xml: <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/NCT05993637</url>
    </required_header>
    <id_info>
      <org_study_id>F-473945936</org_study_id>
      <nct_id>NCT05993637</nct_id>
    </id_info>
    <brief_title>Comparison of Proprioception for HTO (High Tibial Osteotomy) and UKA (Unicompartmantal Knee Arthroplasty)</brief_title>
    <official_title>A Comparison of the Effects of High Tibial Osteotomy and Unicompartmental Knee Arthroplasty Surgeries on Proprioception Applied to Individuals With Medial Gonarthrosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul University - Cerrahpasa (IUC)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul University - Cerrahpasa (IUC)</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>
        Osteoarthritis of the knee (KOA), a common degenerative joint disease, affects a significant&#xD;
        part of the world's population. Although it can hold all the compartments in the knee joint,&#xD;
        isolated medial compartment involvement has been reported in about 85% of individuals&#xD;
        diagnosed with KOA.&#xD;
  &#xD;
        In the management of degenerative medial gonarthrosis; symptomatic relief and provide&#xD;
        orthopaedic surgeons with the aim to slow down the progression of Total Knee Arthroplasty&#xD;
        (TKA) unikompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) is used. In&#xD;
        recent years, HTO and UKA have been preferred more frequently among these surgical methods&#xD;
        due to a number of advantages they provide for patients.&#xD;
  &#xD;
        As a result of the orthopedic surgeries performed, interventions are made on bone and joint&#xD;
        structures and problems may occur in the proprioceptive inputs provided by the body. In UKA,&#xD;
        a new joint structure is created by changing the bone structure and removing the tibial&#xD;
        plateau, while in HTO, the existing bone structure is preserved and a positional change is&#xD;
        created. Thus, while it is expected that the proprioceptive response to be different between&#xD;
        the two surgeries, no studies have been found in the literature on this issue. Accordingly,&#xD;
        the purpose of this study is to compare the effects of HTO and UKA surgeries applied to&#xD;
        individuals diagnosed with medial gonarthrosis on the proprioception of patients and to&#xD;
        examine the effects of HTO and UKA surgeries on patients diagnosed with medial gonarthrosis.&#xD;
  &#xD;
        H0: There is no difference between the surgical methods applied when the proprioception of&#xD;
        patients with HTO and UKA surgeries planned for individuals with medial gonarthrosis is&#xD;
        considered.&#xD;
  &#xD;
        H1: There is a difference between the surgical methods applied when the proprioception of&#xD;
        patients with HTO and UKA surgeries planned for individuals with medial gonarthrosis are&#xD;
        considered.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Volunteer participants who have been diagnosed with medial gonarthrosis and have varus&#xD;
        deformity and have undergone surgery will be included. The surgical groups will be divided&#xD;
        into two categories: HTO and UKA. Evaluations of the participants in terms of proprioception&#xD;
        will be made. A voluntary consent form will be obtained from the participants.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">May 2024</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Romberg Test</measure>
      <time_frame>Day 1</time_frame>
      <description>The patient is asked to stand in an upright position with his feet open at shoulder level and his arms free at the sides. The patient, who does not receive any support, is asked to stand first with his eyes open and then with his eyes closed. While the patient is standing still, the time until the moment when his balance is disturbed is recorded.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Knee Society Score</measure>
      <time_frame>Day 1</time_frame>
      <description>The system is divided into a knee score, which assesses only the knee joint itself, and functional scores, which assesses the patient's ability to walk and climb stairs. As a result of the dual rating system, the problem of decreasing knee scores associated with patient weakness is eliminated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>WOMAC</measure>
      <time_frame>Day 1</time_frame>
      <description>It is a scale that evaluates the disability associated with these conditions in hip and/or knee osteoarthritis. It consists of three parts: pain, stiffness and physical function. It contains a total of 24 substances.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Single Leg Stance Test</measure>
      <time_frame>Day 1</time_frame>
      <description>It is used to evaluate static posture and balance control. The patient should stand unaided on one leg from the moment when the other foot leaves the floor until the time when the foot touches the floor again or the arms leave the hips.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5-times Sit to Stand Test</measure>
      <time_frame>Day 1</time_frame>
      <description>It is used to assess the functional strength of the lower extremities, transitional movements, balance and the risk of falls. Participants are evaluated by sitting on a back-supported chair five times and holding it for a while while getting up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change from baseline Gait Analyzer for walking speed at 8 weeks (m/sec)</measure>
      <time_frame>Day 1</time_frame>
      <description>It is a smartphone-based application for analyzing walking parameters in real time. It can measure walking speed, step duration, step length, cadence and symmetry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change from baseline Gait Analyzer for step time at 8 weeks (sec)</measure>
      <time_frame>Day 1</time_frame>
      <description>It is a smartphone-based application for analyzing walking parameters in real time. It can measure walking speed, step duration, step length, cadence and symmetry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change from baseline Gait Analyzer for step lenght at 8 weeks (m)</measure>
      <time_frame>Day 1</time_frame>
      <description>It is a smartphone-based application for analyzing walking parameters in real time. It can measure walking speed, step duration, step length, cadence and symmetry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change from baseline Gait Analyzer for cadance at 8 weeks (step/min)</measure>
      <time_frame>Day 1</time_frame>
      <description>It is a smartphone-based application for analyzing walking parameters in real time. It can measure walking speed, step duration, step length, cadence and symmetry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change from baseline Gait Analyzer for symmetry at 8 weeks (%)</measure>
      <time_frame>Day 1</time_frame>
      <description>It is a smartphone-based application for analyzing walking parameters in real time. It can measure walking speed, step duration, step length, cadence and symmetry.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>High Tibial Osteotomy</arm_group_label>
      <description>patients who were diagnosed with medial gonarthrosis and underwent HTO surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Unicompartmantal Knee Arthroplasty</arm_group_label>
      <description>patients who were diagnosed with medial gonarthrosis and underwent UKA surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Examination of propriception</intervention_name>
      <description>application of the tests used in proprioception assessment to patients by a physiotherapist</description>
      <arm_group_label>High Tibial Osteotomy</arm_group_label>
      <arm_group_label>Unicompartmantal Knee Arthroplasty</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who have been diagnosed with medial gonarthrosis and undergone surgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Undergoing surgery at the age of 50-65&#xD;
  &#xD;
            -  Performing unilateral UKA or HTO surgery&#xD;
  &#xD;
            -  Moderate medial knee arthrosis on pre-op X-ray&#xD;
  &#xD;
            -  Presence of mild varus deformity in the pre-op period&#xD;
  &#xD;
            -  Should be BMI&lt;30&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Regular exercise at least 3 days a week, 150 minutes, moderate intensity&#xD;
  &#xD;
            -  Having undergone revision surgery&#xD;
  &#xD;
            -  The presence of any other orthopedic problems/problems and surgery&#xD;
  &#xD;
            -  Concomitant of a common rheumatological disease&#xD;
  &#xD;
            -  Presence of neurological problems/problems&#xD;
  &#xD;
            -  Having visual and auditory problems at a level that prevents communication&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ipek Yeldan Karagoz, Prof.</last_name>
      <role>Study Director</role>
      <affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Aysenur Erekdag, BsC</last_name>
      <phone>+905548959013</phone>
      <email>aysenurerekdag@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Omer Naci Ergin, Asst. Prof.</last_name>
      <phone>+905325051388</phone>
      <email>omnaer@gmail.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Willis-Owen CA, Brust K, Alsop H, Miraldo M, Cobb JP. Unicondylar knee arthroplasty in the UK National Health Service: an analysis of candidacy, outcome and cost efficacy. Knee. 2009 Dec;16(6):473-8. doi: 10.1016/j.knee.2009.04.006. Epub 2009 May 22.</citation>
      <PMID>19464898</PMID>
    </reference>
    <reference>
      <citation>Johal S, Nakano N, Baxter M, Hujazi I, Pandit H, Khanduja V. Unicompartmental Knee Arthroplasty: The Past, Current Controversies, and Future Perspectives. J Knee Surg. 2018 Nov;31(10):992-998. doi: 10.1055/s-0038-1625961. Epub 2018 Mar 7.</citation>
      <PMID>29514367</PMID>
    </reference>
    <reference>
      <citation>Cao Z, Mai X, Wang J, Feng E, Huang Y. Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy for Knee Osteoarthritis: A Systematic Review and Meta-Analysis. J Arthroplasty. 2018 Mar;33(3):952-959. doi: 10.1016/j.arth.2017.10.025. Epub 2017 Dec 2.</citation>
      <PMID>29203354</PMID>
    </reference>
    <reference>
      <citation>He M, Zhong X, Li Z, Shen K, Zeng W. Progress in the treatment of knee osteoarthritis with high tibial osteotomy: a systematic review. Syst Rev. 2021 Feb 14;10(1):56. doi: 10.1186/s13643-021-01601-z.</citation>
      <PMID>33583421</PMID>
    </reference>
    <reference>
      <citation>Santoso MB, Wu L. Unicompartmental knee arthroplasty, is it superior to high tibial osteotomy in treating unicompartmental osteoarthritis? A meta-analysis and systemic review. J Orthop Surg Res. 2017 Mar 28;12(1):50. doi: 10.1186/s13018-017-0552-9.</citation>
      <PMID>28351371</PMID>
    </reference>
    <reference>
      <citation>Ghai S, Driller M, Ghai I. Effects of joint stabilizers on proprioception and stability: A systematic review and meta-analysis. Phys Ther Sport. 2017 May;25:65-75. doi: 10.1016/j.ptsp.2016.05.006. Epub 2016 May 18.</citation>
      <PMID>28262354</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
      <investigator_full_name>Aysenur Erekdag</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Gonarthrosis</keyword>
    <keyword>High Tibial Osteotomy</keyword>
    <keyword>Unicompartmantal Knee Arthrodesis</keyword>
    <keyword>Proprioception</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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993637
  org study id: F-473945936
  nct id: NCT05993637
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Osteoarthritis of the knee (KOA), a common degenerative joint disease, affects a significant
        part of the world's population. Although it can hold all the compartments in the knee joint,
        isolated medial compartment involvement has been reported in about 85% of individuals
        diagnosed with KOA.
  
        In the management of degenerative medial gonarthrosis; symptomatic relief and provide
        orthopaedic surgeons with the aim to slow down the progression of Total Knee Arthroplasty
        (TKA) unikompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) is used. In
        recent years, HTO and UKA have been preferred more frequently among these surgical methods
        due to a number of advantages they provide for patients.
  
        As a result of the orthopedic surgeries performed, interventions are made on bone and joint
        structures and problems may occur in the proprioceptive inputs provided by the body. In UKA,
        a new joint structure is created by changing the bone structure and removing the tibial
        plateau, while in HTO, the existing bone structure is preserved and a positional change is
        created. Thus, while it is expected that the proprioceptive response to be different between
        the two surgeries, no studies have been found in the literature on this issue. Accordingly,
        the purpose of this study is to compare the effects of HTO and UKA surgeries applied to
        individuals diagnosed with medial gonarthrosis on the proprioception of patients and to
        examine the effects of HTO and UKA surgeries on patients diagnosed with medial gonarthrosis.
  
        H0: There is no difference between the surgical methods applied when the proprioception of
        patients with HTO and UKA surgeries planned for individuals with medial gonarthrosis is
        considered.
  
        H1: There is a difference between the surgical methods applied when the proprioception of
        patients with HTO and UKA surgeries planned for individuals with medial gonarthrosis are
        considered.
  Volunteer participants who have been diagnosed with medial gonarthrosis and have varus
        deformity and have undergone surgery will be included. The surgical groups will be divided
        into two categories: HTO and UKA. Evaluations of the participants in terms of proprioception
        will be made. A voluntary consent form will be obtained from the participants.
  observational model: Cohort
  time perspective: Prospective
  measure: Romberg Test
  time frame: Day 1
  description: The patient is asked to stand in an upright position with his feet open at shoulder level and his arms free at the sides. The patient, who does not receive any support, is asked to stand first with his eyes open and then with his eyes closed. While the patient is standing still, the time until the moment when his balance is disturbed is recorded.
  measure: Knee Society Score
  time frame: Day 1
  description: The system is divided into a knee score, which assesses only the knee joint itself, and functional scores, which assesses the patient's ability to walk and climb stairs. As a result of the dual rating system, the problem of decreasing knee scores associated with patient weakness is eliminated.
  measure: WOMAC
  time frame: Day 1
  description: It is a scale that evaluates the disability associated with these conditions in hip and/or knee osteoarthritis. It consists of three parts: pain, stiffness and physical function. It contains a total of 24 substances.
  measure: Single Leg Stance Test
  time frame: Day 1
  description: It is used to evaluate static posture and balance control. The patient should stand unaided on one leg from the moment when the other foot leaves the floor until the time when the foot touches the floor again or the arms leave the hips.
  measure: 5-times Sit to Stand Test
  time frame: Day 1
  description: It is used to assess the functional strength of the lower extremities, transitional movements, balance and the risk of falls. Participants are evaluated by sitting on a back-supported chair five times and holding it for a while while getting up.
  measure: change from baseline Gait Analyzer for walking speed at 8 weeks (m/sec)
  time frame: Day 1
  description: It is a smartphone-based application for analyzing walking parameters in real time. It can measure walking speed, step duration, step length, cadence and symmetry.
  measure: change from baseline Gait Analyzer for step time at 8 weeks (sec)
  time frame: Day 1
  description: It is a smartphone-based application for analyzing walking parameters in real time. It can measure walking speed, step duration, step length, cadence and symmetry.
  measure: change from baseline Gait Analyzer for step lenght at 8 weeks (m)
  time frame: Day 1
  description: It is a smartphone-based application for analyzing walking parameters in real time. It can measure walking speed, step duration, step length, cadence and symmetry.
  measure: change from baseline Gait Analyzer for cadance at 8 weeks (step/min)
  time frame: Day 1
  description: It is a smartphone-based application for analyzing walking parameters in real time. It can measure walking speed, step duration, step length, cadence and symmetry.
  measure: change from baseline Gait Analyzer for symmetry at 8 weeks (%)
  time frame: Day 1
  description: It is a smartphone-based application for analyzing walking parameters in real time. It can measure walking speed, step duration, step length, cadence and symmetry.
  arm group label: High Tibial Osteotomy
  description: patients who were diagnosed with medial gonarthrosis and underwent HTO surgery
  arm group label: Unicompartmantal Knee Arthroplasty
  description: patients who were diagnosed with medial gonarthrosis and underwent UKA surgery
  intervention type: Other
  intervention name: Examination of propriception
  description: application of the tests used in proprioception assessment to patients by a physiotherapist
  arm group label: High Tibial Osteotomy
  arm group label: Unicompartmantal Knee Arthroplasty
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Ipek Yeldan Karagoz, Prof.
  role: Study Director
  affiliation: Istanbul University - Cerrahpasa (IUC)
  last name: Aysenur Erekdag, BsC
  phone: +905548959013
  email: aysenurerekdag@gmail.com
  last name: Omer Naci Ergin, Asst. Prof.
  phone: +905325051388
  email: omnaer@gmail.com
  citation: Willis-Owen CA, Brust K, Alsop H, Miraldo M, Cobb JP. Unicondylar knee arthroplasty in the UK National Health Service: an analysis of candidacy, outcome and cost efficacy. Knee. 2009 Dec;16(6):473-8. doi: 10.1016/j.knee.2009.04.006. Epub 2009 May 22.
  PMID: 19464898
  citation: Johal S, Nakano N, Baxter M, Hujazi I, Pandit H, Khanduja V. Unicompartmental Knee Arthroplasty: The Past, Current Controversies, and Future Perspectives. J Knee Surg. 2018 Nov;31(10):992-998. doi: 10.1055/s-0038-1625961. Epub 2018 Mar 7.
  PMID: 29514367
  citation: Cao Z, Mai X, Wang J, Feng E, Huang Y. Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy for Knee Osteoarthritis: A Systematic Review and Meta-Analysis. J Arthroplasty. 2018 Mar;33(3):952-959. doi: 10.1016/j.arth.2017.10.025. Epub 2017 Dec 2.
  PMID: 29203354
  citation: He M, Zhong X, Li Z, Shen K, Zeng W. Progress in the treatment of knee osteoarthritis with high tibial osteotomy: a systematic review. Syst Rev. 2021 Feb 14;10(1):56. doi: 10.1186/s13643-021-01601-z.
  PMID: 33583421
  citation: Santoso MB, Wu L. Unicompartmental knee arthroplasty, is it superior to high tibial osteotomy in treating unicompartmental osteoarthritis? A meta-analysis and systemic review. J Orthop Surg Res. 2017 Mar 28;12(1):50. doi: 10.1186/s13018-017-0552-9.
  PMID: 28351371
  citation: Ghai S, Driller M, Ghai I. Effects of joint stabilizers on proprioception and stability: A systematic review and meta-analysis. Phys Ther Sport. 2017 May;25:65-75. doi: 10.1016/j.ptsp.2016.05.006. Epub 2016 May 18.
  PMID: 28262354
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul University - Cerrahpasa (IUC)
  investigator full name: Aysenur Erekdag
  investigator title: Principal Investigator
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee