<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/NCT02984462</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2015/39</org_study_id>
    <nct_id>NCT02984462</nct_id>
  </id_info>
  <brief_title>Akin Osteotomy With or Without Fixation</brief_title>
  <acronym>AKIN</acronym>
  <official_title>Is Fixation of Percutaneous Akin Osteotomy Enhanced First Ray Post-operative Mobility? A Prospective Randomized Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a prospective randomized study about hallux valgus surgery. The investigator try&#xD;
      to assess if the fixation of percutaneous Akin osteotomy with a cannulated screw have an&#xD;
      incidence in the first ray mobility since the two technics ( fixation and no-fixation) are&#xD;
      described and practiced, and since the stiffness of the first metatarso-phalangeal joint is&#xD;
      determinant in the result of this functional surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It's a prospective monocentric randomized work about forefoot surgery. Every patient included&#xD;
      undergoes an hallux valgus chevron osteotomy of the first metatarsal associated with a&#xD;
      percutaneous Akin osteotomy of the first phalange. The investigators study the impact of the&#xD;
      fixation of percutaneous Akin osteotomy ( osteotomy of the first phalange of hallux) with two&#xD;
      arms: one with fixation of the percutaneous Akin osteotomy, and one with a non-fixed&#xD;
      percutaneous Akin osteotomy This study as been approved by Institutional review board;&#xD;
      written informed consent is required for all patients before inclusion.&#xD;
&#xD;
      The clinic follow-up of each patients included in the study will be the same of the normal&#xD;
      follow-up for this type of surgery in our practice. This includes clinical exam, radiologic&#xD;
      exam, and functional score AOFAS before surgery, at 6 weeks after the surgery, four months&#xD;
      after surgery and finally one year after the surgery.&#xD;
&#xD;
      The primary outcome measure which is the first metatarso-phalangeal global mobility will be&#xD;
      blindly measure by an observator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 31, 2017</start_date>
  <completion_date type="Actual">September 8, 2020</completion_date>
  <primary_completion_date type="Actual">September 8, 2020</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global Mobility in degrees of the metatarso-phalangeal joint of the hallux one year after the surgery.</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Angle between Metatarsus 1 and Phalanx 1</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angle between Metatarsus 1 and Metatarsus 2</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angle between Phalanx 1 and Phalanx 2</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distal Metatarsal Articular Angle</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DM2A angle, calculated preoperatively by measuring the angle between the metatarsal diaphysis M2 and the tangent at the vertex of the distal articular surface</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DM2A angle, calculated at last follow-up by measuring the angle between the metatarsal diaphysis M2 and the tangent at the vertex of the distal articular surface</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kitaoka Score</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Hallux Valgus</condition>
  <arm_group>
    <arm_group_label>screw fixation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surgical Percutaneous Akin osteotomy with fixation by a percutaneous cannulated screw and forefoot surgery dressing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No fixation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Surgical Percutaneous Akin osteotomy non-fixed, hold by forefoot surgery dressing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>percutaneous Akin osteotomy</intervention_name>
    <description>The act to AKIN is osteotomy in percutaneous; This technique can be performed with or without fixation, and both methods make reference in the literature. With fixation method to get rid of the risk of loss of the surgical reduction of the misalignment, but requires an additional surgical procedure marked by the implementation of a percutaneous cannulated screw on part of the osteotomy. Without fixing method allows to get rid of this gesture, and risk a possible annoys by osteo-synthesis material. Surgical dressings of surgery of hallux valgus allow to keep the reduction for 15 days. Both techniques give excellent results and are performed in our service of routinely.</description>
    <arm_group_label>screw fixation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient which need hallux valgus surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hallux rigidus&#xD;
&#xD;
          -  Trouble of rotation of the the hallux&#xD;
&#xD;
          -  Rheumatoid forefoot&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julien LUCAS Y HERNADEZ, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antoine BENARD, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique; University Hospital, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Bordeaux - Hospital Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>October 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>November 27, 2020</last_update_submitted>
  <last_update_submitted_qc>November 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>percutaneous</keyword>
  <keyword>non-fixed</keyword>
  <keyword>Akin ;</keyword>
  <keyword>osteotomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hallux Valgus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02984462
org study id: CHUBX 2015/39
nct id: NCT02984462
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is a prospective randomized study about hallux valgus surgery. The investigator try
      to assess if the fixation of percutaneous Akin osteotomy with a cannulated screw have an
      incidence in the first ray mobility since the two technics ( fixation and no-fixation) are
      described and practiced, and since the stiffness of the first metatarso-phalangeal joint is
      determinant in the result of this functional surgery.
It's a prospective monocentric randomized work about forefoot surgery. Every patient included
      undergoes an hallux valgus chevron osteotomy of the first metatarsal associated with a
      percutaneous Akin osteotomy of the first phalange. The investigators study the impact of the
      fixation of percutaneous Akin osteotomy ( osteotomy of the first phalange of hallux) with two
      arms: one with fixation of the percutaneous Akin osteotomy, and one with a non-fixed
      percutaneous Akin osteotomy This study as been approved by Institutional review board;
      written informed consent is required for all patients before inclusion.

      The clinic follow-up of each patients included in the study will be the same of the normal
      follow-up for this type of surgery in our practice. This includes clinical exam, radiologic
      exam, and functional score AOFAS before surgery, at 6 weeks after the surgery, four months
      after surgery and finally one year after the surgery.

      The primary outcome measure which is the first metatarso-phalangeal global mobility will be
      blindly measure by an observator.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Global Mobility in degrees of the metatarso-phalangeal joint of the hallux one year after the surgery.
time frame: 12 months
measure: Angle between Metatarsus 1 and Phalanx 1
time frame: 12 months
measure: Angle between Metatarsus 1 and Metatarsus 2
time frame: 12 months
measure: Angle between Phalanx 1 and Phalanx 2
time frame: 12 months
measure: Distal Metatarsal Articular Angle
time frame: 12 months
measure: DM2A angle, calculated preoperatively by measuring the angle between the metatarsal diaphysis M2 and the tangent at the vertex of the distal articular surface
time frame: 12 months
measure: DM2A angle, calculated at last follow-up by measuring the angle between the metatarsal diaphysis M2 and the tangent at the vertex of the distal articular surface
time frame: 12 months
measure: Kitaoka Score
time frame: 12 months
arm group label: screw fixation
arm group type: Experimental
description: Surgical Percutaneous Akin osteotomy with fixation by a percutaneous cannulated screw and forefoot surgery dressing.
arm group label: No fixation
arm group type: No Intervention
description: Surgical Percutaneous Akin osteotomy non-fixed, hold by forefoot surgery dressing.
intervention type: Procedure
intervention name: percutaneous Akin osteotomy
description: The act to AKIN is osteotomy in percutaneous; This technique can be performed with or without fixation, and both methods make reference in the literature. With fixation method to get rid of the risk of loss of the surgical reduction of the misalignment, but requires an additional surgical procedure marked by the implementation of a percutaneous cannulated screw on part of the osteotomy. Without fixing method allows to get rid of this gesture, and risk a possible annoys by osteo-synthesis material. Surgical dressings of surgery of hallux valgus allow to keep the reduction for 15 days. Both techniques give excellent results and are performed in our service of routinely.
arm group label: screw fixation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Julien LUCAS Y HERNADEZ, MD
role: Principal Investigator
affiliation: University Hospital, Bordeaux
last name: Antoine BENARD, MD
role: Study Chair
affiliation: Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique; University Hospital, Bordeaux
facility: 
country: France
responsible party type: Sponsor
mesh term: Hallux Valgus
sharing ipd: No