<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/NCT01725893</url>
  </required_header>
  <id_info>
    <org_study_id>201202038RIC</org_study_id>
    <nct_id>NCT01725893</nct_id>
  </id_info>
  <brief_title>Percutaneous Tenotomy of the Toe Flexor Tendon is a Simple and Efficient Method in Treating Checkrein Deformity</brief_title>
  <official_title>Percutaneous Tenotomy of the Toe Flexor Tendon is a Simple and Efficient Method in Treating Checkrein Deformity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Checkrein deformity represents a dynamic claw toe deformity. Surgical intervention is the&#xD;
      treatment of choice and many methods have been proposed. The purpose of this study is to&#xD;
      evaluate the outcomes and complications of percutaneous segmental tenotomy of the toe flexor&#xD;
      tendons.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators reviewed fourteen patients with checkrein deformity who underwent surgery&#xD;
      in our hospital between 1993 and 2010. Five patients received FHL and flexor digitorum longus&#xD;
      (FDL) tenolysis at the musculotendinous junction; among them, two also underwent Z-plasty&#xD;
      lengthening of the FHL tendon. Nine patients underwent percutaneous segmental toe flexor&#xD;
      tenotomy. The Hallux Metatarsophalangeal- Interphalangeal Scale (Hallux MTP-IP scale) and&#xD;
      Foot and Ankle Outcome Score (FAOS), English version LK1.0 self-explanatory questionnaire&#xD;
      were used to evaluate the functional outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2012</start_date>
  <completion_date type="Anticipated">March 2013</completion_date>
  <primary_completion_date type="Anticipated">January 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">14</enrollment>
  <condition>Claw Toe</condition>
  <eligibility>
    <study_pop>
      <textblock>
        There were fourteen patients with checkrein deformity who underwent surgery in our hospital&#xD;
        between 1993 and 2010.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with checkrein deformity who underwent surgery in our hospital between 1993&#xD;
             and 2010.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had static or rigid claw toe deformity&#xD;
&#xD;
          -  Patients who had claw toe deformity secondary to neuromuscular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>73 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong-Nerng Ho, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>National Taiwan University Hospital (NTUH) Research Ethics Committee (REC)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jin-Tzer Ho, M.D</last_name>
    <phone>886 2 23123456</phone>
    <phone_ext>62515</phone_ext>
    <email>herginger@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin-Tzer Ho, M.D</last_name>
      <phone>886 2 23123456</phone>
      <phone_ext>62515</phone_ext>
      <email>herginger@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Pei-Yu Chen, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>Lee HS, Kim JS, Park SS, Lee DH, Park JM, Wapner KL. Treatment of checkrein deformity of the hallux. J Bone Joint Surg Br. 2008 Aug;90(8):1055-8. doi: 10.1302/0301-620X.90B8.20563.</citation>
    <PMID>18669962</PMID>
  </results_reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>November 13, 2012</last_update_submitted>
  <last_update_submitted_qc>November 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Taiwan University Hospital</investigator_affiliation>
    <investigator_full_name>National Taiwan University Hospital</investigator_full_name>
    <investigator_title>National Taiwan University Hospital (NTUH) Research Ethics Committee (REC)</investigator_title>
  </responsible_party>
  <keyword>Claw Toe</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hammer Toe Syndrome</mesh_term>
  </condition_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/NCT01725893
org study id: 201202038RIC
nct id: NCT01725893
lead sponsor: 
has dmc: Yes
Checkrein deformity represents a dynamic claw toe deformity. Surgical intervention is the
      treatment of choice and many methods have been proposed. The purpose of this study is to
      evaluate the outcomes and complications of percutaneous segmental tenotomy of the toe flexor
      tendons.
The investigators reviewed fourteen patients with checkrein deformity who underwent surgery
      in our hospital between 1993 and 2010. Five patients received FHL and flexor digitorum longus
      (FDL) tenolysis at the musculotendinous junction; among them, two also underwent Z-plasty
      lengthening of the FHL tendon. Nine patients underwent percutaneous segmental toe flexor
      tenotomy. The Hallux Metatarsophalangeal- Interphalangeal Scale (Hallux MTP-IP scale) and
      Foot and Ankle Outcome Score (FAOS), English version LK1.0 self-explanatory questionnaire
      were used to evaluate the functional outcomes.
observational model: Case-Only
time perspective: Retrospective
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 73 Years
healthy volunteers: No
last name: Hong-Nerng Ho, Professor
role: Study Chair
affiliation: National Taiwan University Hospital (NTUH) Research Ethics Committee (REC)
last name: Jin-Tzer Ho, M.D
phone: 886 2 23123456
phone ext: 62515
email: herginger@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
citation: Lee HS, Kim JS, Park SS, Lee DH, Park JM, Wapner KL. Treatment of checkrein deformity of the hallux. J Bone Joint Surg Br. 2008 Aug;90(8):1055-8. doi: 10.1302/0301-620X.90B8.20563.
PMID: 18669962
responsible party type: Principal Investigator
investigator affiliation: National Taiwan University Hospital
investigator full name: National Taiwan University Hospital
investigator title: National Taiwan University Hospital (NTUH) Research Ethics Committee (REC)
mesh term: Hammer Toe Syndrome