<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/NCT03753282</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01264; ch18Saxer3</org_study_id>
    <nct_id>NCT03753282</nct_id>
  </id_info>
  <brief_title>Outcome After Avascular Necrosis of the Femoral Head in Young Patients</brief_title>
  <acronym>AVN</acronym>
  <official_title>Outcome After Avascular Necrosis of the Femoral Head in Young Patients - Retrospective Analysis With a Min. 10-year Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      1. The course of AVN between Initial diagnosis and total hip replacement (THA) is analysed.&#xD;
           The impact of early interventions versus conservative therapy in AVN before THA will be&#xD;
           evaluated.&#xD;
&#xD;
        2. The short and long term outcomes of AVN patients undergoing THA with respect to&#xD;
           complications, reoperations and quality of life are investigated. Potential risk factors&#xD;
           for adverse outcomes will be investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is to describe the course of avascular necrosis (AVN) of the femoral head from&#xD;
      initial diagnosis and to collect data on treatment options and the further course in these&#xD;
      cases. The duration from initial diagnosis of AVN to joint replacement as total hip&#xD;
      arthroplasty (THA) will be analysed and the course after joint replacement with potential&#xD;
      short- and long-term complications will be evaluated.&#xD;
&#xD;
      The impact of THA after AVN on activities of daily living will be assessed by Euroquol 5&#xD;
      Dimensions (EQ-5D-5L) and Hip disability and Osteoarthritis Outcome Score (HOOS)&#xD;
      questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    difficulty enrolling patients, no patient recruited&#xD;
  </why_stopped>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Actual">March 5, 2019</completion_date>
  <primary_completion_date type="Actual">March 5, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>arthroplasty-free interval (time until THA)</measure>
    <time_frame>single time point assessment at baseline</time_frame>
    <description>time from first diagnosis of AVN to joint replacement = time to event data (in the years between 1999-2006)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>rate of reoperations after THA</measure>
    <time_frame>single time point assessment at baseline</time_frame>
    <description>reoperation after THA = time to event data (in the years between 2000-2007)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hip disability and Osteoarthritis Outcome Score (HOOS)</measure>
    <time_frame>single time point assessment at baseline</time_frame>
    <description>40 item questionnaire to assess patient-relevant outcomes in five separate subscales (pain, symptoms, activity of daily living, sport and recreation function and hip related quality of life). Scores are: None, Mild, Moderate, Severe, Extreme</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Euroquol 5 Dimensions (EQ-5D-5L)</measure>
    <time_frame>single time point assessment at baseline</time_frame>
    <description>Five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Avascular Necrosis of the Femoral Head</condition>
  <arm_group>
    <arm_group_label>Population 1</arm_group_label>
    <description>Patients with a first AVN-related contact (initial or confirmed diagnosis) at the Universitätsspital Basel (USB) or Kantonsspital Basel-Liestal (KSBL) in the years between 1999-2006 (being assessed by questionnaires for patient reported outcome and questionnaire for course of the disease)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Population 2</arm_group_label>
    <description>Patients with a THA because of AVN in the years 2000-2007 (being assessed by questionnaires for patient reported outcome and questionnaire for course of the disease)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaires for patient reported outcome</intervention_name>
    <description>questionnaires with respect to outcomes:&#xD;
Reoperations&#xD;
Short term complications&#xD;
Long term complications&#xD;
EQ-5D (current)&#xD;
HOOS (current)&#xD;
disease related change of occupation&#xD;
use of walking aids&#xD;
comorbidities&#xD;
medication</description>
    <arm_group_label>Population 1</arm_group_label>
    <arm_group_label>Population 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire for course of the disease</intervention_name>
    <description>questionnaires to assess course of the disease:&#xD;
from initial diagnosis of AVN to joint replacement as total hip arthroplasty (THA)&#xD;
therapeutic interventions</description>
    <arm_group_label>Population 1</arm_group_label>
    <arm_group_label>Population 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Population 1: Patients with a first AVN-related contact (initial or confirmed diagnosis) at&#xD;
        the USB or KSBL Liestal in the years between 1999-2006.&#xD;
&#xD;
        Population 2: Patients with a THA because of AVN at the USB or KSBL Liestal in the years&#xD;
        2000-2007.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  MRI of the hip available from diagnosis at the USB or KSBL Liestal&#xD;
&#xD;
          -  Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insufficient knowledge of project languages (English, German, French)&#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>Franziska Saxer, Dr. med</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dep. of Orthopedic and Trauma Surgery; University Hospital Basel</affiliation>
  </overall_official>
  <removed_countries>
    <country>Switzerland</country>
  </removed_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>March 27, 2019</last_update_submitted>
  <last_update_submitted_qc>March 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Total hip arthroplasty</keyword>
  <keyword>Total hip replacement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteonecrosis</mesh_term>
    <mesh_term>Femur Head Necrosis</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03753282
org study id: 2018-01264; ch18Saxer3
nct id: NCT03753282
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
1. The course of AVN between Initial diagnosis and total hip replacement (THA) is analysed.
           The impact of early interventions versus conservative therapy in AVN before THA will be
           evaluated.

        2. The short and long term outcomes of AVN patients undergoing THA with respect to
           complications, reoperations and quality of life are investigated. Potential risk factors
           for adverse outcomes will be investigated.
The study is to describe the course of avascular necrosis (AVN) of the femoral head from
      initial diagnosis and to collect data on treatment options and the further course in these
      cases. The duration from initial diagnosis of AVN to joint replacement as total hip
      arthroplasty (THA) will be analysed and the course after joint replacement with potential
      short- and long-term complications will be evaluated.

      The impact of THA after AVN on activities of daily living will be assessed by Euroquol 5
      Dimensions (EQ-5D-5L) and Hip disability and Osteoarthritis Outcome Score (HOOS)
      questionnaires.
observational model: Cohort
time perspective: Retrospective
measure: arthroplasty-free interval (time until THA)
time frame: single time point assessment at baseline
description: time from first diagnosis of AVN to joint replacement = time to event data (in the years between 1999-2006)
measure: rate of reoperations after THA
time frame: single time point assessment at baseline
description: reoperation after THA = time to event data (in the years between 2000-2007)
measure: Hip disability and Osteoarthritis Outcome Score (HOOS)
time frame: single time point assessment at baseline
description: 40 item questionnaire to assess patient-relevant outcomes in five separate subscales (pain, symptoms, activity of daily living, sport and recreation function and hip related quality of life). Scores are: None, Mild, Moderate, Severe, Extreme
measure: Euroquol 5 Dimensions (EQ-5D-5L)
time frame: single time point assessment at baseline
description: Five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
arm group label: Population 1
description: Patients with a first AVN-related contact (initial or confirmed diagnosis) at the Universitätsspital Basel (USB) or Kantonsspital Basel-Liestal (KSBL) in the years between 1999-2006 (being assessed by questionnaires for patient reported outcome and questionnaire for course of the disease)
arm group label: Population 2
description: Patients with a THA because of AVN in the years 2000-2007 (being assessed by questionnaires for patient reported outcome and questionnaire for course of the disease)
intervention type: Other
intervention name: questionnaires for patient reported outcome
description: questionnaires with respect to outcomes:
Reoperations
Short term complications
Long term complications
EQ-5D (current)
HOOS (current)
disease related change of occupation
use of walking aids
comorbidities
medication
arm group label: Population 1
arm group label: Population 2
intervention type: Other
intervention name: questionnaire for course of the disease
description: questionnaires to assess course of the disease:
from initial diagnosis of AVN to joint replacement as total hip arthroplasty (THA)
therapeutic interventions
arm group label: Population 1
arm group label: Population 2
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Franziska Saxer, Dr. med
role: Principal Investigator
affiliation: Dep. of Orthopedic and Trauma Surgery; University Hospital Basel
country: Switzerland
responsible party type: Sponsor
mesh term: Osteonecrosis
mesh term: Femur Head Necrosis
mesh term: Necrosis