<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/NCT03227549</url>
  </required_header>
  <id_info>
    <org_study_id>THA DSA</org_study_id>
    <nct_id>NCT03227549</nct_id>
  </id_info>
  <brief_title>Investigating the Direct Superior Approach for Total Hip Arthroplasty as an Effective Alternative to Traditional Posterior Approach</brief_title>
  <official_title>Investigating the Direct Superior Approach for Total Hip Arthroplasty as an Effective Alternative to Traditional Posterior Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nova Scotia Health Authority</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>
      Hip replacement surgery is an effective option for treating pain and functional impairment in&#xD;
      chronic hip conditions. Various surgical approaches have been developed to expose the hip&#xD;
      joint for the procedure, each with advantages and disadvantages. The posterior approach (PA)&#xD;
      to total hip replacement is a commonly used exposure method. This approach involves a large&#xD;
      incision and requires multiple cuts through muscle and other soft tissues to expose the hip&#xD;
      joint. Despite excellent outcomes, the PA is known to have an increased rate of dislocation&#xD;
      compared to other exposures. The direct superior (DS) approach has been developed to improve&#xD;
      the PA by decreasing the amount of soft tissue injury at the time of surgery and improving&#xD;
      postoperative stability. The DS approach involves a much shorter incision and reduces the&#xD;
      need to damage as much soft tissues surrounding the hip joint during exposure. Specialized&#xD;
      equipment developed for this technique allows the surgeon to place the hip replacement&#xD;
      components. The proposed research study is designed to address a deficit in knowledge&#xD;
      regarding outcomes on patients who have had a DS approach for total hip arthroplasty. This&#xD;
      study will provide much needed insight into the advantages and disadvantages of the DS&#xD;
      approach as compared to PA for total hip arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to compare the health status and functional outcomes&#xD;
      of patients who have undergone total hip arthroplasty (THA) utilizing the direct superior&#xD;
      (DS) approach to those who have undergone THA utilizing the posterior approach (PA). The aim&#xD;
      is to quantify changes in functional status using accelerometer-based gait analysis and&#xD;
      self-reported questionnaires, and to assess peri-operative recovery including narcotic use,&#xD;
      length of stay, blood loss, complications and readmission for any reason.&#xD;
&#xD;
      It is hypothesized that patients who undergo THA utilizing the DS approach will have more&#xD;
      favorable results in terms of health status and functional outcomes when compared to those&#xD;
      who receive the PA approach. It is expected that patients in the DS group will display an&#xD;
      earlier improvement in gait postoperatively, will have a shorter length of stay in hospital,&#xD;
      and will have decreased postoperative pain as measured by narcotic use. No measurable&#xD;
      difference in the position of the THA implants is expected between groups.&#xD;
&#xD;
      The proposed clinical study is a prospective randomized trial of 80 patients undergoing total&#xD;
      hip arthroplasty utilizing either a PA or DS approach. Postoperative outcomes including&#xD;
      narcotic use, length of stay and complications will be abstracted from the chart and any&#xD;
      readmissions will be documented. Follow-up exams will occur at 6 weeks, 6 months, 12 months&#xD;
      and 24 months from time of surgery. Radiographic evaluation will be performed at each&#xD;
      interval to assess the position of the implants. Gait symmetry data will be collected&#xD;
      pre-operatively as well as at 6 months, 12 months, and 24 months and will be assessed for&#xD;
      longitudinal changes in characteristics such as stride frequency, envelope, surge, lurch and&#xD;
      functional leg length discrepancy. Health status, functional outcome, and patient quality of&#xD;
      life measures will be recorded at all follow-up intervals. Joint function will be assessed&#xD;
      before and after surgery using the EuroQol questionnaire, Oxford 12 Hip questionnaire,&#xD;
      Self-Administered Comorbidity Questionnaire (SCQ), visual analogue scales (VAS) for pain and&#xD;
      satisfaction, and UCLA Activity Level Scale. Rates of infection, instability and revision for&#xD;
      any cause will be monitored for the duration of the 2 year follow-up.&#xD;
&#xD;
      Pre-operative subject characteristics will be compared between groups using Student's t-tests&#xD;
      (unpaired, two-sided). For the post-operative follow-up questionnaire and radiographic data,&#xD;
      two-way repeated measures analyses of variance (ANOVA) for group differences will be used to&#xD;
      analyze data collected at multiple time points. Gait data will be analyzed using Gaitview&#xD;
      software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 19, 2018</start_date>
  <completion_date type="Anticipated">March 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2019</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>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>EQ-5D patient reported outcome measure</measure>
    <time_frame>2 years</time_frame>
    <description>Health status measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxford-12 patient reported outcome measure</measure>
    <time_frame>2 years</time_frame>
    <description>Functional outcome measure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>0 - 30 days</time_frame>
    <description>Time until discharge from hospital following surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Total Hip Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Direct Superior Approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention being tested is the surgical approach.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Posterior Approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Direct Superior Approach</intervention_name>
    <description>Total hip arthroplasty using direct superior approach</description>
    <arm_group_label>Direct Superior Approach</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Total Hip Arthroplasty</intervention_name>
    <description>Total Hip Arthroplasty using direct superior or posterior approach</description>
    <arm_group_label>Direct Superior Approach</arm_group_label>
    <arm_group_label>Posterior Approach</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Posterior Approach</intervention_name>
    <description>Total Hip Arthroplasty using posterior approach</description>
    <arm_group_label>Posterior Approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic osteoarthritis of the hip indicating surgical intervention&#xD;
&#xD;
          -  Uncemented femoral stem and acetabular cup indicated&#xD;
&#xD;
          -  Patients between the ages of 18 and 80, inclusive.&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 18 years of age, or 81 years of age and older&#xD;
&#xD;
          -  Active or prior infection of the affected hip&#xD;
&#xD;
          -  Morbid obesity (BMI &gt; 45)&#xD;
&#xD;
          -  Medical condition precluding major surgery&#xD;
&#xD;
          -  Severe osteoporosis or osteopenia&#xD;
&#xD;
          -  Neuromuscular impairment&#xD;
&#xD;
          -  Patients with known or tested-positive allergy to metals&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>81 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Capital District Health Authority</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 3A7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elise Laende</last_name>
      <phone>902-473-3883</phone>
      <email>elise.laende@cdha.nshealth.ca</email>
    </contact>
    <investigator>
      <last_name>Glen Richardson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>June 22, 2017</study_first_submitted>
  <study_first_submitted_qc>July 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>February 5, 2018</last_update_submitted>
  <last_update_submitted_qc>February 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>Glen Richardson</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT03227549
org study id: THA DSA
nct id: NCT03227549
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hip replacement surgery is an effective option for treating pain and functional impairment in
      chronic hip conditions. Various surgical approaches have been developed to expose the hip
      joint for the procedure, each with advantages and disadvantages. The posterior approach (PA)
      to total hip replacement is a commonly used exposure method. This approach involves a large
      incision and requires multiple cuts through muscle and other soft tissues to expose the hip
      joint. Despite excellent outcomes, the PA is known to have an increased rate of dislocation
      compared to other exposures. The direct superior (DS) approach has been developed to improve
      the PA by decreasing the amount of soft tissue injury at the time of surgery and improving
      postoperative stability. The DS approach involves a much shorter incision and reduces the
      need to damage as much soft tissues surrounding the hip joint during exposure. Specialized
      equipment developed for this technique allows the surgeon to place the hip replacement
      components. The proposed research study is designed to address a deficit in knowledge
      regarding outcomes on patients who have had a DS approach for total hip arthroplasty. This
      study will provide much needed insight into the advantages and disadvantages of the DS
      approach as compared to PA for total hip arthroplasty.
The primary objective of this study is to compare the health status and functional outcomes
      of patients who have undergone total hip arthroplasty (THA) utilizing the direct superior
      (DS) approach to those who have undergone THA utilizing the posterior approach (PA). The aim
      is to quantify changes in functional status using accelerometer-based gait analysis and
      self-reported questionnaires, and to assess peri-operative recovery including narcotic use,
      length of stay, blood loss, complications and readmission for any reason.

      It is hypothesized that patients who undergo THA utilizing the DS approach will have more
      favorable results in terms of health status and functional outcomes when compared to those
      who receive the PA approach. It is expected that patients in the DS group will display an
      earlier improvement in gait postoperatively, will have a shorter length of stay in hospital,
      and will have decreased postoperative pain as measured by narcotic use. No measurable
      difference in the position of the THA implants is expected between groups.

      The proposed clinical study is a prospective randomized trial of 80 patients undergoing total
      hip arthroplasty utilizing either a PA or DS approach. Postoperative outcomes including
      narcotic use, length of stay and complications will be abstracted from the chart and any
      readmissions will be documented. Follow-up exams will occur at 6 weeks, 6 months, 12 months
      and 24 months from time of surgery. Radiographic evaluation will be performed at each
      interval to assess the position of the implants. Gait symmetry data will be collected
      pre-operatively as well as at 6 months, 12 months, and 24 months and will be assessed for
      longitudinal changes in characteristics such as stride frequency, envelope, surge, lurch and
      functional leg length discrepancy. Health status, functional outcome, and patient quality of
      life measures will be recorded at all follow-up intervals. Joint function will be assessed
      before and after surgery using the EuroQol questionnaire, Oxford 12 Hip questionnaire,
      Self-Administered Comorbidity Questionnaire (SCQ), visual analogue scales (VAS) for pain and
      satisfaction, and UCLA Activity Level Scale. Rates of infection, instability and revision for
      any cause will be monitored for the duration of the 2 year follow-up.

      Pre-operative subject characteristics will be compared between groups using Student's t-tests
      (unpaired, two-sided). For the post-operative follow-up questionnaire and radiographic data,
      two-way repeated measures analyses of variance (ANOVA) for group differences will be used to
      analyze data collected at multiple time points. Gait data will be analyzed using Gaitview
      software.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: EQ-5D patient reported outcome measure
time frame: 2 years
description: Health status measure
measure: Oxford-12 patient reported outcome measure
time frame: 2 years
description: Functional outcome measure
measure: Length of stay
time frame: 0 - 30 days
description: Time until discharge from hospital following surgery
arm group label: Direct Superior Approach
arm group type: Experimental
description: The intervention being tested is the surgical approach.
arm group label: Posterior Approach
arm group type: Active Comparator
intervention type: Procedure
intervention name: Direct Superior Approach
description: Total hip arthroplasty using direct superior approach
arm group label: Direct Superior Approach
intervention type: Device
intervention name: Total Hip Arthroplasty
description: Total Hip Arthroplasty using direct superior or posterior approach
arm group label: Direct Superior Approach
arm group label: Posterior Approach
intervention type: Procedure
intervention name: Posterior Approach
description: Total Hip Arthroplasty using posterior approach
arm group label: Posterior Approach
criteria: 
gender: All
minimum age: 18 Years
maximum age: 81 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: Glen Richardson
investigator title: Principal Investigator
sharing ipd: No