<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/NCT02970253</url>
  </required_header>
  <id_info>
    <org_study_id>16/076U</org_study_id>
    <nct_id>NCT02970253</nct_id>
  </id_info>
  <brief_title>Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular Resection Versus Capsular Flap Retention</brief_title>
  <official_title>Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular Resection Versus Capsular Flap Retention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ZOL</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ZOL</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular resection versus&#xD;
      capsular flap retention.&#xD;
&#xD;
      Prospective study design comparing clinical data in randomized THA patients who either had&#xD;
      capsular resection or capsular flap retention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">November 11, 2018</primary_completion_date>
  <phase>Phase 1</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical data will be measured with scoring list HHS (Harris Hip Score).</measure>
    <time_frame>One year</time_frame>
    <description>Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list HHS (Harris Hip Score).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical data will be measured with scoring list WOMAC (The Western Ontario and McMaster Universities Arthritis Index).</measure>
    <time_frame>One year</time_frame>
    <description>Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list WOMAC (The Western Ontario and McMaster Universities Arthritis Index).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical data will be measured with scoring list UCLA (University of California Los Angles activity score).</measure>
    <time_frame>One year</time_frame>
    <description>Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list UCLA ((University of California Los Angles activity score).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical data will be measured with scoring list HOOS (Hip dysfunction and Osteoarthritis Outcome Score).</measure>
    <time_frame>One year</time_frame>
    <description>Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring lists HOOS (Hip dysfunction and Osteoarthritis Outcome Score).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">190</enrollment>
  <condition>Coxarthritis</condition>
  <arm_group>
    <arm_group_label>Capsular resection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Capsular resection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Capsular retention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Capsular retention</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Capsular resection</intervention_name>
    <description>Capsular resection</description>
    <arm_group_label>Capsular resection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Capsular retention</intervention_name>
    <description>Capsular retention</description>
    <arm_group_label>Capsular retention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary THA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neurologic disease&#xD;
&#xD;
          -  painful contralateral THA&#xD;
&#xD;
          -  severe back or knee pain&#xD;
&#xD;
          -  rheumatology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ZOL</name>
      <address>
        <city>Genk</city>
        <state>Limburg</state>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 3, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>February 10, 2020</last_update_submitted>
  <last_update_submitted_qc>February 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>ZOL</investigator_affiliation>
    <investigator_full_name>Jens Vanbiervliet</investigator_full_name>
    <investigator_title>Resident Orthopedic Surgery</investigator_title>
  </responsible_party>
  <!-- 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/NCT02970253
org study id: 16/076U
nct id: NCT02970253
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular resection versus
      capsular flap retention.

      Prospective study design comparing clinical data in randomized THA patients who either had
      capsular resection or capsular flap retention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Clinical data will be measured with scoring list HHS (Harris Hip Score).
time frame: One year
description: Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list HHS (Harris Hip Score).
measure: Clinical data will be measured with scoring list WOMAC (The Western Ontario and McMaster Universities Arthritis Index).
time frame: One year
description: Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list WOMAC (The Western Ontario and McMaster Universities Arthritis Index).
measure: Clinical data will be measured with scoring list UCLA (University of California Los Angles activity score).
time frame: One year
description: Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list UCLA ((University of California Los Angles activity score).
measure: Clinical data will be measured with scoring list HOOS (Hip dysfunction and Osteoarthritis Outcome Score).
time frame: One year
description: Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring lists HOOS (Hip dysfunction and Osteoarthritis Outcome Score).
arm group label: Capsular resection
arm group type: Active Comparator
description: Capsular resection
arm group label: Capsular retention
arm group type: Active Comparator
description: Capsular retention
intervention type: Procedure
intervention name: Capsular resection
description: Capsular resection
arm group label: Capsular resection
intervention type: Procedure
intervention name: Capsular retention
description: Capsular retention
arm group label: Capsular retention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: ZOL
investigator full name: Jens Vanbiervliet
investigator title: Resident Orthopedic Surgery