<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/NCT03248687</url>
  </required_header>
  <id_info>
    <org_study_id>1000053044</org_study_id>
    <nct_id>NCT03248687</nct_id>
  </id_info>
  <brief_title>Distal Radius Buckle Fracture Follow up Study</brief_title>
  <official_title>Home Management Versus Primary Care Physician Follow up in Children With Distal Radius Fractures: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Physician Services Incorporated</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hospital for Sick Children</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 investigators will be enrolling children with distal radius buckle fractures, treating&#xD;
      them with a removable splint and randomizing them to follow up as needed vs required follow&#xD;
      up with a primary care physician 1-2 weeks after the ED visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Buckle fractures of the distal forearm that include the radius are the most common fracture&#xD;
      in childhood, and the risk of this fracture occurring is about 1 in every 25 children.Despite&#xD;
      the high frequency of this fracture, it is a very stable injury and thus can be safely&#xD;
      treated with a removable wrist splint while the fracture heals. Furthermore, authors have&#xD;
      concluded that since orthopedic intervention is exceedingly rare, this type of fracture may&#xD;
      safely be followed by a primary care physician (PCP) or managed at home.&#xD;
&#xD;
      In Canada, about 50% of these injuries are routinely discharged from the ED for follow up&#xD;
      with the PCP, instead of an orthopedic clinic. The investigators' work examined the&#xD;
      management outcomes of 180 children with a distal radius buckle fractures who were treated in&#xD;
      an ED with a removable splint, given anticipatory guidance, and advised to follow up in two&#xD;
      weeks with their PCP. We demonstrated that PCP follow up was safe and effective, with about&#xD;
      90% of patients completing their care at the PCP without additional visits to an ED or&#xD;
      orthopedic surgeon. All patients recovered as expected without complications. However, about&#xD;
      50% of these patients did not receive additional anticipatory guidance from their PCPs on&#xD;
      duration of splint use or expected timing of return to usual activities at the PCP visit.&#xD;
      Nevertheless, patients with and without this additional anticipatory guidance reported a&#xD;
      similar duration of splint use and timing for return to usual activities, largely based on&#xD;
      what was recommended at the ED visit. Since these injuries are inherently stable, carry an&#xD;
      excellent prognosis, and are treated with a splint that can be removed at home in accordance&#xD;
      with anticipatory guidance provided in the ED, it calls into question the need for any&#xD;
      routine physician follow up of these common minor fractures.&#xD;
&#xD;
      If home management of distal radius buckle fracture after ED discharge demonstrated safety&#xD;
      and effectiveness in a methodologically robust study, it would have clear advantages for&#xD;
      patients and families, physicians, and the health care system. The frustrations of lengthy&#xD;
      clinic visits and transport difficulties would be avoided. Parents would miss less time away&#xD;
      from work or other priorities, and the patients themselves would not miss school. In&#xD;
      medically under-serviced communities in particular, patients would avoid long travel&#xD;
      distances to see a physician for this minor injury where physician intervention after the ED&#xD;
      visit is rarely required. Furthermore, it will obviate the need to shift the care of these&#xD;
      common minor fractures from the orthopedic surgeon to the PCP, relieving some pressure on&#xD;
      health care practitioners and increase availability for other patients more in need of&#xD;
      physician services. Importantly, the potential for reduced use of superfluous health care&#xD;
      services for this common injury is also likely to result in health care cost savings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 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>Enrolled patients will be randomized to one of two follow up arms</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The outcomes assessor will not know if the patient was followed at home or by a primary care provider.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Activity Scales for Kids - Performance Version, which is a validated activity scale that measures the ability of a child's physical function</measure>
    <time_frame>Three weeks post injury</time_frame>
    <description>The Activity Scales for Kids is a validated activity scale that measures a child's physical function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of children with splint use &quot;almost all of the time&quot; &gt; 3 weeks duration</measure>
    <time_frame>12 weeks</time_frame>
    <description>The investigators will ask parents at three weeks if they use the splint, &quot;almost never,&quot; &quot;sometimes,&quot; &quot;frequently,&quot; or &quot;almost all of the time.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of children who received unscheduled visits to a physician for the index wrist injury, obtained by parental report and Canadian Institute of Health Information data</measure>
    <time_frame>12 weeks</time_frame>
    <description>At 12 weeks, the investigators will determine which children visited a physician for the index wrist injury as per parental report and/or data available from CIHI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of parents who rated the satisfaction with their care as &quot;very satisfied/satisfied.&quot;</measure>
    <time_frame>4 weeks</time_frame>
    <description>The investigators will ask parents to rate the satisfaction with their care at 4 weeks on the following scale: &quot;unsatisfied,&quot; somewhat satisfied,&quot; and &quot;very satisfied.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Economic Evaluation - dollar values will be obtained for patient and health care costs and compared between the groups.</measure>
    <time_frame>12 weeks</time_frame>
    <description>The investigators will determine costs of patient and health care events using available sources for this information.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">149</enrollment>
  <condition>Distal Radius Fracture</condition>
  <arm_group>
    <arm_group_label>Home follow up</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with a distal radius buckle fracture treated in a removable splint will be provided with discharge instructions and anticipatory guidance without any scheduled physician follow up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Primary Care Physician Follow up</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with a distal radius buckle fracture treated in a removable splint will be provided with discharge instructions and anticipatory guidance with scheduled primary care physician follow up at 1-2 weeks post visit to the emergency department.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Follow up</intervention_name>
    <description>The intervention will be method of follow up.</description>
    <arm_group_label>Home follow up</arm_group_label>
    <arm_group_label>Primary Care Physician Follow up</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Otherwise healthy children aged 5 to 17 years who present to the study ED within three&#xD;
             days of a wrist injury that is diagnosed in the ED as a distal radius buckle fracture&#xD;
             will be eligible for enrolment. Furthermore, approximately 15% of children with this&#xD;
             fracture have an associated ulnar buckle or ulnar styloid fracture. In previous&#xD;
             similar research, children with these associated ulnar fractures were included in the&#xD;
             study population. Thus, distal radius buckle fractures with or without an associated&#xD;
             buckle/styloid fracture of the distal ulna will be eligible for participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Children at risk for pathologic fractures such as those with congenital or acquired&#xD;
             bony disease (Appendix I).&#xD;
&#xD;
          2. Congenital anomalies of the extremities which may complicate clinical or radiographic&#xD;
             assessment.&#xD;
&#xD;
          3. Multisystem trauma and multiple fractures of the same limb since these patients would&#xD;
             require additional management and follow-up beyond that of an isolated buckle&#xD;
             fracture.&#xD;
&#xD;
          4. Patients cognitively and developmentally delayed such that they are unable to&#xD;
             communicate pain or have limited performance in activities of daily living at&#xD;
             baseline.&#xD;
&#xD;
          5. Past history of ipsilateral distal radius/ulna fracture within 3 months of enrollment.&#xD;
&#xD;
          6. Patients who do not have phone or electronic mail access. This will preclude follow up&#xD;
             of these patients.&#xD;
&#xD;
          7. Patients in whom the English language is so limited that consent and/or follow up is&#xD;
             not possible.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kathy Boutis</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>May 8, 2020</last_update_submitted>
  <last_update_submitted_qc>May 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Kathy Boutis</investigator_full_name>
    <investigator_title>Staff Physician and Sr. Associate Scientist</investigator_title>
  </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>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/NCT03248687
org study id: 1000053044
nct id: NCT03248687
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators will be enrolling children with distal radius buckle fractures, treating
      them with a removable splint and randomizing them to follow up as needed vs required follow
      up with a primary care physician 1-2 weeks after the ED visit.
Buckle fractures of the distal forearm that include the radius are the most common fracture
      in childhood, and the risk of this fracture occurring is about 1 in every 25 children.Despite
      the high frequency of this fracture, it is a very stable injury and thus can be safely
      treated with a removable wrist splint while the fracture heals. Furthermore, authors have
      concluded that since orthopedic intervention is exceedingly rare, this type of fracture may
      safely be followed by a primary care physician (PCP) or managed at home.

      In Canada, about 50% of these injuries are routinely discharged from the ED for follow up
      with the PCP, instead of an orthopedic clinic. The investigators' work examined the
      management outcomes of 180 children with a distal radius buckle fractures who were treated in
      an ED with a removable splint, given anticipatory guidance, and advised to follow up in two
      weeks with their PCP. We demonstrated that PCP follow up was safe and effective, with about
      90% of patients completing their care at the PCP without additional visits to an ED or
      orthopedic surgeon. All patients recovered as expected without complications. However, about
      50% of these patients did not receive additional anticipatory guidance from their PCPs on
      duration of splint use or expected timing of return to usual activities at the PCP visit.
      Nevertheless, patients with and without this additional anticipatory guidance reported a
      similar duration of splint use and timing for return to usual activities, largely based on
      what was recommended at the ED visit. Since these injuries are inherently stable, carry an
      excellent prognosis, and are treated with a splint that can be removed at home in accordance
      with anticipatory guidance provided in the ED, it calls into question the need for any
      routine physician follow up of these common minor fractures.

      If home management of distal radius buckle fracture after ED discharge demonstrated safety
      and effectiveness in a methodologically robust study, it would have clear advantages for
      patients and families, physicians, and the health care system. The frustrations of lengthy
      clinic visits and transport difficulties would be avoided. Parents would miss less time away
      from work or other priorities, and the patients themselves would not miss school. In
      medically under-serviced communities in particular, patients would avoid long travel
      distances to see a physician for this minor injury where physician intervention after the ED
      visit is rarely required. Furthermore, it will obviate the need to shift the care of these
      common minor fractures from the orthopedic surgeon to the PCP, relieving some pressure on
      health care practitioners and increase availability for other patients more in need of
      physician services. Importantly, the potential for reduced use of superfluous health care
      services for this common injury is also likely to result in health care cost savings.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Enrolled patients will be randomized to one of two follow up arms
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
masking description: The outcomes assessor will not know if the patient was followed at home or by a primary care provider.
measure: Activity Scales for Kids - Performance Version, which is a validated activity scale that measures the ability of a child's physical function
time frame: Three weeks post injury
description: The Activity Scales for Kids is a validated activity scale that measures a child's physical function
measure: Proportion of children with splint use "almost all of the time" > 3 weeks duration
time frame: 12 weeks
description: The investigators will ask parents at three weeks if they use the splint, "almost never," "sometimes," "frequently," or "almost all of the time."
measure: Proportion of children who received unscheduled visits to a physician for the index wrist injury, obtained by parental report and Canadian Institute of Health Information data
time frame: 12 weeks
description: At 12 weeks, the investigators will determine which children visited a physician for the index wrist injury as per parental report and/or data available from CIHI
measure: Proportion of parents who rated the satisfaction with their care as "very satisfied/satisfied."
time frame: 4 weeks
description: The investigators will ask parents to rate the satisfaction with their care at 4 weeks on the following scale: "unsatisfied," somewhat satisfied," and "very satisfied."
measure: Health Economic Evaluation - dollar values will be obtained for patient and health care costs and compared between the groups.
time frame: 12 weeks
description: The investigators will determine costs of patient and health care events using available sources for this information.
arm group label: Home follow up
arm group type: Experimental
description: Patients with a distal radius buckle fracture treated in a removable splint will be provided with discharge instructions and anticipatory guidance without any scheduled physician follow up.
arm group label: Primary Care Physician Follow up
arm group type: Active Comparator
description: Patients with a distal radius buckle fracture treated in a removable splint will be provided with discharge instructions and anticipatory guidance with scheduled primary care physician follow up at 1-2 weeks post visit to the emergency department.
intervention type: Other
intervention name: Follow up
description: The intervention will be method of follow up.
arm group label: Home follow up
arm group label: Primary Care Physician Follow up
criteria: 
gender: All
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Kathy Boutis
investigator title: Staff Physician and Sr. Associate Scientist
mesh term: Fractures, Bone
mesh term: Radius Fractures
mesh term: Wrist Fractures
sharing ipd: No