<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/NCT04454021</url>
  </required_header>
  <id_info>
    <org_study_id>wjqsportsmed163</org_study_id>
    <nct_id>NCT04454021</nct_id>
  </id_info>
  <brief_title>Change in Muscle Volume in Patients With Unilateral Femoro-acetabular Impingement Syndrome After Hip Arthroscopy</brief_title>
  <official_title>Change in Muscle Volume in Patients With Unilateral Femoro-acetabular Impingement Syndrome After Hip Arthroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</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 purpose of this study was to investigate the change in muscle volume around the hip in&#xD;
      patients with unilateral femoro-acetabular impingement (FAI) after arthroscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We performed a retrospective review of magnetic resonance imaging (MRI) data of FAI patients&#xD;
      who underwent hip arthroscopy between January 1, 2016, and July 1, 2018. &quot;Image J&quot; with an&#xD;
      embedded region-of-interest (ROI) tool was used to calculate the cross-sectional area (CSA)&#xD;
      of muscles on MRI. Wilcoxon signed-rank test was used to determine the differences between&#xD;
      preoperative and postperative hip muscle CSA. The correlations of change in muscle CSA with&#xD;
      age, gender, BMI, pain level, preoperative symptom duration, and multiple validated&#xD;
      patient-reported outcomes were also analyzed with a spearman rank correlation test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2020</start_date>
  <completion_date type="Actual">March 10, 2020</completion_date>
  <primary_completion_date type="Actual">March 10, 2020</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>
  <primary_outcome>
    <measure>Change in muscle volume after hip arthroscopy</measure>
    <time_frame>at least two years after hip arthroscopy</time_frame>
    <description>hip muscle cross-sectional area of patients with unilateral FAI</description>
  </primary_outcome>
  <enrollment type="Actual">51</enrollment>
  <condition>Femoro-acetabular Impingement (FAI)</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>hip arthroscopy</intervention_name>
    <description>hip arthroscopy was performed when symptoms were not alleviated by nonsurgical treatment</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients who underwent primary hip arthroscopy for the treatment of symptomatic FAI&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) Age 18-50 years; (2) symptoms, physical examination, imaging evidence in&#xD;
             accordance with FAI; (3) symptoms that were not alleviated by nonsurgical treatment;&#xD;
             (4) the operation is performed by the same senior operator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) bilateral symptoms; (2) revision surgery; (3) advanced osteoarthritis; (4)&#xD;
             acetabular dysplasia; (5) history of hip and knee joint disease and operation; (6)&#xD;
             osteonecrosis of hip; (7) sacroiliac joint disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Jianquan Wang</name>
      <address>
        <city>Beijing</city>
        <state>Haidian District</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>femoro-acetabular impingement</keyword>
  <keyword>hip muscle volume</keyword>
  <keyword>cross-sectional area</keyword>
  <keyword>arthroscopy</keyword>
  <keyword>MRI images</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Femoracetabular Impingement</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/NCT04454021
org study id: wjqsportsmed163
nct id: NCT04454021
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to investigate the change in muscle volume around the hip in
      patients with unilateral femoro-acetabular impingement (FAI) after arthroscopy.
We performed a retrospective review of magnetic resonance imaging (MRI) data of FAI patients
      who underwent hip arthroscopy between January 1, 2016, and July 1, 2018. "Image J" with an
      embedded region-of-interest (ROI) tool was used to calculate the cross-sectional area (CSA)
      of muscles on MRI. Wilcoxon signed-rank test was used to determine the differences between
      preoperative and postperative hip muscle CSA. The correlations of change in muscle CSA with
      age, gender, BMI, pain level, preoperative symptom duration, and multiple validated
      patient-reported outcomes were also analyzed with a spearman rank correlation test.
observational model: Case-Only
time perspective: Retrospective
measure: Change in muscle volume after hip arthroscopy
time frame: at least two years after hip arthroscopy
description: hip muscle cross-sectional area of patients with unilateral FAI
intervention type: Procedure
intervention name: hip arthroscopy
description: hip arthroscopy was performed when symptoms were not alleviated by nonsurgical treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
facility: 
country: China
responsible party type: Sponsor
mesh term: Femoracetabular Impingement
sharing ipd: No