<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/NCT03751618</url>
  </required_header>
  <id_info>
    <org_study_id>2017-CSV-001</org_study_id>
    <nct_id>NCT03751618</nct_id>
  </id_info>
  <brief_title>Evaluation of Non Inferiority of Non Capsular Suture in Femoroacetabular Impingement Arthroscopic Treatment</brief_title>
  <acronym>SUTURCAP</acronym>
  <official_title>Prospective Study, Monocentric, Randomized, Double Blind Evaluating the Non Inferiority of Non Capsular Suture in Arthroscopic Treatment of Cam or Mixed-type Femoroacetabular Impingement Without Hip Dysplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinique de la Sauvegarde</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinique de la Sauvegarde</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Since last past decade, arthroscopic hip surgery proved its efficacy in femoroacetabular&#xD;
      impingement treatment. However, no consensus exist concerning capsular suture or not.&#xD;
      According to capsular incision size, articular instability can persist if no suture is&#xD;
      performed. In contrast, tightly suture can cause post-operative joint stiffness.&#xD;
&#xD;
      This study aims to evaluate the non inferiority of non capsular suture after hip arthroscopy&#xD;
      treatment of cam or mixed-type femoroacetabular impingement, without hip dysplasia, after 2&#xD;
      years follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Main Objective :&#xD;
&#xD;
      Non inferiority evaluation of non capsular suture after hip arthroscopy treatment of cam or&#xD;
      mixed-type femoroacetabular impingement, without hip dysplasia, after 2 years follow-up.&#xD;
&#xD;
      The primary study endpoint is the patient reported outcomes (HAGOS score; iHOT-12 and MHHS)&#xD;
      at 2 years follow-up.&#xD;
&#xD;
      Secundary objectives :&#xD;
&#xD;
        -  Clinical results at 6 month and 1 year follow-up&#xD;
&#xD;
        -  Specific complications occuring and frequences&#xD;
&#xD;
        -  Patient quality of life,&#xD;
&#xD;
        -  The return to sport,&#xD;
&#xD;
        -  Sport level after surgery compare to sport level before surgery&#xD;
&#xD;
        -  Pain&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2018</start_date>
  <completion_date type="Actual">June 1, 2023</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</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>
    <intervention_model_description>Prospective, monocentric, randomized, double blind study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>patient reported outcomes (questionnaires)</measure>
    <time_frame>2 years</time_frame>
    <description>HAGOS score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>patient reported outcomes (questionnaires)</measure>
    <time_frame>6 months</time_frame>
    <description>modified Harris Hip Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient reported outcomes (questionnaires)</measure>
    <time_frame>1 year</time_frame>
    <description>iHOT-12</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Femoral Acetabular Impingement</condition>
  <arm_group>
    <arm_group_label>Capsular suture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsular suture at the end of hip arthroscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No capsular suture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>No capsular suture at the end of hip arthroscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hip arthroscopy</intervention_name>
    <description>Suture will be realized with two simple suture knots (non resorbable suture material). These suture knots will be performed at the end of hip arthroscopy. Correct capsular suture will be controlled under arthroscopy video.&#xD;
Patients randomized in control arm will not received capsular suture at the end of the procedure.</description>
    <arm_group_label>Capsular suture</arm_group_label>
    <arm_group_label>No capsular suture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient &lt; 18 years old&#xD;
&#xD;
          -  Patient who can be followed for 2 years&#xD;
&#xD;
          -  Patient with confirmed diagnostic of femoroacetabular impingement came or mixed-types,&#xD;
             without dysplasia and with VCE angle &gt; 25°, without prearthrosic lesion and Tonnis 0&#xD;
             ou Tonnis 1, radiographic assement&#xD;
&#xD;
          -  Patient must sign an informed consent form indicating that he or she understands the&#xD;
             purpose of procedure required for the study and accepts to participate in the study.&#xD;
&#xD;
          -  Patient affiliated to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with no wittren informed consent&#xD;
&#xD;
          -  Patient presenting osteoarthritis (Tonnis stage 2) or only pincer impingement&#xD;
&#xD;
          -  Hyperlaxity&#xD;
&#xD;
          -  Dysplasia (VCE &lt;25°)&#xD;
&#xD;
          -  Patient already underwent hip arthroscopy&#xD;
&#xD;
          -  Patient already underwent previous hip surgery&#xD;
&#xD;
          -  Patient needing bilateral hip arthroscopy &lt; 2 years&#xD;
&#xD;
          -  Persons deprived of their freedom or under guardianship or incapable of giving consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinique de la Sauvegarde</name>
      <address>
        <city>Lyon</city>
        <zip>69009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 3, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hip arthroscopy</keyword>
  <keyword>capsular suture</keyword>
  <keyword>Femoral Acetabular Impingement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Femoracetabular Impingement</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/NCT03751618
org study id: 2017-CSV-001
nct id: NCT03751618
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Since last past decade, arthroscopic hip surgery proved its efficacy in femoroacetabular
      impingement treatment. However, no consensus exist concerning capsular suture or not.
      According to capsular incision size, articular instability can persist if no suture is
      performed. In contrast, tightly suture can cause post-operative joint stiffness.

      This study aims to evaluate the non inferiority of non capsular suture after hip arthroscopy
      treatment of cam or mixed-type femoroacetabular impingement, without hip dysplasia, after 2
      years follow-up.
Main Objective :

      Non inferiority evaluation of non capsular suture after hip arthroscopy treatment of cam or
      mixed-type femoroacetabular impingement, without hip dysplasia, after 2 years follow-up.

      The primary study endpoint is the patient reported outcomes (HAGOS score; iHOT-12 and MHHS)
      at 2 years follow-up.

      Secundary objectives :

        -  Clinical results at 6 month and 1 year follow-up

        -  Specific complications occuring and frequences

        -  Patient quality of life,

        -  The return to sport,

        -  Sport level after surgery compare to sport level before surgery

        -  Pain
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, monocentric, randomized, double blind study
primary purpose: Other
masking: Double (Participant, Investigator)
measure: patient reported outcomes (questionnaires)
time frame: 2 years
description: HAGOS score
measure: patient reported outcomes (questionnaires)
time frame: 6 months
description: modified Harris Hip Score
measure: patient reported outcomes (questionnaires)
time frame: 1 year
description: iHOT-12
arm group label: Capsular suture
arm group type: Experimental
description: Capsular suture at the end of hip arthroscopy
arm group label: No capsular suture
arm group type: Active Comparator
description: No capsular suture at the end of hip arthroscopy
intervention type: Procedure
intervention name: Hip arthroscopy
description: Suture will be realized with two simple suture knots (non resorbable suture material). These suture knots will be performed at the end of hip arthroscopy. Correct capsular suture will be controlled under arthroscopy video.
Patients randomized in control arm will not received capsular suture at the end of the procedure.
arm group label: Capsular suture
arm group label: No capsular suture
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Femoracetabular Impingement