<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/NCT04422717</url>
  </required_header>
  <id_info>
    <org_study_id>IstanbulPMRTRH-HCK1</org_study_id>
    <nct_id>NCT04422717</nct_id>
  </id_info>
  <brief_title>Femoral Cartilage Thickness In Patients With Lower Limb Amputation</brief_title>
  <official_title>Ultrasonographic Evaluation of Femoral Cartilage Thickness In Patients With Lower Limb Amputation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Physical Medicine Rehabilitation Training 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>
      The aim of the study to investigate any relation with functional parameters and femoral&#xD;
      cartilage thickness evaluation by ultrasonography in lower extremity amputate individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this prospective observational study, subjects approached Tertiary Rehabilitation Clinics&#xD;
      for prothesis recipe or long term outpatient follow up was 150 people. Among them 76 subjects&#xD;
      accepted to enroll study. Informed consent was taken. Subjects firstly performed clinical&#xD;
      parameters at the first doctor's control. Knee radiography has been performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">December 15, 2019</completion_date>
  <primary_completion_date type="Actual">December 15, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Ultrasonographic Evaluation of Femoral Cartilage Thickness</measure>
    <time_frame>Day 1</time_frame>
    <description>The transtibial amputee's both knees femoral cartilage are measured. The transfemoral group is measured only femoral cartilage of intact side. 10 subjects are randomised for intraobserver reliability and reevaluated one month after their first measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trinity Amputation and Prosthesis Experience Scale (TAPES)</measure>
    <time_frame>Day 1</time_frame>
    <description>Trinity Amputation and Prosthesis Experience Scale(3 parts) TAPES Psychosocial maximum:75 minimum:15 points. Higher points indicate better psychosocial outcomes. TAPES activity restriction Maximum:24 minimum:0 points. Higher points indicate more activity restricted. TAPES Prosthesis Pleasant Maximum:75 Minimum:15 higher points indicate much pleasant about prothesis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Houghton Scale</measure>
    <time_frame>Day 1</time_frame>
    <description>The Houghton scale is a 4-item instrument that accesses prosthetic use in people with lower extremity amputations. It reflects a person's perception of prosthetic use. It's self-administered and easy to score. Maximum:12 points. Minimum:0 Higher scores indicate better accesses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form - 12 (SF-12)</measure>
    <time_frame>Day 1</time_frame>
    <description>The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. Maximum:43 points minimum:12 points. Higher points indicate a higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls Efficacy Scale</measure>
    <time_frame>Day 1</time_frame>
    <description>On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, how confident are you that you do the following activities without falling? A total score of greater than 70 indicates that the person has a fear of falling. Minimum:0 Maximum:100 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medicare Functional Classification Levels (K levels)</measure>
    <time_frame>Day 1</time_frame>
    <description>Level 0: Does not have the ability or potential to ambulate or transfer safely with or without assistance and a prosthesis does not enhance their quality of life or mobility Level 1: Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence. Typical of the limited and unlimited household ambulators.&#xD;
Level 2: Has the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator.&#xD;
Level 3: Has the ability or potential for ambulation with variable cadence. Typical of the community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion.&#xD;
Level 4: Typical of the prosthetic demands of the child, active adult, or athlete. Minimum: K0 Maximum: K4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locomotor Capabilities Index (LCI) -5</measure>
    <time_frame>Day 1</time_frame>
    <description>The LCI is a disease-specific, self-administered instrument for assessing locomotor abilities generally considered essential for basic and advanced activity daily livings of people with lower-limb amputation and an enabling factor associated with long-term prosthetic use. It is easily administered and quickly completed. Maximum:56 Minimum:0 points. Higher scores indicate better locomotor capacity.</description>
  </secondary_outcome>
  <enrollment type="Actual">75</enrollment>
  <condition>Amputation</condition>
  <condition>Osteo Arthritis Knee</condition>
  <eligibility>
    <study_pop>
      <textblock>
        In this prospective observational study, subjects approached Tertiary Rehabilitation&#xD;
        Clinics for prothesis recipe or long term outpatient follow up was 150 people. Among them&#xD;
        76 subjects accepted to enroll study.İnformed consent was taken.1 subject not acceptable&#xD;
        with inclusion criteria was excluded.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being a single lower limb amputation&#xD;
&#xD;
          -  At least one year after the amputation operation&#xD;
&#xD;
          -  Prosthesis use for the last 6 months&#xD;
&#xD;
          -  Being traumatic or vascular&#xD;
&#xD;
          -  Not having stump infection&#xD;
&#xD;
          -  Muscle strength over stump should be at least 3/5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Doing quadriceps exercise in the last 3 months&#xD;
&#xD;
          -  Trauma, surgery, and knee injections within 6 months (PRP, hyaluronic acid),&#xD;
             Chondroitin-glucosamine use.&#xD;
&#xD;
        Being any of the active synovitides, Rheumatoid arthritis, spondyloarthritis, pseudogout,&#xD;
        coxarthrosis, neuromuscular diseases&#xD;
&#xD;
          -  Having an additional disease that will cause psychiatric adjustment problem&#xD;
&#xD;
          -  Subjects are younger than 18 years&#xD;
&#xD;
          -  Bilateral amputated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Habip Can Küçük, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul Physical Medicine Rehabilitation Training &amp; Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34186</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Akkaya N, Akkaya S, Ozcakar L, Demirkan F, Kiter E, Konukcu S, Ardic F. Ultrasonographic measurement of the distal femoral cartilage thickness in patients with unilateral transtibial amputation. Prosthet Orthot Int. 2013 Aug;37(4):268-74. doi: 10.1177/0309364612464233. Epub 2012 Nov 9.</citation>
    <PMID>23144161</PMID>
  </results_reference>
  <results_reference>
    <citation>Kesikburun S, Koroglu O, Yasar E, Guzelkucuk U, Yazcoglu K, Tan AK. Comparison of Intact Knee Cartilage Thickness in Patients with Traumatic Lower Extremity Amputation and Nonimpaired Individuals. Am J Phys Med Rehabil. 2015 Aug;94(8):602-8. doi: 10.1097/PHM.0000000000000216.</citation>
    <PMID>25299529</PMID>
  </results_reference>
  <results_reference>
    <citation>Sahin Onat S, Malas FU, Ozturk GT, Akkaya N, Kara M, Ozcakar L. Ultrasonographic assessment of the quadriceps muscle and femoral cartilage in transtibial amputees using different prostheses. Prosthet Orthot Int. 2016 Aug;40(4):484-9. doi: 10.1177/0309364615592701. Epub 2015 Jul 9.</citation>
    <PMID>26163535</PMID>
  </results_reference>
  <results_reference>
    <citation>Ozcakar L, Tunc H, Oken O, Unlu Z, Durmus B, Baysal O, Altay Z, Tok F, Akkaya N, Dogu B, Capkin E, Bardak A, Carli AB, Bugdayci D, Toktas H, Diracoglu D, Gunduz B, Erhan B, Kocabas H, Erden G, Gunendi Z, Kesikburun S, Omac OK, Taskaynatan MA, Senel K, Ugur M, Yalcinkaya EY, Ones K, Atan C, Akgun K, Bilgici A, Kuru O, Ozgocmen S. Femoral cartilage thickness measurements in healthy individuals: learning, practicing and publishing with TURK-MUSCULUS. J Back Musculoskelet Rehabil. 2014;27(2):117-24. doi: 10.3233/BMR-130441.</citation>
    <PMID>24284270</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Amputate</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>ultrasonography</keyword>
  <keyword>osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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/NCT04422717
org study id: IstanbulPMRTRH-HCK1
nct id: NCT04422717
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study to investigate any relation with functional parameters and femoral
      cartilage thickness evaluation by ultrasonography in lower extremity amputate individuals.
In this prospective observational study, subjects approached Tertiary Rehabilitation Clinics
      for prothesis recipe or long term outpatient follow up was 150 people. Among them 76 subjects
      accepted to enroll study. Informed consent was taken. Subjects firstly performed clinical
      parameters at the first doctor's control. Knee radiography has been performed.
observational model: Cohort
time perspective: Cross-Sectional
measure: Ultrasonographic Evaluation of Femoral Cartilage Thickness
time frame: Day 1
description: The transtibial amputee's both knees femoral cartilage are measured. The transfemoral group is measured only femoral cartilage of intact side. 10 subjects are randomised for intraobserver reliability and reevaluated one month after their first measure.
measure: Trinity Amputation and Prosthesis Experience Scale (TAPES)
time frame: Day 1
description: Trinity Amputation and Prosthesis Experience Scale(3 parts) TAPES Psychosocial maximum:75 minimum:15 points. Higher points indicate better psychosocial outcomes. TAPES activity restriction Maximum:24 minimum:0 points. Higher points indicate more activity restricted. TAPES Prosthesis Pleasant Maximum:75 Minimum:15 higher points indicate much pleasant about prothesis
measure: Houghton Scale
time frame: Day 1
description: The Houghton scale is a 4-item instrument that accesses prosthetic use in people with lower extremity amputations. It reflects a person's perception of prosthetic use. It's self-administered and easy to score. Maximum:12 points. Minimum:0 Higher scores indicate better accesses.
measure: Short Form - 12 (SF-12)
time frame: Day 1
description: The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. Maximum:43 points minimum:12 points. Higher points indicate a higher quality of life.
measure: Falls Efficacy Scale
time frame: Day 1
description: On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, how confident are you that you do the following activities without falling? A total score of greater than 70 indicates that the person has a fear of falling. Minimum:0 Maximum:100 points.
measure: Medicare Functional Classification Levels (K levels)
time frame: Day 1
description: Level 0: Does not have the ability or potential to ambulate or transfer safely with or without assistance and a prosthesis does not enhance their quality of life or mobility Level 1: Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence. Typical of the limited and unlimited household ambulators.
Level 2: Has the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator.
Level 3: Has the ability or potential for ambulation with variable cadence. Typical of the community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion.
Level 4: Typical of the prosthetic demands of the child, active adult, or athlete. Minimum: K0 Maximum: K4
measure: Locomotor Capabilities Index (LCI) -5
time frame: Day 1
description: The LCI is a disease-specific, self-administered instrument for assessing locomotor abilities generally considered essential for basic and advanced activity daily livings of people with lower-limb amputation and an enabling factor associated with long-term prosthetic use. It is easily administered and quickly completed. Maximum:56 Minimum:0 points. Higher scores indicate better locomotor capacity.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Habip Can Küçük, MD
role: Principal Investigator
affiliation: Istanbul Physical Medicine Rehabilitation Training & Research Hospital
facility: 
facility: 
country: Turkey
citation: Akkaya N, Akkaya S, Ozcakar L, Demirkan F, Kiter E, Konukcu S, Ardic F. Ultrasonographic measurement of the distal femoral cartilage thickness in patients with unilateral transtibial amputation. Prosthet Orthot Int. 2013 Aug;37(4):268-74. doi: 10.1177/0309364612464233. Epub 2012 Nov 9.
PMID: 23144161
citation: Kesikburun S, Koroglu O, Yasar E, Guzelkucuk U, Yazcoglu K, Tan AK. Comparison of Intact Knee Cartilage Thickness in Patients with Traumatic Lower Extremity Amputation and Nonimpaired Individuals. Am J Phys Med Rehabil. 2015 Aug;94(8):602-8. doi: 10.1097/PHM.0000000000000216.
PMID: 25299529
citation: Sahin Onat S, Malas FU, Ozturk GT, Akkaya N, Kara M, Ozcakar L. Ultrasonographic assessment of the quadriceps muscle and femoral cartilage in transtibial amputees using different prostheses. Prosthet Orthot Int. 2016 Aug;40(4):484-9. doi: 10.1177/0309364615592701. Epub 2015 Jul 9.
PMID: 26163535
citation: Ozcakar L, Tunc H, Oken O, Unlu Z, Durmus B, Baysal O, Altay Z, Tok F, Akkaya N, Dogu B, Capkin E, Bardak A, Carli AB, Bugdayci D, Toktas H, Diracoglu D, Gunduz B, Erhan B, Kocabas H, Erden G, Gunendi Z, Kesikburun S, Omac OK, Taskaynatan MA, Senel K, Ugur M, Yalcinkaya EY, Ones K, Atan C, Akgun K, Bilgici A, Kuru O, Ozgocmen S. Femoral cartilage thickness measurements in healthy individuals: learning, practicing and publishing with TURK-MUSCULUS. J Back Musculoskelet Rehabil. 2014;27(2):117-24. doi: 10.3233/BMR-130441.
PMID: 24284270
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No