<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/NCT01726855</url>
  </required_header>
  <id_info>
    <org_study_id>sun_rising</org_study_id>
    <nct_id>NCT01726855</nct_id>
  </id_info>
  <brief_title>Prevention of Adhesions Following Flexor Tendon Injury Within Zone II With Vascularized Finger Dorsal Fascial Flap</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Hospital of Tangshan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second Hospital of Tangshan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to report a new method of flexor tendon repair in zone II with&#xD;
      combined standard modified Kessler technique and vascularized finger dorsal fascial flap&#xD;
      pedicled with dorsal cutaneous branch of proper digital artery ,which is transported to&#xD;
      finger volar for placement of a mechanical barrier between flexor digitorum superficialis&#xD;
      /profundus tendons. The function outcomes of 14 patients (Group A) with flexor tendon repair&#xD;
      in zone II with this new technique were compared with those of 32 patients (Group B) with&#xD;
      flexor tendon repair in zone II with standard modified Kessler technique. This new technique&#xD;
      may prevent serious adhesions between flexor digitorum superficialis /profundus tendons.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the modified Strickland system</measure>
    <time_frame>3~12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>degrees of the maximum active flexion at the distal interphalangeal joint</measure>
    <time_frame>3~12 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1</enrollment>
  <condition>Restoration of the Sliding Function Effectively After Flexor Tendon Repair Within Zone II</condition>
  <arm_group>
    <arm_group_label>dorsal fascial flap</arm_group_label>
    <description>combined with standard modified Kessler technique and vascularized finger dorsal fascial flap pedicled with dorsal cutaneous branch of proper digital artery ,which is transported to finger palmar for placement of a mechanical barrier between flexor digitorum superficialis /profundus tendons.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard modified Kessler technique</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>vascularized finger dorsal fascial flap</intervention_name>
    <arm_group_label>dorsal fascial flap</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients requiring flexor tendon repair or reconstruction within zoneⅡ&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients requiring flexor tendon repair or reconstruction within zoneⅡ&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>the Second Hospital of Tangshan</name>
      <address>
        <city>Tangshan</city>
        <state>Hebei</state>
        <zip>063000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 11, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>November 14, 2012</last_update_submitted>
  <last_update_submitted_qc>November 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tendon repair</keyword>
  <!-- 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/NCT01726855
org study id: sun_rising
nct id: NCT01726855
lead sponsor: 
has dmc: Yes
The purpose of this study was to report a new method of flexor tendon repair in zone II with
      combined standard modified Kessler technique and vascularized finger dorsal fascial flap
      pedicled with dorsal cutaneous branch of proper digital artery ,which is transported to
      finger volar for placement of a mechanical barrier between flexor digitorum superficialis
      /profundus tendons. The function outcomes of 14 patients (Group A) with flexor tendon repair
      in zone II with this new technique were compared with those of 32 patients (Group B) with
      flexor tendon repair in zone II with standard modified Kessler technique. This new technique
      may prevent serious adhesions between flexor digitorum superficialis /profundus tendons.
observational model: Case-Control
time perspective: Retrospective
measure: the modified Strickland system
time frame: 3~12 months
measure: degrees of the maximum active flexion at the distal interphalangeal joint
time frame: 3~12 months
arm group label: dorsal fascial flap
description: combined with standard modified Kessler technique and vascularized finger dorsal fascial flap pedicled with dorsal cutaneous branch of proper digital artery ,which is transported to finger palmar for placement of a mechanical barrier between flexor digitorum superficialis /profundus tendons.
arm group label: standard modified Kessler technique
intervention type: Procedure
intervention name: vascularized finger dorsal fascial flap
arm group label: dorsal fascial flap
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor