<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/NCT04486534</url>
  </required_header>
  <id_info>
    <org_study_id>4</org_study_id>
    <nct_id>NCT04486534</nct_id>
  </id_info>
  <brief_title>The Assessment of Talar Cartilage in Patients With Unilateral Traumatic Transtibial Amputation</brief_title>
  <official_title>The Assessment of Talar Cartilage, Tibialis Antetior and Gastrocnemius Muscles in Patients With Unilateral Traumatic Transtibial Amputation: a Clinical and Sonographic-controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gaziler Physical Medicine and Rehabilitation Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gaziler Physical Medicine and Rehabilitation Education and Research 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>
      Increased risk of osteoarthritis (OA) has been previously demonstrated in patients with lower&#xD;
      limb amputation. Although there are many studies on knee joint of intact limb of amputees in&#xD;
      the literature, the number of studies on intact foot and ankle is extremely limited. The&#xD;
      primary aim of the study is to compare the intact talar cartilage, tibialis anterior and&#xD;
      gastrocnemius muscle thickness measurements of traumatic unilateral transtibial amputee&#xD;
      patients with that of healthy individuals using ultrasound. The secondary aim is to&#xD;
      investigate the relationship between cartilage and muscle thickness measurements with&#xD;
      clinical parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods: A total of 36 patients with unilateral transtibial amputations and 36 age and body&#xD;
      mass index (BMI)-matched male controls will be participated in this cross-sectional study.&#xD;
      Functional performance will be assessed by 6-minute walking distance (in meter). The Foot and&#xD;
      Ankle Outcome Score (FAOS) will be used for the assessment of the symptoms and the functional&#xD;
      limitations of the foot and ankle. The health-related quality of life of the subjects will be&#xD;
      evaluated with Short Form-36 (SF-36). Subjects' talar cartilage, tibialis anterior and&#xD;
      gastrocnemius muscle thickness measurements will be performed using musculoskeletal&#xD;
      ultrasound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 26, 2020</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">January 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements</measure>
    <time_frame>through study completion, an average of one and a half months</time_frame>
    <description>Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed by using ultrasound.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6-minute walking test</measure>
    <time_frame>through study completion, an average of one and a half months</time_frame>
    <description>Functional performance will be assessed by 6-minute walking distance (in meter)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Foot and Ankle Outcome Score (FAOS)</measure>
    <time_frame>through study completion, an average of one and a half months</time_frame>
    <description>The Foot and Ankle Outcome Score (FAOS) will be used for the assessment of the symptoms and the functional limitations of the foot and ankle. The FAOS consists of 42 questions, divided into five different patient-relevant subscales: pain (nine questions); symptoms such as stiffness, swelling and range of motion (seven questions); activities of daily living (17 questions); ability to perform sports and recreational activities (five questions); and foot/ankle-related quality of life (four questions). Answers are given on a five-point Likert scale. Total and subscores are calculated by summing the scores of the individual items. The total score is recoded into a 0-100 scale, with 100 representing no symptoms or limitations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form-36 (SF-36)</measure>
    <time_frame>through study completion, an average of one and a half months</time_frame>
    <description>The health-related quality of life of the subjects will be evaluated with Short Form-36 (SF-36). This comprises 36 questions related to eight different subscales, physical functioning, bodily pain, role limitation, due to physical health problems, general health perceptions, vitality, energy and fatigue, role limitations due to emotional problems, social functioning and general mental health, which covers psychological distress and wellbeing. Each of eight subscales is scored between 0 and 100, with higher scores indicating a better quality of life.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">72</enrollment>
  <condition>Traumatic Amputation of Lower Extremity</condition>
  <condition>Cartilage Degeneration</condition>
  <arm_group>
    <arm_group_label>Case group</arm_group_label>
    <description>36 patients between the ages of 18-65, who have been followed up for at least 3 months with the diagnosis of unilateral transtibial amputation and who have been using prostheses for at least 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>36 age and body mass index (BMI)-matched healthy controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Musculoskeletal ultrasound</intervention_name>
    <description>Subjects' talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed using musculoskeletal ultrasound.</description>
    <arm_group_label>Case group</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 36 patients with unilateral transtibial amputations and 36 age and BMI-matched&#xD;
        healthy controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between the ages of 18-65&#xD;
&#xD;
          -  Patients who have been followed up for at least 3 months with the diagnosis of&#xD;
             unilateral transtibial amputation&#xD;
&#xD;
          -  Patients who have been using prostheses for at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bilateral amputation&#xD;
&#xD;
          -  Previous history of any trauma/surgical history of the lower extremities (other than&#xD;
             amputation)&#xD;
&#xD;
          -  Rheumatic diseases&#xD;
&#xD;
          -  Contracture of the knee and the ankle of the intact limb&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Merve Orucu Atar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gaziler PMR, Training and Research Hospital, Department of PMR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Merve Orucu Atar</name>
      <address>
        <city>Ankara</city>
        <state>Cankaya</state>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gaziler Physical Medicine and Rehabilitation Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Yasin Demir</investigator_full_name>
    <investigator_title>Physical Medicine and Rehabilitation Specialist</investigator_title>
  </responsible_party>
  <keyword>Amputation</keyword>
  <keyword>Transtibial</keyword>
  <keyword>Prosthesis</keyword>
  <keyword>Cartilage</keyword>
  <keyword>Muscle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amputation, Traumatic</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/NCT04486534
org study id: 4
nct id: NCT04486534
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Increased risk of osteoarthritis (OA) has been previously demonstrated in patients with lower
      limb amputation. Although there are many studies on knee joint of intact limb of amputees in
      the literature, the number of studies on intact foot and ankle is extremely limited. The
      primary aim of the study is to compare the intact talar cartilage, tibialis anterior and
      gastrocnemius muscle thickness measurements of traumatic unilateral transtibial amputee
      patients with that of healthy individuals using ultrasound. The secondary aim is to
      investigate the relationship between cartilage and muscle thickness measurements with
      clinical parameters.
Methods: A total of 36 patients with unilateral transtibial amputations and 36 age and body
      mass index (BMI)-matched male controls will be participated in this cross-sectional study.
      Functional performance will be assessed by 6-minute walking distance (in meter). The Foot and
      Ankle Outcome Score (FAOS) will be used for the assessment of the symptoms and the functional
      limitations of the foot and ankle. The health-related quality of life of the subjects will be
      evaluated with Short Form-36 (SF-36). Subjects' talar cartilage, tibialis anterior and
      gastrocnemius muscle thickness measurements will be performed using musculoskeletal
      ultrasound.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements
time frame: through study completion, an average of one and a half months
description: Talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed by using ultrasound.
measure: 6-minute walking test
time frame: through study completion, an average of one and a half months
description: Functional performance will be assessed by 6-minute walking distance (in meter)
measure: The Foot and Ankle Outcome Score (FAOS)
time frame: through study completion, an average of one and a half months
description: The Foot and Ankle Outcome Score (FAOS) will be used for the assessment of the symptoms and the functional limitations of the foot and ankle. The FAOS consists of 42 questions, divided into five different patient-relevant subscales: pain (nine questions); symptoms such as stiffness, swelling and range of motion (seven questions); activities of daily living (17 questions); ability to perform sports and recreational activities (five questions); and foot/ankle-related quality of life (four questions). Answers are given on a five-point Likert scale. Total and subscores are calculated by summing the scores of the individual items. The total score is recoded into a 0-100 scale, with 100 representing no symptoms or limitations.
measure: Short Form-36 (SF-36)
time frame: through study completion, an average of one and a half months
description: The health-related quality of life of the subjects will be evaluated with Short Form-36 (SF-36). This comprises 36 questions related to eight different subscales, physical functioning, bodily pain, role limitation, due to physical health problems, general health perceptions, vitality, energy and fatigue, role limitations due to emotional problems, social functioning and general mental health, which covers psychological distress and wellbeing. Each of eight subscales is scored between 0 and 100, with higher scores indicating a better quality of life.
arm group label: Case group
description: 36 patients between the ages of 18-65, who have been followed up for at least 3 months with the diagnosis of unilateral transtibial amputation and who have been using prostheses for at least 3 months
arm group label: Control group
description: 36 age and body mass index (BMI)-matched healthy controls
intervention type: Other
intervention name: Musculoskeletal ultrasound
description: Subjects' talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed using musculoskeletal ultrasound.
arm group label: Case group
arm group label: Control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Merve Orucu Atar, MD
role: Principal Investigator
affiliation: Gaziler PMR, Training and Research Hospital, Department of PMR
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
investigator full name: Yasin Demir
investigator title: Physical Medicine and Rehabilitation Specialist
mesh term: Amputation, Traumatic
sharing ipd: No