<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/NCT02977910</url>
  </required_header>
  <id_info>
    <org_study_id>56014768-4</org_study_id>
    <nct_id>NCT02977910</nct_id>
  </id_info>
  <brief_title>Treatment Strategy of Ankle Fracture Combined With Deltoid Ligament Rupture</brief_title>
  <official_title>Comparative Study for Ankle Fracture Combined With Deltoid Ligament Rupture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liming Cheng</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Tongji Hospital, Tongji University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ankle fracture is very common which is often combined with deltoid ligament injury. Although&#xD;
      the incidence of deltoid ligament injury is high, but there is no unified and effective&#xD;
      diagnosis method. Even whether the ankle fracture with deltoid ligament rupture needs&#xD;
      surgical repair is still controversial. There is no high-level, multi-center, large sample,&#xD;
      long-term follow-up clinical evidence to prove whether the repair of deltoid ligament is&#xD;
      necessary or not. The main content of the project: 1 Achieve accurate classification of&#xD;
      deltoid ligament rupture with intraoperative exploration. 2 Study the surgical indications&#xD;
      and treatment guidelines by comparative study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparative study for ankle fracture combined with deltoid ligament rupture: with &amp; without&#xD;
      repair of ligament&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AOFAS score</measure>
    <time_frame>12 months after surgery</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Ankle Fractures</condition>
  <arm_group>
    <arm_group_label>with repair of deltoid ligament</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>open reduction and internal fixation with repair of deltoid ligament</description>
  </arm_group>
  <arm_group>
    <arm_group_label>without repair of deltoid ligament</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>open reduction and internal fixation without repair of deltoid ligament</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>repair of deltoid ligament</intervention_name>
    <description>intraoperative repair of deltoid ligament combined with ORIF</description>
    <arm_group_label>with repair of deltoid ligament</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ankle fracture with deltoid ligament rupture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ankle fracture without deltoid ligament rupture&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 26, 2016</last_update_submitted>
  <last_update_submitted_qc>November 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Tongji Hospital, Tongji University School of Medicine</investigator_affiliation>
    <investigator_full_name>Liming Cheng</investigator_full_name>
    <investigator_title>Director, Head of orthopedics, Pricipal investigator, Clinical 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>Rupture</mesh_term>
    <mesh_term>Ankle Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02977910
org study id: 56014768-4
nct id: NCT02977910
lead sponsor: 
has dmc: No
Ankle fracture is very common which is often combined with deltoid ligament injury. Although
      the incidence of deltoid ligament injury is high, but there is no unified and effective
      diagnosis method. Even whether the ankle fracture with deltoid ligament rupture needs
      surgical repair is still controversial. There is no high-level, multi-center, large sample,
      long-term follow-up clinical evidence to prove whether the repair of deltoid ligament is
      necessary or not. The main content of the project: 1 Achieve accurate classification of
      deltoid ligament rupture with intraoperative exploration. 2 Study the surgical indications
      and treatment guidelines by comparative study.
Comparative study for ankle fracture combined with deltoid ligament rupture: with & without
      repair of ligament
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: AOFAS score
time frame: 12 months after surgery
arm group label: with repair of deltoid ligament
arm group type: Experimental
description: open reduction and internal fixation with repair of deltoid ligament
arm group label: without repair of deltoid ligament
arm group type: No Intervention
description: open reduction and internal fixation without repair of deltoid ligament
intervention type: Procedure
intervention name: repair of deltoid ligament
description: intraoperative repair of deltoid ligament combined with ORIF
arm group label: with repair of deltoid ligament
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Shanghai Tongji Hospital, Tongji University School of Medicine
investigator full name: Liming Cheng
investigator title: Director, Head of orthopedics, Pricipal investigator, Clinical professor
mesh term: Fractures, Bone
mesh term: Rupture
mesh term: Ankle Fractures
sharing ipd: Undecided