<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/NCT02198768</url>
  </required_header>
  <id_info>
    <org_study_id>06-12-03A</org_study_id>
    <nct_id>NCT02198768</nct_id>
  </id_info>
  <brief_title>Ankle Fracture vs Ankle Fracture-Dislocation</brief_title>
  <official_title>Functional Outcome After Ankle Fractures and Ankle Fracture-Dislocations: A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare outcomes of patients with an ankle fracture to those&#xD;
      with ankle fracture-dislocations. We hypothesize that long-term clinical outcomes for&#xD;
      patients sustaining ankle fracture dislocations are poorer than those without dislocation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Orthopaedic literature has very limited data regarding outcomes following ankle fracture&#xD;
      dislocations. Increased knowledge of the long-term consequences of these injuries could usher&#xD;
      in changes to treatment paradigms, potentially resulting in improved outcomes. Thirty&#xD;
      patients will be enrolled into two arms of this prospective study: isolated ankle fractures&#xD;
      and ankle fracture dislocations. Patients will be followed through their operative and&#xD;
      postoperative course and clinical and radiographic assessments will be analyzed. We plan to&#xD;
      compare the clinical, radiographic, and functional outcomes of patients with ankle fractures&#xD;
      to those with ankle fracture-dislocations. We also plan to identify factors that contribute&#xD;
      to or predict poor clinical, functional, and/or radiographic outcomes in patients with ankle&#xD;
      fractures and fracture-dislocations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Functional Outcome</measure>
    <time_frame>6, 12, and 24 months</time_frame>
    <description>Clinical and functional outcomes will be measured using the Foot and Ankle Ability Measure (FAAM) and the Short Form Musculoskeletal Functional Assessment (SMFA).&#xD;
Radiographic analysis will be performed to determine nonunion, malunion, joint space incongruity, hardware failure/loosening, and/or severity of osteoarthritis. The Van Dijk grading scale will be used for radiographic assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiographic Outcome</measure>
    <time_frame>24 month</time_frame>
    <description>Radiographic analysis will be performed to determine nonunion, malunion, joint space incongruity, hardware failure/loosening, and/or severity of osteoarthritis. The Van Dijk grading scale will be used for radiographic assessment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Additional surgical procedures</measure>
    <time_frame>2 years</time_frame>
    <description>Documentation of any additional surgical procedures conducted on the affected ankle. Any surgical procedure will be noted. These may include debridement for infection or dehiscence, revision for hardware failure, arthroscopy, ankle arthrodesis, or cartilage restoration procedures.</description>
  </other_outcome>
  <other_outcome>
    <measure>Postoperative Complications</measure>
    <time_frame>2 years</time_frame>
    <description>Postoperative complications will be documented and analyzed to determine if there are significant differences between the two groups. These will include infection requiring antibiotics or debridement, hardware failure, nerve or vascular injury, deep venous thrombosis, or revision surgery.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Ankle Fractures</condition>
  <arm_group>
    <arm_group_label>Ankle Fracture</arm_group_label>
    <description>Patients with isolated ankle fractures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ankle Fracture-Dislocation</arm_group_label>
    <description>Patients with ankle fracture-dislocations.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Population will be selected from Carolinas Medical Center Level I Trauma Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who sustain an isolated bi-malleolar or trimalleolar ankle fracture or an&#xD;
             ankle fracture-dislocation requiring open reduction internal fixation&#xD;
&#xD;
          -  Patients ages 18 and over&#xD;
&#xD;
          -  The subject is psychosocially, mentally, and physically able to understand and comply&#xD;
             with the requirements of the study&#xD;
&#xD;
          -  Open and closed fractures (excluding Gustilo grade 3)&#xD;
&#xD;
          -  English must be patient's primary language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous injury or significant osteoarthritis to the affected ankle&#xD;
&#xD;
          -  Current ipsilateral or contralateral lower extremity injury with the exception of a&#xD;
             contralateral ankle fracture or fracture-dislocation&#xD;
&#xD;
          -  Retained hardware from a previous injury at or around the tibia-talar joint of the&#xD;
             affected extremity&#xD;
&#xD;
          -  Patients under the age of 18&#xD;
&#xD;
          -  History of inflammatory arthropathy&#xD;
&#xD;
          -  Traumatic Brain Injury or Spinal Cord Injury preventing weightbearing on the lower&#xD;
             extremities&#xD;
&#xD;
          -  The subject has another concurrent physical or mental condition that is likely to&#xD;
             affect compliance with the study requirements&#xD;
&#xD;
          -  Patients with Gustilo grade 3B and 3C open fractures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Bosse, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carolinas Medical Center- Main</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>March 28, 2013</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ankle fracture</keyword>
  <keyword>ankle fracture-dislocation</keyword>
  <keyword>prospective</keyword>
  <keyword>observational</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Dislocations</mesh_term>
    <mesh_term>Fracture Dislocation</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Ankle Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data Sharing will need to be discussed with investigators.</ipd_description>
  </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/NCT02198768
org study id: 06-12-03A
nct id: NCT02198768
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare outcomes of patients with an ankle fracture to those
      with ankle fracture-dislocations. We hypothesize that long-term clinical outcomes for
      patients sustaining ankle fracture dislocations are poorer than those without dislocation.
Orthopaedic literature has very limited data regarding outcomes following ankle fracture
      dislocations. Increased knowledge of the long-term consequences of these injuries could usher
      in changes to treatment paradigms, potentially resulting in improved outcomes. Thirty
      patients will be enrolled into two arms of this prospective study: isolated ankle fractures
      and ankle fracture dislocations. Patients will be followed through their operative and
      postoperative course and clinical and radiographic assessments will be analyzed. We plan to
      compare the clinical, radiographic, and functional outcomes of patients with ankle fractures
      to those with ankle fracture-dislocations. We also plan to identify factors that contribute
      to or predict poor clinical, functional, and/or radiographic outcomes in patients with ankle
      fractures and fracture-dislocations.
observational model: Cohort
time perspective: Prospective
measure: Change in Functional Outcome
time frame: 6, 12, and 24 months
description: Clinical and functional outcomes will be measured using the Foot and Ankle Ability Measure (FAAM) and the Short Form Musculoskeletal Functional Assessment (SMFA).
Radiographic analysis will be performed to determine nonunion, malunion, joint space incongruity, hardware failure/loosening, and/or severity of osteoarthritis. The Van Dijk grading scale will be used for radiographic assessment.
measure: Radiographic Outcome
time frame: 24 month
description: Radiographic analysis will be performed to determine nonunion, malunion, joint space incongruity, hardware failure/loosening, and/or severity of osteoarthritis. The Van Dijk grading scale will be used for radiographic assessment.
measure: Additional surgical procedures
time frame: 2 years
description: Documentation of any additional surgical procedures conducted on the affected ankle. Any surgical procedure will be noted. These may include debridement for infection or dehiscence, revision for hardware failure, arthroscopy, ankle arthrodesis, or cartilage restoration procedures.
measure: Postoperative Complications
time frame: 2 years
description: Postoperative complications will be documented and analyzed to determine if there are significant differences between the two groups. These will include infection requiring antibiotics or debridement, hardware failure, nerve or vascular injury, deep venous thrombosis, or revision surgery.
arm group label: Ankle Fracture
description: Patients with isolated ankle fractures.
arm group label: Ankle Fracture-Dislocation
description: Patients with ankle fracture-dislocations.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Bosse, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Joint Dislocations
mesh term: Fracture Dislocation
mesh term: Fractures, Bone
mesh term: Ankle Fractures
sharing ipd: Undecided
ipd description: Data Sharing will need to be discussed with investigators.