<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/NCT03765619</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300002057</org_study_id>
    <nct_id>NCT03765619</nct_id>
  </id_info>
  <brief_title>Postoperative Aspirin and Ankle Fracture Healing</brief_title>
  <official_title>Effects of Postoperative Aspirin on Ankle Fracture Healing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</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>
      This study aims to identify if postoperative aspirin use leads to a delay in fracture&#xD;
      healing. NSAIDs have long been avoided in the management of fractures, due to the belief that&#xD;
      they may impair fracture healing. As aspirin is frequently prescribed for long-term&#xD;
      management of various medical conditions, it is worth understanding if continuing to take&#xD;
      aspirin during the process of fracture healing has a clinically significant effect on the&#xD;
      rate of fracture healing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite any new clinical research on aspirin's effects on fracture healing, it is now being&#xD;
      used more commonly in the setting of fracture due to its effectiveness as a means of VTE&#xD;
      prophylaxis following major orthopedic surgery.5 Additionally, aspirin offers the benefit of&#xD;
      acting as an analgesic and many patients are prescribed aspirin in the long-term management&#xD;
      of various health conditions. With all of the potential therapeutic benefits of aspirin, it&#xD;
      is worth understanding whether prescribing this medication following operative fracture&#xD;
      repair may impose a risk of delayed fracture healing.&#xD;
&#xD;
      Patients undergoing surgical repair of ankle fractures at UAB who are deemed healthy enough&#xD;
      for orthopedic surgery will be enrolled. Patients with multiple traumatic injuries, patients&#xD;
      taking any type of blood-thinner medication, and patients taking aspirin prior to the start&#xD;
      of the study will be excluded. No other exclusions will be made based on prior health&#xD;
      conditions. There will be a group of patients that receives no aspirin and a group that does&#xD;
      receive aspirin. Approximately 250 patients will be randomly assigned to each group.&#xD;
&#xD;
      Patients will be identified for potential enrollment based on their plan to undergo surgical&#xD;
      repair of ankle fracture at UAB hospital during the IRB approval period. This study will&#xD;
      follow patients following routine protocol for ankle fracture repair and follow-up. Patients&#xD;
      will be randomized into a group that is prescribed aspirin (325 mg) post-operatively vs. not&#xD;
      prescribed aspirin. Patients will be followed throughout their recovery process. Patients&#xD;
      will be scheduled for follow-up appointments with the operating physician at 2 weeks, 6&#xD;
      weeks, 3 months, 6 months, and 1 year following surgery. Patients will be asked to give a&#xD;
      pain score (scale 1-10) and complete an SF-12 functional outcomes survey at each follow-up&#xD;
      appointment. In line with normal protocol following fracture repair, radiographs will also be&#xD;
      taken at each follow-up appointment to monitor the progression of fracture healing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 12, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2025</primary_completion_date>
  <phase>Early Phase 1</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>Prevention</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ankle Fracture Healing</measure>
    <time_frame>0 - 12 months following surgery</time_frame>
    <description>Union Rates of Ankle Fractures postoperatively as assessed clinically and radiographically. X-rays will be taken at each postoperative visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Outcomes</measure>
    <time_frame>0 - 12 months following surgery</time_frame>
    <description>Patients will complete an Short Form-12 functional outcomes survey at each follow-up appointment, which is a health outcomes scale that includes assessment of general health, physical function, pain, social function, and mental health. Scores are combined to give Physical Health Composite Scores and Mental Health Composite Scores. Scale is 0 - 100, with lower scores indicating worse outcomes, and higher scores indicating better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale for Pain</measure>
    <time_frame>0 - 12 months following surgery</time_frame>
    <description>Patients will disclose their pain level using the Visual Analog Scale, which measures pain on a scale of 0 - 100, with 0 indicating no pain and 100 indicating severe pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Ankle Fractures</condition>
  <arm_group>
    <arm_group_label>Aspirin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>250 patients will be randomized to receive Aspirin postoperatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Aspirin</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>250 patients will be randomized to not receive Aspirin postoperatively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>250 patients will be randomized to receive postoperative Aspirin.</description>
    <arm_group_label>Aspirin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years of age&#xD;
&#xD;
          -  healthy enough for orthopedic surgery&#xD;
&#xD;
          -  slated to undergo surgical repair of ankle fracture at UAB&#xD;
&#xD;
          -  able to give consent All ankle fractures (lateral malleolus, medial malleolus,&#xD;
             bimalleolar, trimalleolar, and proximal fibula) will be included in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  inability to give consent&#xD;
&#xD;
          -  Pilon fractures&#xD;
&#xD;
          -  Multiple traumatic fractures&#xD;
&#xD;
          -  Known history of aspirin allergy&#xD;
&#xD;
          -  History of severe reaction to aspirin&#xD;
&#xD;
          -  History of bleeding disorder&#xD;
&#xD;
          -  Other clear contraindication to being prescribed aspirin&#xD;
&#xD;
          -  Taking blood-thinning medications (heparin, apixaban, etc)&#xD;
&#xD;
          -  Taking aspirin prior to the start of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Aaradhana J Jha, M.D.</last_name>
    <phone>617-378-5116</phone>
    <email>aaradhana.jha@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Melanese Leonard-Warren, BSN, MSN, RN</last_name>
    <phone>205-975-2671</phone>
    <email>mnleonard@uabmc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UAB Highland Hospital</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aaradhana J. Jha, M.D.</last_name>
      <phone>617-378-5116</phone>
      <email>aaradhana.jha@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ashish B. Shah, M.D.</last_name>
      <email>ashishshah@uabmc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Ashish Shah</investigator_full_name>
    <investigator_title>M.D., Associate Professor</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>Ankle Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</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/NCT03765619
org study id: IRB-300002057
nct id: NCT03765619
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study aims to identify if postoperative aspirin use leads to a delay in fracture
      healing. NSAIDs have long been avoided in the management of fractures, due to the belief that
      they may impair fracture healing. As aspirin is frequently prescribed for long-term
      management of various medical conditions, it is worth understanding if continuing to take
      aspirin during the process of fracture healing has a clinically significant effect on the
      rate of fracture healing.
Despite any new clinical research on aspirin's effects on fracture healing, it is now being
      used more commonly in the setting of fracture due to its effectiveness as a means of VTE
      prophylaxis following major orthopedic surgery.5 Additionally, aspirin offers the benefit of
      acting as an analgesic and many patients are prescribed aspirin in the long-term management
      of various health conditions. With all of the potential therapeutic benefits of aspirin, it
      is worth understanding whether prescribing this medication following operative fracture
      repair may impose a risk of delayed fracture healing.

      Patients undergoing surgical repair of ankle fractures at UAB who are deemed healthy enough
      for orthopedic surgery will be enrolled. Patients with multiple traumatic injuries, patients
      taking any type of blood-thinner medication, and patients taking aspirin prior to the start
      of the study will be excluded. No other exclusions will be made based on prior health
      conditions. There will be a group of patients that receives no aspirin and a group that does
      receive aspirin. Approximately 250 patients will be randomly assigned to each group.

      Patients will be identified for potential enrollment based on their plan to undergo surgical
      repair of ankle fracture at UAB hospital during the IRB approval period. This study will
      follow patients following routine protocol for ankle fracture repair and follow-up. Patients
      will be randomized into a group that is prescribed aspirin (325 mg) post-operatively vs. not
      prescribed aspirin. Patients will be followed throughout their recovery process. Patients
      will be scheduled for follow-up appointments with the operating physician at 2 weeks, 6
      weeks, 3 months, 6 months, and 1 year following surgery. Patients will be asked to give a
      pain score (scale 1-10) and complete an SF-12 functional outcomes survey at each follow-up
      appointment. In line with normal protocol following fracture repair, radiographs will also be
      taken at each follow-up appointment to monitor the progression of fracture healing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Ankle Fracture Healing
time frame: 0 - 12 months following surgery
description: Union Rates of Ankle Fractures postoperatively as assessed clinically and radiographically. X-rays will be taken at each postoperative visit.
measure: Functional Outcomes
time frame: 0 - 12 months following surgery
description: Patients will complete an Short Form-12 functional outcomes survey at each follow-up appointment, which is a health outcomes scale that includes assessment of general health, physical function, pain, social function, and mental health. Scores are combined to give Physical Health Composite Scores and Mental Health Composite Scores. Scale is 0 - 100, with lower scores indicating worse outcomes, and higher scores indicating better outcomes.
measure: Visual Analog Scale for Pain
time frame: 0 - 12 months following surgery
description: Patients will disclose their pain level using the Visual Analog Scale, which measures pain on a scale of 0 - 100, with 0 indicating no pain and 100 indicating severe pain.
arm group label: Aspirin
arm group type: Experimental
description: 250 patients will be randomized to receive Aspirin postoperatively.
arm group label: Non-Aspirin
arm group type: No Intervention
description: 250 patients will be randomized to not receive Aspirin postoperatively.
intervention type: Drug
intervention name: Aspirin
description: 250 patients will be randomized to receive postoperative Aspirin.
arm group label: Aspirin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 110 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aaradhana J Jha, M.D.
phone: 617-378-5116
email: aaradhana.jha@gmail.com
last name: Melanese Leonard-Warren, BSN, MSN, RN
phone: 205-975-2671
email: mnleonard@uabmc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Ashish Shah
investigator title: M.D., Associate Professor
mesh term: Fractures, Bone
mesh term: Ankle Fractures
mesh term: Aspirin