD;
      Secondary outcomes will include Patient Reported Outcome Measures for physical function, such&#xD;
      as Pedi-FABS, PROMIS (Patient Reported Outcomes Measurement Information System) Upper&#xD;
      Extremities , and UCLA (University of California Los Angelos) Activity Scale, and&#xD;
      pain/comfort levels,such as PROMIS Pediatric Pain Interference, PROMIS Pediatric Pain&#xD;
      Intensity, and VAS ( Visual Analogue Scale) comfort in cast. In addition, secondary outcomes&#xD;
      include complications (skin irritation, compartment syndrome, elbow stiffness, cast saw burns&#xD;
      etc). The investigators will assess potential risk factors for loss of reduction including&#xD;
      initial displacement, level of fracture (physeal, metaphyseal, meta-diaphyseal), initial&#xD;
      translation, initial angulation, age, sex, cast index, padding index, adequacy of initial&#xD;
      reduction, and provider level of training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The most common type of fracture in pediatric patients is the distal third forearm fracture,&#xD;
      with over 600,000 cases in the in the United States each year. Traditionally long arm casts&#xD;
      have been used for displaced distal forearm fractures, but it may be the case that short arm&#xD;
      casts are sufficient. Three RCTs (Randomized Control Trials) have been performed comparing&#xD;
      the efficacy of plaster short and long arm casts for displaced distal forearm fractures;&#xD;
      these studies have shown no significant difference in angulation or displacement. If short&#xD;
      and long arm casts offer comparable stability, the short arm version would likely be&#xD;
      desirable as patient satisfaction and cost effectiveness are improved with short arm casts.&#xD;
&#xD;
      Despite the results of three well-executed RCTs, it is still common practice for long arm&#xD;
      casts to be applied for distal forearm fractures. Many surgeons continue to recommend that&#xD;
      their residents apply long arm casts for all displaced forearm fractures, including distal&#xD;
      third fractures. At NYP (New York Presbyterian) Cornell and NYP Queens, residents routinely&#xD;
      apply long arm casts for all forearm fractures.&#xD;
&#xD;
      Long arm casts are more likely to result in elbow stiffness, although this is often a&#xD;
      temporary complication. Long arm casts also require more material and take longer to apply or&#xD;
      remove, potentially leading to higher treatment costs. Additionally, when a longer cast is&#xD;
      worn there is a larger distance where a cast burn could occur. Skin irritation, particularly&#xD;
      at the cubital fossa, is likely more common with a long arm cast, and they are overall less&#xD;
      comfortable, due to elbow restriction and a heavier weight.&#xD;
&#xD;
      Short arm casts that are well molded to the arm's contours have been shown to control forearm&#xD;
      supination and pronation. A low cast index has been shown to significantly increase the rate&#xD;
      of fracture redisplacement. The cast index determines the quality of cast molding, and is&#xD;
      measured by dividing the sagittal width of the cast by the coronal width. Substantial changes&#xD;
      in cast angulation have been attributed to poor cast-molding and a low cast index. The&#xD;
      results suggested that short arm casts when appropriately molded can be effective in treating&#xD;
      fractures of the distal third of the forearm.&#xD;
&#xD;
      If short arm casts are equivalent in providing stability for distal third forearm fractures,&#xD;
      providers should be using them preferentially to avoid the potential complications of elbow&#xD;
      stiffness, cast burn, skin irritation, and patient dissatisfaction. However, surgeons persist&#xD;
      with using long arm casts. Rationale for the persistent use of long arm cast is believed to&#xD;
      include anecdotal concerns of residents placing inadequate short arm casts, leading to an&#xD;
      increased risk for translation or angulation requiring recasting.&#xD;
&#xD;
      Previous RCTs, however, do not provide clear recommendations, merely demonstrating that&#xD;
      treatment using short and long arm casts lead to similar outcomes. Additionally, these past&#xD;
      RCTs have limitations. Previous studies were conducted with plaster casts and could not&#xD;
      extend their findings to other casting material. Valving techniques were also not noted in&#xD;
      these studies; it is unclear whether or not casts were bivalved, which is currently the&#xD;
      standard of care in the United States. These previous studies also randomized patients to&#xD;
      short or long arm cast prior to cast application. As a result, it is possible that when long&#xD;
      arm casts were applied the portion of cast overlying the fracture site was not molded as&#xD;
      carefully as for short arm casts. Previous studies commented on cast index, but it was not&#xD;
      clear whether residents were trained in ideal cast application and molding prior to study&#xD;
      initiation. Finally, the outcome measures used in previous studies were an arbitrary loss in&#xD;
      angulation or translation, instead of a focus on whether the fracture slipped sufficiently to&#xD;
      change the treatment required (need for cast wedging, repeat reduction and casting, or&#xD;
      surgical intervention).&#xD;
&#xD;
      The aim of the study is to determine by multicenter randomized controlled trial whether short&#xD;
      arm fiberglass casts are as effective as long arm casts for immobilizing displaced pediatric&#xD;
      distal third forearm fractures that have undergone closed reduction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Anticipated">February 11, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 11, 2024</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>Parallel Assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients requiring repeat intervention due to loss of alignment</measure>
    <time_frame>Up to 7 months</time_frame>
    <description>Proportion of patients requiring repeat intervention (cast wedging, recasting, or surgical intervention) following short arm vs long arm cast application.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain assessed by patient reported outcomes - Surveys</measure>
    <time_frame>1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks</time_frame>
    <description>Patient Reported Outcome Measures for pain as assessed by PROMIS(Patient-Reported Outcomes Measurement Information System) Pediatric Pain Interference. Highest raw score is 32, lowest raw score is 0, it is interpreted by t-score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessed by patient reported outcomes - Surveys</measure>
    <time_frame>1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks</time_frame>
    <description>Patient Reported Outcome Measures for pain as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Pain Intensity. Highest raw score is 32, lowest raw score is 0, it is interpreted by t-score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comfort assessed by patient reported outcomes - Scale</measure>
    <time_frame>1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks</time_frame>
    <description>Patient Reported Outcome Measures for pain as assessed by Visual Analog Scale (VAS) comfort in cast. VAS measures the amount of pain that a patient feels currently and ranges across a continuum from none to an extreme amount of pain. Higher values represent more pain/ worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical function assessed by patient reported outcomes - Surveys</measure>
    <time_frame>1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks</time_frame>
    <description>Patient Reported Outcome Measures for pain as assessed by Pedi-FABS ( Pediatric Functional Activity Brief Scale). Scoring of the Hospital for Special Surgery PediatricFunctional Activity Brief Scale is performed by addingpoints from each question for total possible score range from1 to 30 points. For ''Running'', ''Cutting'', ''Decelerating'',''Pivoting'', ''Duration'', and ''Endurance'', each question is worth 0, 1, 2, 3, or 4 points. Higher values mean that the child is more active.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical function assessed by patient reported outcomes - Surveys</measure>
    <time_frame>1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks</time_frame>
    <description>Patient Reported Outcome Measures for pain as assessed by PROMIS ( Patient-Reported Outcomes Measurement Information System) Upper Extremity. Within the Pediatric Upper Extremity short form, there are two items (3880R2 and 3881R1) with collapsed response categories. These items have response options scored as 3=With no trouble, 2=With a little trouble, 1=With some trouble, 0=With a lot of trouble, 0=Not able to do.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical function assessed by patient reported outcomes - Surveys</measure>
    <time_frame>1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks</time_frame>
    <description>Patient Reported Outcome Measures for pain as assessed by UCLA Activity Scale (University of California, Los Angeles Activity Scale). 1 is the lowest raw score, and 10 is the highest raw score. 1= 1: Wholly Inactive, dependent on others, and can not leave residence and 10= 10: Regularly participates in impact sports.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with complications</measure>
    <time_frame>1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks</time_frame>
    <description>irritation, compartment syndrome, elbow stiffness, cast saw burns etc</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Distal Forearm Fractures</condition>
  <arm_group>
    <arm_group_label>Long Arm Fiberglass Cast</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conscious sedation will be provided to patient while the reduction is performed by a cast trained orthopedic resident using standard techniques under fluoroscopic guidance. The arm will be held by an assistant or finger traps in the absence thereof. The arm will not be suspended until after the manipulation is performed. A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be extended to the shoulder joint if the patient is assigned to the long arm cast group. The mold will then be applied and cast construct will be bivalved and taped.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Short Arm Fiberglass Cast</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conscious sedation will be provided to patient while the reduction is performed by a cast trained orthopedic resident using standard techniques under fluoroscopic guidance. The arm will be held by an assistant or finger traps in the absence thereof. The arm will not be suspended until after the manipulation is performed. A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be complete at this point if the patient is assigned to the short arm cast group. The mold will then be applied and cast construct will be bivalved and taped.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Closed Reduction</intervention_name>
    <description>The primary goal of closed reduction is to maintain appropriate bony alignment and angulation to allow for appropriate healing.</description>
    <arm_group_label>Long Arm Fiberglass Cast</arm_group_label>
    <arm_group_label>Short Arm Fiberglass Cast</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Long Arm Fiberglass Cast</intervention_name>
    <description>A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be extended to the shoulder joint if the patient is assigned to the long arm cast group. The mold will then be applied and cast construct will be bivalved and taped.</description>
    <arm_group_label>Long Arm Fiberglass Cast</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Short Arm Fiberglass Cast</intervention_name>
    <description>A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be complete at this point if the patient is assigned to the short arm cast group. The mold will then be applied and cast construct will be bivalved and taped.</description>
    <arm_group_label>Short Arm Fiberglass Cast</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients 4-12 years of age&#xD;
&#xD;
          -  Displaced distal third forearm fracture (physeal, metaphyseal, meta-diaphyseal)&#xD;
             requiring closed reduction&#xD;
&#xD;
          -  Displacement must be: For children 4-9: angulation &gt;30 degrees and/or 100% translation&#xD;
             on either AP (anteroposterior) or lateral view. For children 10-12: angulation &gt; 15&#xD;
             degrees and/or &gt;50% translation on either AP or lateral view&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing additional orthopedic procedures at the time closed reduction of&#xD;
             distal arm fracture&#xD;
&#xD;
          -  Patient with a presenting open fracture&#xD;
&#xD;
          -  A known pathologic fracture&#xD;
&#xD;
          -  Patient with a refracture through pre-existing fracture lines&#xD;
&#xD;
          -  Patients with compartment syndrome or neuropathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emiyl R Dodwell, MD MPH FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Emily R Dodwell, MD MPH FRCSC</last_name>
    <phone>212-606-1451</phone>
    <phone_ext>212</phone_ext>
    <email>dodwelle@hss.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Grace Wang, BA</last_name>
    <phone>212-774-2121</phone>
    <phone_ext>212</phone_ext>
    <email>wangg@hss.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily R Dodwell, MD MPH FRCSC</last_name>
    </contact>
    <investigator>
      <last_name>Roger Widmann, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniel W Green, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>John S Blanco, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>David M Scher, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Shevaun M Doyle, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Peter D Fabricant, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ernest Sink, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Nellans KW, Kowalski E, Chung KC. The epidemiology of distal radius fractures. Hand Clin. 2012 May;28(2):113-25. doi: 10.1016/j.hcl.2012.02.001. Epub 2012 Apr 14.</citation>
    <PMID>22554654</PMID>
  </reference>
  <reference>
    <citation>Bohm ER, Bubbar V, Yong Hing K, Dzus A. Above and below-the-elbow plaster casts for distal forearm fractures in children. A randomized controlled trial. J Bone Joint Surg Am. 2006 Jan;88(1):1-8. doi: 10.2106/JBJS.E.00320.</citation>
    <PMID>16391243</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>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>Colaris JW, Allema JH, Biter LU, Reijman M, van de Ven CP, de Vries MR, Bloem RM, Kerver AJ, Verhaar JA. Conversion to below-elbow cast after 3 weeks is safe for diaphyseal both-bone forearm fractures in children. Acta Orthop. 2013 Oct;84(5):489-94. doi: 10.3109/17453674.2013.850010. Epub 2013 Oct 31.</citation>
    <PMID>24171685</PMID>
  </reference>
  <reference>
    <citation>Worlock P, Stower M. Fracture patterns in Nottingham children. J Pediatr Orthop. 1986 Nov-Dec;6(6):656-60. doi: 10.1097/01241398-198611000-00003.</citation>
    <PMID>3793885</PMID>
  </reference>
  <reference>
    <citation>Webb JE, Lewallen LW, Christophersen C, Krych AJ, McIntosh AL. Clinical outcome of internal fixation of unstable juvenile osteochondritis dissecans lesions of the knee. Orthopedics. 2013 Nov;36(11):e1444-9. doi: 10.3928/01477447-20131021-30.</citation>
    <PMID>24200451</PMID>
  </reference>
  <reference>
    <citation>Kamat AS, Pierse N, Devane P, Mutimer J, Horne G. Redefining the cast index: the optimum technique to reduce redisplacement in pediatric distal forearm fractures. J Pediatr Orthop. 2012 Dec;32(8):787-91. doi: 10.1097/BPO.0b013e318272474d.</citation>
    <PMID>23147621</PMID>
  </reference>
  <reference>
    <citation>Chess DG, Hyndman JC, Leahey JL, Brown DC, Sinclair AM. Short arm plaster cast for distal pediatric forearm fractures. J Pediatr Orthop. 1994 Mar-Apr;14(2):211-3. doi: 10.1097/01241398-199403000-00015.</citation>
    <PMID>8188836</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Displaced distal third forearm</keyword>
  <keyword>Pediatric Patients</keyword>
  <keyword>Closed reduction</keyword>
  <keyword>Cast</keyword>
  <keyword>Patient centered outcome data</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>
    <mesh_term>Wrist Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calpastatin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03835065
org study id: 2017-1930
nct id: NCT03835065
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to determine by multicenter randomized controlled trial whether short
      arm fiberglass casts are as effective as long arm casts for immobilizing displaced pediatric
      distal third forearm fractures that have undergone closed reduction.

      The primary outcome is loss of reduction requiring cast wedging, recasting, repeat reduction,
      or surgical intervention.

      Secondary outcomes will include Patient Reported Outcome Measures for physical function, such
      as Pedi-FABS, PROMIS (Patient Reported Outcomes Measurement Information System) Upper
      Extremities , and UCLA (University of California Los Angelos) Activity Scale, and
      pain/comfort levels,such as PROMIS Pediatric Pain Interference, PROMIS Pediatric Pain
      Intensity, and VAS ( Visual Analogue Scale) comfort in cast. In addition, secondary outcomes
      include complications (skin irritation, compartment syndrome, elbow stiffness, cast saw burns
      etc). The investigators will assess potential risk factors for loss of reduction including
      initial displacement, level of fracture (physeal, metaphyseal, meta-diaphyseal), initial
      translation, initial angulation, age, sex, cast index, padding index, adequacy of initial
      reduction, and provider level of training.
The most common type of fracture in pediatric patients is the distal third forearm fracture,
      with over 600,000 cases in the in the United States each year. Traditionally long arm casts
      have been used for displaced distal forearm fractures, but it may be the case that short arm
      casts are sufficient. Three RCTs (Randomized Control Trials) have been performed comparing
      the efficacy of plaster short and long arm casts for displaced distal forearm fractures;
      these studies have shown no significant difference in angulation or displacement. If short
      and long arm casts offer comparable stability, the short arm version would likely be
      desirable as patient satisfaction and cost effectiveness are improved with short arm casts.

      Despite the results of three well-executed RCTs, it is still common practice for long arm
      casts to be applied for distal forearm fractures. Many surgeons continue to recommend that
      their residents apply long arm casts for all displaced forearm fractures, including distal
      third fractures. At NYP (New York Presbyterian) Cornell and NYP Queens, residents routinely
      apply long arm casts for all forearm fractures.

      Long arm casts are more likely to result in elbow stiffness, although this is often a
      temporary complication. Long arm casts also require more material and take longer to apply or
      remove, potentially leading to higher treatment costs. Additionally, when a longer cast is
      worn there is a larger distance where a cast burn could occur. Skin irritation, particularly
      at the cubital fossa, is likely more common with a long arm cast, and they are overall less
      comfortable, due to elbow restriction and a heavier weight.

      Short arm casts that are well molded to the arm's contours have been shown to control forearm
      supination and pronation. A low cast index has been shown to significantly increase the rate
      of fracture redisplacement. The cast index determines the quality of cast molding, and is
      measured by dividing the sagittal width of the cast by the coronal width. Substantial changes
      in cast angulation have been attributed to poor cast-molding and a low cast index. The
      results suggested that short arm casts when appropriately molded can be effective in treating
      fractures of the distal third of the forearm.

      If short arm casts are equivalent in providing stability for distal third forearm fractures,
      providers should be using them preferentially to avoid the potential complications of elbow
      stiffness, cast burn, skin irritation, and patient dissatisfaction. However, surgeons persist
      with using long arm casts. Rationale for the persistent use of long arm cast is believed to
      include anecdotal concerns of residents placing inadequate short arm casts, leading to an
      increased risk for translation or angulation requiring recasting.

      Previous RCTs, however, do not provide clear recommendations, merely demonstrating that
      treatment using short and long arm casts lead to similar outcomes. Additionally, these past
      RCTs have limitations. Previous studies were conducted with plaster casts and could not
      extend their findings to other casting material. Valving techniques were also not noted in
      these studies; it is unclear whether or not casts were bivalved, which is currently the
      standard of care in the United States. These previous studies also randomized patients to
      short or long arm cast prior to cast application. As a result, it is possible that when long
      arm casts were applied the portion of cast overlying the fracture site was not molded as
      carefully as for short arm casts. Previous studies commented on cast index, but it was not
      clear whether residents were trained in ideal cast application and molding prior to study
      initiation. Finally, the outcome measures used in previous studies were an arbitrary loss in
      angulation or translation, instead of a focus on whether the fracture slipped sufficiently to
      change the treatment required (need for cast wedging, repeat reduction and casting, or
      surgical intervention).

      The aim of the study is to determine by multicenter randomized controlled trial whether short
      arm fiberglass casts are as effective as long arm casts for immobilizing displaced pediatric
      distal third forearm fractures that have undergone closed reduction.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Patients requiring repeat intervention due to loss of alignment
time frame: Up to 7 months
description: Proportion of patients requiring repeat intervention (cast wedging, recasting, or surgical intervention) following short arm vs long arm cast application.
measure: Pain assessed by patient reported outcomes - Surveys
time frame: 1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks
description: Patient Reported Outcome Measures for pain as assessed by PROMIS(Patient-Reported Outcomes Measurement Information System) Pediatric Pain Interference. Highest raw score is 32, lowest raw score is 0, it is interpreted by t-score.
measure: Pain assessed by patient reported outcomes - Surveys
time frame: 1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks
description: Patient Reported Outcome Measures for pain as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Pain Intensity. Highest raw score is 32, lowest raw score is 0, it is interpreted by t-score.
measure: Comfort assessed by patient reported outcomes - Scale
time frame: 1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks
description: Patient Reported Outcome Measures for pain as assessed by Visual Analog Scale (VAS) comfort in cast. VAS measures the amount of pain that a patient feels currently and ranges across a continuum from none to an extreme amount of pain. Higher values represent more pain/ worse outcome.
measure: Physical function assessed by patient reported outcomes - Surveys
time frame: 1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks
description: Patient Reported Outcome Measures for pain as assessed by Pedi-FABS ( Pediatric Functional Activity Brief Scale). Scoring of the Hospital for Special Surgery PediatricFunctional Activity Brief Scale is performed by addingpoints from each question for total possible score range from1 to 30 points. For ''Running'', ''Cutting'', ''Decelerating'',''Pivoting'', ''Duration'', and ''Endurance'', each question is worth 0, 1, 2, 3, or 4 points. Higher values mean that the child is more active.
measure: Physical function assessed by patient reported outcomes - Surveys
time frame: 1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks
description: Patient Reported Outcome Measures for pain as assessed by PROMIS ( Patient-Reported Outcomes Measurement Information System) Upper Extremity. Within the Pediatric Upper Extremity short form, there are two items (3880R2 and 3881R1) with collapsed response categories. These items have response options scored as 3=With no trouble, 2=With a little trouble, 1=With some trouble, 0=With a lot of trouble, 0=Not able to do.
measure: Physical function assessed by patient reported outcomes - Surveys
time frame: 1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks
description: Patient Reported Outcome Measures for pain as assessed by UCLA Activity Scale (University of California, Los Angeles Activity Scale). 1 is the lowest raw score, and 10 is the highest raw score. 1= 1: Wholly Inactive, dependent on others, and can not leave residence and 10= 10: Regularly participates in impact sports.
measure: Number of Participants with complications
time frame: 1 week +/- 5 days visit, 3 weeks +/- 1 week, 6 weeks +/- 1 week, 3 months +/- 2 weeks , 6 months +/- 4 weeks
description: irritation, compartment syndrome, elbow stiffness, cast saw burns etc
arm group label: Long Arm Fiberglass Cast
arm group type: Active Comparator
description: Conscious sedation will be provided to patient while the reduction is performed by a cast trained orthopedic resident using standard techniques under fluoroscopic guidance. The arm will be held by an assistant or finger traps in the absence thereof. The arm will not be suspended until after the manipulation is performed. A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be extended to the shoulder joint if the patient is assigned to the long arm cast group. The mold will then be applied and cast construct will be bivalved and taped.
arm group label: Short Arm Fiberglass Cast
arm group type: Experimental
description: Conscious sedation will be provided to patient while the reduction is performed by a cast trained orthopedic resident using standard techniques under fluoroscopic guidance. The arm will be held by an assistant or finger traps in the absence thereof. The arm will not be suspended until after the manipulation is performed. A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be complete at this point if the patient is assigned to the short arm cast group. The mold will then be applied and cast construct will be bivalved and taped.
intervention type: Procedure
intervention name: Closed Reduction
description: The primary goal of closed reduction is to maintain appropriate bony alignment and angulation to allow for appropriate healing.
arm group label: Long Arm Fiberglass Cast
arm group label: Short Arm Fiberglass Cast
intervention type: Other
intervention name: Long Arm Fiberglass Cast
description: A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be extended to the shoulder joint if the patient is assigned to the long arm cast group. The mold will then be applied and cast construct will be bivalved and taped.
arm group label: Long Arm Fiberglass Cast
intervention type: Other
intervention name: Short Arm Fiberglass Cast
description: A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be complete at this point if the patient is assigned to the short arm cast group. The mold will then be applied and cast construct will be bivalved and taped.
arm group label: Short Arm Fiberglass Cast
criteria: 
gender: All
minimum age: 4 Years
maximum age: 12 Years
healthy volunteers: No
last name: Emiyl R Dodwell, MD MPH FRCSC
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
last name: Emily R Dodwell, MD MPH FRCSC
phone: 212-606-1451
phone ext: 212
email: dodwelle@hss.edu
last name: Grace Wang, BA
phone: 212-774-2121
phone ext: 212
email: wangg@hss.edu
facility: 
status: Recruiting
contact: 
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country: United States
citation: Nellans KW, Kowalski E, Chung KC. The epidemiology of distal radius fractures. Hand Clin. 2012 May;28(2):113-25. doi: 10.1016/j.hcl.2012.02.001. Epub 2012 Apr 14.
PMID: 22554654
citation: Bohm ER, Bubbar V, Yong Hing K, Dzus A. Above and below-the-elbow plaster casts for distal forearm fractures in children. A randomized controlled trial. J Bone Joint Surg Am. 2006 Jan;88(1):1-8. doi: 10.2106/JBJS.E.00320.
PMID: 16391243
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: 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: Colaris JW, Allema JH, Biter LU, Reijman M, van de Ven CP, de Vries MR, Bloem RM, Kerver AJ, Verhaar JA. Conversion to below-elbow cast after 3 weeks is safe for diaphyseal both-bone forearm fractures in children. Acta Orthop. 2013 Oct;84(5):489-94. doi: 10.3109/17453674.2013.850010. Epub 2013 Oct 31.
PMID: 24171685
citation: Worlock P, Stower M. Fracture patterns in Nottingham children. J Pediatr Orthop. 1986 Nov-Dec;6(6):656-60. doi: 10.1097/01241398-198611000-00003.
PMID: 3793885
citation: Webb JE, Lewallen LW, Christophersen C, Krych AJ, McIntosh AL. Clinical outcome of internal fixation of unstable juvenile osteochondritis dissecans lesions of the knee. Orthopedics. 2013 Nov;36(11):e1444-9. doi: 10.3928/01477447-20131021-30.
PMID: 24200451
citation: Kamat AS, Pierse N, Devane P, Mutimer J, Horne G. Redefining the cast index: the optimum technique to reduce redisplacement in pediatric distal forearm fractures. J Pediatr Orthop. 2012 Dec;32(8):787-91. doi: 10.1097/BPO.0b013e318272474d.
PMID: 23147621
citation: Chess DG, Hyndman JC, Leahey JL, Brown DC, Sinclair AM. Short arm plaster cast for distal pediatric forearm fractures. J Pediatr Orthop. 1994 Mar-Apr;14(2):211-3. doi: 10.1097/01241398-199403000-00015.
PMID: 8188836
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Radius Fractures
mesh term: Wrist Fractures
mesh term: Calpastatin