<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/NCT02997579</url>
  </required_header>
  <id_info>
    <org_study_id>COA113/2559</org_study_id>
    <nct_id>NCT02997579</nct_id>
  </id_info>
  <brief_title>Comparison of Vibration Arthrometry Between Patella Resurfacing and Patella Non-resurfacing in Total Knee Replacement Patients</brief_title>
  <official_title>Prospective Randomized Controlled Trial: Comparison of Vibration Arthrometry Between Patella Resurfacing and Patella Non-resurfacing in Total Knee Replacement Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Navamindradhiraj University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Navamindradhiraj University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patellar crepitus is a complication of total knee arthroplasty (TKA).The development of&#xD;
      patellar crepitus after TKA are related to many factors such as femoral component design,&#xD;
      surgical errors, and postoperative patellar baja. However, it is unclear whether patella&#xD;
      resurfacing or patella non-resurfacing are associate with patellar crepitus. The primary&#xD;
      objective of this study are to compare the prevalence of patellar crepitus and the mean value&#xD;
      of vibroacoustic signal between patellar-resurfacing and patellar non-resurfacing in TKA. The&#xD;
      secondary objective is to study the association between patellar crepitus and vibroacoustic&#xD;
      signal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">December 15, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of patellar crepitus</measure>
    <time_frame>pre-op, 3, 6 month</time_frame>
    <description>patellar crepitus investigate by physical examination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change of mean of vibroacoustic signal</measure>
    <time_frame>pre-op, 3, 6 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patellar crepitus related to mean of vibroacoustic signal</measure>
    <time_frame>pre-op, 3, 6 month</time_frame>
    <description>study the association between patellar crepitus and vibroacoustic signal, patellar crepitus investigate by physical examination and mean of vibroacoustic signal assessed by an acceleration sensor</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Patellar Crepitus</condition>
  <condition>Vibroacoustic Signal</condition>
  <arm_group>
    <arm_group_label>patellar resurfacing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patellar resurfacing TKA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patellar non-resurfacing</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patellar non-resurfacing TKA</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>patellar resurfacing</intervention_name>
    <description>patellar component insert with cement</description>
    <arm_group_label>patellar resurfacing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary osteoarthritis of knee&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  rheumatoid arthritis&#xD;
&#xD;
          -  morbid obesity&#xD;
&#xD;
          -  severe patellofemoral joint destruction&#xD;
&#xD;
          -  patella maltracking&#xD;
&#xD;
          -  patellofemoral incongruent&#xD;
&#xD;
          -  inflammatory arthritis&#xD;
&#xD;
          -  refuse to participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Satit Thiengwittayaporn, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Navamindradhiraj University</name>
      <address>
        <city>Dusit</city>
        <state>Bangkok</state>
        <zip>10300</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <reference>
    <citation>Baczkowicz D, Majorczyk E. Joint motion quality in vibroacoustic signal analysis for patients with patellofemoral joint disorders. BMC Musculoskelet Disord. 2014 Dec 12;15:426. doi: 10.1186/1471-2474-15-426.</citation>
    <PMID>25496721</PMID>
  </reference>
  <reference>
    <citation>Tanaka N, Hoshiyama M. Vibroarthrography in patients with knee arthropathy. J Back Musculoskelet Rehabil. 2012;25(2):117-22. doi: 10.3233/BMR-2012-0319.</citation>
    <PMID>22684203</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>January 4, 2019</last_update_submitted>
  <last_update_submitted_qc>January 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Navamindradhiraj University</investigator_affiliation>
    <investigator_full_name>Satit Thiengwittayaporn</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <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/NCT02997579
org study id: COA113/2559
nct id: NCT02997579
lead sponsor: 
has dmc: Yes
Patellar crepitus is a complication of total knee arthroplasty (TKA).The development of
      patellar crepitus after TKA are related to many factors such as femoral component design,
      surgical errors, and postoperative patellar baja. However, it is unclear whether patella
      resurfacing or patella non-resurfacing are associate with patellar crepitus. The primary
      objective of this study are to compare the prevalence of patellar crepitus and the mean value
      of vibroacoustic signal between patellar-resurfacing and patellar non-resurfacing in TKA. The
      secondary objective is to study the association between patellar crepitus and vibroacoustic
      signal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
measure: change of patellar crepitus
time frame: pre-op, 3, 6 month
description: patellar crepitus investigate by physical examination
measure: change of mean of vibroacoustic signal
time frame: pre-op, 3, 6 month
measure: Number of patellar crepitus related to mean of vibroacoustic signal
time frame: pre-op, 3, 6 month
description: study the association between patellar crepitus and vibroacoustic signal, patellar crepitus investigate by physical examination and mean of vibroacoustic signal assessed by an acceleration sensor
arm group label: patellar resurfacing
arm group type: Experimental
description: patellar resurfacing TKA
arm group label: patellar non-resurfacing
arm group type: No Intervention
description: patellar non-resurfacing TKA
intervention type: Procedure
intervention name: patellar resurfacing
description: patellar component insert with cement
arm group label: patellar resurfacing
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Satit Thiengwittayaporn, M.D.
role: Principal Investigator
affiliation: Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
facility: 
country: Thailand
citation: Baczkowicz D, Majorczyk E. Joint motion quality in vibroacoustic signal analysis for patients with patellofemoral joint disorders. BMC Musculoskelet Disord. 2014 Dec 12;15:426. doi: 10.1186/1471-2474-15-426.
PMID: 25496721
citation: Tanaka N, Hoshiyama M. Vibroarthrography in patients with knee arthropathy. J Back Musculoskelet Rehabil. 2012;25(2):117-22. doi: 10.3233/BMR-2012-0319.
PMID: 22684203
responsible party type: Principal Investigator
investigator affiliation: Navamindradhiraj University
investigator full name: Satit Thiengwittayaporn
investigator title: Associate Professor
sharing ipd: No