<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/NCT03768895</url>
  </required_header>
  <id_info>
    <org_study_id>MRI center</org_study_id>
    <nct_id>NCT03768895</nct_id>
  </id_info>
  <brief_title>Assement of the Morphological Characteristics of the Hips and Correlating Them With the Pathology Found</brief_title>
  <official_title>Assement of the Morphological Characteristics of the Hips and Correlating Them With the Pathology Found</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Zaragoza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Zaragoza</source>
  <oversight_info>
    <has_dmc>Yes</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 investigators' objective is the anatomical analysis of hips studied through MRI,&#xD;
      assessing their morphological characteristics and correlating them with the pathology found.&#xD;
&#xD;
      A retrospective search was performed using a database of consecutive reports of 137 adults&#xD;
      pelvis MRI examinations obtained at MRI center in Zaragoza.&#xD;
&#xD;
      In all the images the investigators are going to measure the ischiofemoral space, quadratus&#xD;
      femoris space, cervicodiaphysal angle and femoral version angle. The investigators evaluated&#xD;
      different qualitative changes in the signal intensity of the quadratus femoris muscle as&#xD;
      normal, edema, fatty infiltration or atrophy, and of the gluteus muscles as tendinopathy or&#xD;
      atrophy, too.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators' objective is the anatomical analysis of hips studied through MRI,&#xD;
      assessing their morphological characteristics and correlating them with the pathology found.&#xD;
&#xD;
      A retrospective search was performed using a database of consecutive reports of 137 adults&#xD;
      pelvis MRI examinations obtained at MRI center in Zaragoza.&#xD;
&#xD;
      The investigators create a protocol for a retrospective review study, with the aim of&#xD;
      analysis all the recorded MRI findings during this time. The criteria for patient inclusion&#xD;
      were: Age &gt; 18 years old, who had realised a pelvis MRI for any cause at MRI Center.&#xD;
      Exclusion criteria included age &lt; 18 years old, inadequate imaging quality, medical history&#xD;
      likely to affect pelvic and hip morphometry: pelvic oncological disease, infection or&#xD;
      inflammatory arthritis, postsurgical change disruptions, soft tissue abnormality, avascular&#xD;
      necrosis, or pelvic and hip fracture.&#xD;
&#xD;
      In all the images the investigators are going to measure the ischiofemoral space, quadratus&#xD;
      femoris space, cervicodiaphysal angle and femoral version angle. The investigators evaluated&#xD;
      different qualitative changes in the signal intensity of the quadratus femoris muscle as&#xD;
      normal, edema, fatty infiltration or atrophy, and of the gluteus muscles as tendinopathy or&#xD;
      atrophy, too.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Ischiofemoral Space</measure>
    <time_frame>1 day</time_frame>
    <description>the smallest distance between the lateral cortex of the ischial tuberosity and medial cortex of the lesser trochanter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quadratus Femoris Space</measure>
    <time_frame>1 day</time_frame>
    <description>the smallest space for passage of the quadratus femoris muscle delimited by the superolateral surface of the hamstring tendons and the posteromedial surface of the iliopsoas tendón or lesser trochanter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cervicodiaphyseal angle</measure>
    <time_frame>1 day</time_frame>
    <description>The cervicodiaphyseal angle is formed by the axis of the femoral neck that joins the femoral head with the axis of the femoral shaft.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Femoral version</measure>
    <time_frame>1 day</time_frame>
    <description>The femoral version or femoral torsion angle is called the projection on the transverse plane of a longitudinal axis of the femoral neck at the center of the femoral head</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Hip Pain Chronic</condition>
  <condition>Musculoskeletal Disease</condition>
  <condition>Femoral Anteversion</condition>
  <arm_group>
    <arm_group_label>MRI group</arm_group_label>
    <description>The criteria for patient inclusion were: Age &gt; 18 years old, who had realised a pelvis MRI for any cause at MRI Center. Exclusion criteria included age &lt; 18 years old, inadequate imaging quality, medical history likely to affect pelvic and hip morphometry: pelvic oncological disease, infection or inflammatory arthritis, postsurgical change disruptions, soft tissue abnormality, avascular necrosis, or pelvic and hip fracture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>The technique used was coronal and axial T1 and T2*WI sequences of the pelvis and femurs.&#xD;
The MRI machine used is a HITACHI AIRIS-II1 model, with permanent vertical magnetic field of 0.3 Tesla, and the used sequences areT1, T2*WI.</description>
    <arm_group_label>MRI group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        People who had realised a pelvis MRI for any cause at MRI Center in Zaragoza.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years old&#xD;
&#xD;
          -  Inadequate imaging quality&#xD;
&#xD;
          -  Medical history likely to affect pelvic and hip morphometry: pelvic oncological&#xD;
             disease, infection or inflammatory arthritis, postsurgical change disruptions, soft&#xD;
             tissue abnormality, avascular necrosis, or pelvic and hip fracture.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dra. Roca Diagnóstico Médico. CEMEDI</name>
      <address>
        <city>Zaragoza</city>
        <zip>50006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>February 15, 2019</last_update_submitted>
  <last_update_submitted_qc>February 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Zaragoza</investigator_affiliation>
    <investigator_full_name>Maria Pilar López Royo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03768895
org study id: MRI center
nct id: NCT03768895
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators' objective is the anatomical analysis of hips studied through MRI,
      assessing their morphological characteristics and correlating them with the pathology found.

      A retrospective search was performed using a database of consecutive reports of 137 adults
      pelvis MRI examinations obtained at MRI center in Zaragoza.

      In all the images the investigators are going to measure the ischiofemoral space, quadratus
      femoris space, cervicodiaphysal angle and femoral version angle. The investigators evaluated
      different qualitative changes in the signal intensity of the quadratus femoris muscle as
      normal, edema, fatty infiltration or atrophy, and of the gluteus muscles as tendinopathy or
      atrophy, too.
The investigators' objective is the anatomical analysis of hips studied through MRI,
      assessing their morphological characteristics and correlating them with the pathology found.

      A retrospective search was performed using a database of consecutive reports of 137 adults
      pelvis MRI examinations obtained at MRI center in Zaragoza.

      The investigators create a protocol for a retrospective review study, with the aim of
      analysis all the recorded MRI findings during this time. The criteria for patient inclusion
      were: Age > 18 years old, who had realised a pelvis MRI for any cause at MRI Center.
      Exclusion criteria included age < 18 years old, inadequate imaging quality, medical history
      likely to affect pelvic and hip morphometry: pelvic oncological disease, infection or
      inflammatory arthritis, postsurgical change disruptions, soft tissue abnormality, avascular
      necrosis, or pelvic and hip fracture.

      In all the images the investigators are going to measure the ischiofemoral space, quadratus
      femoris space, cervicodiaphysal angle and femoral version angle. The investigators evaluated
      different qualitative changes in the signal intensity of the quadratus femoris muscle as
      normal, edema, fatty infiltration or atrophy, and of the gluteus muscles as tendinopathy or
      atrophy, too.
observational model: Cohort
time perspective: Other
measure: Ischiofemoral Space
time frame: 1 day
description: the smallest distance between the lateral cortex of the ischial tuberosity and medial cortex of the lesser trochanter.
measure: Quadratus Femoris Space
time frame: 1 day
description: the smallest space for passage of the quadratus femoris muscle delimited by the superolateral surface of the hamstring tendons and the posteromedial surface of the iliopsoas tendón or lesser trochanter.
measure: Cervicodiaphyseal angle
time frame: 1 day
description: The cervicodiaphyseal angle is formed by the axis of the femoral neck that joins the femoral head with the axis of the femoral shaft.
measure: Femoral version
time frame: 1 day
description: The femoral version or femoral torsion angle is called the projection on the transverse plane of a longitudinal axis of the femoral neck at the center of the femoral head
arm group label: MRI group
description: The criteria for patient inclusion were: Age > 18 years old, who had realised a pelvis MRI for any cause at MRI Center. Exclusion criteria included age < 18 years old, inadequate imaging quality, medical history likely to affect pelvic and hip morphometry: pelvic oncological disease, infection or inflammatory arthritis, postsurgical change disruptions, soft tissue abnormality, avascular necrosis, or pelvic and hip fracture.
intervention type: Radiation
intervention name: MRI
description: The technique used was coronal and axial T1 and T2*WI sequences of the pelvis and femurs.
The MRI machine used is a HITACHI AIRIS-II1 model, with permanent vertical magnetic field of 0.3 Tesla, and the used sequences areT1, T2*WI.
arm group label: MRI group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Zaragoza
investigator full name: Maria Pilar López Royo
investigator title: Principal Investigator
mesh term: Musculoskeletal Diseases
sharing ipd: Undecided