<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/NCT02981823</url>
  </required_header>
  <id_info>
    <org_study_id>HebeiMUTH_QD_001</org_study_id>
    <nct_id>NCT02981823</nct_id>
  </id_info>
  <brief_title>Effect of Periprosthetic Fracture on Hip Function After Femoral Neck-preserving Total Hip Arthroplasty</brief_title>
  <official_title>Effect of Periprosthetic Fracture on Hip Function After Femoral Neck-preserving Total Hip Arthroplasty: a Prospective, Single-center, Self-controlled Trial With 2-year Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hebei Medical University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hebei Medical University Third Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To provide information on reducing the incidence of periprosthetic fractures during hip&#xD;
      replacement with the CFP prosthetic stem by analyzing the risk factors for periprosthetic&#xD;
      fractures and their effects on hip functional recovery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      History and current related studies Periprosthetic fractures are one of the challenges for&#xD;
      orthopedic surgeons that are more likely to appear during hip replacement with a cementless&#xD;
      prosthesis. Hip replacement with a collum femoris preserving (CFP) prosthetic stem allows the&#xD;
      preservation of the femoral neck and preserves bone tissues as much as possible for&#xD;
      prosthetic revision in the future. However, the occurrence of periprosthetic fractures will&#xD;
      result in a failure surgery. Existing evidence has shown that although hip replacement with&#xD;
      the CFP prosthetic stem can reduce complications and pain, periprosthetic fractures that are&#xD;
      more likely to occur during the surgery badly impact functional recovery in patients.&#xD;
&#xD;
      Adverse events Adverse events which occurred during the follow-up, including hip pain,&#xD;
      prosthetic loosening, spinal cord and nerve injuries, soft tissue infection and poor&#xD;
      prosthetic position, were recorded.&#xD;
&#xD;
      If severe adverse events occurred during the follow-up, their details including the date of&#xD;
      occurrence, type of adverse events and measures taken were recorded and reported to the&#xD;
      principal investigator and the institutional review board within 24 hours.&#xD;
&#xD;
      Data collection, management, analysis, and open access Data collection Clinical data,&#xD;
      including demographic data, disease diagnosis, accompanying diseases, allergic history (drug&#xD;
      allergy) and adverse events, were collected and summarized using standardized case report&#xD;
      forms. These data were processed using Epidata software and electronically input using double&#xD;
      entry system.&#xD;
&#xD;
      Data management After database confirmation, only the project manager was able to access the&#xD;
      database. The locked data were unable to be altered and were preserved by the Third Hospital&#xD;
      of Hebei Medical University.&#xD;
&#xD;
      Data analysis All data were statistically analyzed by professional statisticians who were&#xD;
      responsible for completing an outcome analysis report that was submitted to the project&#xD;
      manager. An independent data monitoring committee was responsible for data monitoring and&#xD;
      management throughout the entire trial to ensure scientific accuracy, stringency,&#xD;
      authenticity, and integrity.&#xD;
&#xD;
      Statistical analysis All data were statistically analyzed by statisticians using SPSS 21.0&#xD;
      software in line with the intention-to-treat principle. Normally distributed measurement data&#xD;
      were expressed as means, standard deviations, minimums, and maximums, while non-normally&#xD;
      distributed data were expressed as lower quartiles, medians, and upper quartiles.&#xD;
&#xD;
      Wilcoxon matched paired test was used for comparative analysis of Harris hip scores and&#xD;
      imaging parameters as determined before and 6, 12, 24 months after operation. Then, a&#xD;
      multivariate logistic regression analysis was used to calculate the regression coefficient,&#xD;
      OR, 95% CI with the Harris scale as the dependent variable for each imaging parameter which&#xD;
      had significant difference. The statistical significance level was α = 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Harris hip scores</measure>
    <time_frame>Changes of baseline and 6 months after operation</time_frame>
    <description>To evaluate the recovery of hip joint function. Harris hip scores have a range of 0-100 points: excellent ≥ 90 points, good 80-89 points, fair 70-79 points, and poor &lt;70 points. The higher score indicates the better function of the hip.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>X-ray image</measure>
    <time_frame>Changes of baseline and month 6, month 12, month 24 after operation</time_frame>
    <description>To observe anteroposterior and frog-leg lateral X-ray films of the hip as well as full-length X-ray films of the bilateral lower extremities.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Total Hip Arthroplasty</condition>
  <arm_group>
    <arm_group_label>hip replacement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients undergo total hip replacement with the collum femoris preserving stem suffered from periprosthetic fractures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>hip replacement</intervention_name>
    <description>The patients undergo hip replacement with the collum femoris preserving stem suffered from periprosthetic fractures.</description>
    <arm_group_label>hip replacement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnostic and staging criteria in line with the Expert consensus on diagnosis and&#xD;
             treatment of adult femoral head necrosis&#xD;
&#xD;
          -  Femoral head necrosis of Association Research Circulation Osseous (ARCO) stages III-IV&#xD;
&#xD;
          -  Unilateral femoral head necrosis&#xD;
&#xD;
          -  Age &lt; 50 years&#xD;
&#xD;
          -  Both genders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Advanced osteoarthritis&#xD;
&#xD;
          -  Secondary osteoarthritis due to acetabular dysplasia&#xD;
&#xD;
          -  Ankylosing spondylitis involving the hip joint&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Inflammatory inflammation of the hip joint&#xD;
&#xD;
          -  Tumor lesions in the hip joint&#xD;
&#xD;
          -  Unable or refusal to sign the informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Di Qin, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hebei Medical University Third Hospital</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periprosthetic Fractures</mesh_term>
  </condition_browse>
  <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/NCT02981823
org study id: HebeiMUTH_QD_001
nct id: NCT02981823
lead sponsor: 
has dmc: Yes
To provide information on reducing the incidence of periprosthetic fractures during hip
      replacement with the CFP prosthetic stem by analyzing the risk factors for periprosthetic
      fractures and their effects on hip functional recovery.
History and current related studies Periprosthetic fractures are one of the challenges for
      orthopedic surgeons that are more likely to appear during hip replacement with a cementless
      prosthesis. Hip replacement with a collum femoris preserving (CFP) prosthetic stem allows the
      preservation of the femoral neck and preserves bone tissues as much as possible for
      prosthetic revision in the future. However, the occurrence of periprosthetic fractures will
      result in a failure surgery. Existing evidence has shown that although hip replacement with
      the CFP prosthetic stem can reduce complications and pain, periprosthetic fractures that are
      more likely to occur during the surgery badly impact functional recovery in patients.

      Adverse events Adverse events which occurred during the follow-up, including hip pain,
      prosthetic loosening, spinal cord and nerve injuries, soft tissue infection and poor
      prosthetic position, were recorded.

      If severe adverse events occurred during the follow-up, their details including the date of
      occurrence, type of adverse events and measures taken were recorded and reported to the
      principal investigator and the institutional review board within 24 hours.

      Data collection, management, analysis, and open access Data collection Clinical data,
      including demographic data, disease diagnosis, accompanying diseases, allergic history (drug
      allergy) and adverse events, were collected and summarized using standardized case report
      forms. These data were processed using Epidata software and electronically input using double
      entry system.

      Data management After database confirmation, only the project manager was able to access the
      database. The locked data were unable to be altered and were preserved by the Third Hospital
      of Hebei Medical University.

      Data analysis All data were statistically analyzed by professional statisticians who were
      responsible for completing an outcome analysis report that was submitted to the project
      manager. An independent data monitoring committee was responsible for data monitoring and
      management throughout the entire trial to ensure scientific accuracy, stringency,
      authenticity, and integrity.

      Statistical analysis All data were statistically analyzed by statisticians using SPSS 21.0
      software in line with the intention-to-treat principle. Normally distributed measurement data
      were expressed as means, standard deviations, minimums, and maximums, while non-normally
      distributed data were expressed as lower quartiles, medians, and upper quartiles.

      Wilcoxon matched paired test was used for comparative analysis of Harris hip scores and
      imaging parameters as determined before and 6, 12, 24 months after operation. Then, a
      multivariate logistic regression analysis was used to calculate the regression coefficient,
      OR, 95% CI with the Harris scale as the dependent variable for each imaging parameter which
      had significant difference. The statistical significance level was α = 0.05.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Harris hip scores
time frame: Changes of baseline and 6 months after operation
description: To evaluate the recovery of hip joint function. Harris hip scores have a range of 0-100 points: excellent ≥ 90 points, good 80-89 points, fair 70-79 points, and poor <70 points. The higher score indicates the better function of the hip.
measure: X-ray image
time frame: Changes of baseline and month 6, month 12, month 24 after operation
description: To observe anteroposterior and frog-leg lateral X-ray films of the hip as well as full-length X-ray films of the bilateral lower extremities.
arm group label: hip replacement
arm group type: Experimental
description: The patients undergo total hip replacement with the collum femoris preserving stem suffered from periprosthetic fractures.
intervention type: Procedure
intervention name: hip replacement
description: The patients undergo hip replacement with the collum femoris preserving stem suffered from periprosthetic fractures.
arm group label: hip replacement
criteria: 
gender: All
minimum age: N/A
maximum age: 50 Years
healthy volunteers: No
last name: Di Qin, Ph.D
role: Principal Investigator
affiliation: Hebei Medical University Third Hospital
responsible party type: Sponsor
mesh term: Periprosthetic Fractures
sharing ipd: No