<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/NCT04500093</url>
  </required_header>
  <id_info>
    <org_study_id>24959901</org_study_id>
    <nct_id>NCT04500093</nct_id>
  </id_info>
  <brief_title>Does Capsulectomy, Performed in Total Hip Arthroplasty With a Direct Anterior Approach Cause Knee Extension Strength Loss?</brief_title>
  <official_title>Does Capsulectomy, Performed in Total Hip Arthroplasty With a Direct Anterior Approach Cause Knee Extension Strength Loss?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif University</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>
      Total hip arthroplasty (THA) has been successful in relieving pain and restoring function in&#xD;
      patients with advanced arthritis of the hip joint. Increased focus on earlier recovery and&#xD;
      decreased postoperative pain has improved overall satisfaction. However, there is still a gap&#xD;
      between the clinical scores in objective surveys and patient satisfaction. Direct anterior&#xD;
      approach total hip arthroplasty has a low dislocation rate, abductor strength restoration,&#xD;
      acceleration, and cosmetic advantages. In this method, capsulotomy with repair or&#xD;
      capsulectomy is applied as the preferences of surgeons. Therefore, this can cause both a&#xD;
      decrease in hip flexion strength and a loss in knee extension strength. Our aim in this study&#xD;
      is to reveal how much muscle loss was caused by comparing both methods with the intact side.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Published data assessing biomechanical performance after THR are sparse. The majority of&#xD;
      studies assessing post-THR hip function using robotic dynamometry have focused on evaluating&#xD;
      surgical outcomes and prosthetic selection. These studies provide insight regarding the&#xD;
      strength deficits of older adults after THR. However, the data are not consistent, making it&#xD;
      difficult to assess the nature of the deficit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2022</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle Weakness</measure>
    <time_frame>1 year</time_frame>
    <description>Newton</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Harris Hip Score</measure>
    <time_frame>1 year</time_frame>
    <description>Score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Coxarthrosis</condition>
  <condition>Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>Capsulotomy with Repair</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Repair after capsulotomy in direct anterior hip arthroplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Capsuloectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Capsuloectomy in direct anterior hip arthroplasty</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Capsulotomy with Repair</intervention_name>
    <description>Capsulotomy with Repair</description>
    <arm_group_label>Capsulotomy with Repair</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Capsuloectomy</intervention_name>
    <description>Capsuloectomy</description>
    <arm_group_label>Capsuloectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All primary THA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary THA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Orkhan Aliyev, MD</last_name>
    <phone>+90 505 991 71 19</phone>
    <email>orkhanaliyev@outlook.com.tr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bezmialem Vakif University</name>
      <address>
        <city>Istanbul</city>
        <state>Fatih</state>
        <zip>34000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 1, 2020</last_update_submitted>
  <last_update_submitted_qc>August 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bezmialem Vakif University</investigator_affiliation>
    <investigator_full_name>Orkhan Aliyev</investigator_full_name>
    <investigator_title>MD, Resident Doctor in Orthopaedic Surgery</investigator_title>
  </responsible_party>
  <keyword>Hip</keyword>
  <keyword>Arthroplasty</keyword>
  <keyword>Quadriceps strenght</keyword>
  <keyword>Muscle Weakness</keyword>
  <keyword>Knee</keyword>
  <keyword>Flexion</keyword>
  <keyword>Extension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
    <mesh_term>Paresis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
  </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/NCT04500093
org study id: 24959901
nct id: NCT04500093
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Total hip arthroplasty (THA) has been successful in relieving pain and restoring function in
      patients with advanced arthritis of the hip joint. Increased focus on earlier recovery and
      decreased postoperative pain has improved overall satisfaction. However, there is still a gap
      between the clinical scores in objective surveys and patient satisfaction. Direct anterior
      approach total hip arthroplasty has a low dislocation rate, abductor strength restoration,
      acceleration, and cosmetic advantages. In this method, capsulotomy with repair or
      capsulectomy is applied as the preferences of surgeons. Therefore, this can cause both a
      decrease in hip flexion strength and a loss in knee extension strength. Our aim in this study
      is to reveal how much muscle loss was caused by comparing both methods with the intact side.
Published data assessing biomechanical performance after THR are sparse. The majority of
      studies assessing post-THR hip function using robotic dynamometry have focused on evaluating
      surgical outcomes and prosthetic selection. These studies provide insight regarding the
      strength deficits of older adults after THR. However, the data are not consistent, making it
      difficult to assess the nature of the deficit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Muscle Weakness
time frame: 1 year
description: Newton
measure: Harris Hip Score
time frame: 1 year
description: Score
arm group label: Capsulotomy with Repair
arm group type: Experimental
description: Repair after capsulotomy in direct anterior hip arthroplasty
arm group label: Capsuloectomy
arm group type: Active Comparator
description: Capsuloectomy in direct anterior hip arthroplasty
intervention type: Procedure
intervention name: Capsulotomy with Repair
description: Capsulotomy with Repair
arm group label: Capsulotomy with Repair
intervention type: Procedure
intervention name: Capsuloectomy
description: Capsuloectomy
arm group label: Capsuloectomy
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
last name: Orkhan Aliyev, MD
phone: +90 505 991 71 19
email: orkhanaliyev@outlook.com.tr
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Bezmialem Vakif University
investigator full name: Orkhan Aliyev
investigator title: MD, Resident Doctor in Orthopaedic Surgery
mesh term: Muscle Weakness
mesh term: Osteoarthritis, Hip
mesh term: Paresis
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)