xml: <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/NCT05969470</url>
    </required_header>
    <id_info>
      <org_study_id>202301173DINA</org_study_id>
      <nct_id>NCT05969470</nct_id>
    </id_info>
    <brief_title>Short Versus Long Intramedullary Nails in the Treatment of Proximal Femur Metastasis.</brief_title>
    <official_title>Compare the Efficacy of Long-nailed and Short-nailed Fixation for Proximal Femur Metastasis - a Non-inferior Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Taiwan University Hospital, Yun-Lin Branch</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Taiwan University Hospital Hsin-Chu Branch</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>National Taiwan University Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this interventional randomized controlled trial is to compare the clinical&#xD;
        outcomes in treating extremities pathological fractures (fractures of limbs caused by&#xD;
        metastatic tumors) or impending pathological fractures with short or long intramedullary&#xD;
        nails. The main questions it aims to answer are:&#xD;
  &#xD;
          1. What is the rate of developing new distant metastasis of the operated extremities?&#xD;
  &#xD;
          2. Does treating extremities (impending) pathological fractures with long intramedullary&#xD;
             nails have lower or similar reoperation rate than the short nails?&#xD;
  &#xD;
          3. Are there any differences when comparing the surgical-related complication, functional&#xD;
             outcomes and life quality assessment between treating extremities (impending)&#xD;
             pathological fractures with long or short intramedullary nails.&#xD;
  &#xD;
        Participants who meet surgical indication will be randomized into either the long or short&#xD;
        intramedullary nail group after informed consent. The patient will receive bone fixation with&#xD;
        the corresponding prosthesis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will be randomized into either long or short intramedullary nail groups.&#xD;
        Participants in the long intramedullary nail group will be fixed with a longer intramedullary&#xD;
        nail (defined as greater than 2/3 of the patient's femur) for proximal femoral (impending)&#xD;
        pathological fractures, while patients in the short intramedullary nail group will be fixed&#xD;
        with a shorter intramedullary nail (defined as less than 2/3 of the patient's femur) for&#xD;
        proximal femoral (impending) pathological fractures. Follow-up will be performed at 1, 3, 6,&#xD;
        and 12 months after surgery to analyze the patient's function, blood sampling values, and&#xD;
        imaging follow-up. The functional capacity will be evaluated by PROMIS questionnaire.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">June 2027</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Reoperation rate</measure>
      <time_frame>Up to 1 year after the intervention</time_frame>
      <description>Percentage of patients receiving revision surgery within 1 year after the intervention. The primary outcome should be compared using non-inferior tests. The non-inferior margin was pre-specified at 25.4%.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in functional outcome on the Patient-Reported Outcomes Measurement Information System-29 scoring at 1,3,6,12 months after the intervention</measure>
      <time_frame>At 1,3,6,12 months after the intervention</time_frame>
      <description>The Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluates physical, mental, and social health in adults and children. It's used to measure symptoms and other aspects of health status in a wide variety of chronic diseases. PROMIS-29 is a particular version of this system that covers multiple domains of health and function. It consists of 29 items in total, spanning seven domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference. Each domain has four questions, with the exception of the pain interference domain, which has five. Each question is scored from 1-5, the higher score indicates better function or quality of life. The sum of the PROMIS results in the raw score, which lies between 4 and 20. There's also a single question evaluating pain intensity, as assessed by pain intensity numeric rating scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiopulmonary complication rate within 30 days after the intervention</measure>
      <time_frame>Up to 30 days after the intervention</time_frame>
      <description>Cardiopulmonary complication includes the following events developing within 30 days after the intervention: O2 desaturation, shock, embolic event, or coma and death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality rate at 1,3,6,12 months after the intervention</measure>
      <time_frame>At 1,3,6,12 months after the intervention</time_frame>
      <description>Percentage of demise at 1,3,6,12 months after the intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of of participants with distant femoral metastasis</measure>
      <time_frame>Up to 1 year after the intervention</time_frame>
      <description>Newly formed metastatic lesions on the same limb distant to the operation site within 1 year after the intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost-effectiveness analysis</measure>
      <time_frame>Up to 2 year after the intervention</time_frame>
      <description>Utility comparison using Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) questionnaire</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Bone Metastases</condition>
    <condition>Pathological Fracture</condition>
    <condition>Pathological Fracture, Left Femur</condition>
    <condition>Pathological Fracture, Right Femur</condition>
    <arm_group>
      <arm_group_label>Short intramedullary nails</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patients receives bone fixation with short intramedullary nails for extremity metastases.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Long intramedullary nails</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The patients receives bone fixation with long intramedullary nails for extremity metastases.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Internal fixation with short intramedullary nails</intervention_name>
      <description>Intramedullary nailing is a method of internal fixation used to treat fractures. An intramedullary nail is a metal rod forced into the marrow canal of a bone to stabilize and align fractures. Participants in this group will be fixed with a shorter intramedullary nail (defined as defined as less than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures.</description>
      <arm_group_label>Short intramedullary nails</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Internal fixation with long intramedullary nails</intervention_name>
      <description>Intramedullary nailing is a method of internal fixation used to treat fractures. An intramedullary nail is a metal rod forced into the marrow canal of a bone to stabilize and align fractures. Participants in this group will be fixed with a longer intramedullary nail (defined as greater than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures.</description>
      <arm_group_label>Long intramedullary nails</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Femur (impending) pathological fracture that is suitable for intramedullary nail&#xD;
               fixation as determined by the physician&#xD;
  &#xD;
            -  Patient is willing to participate in this clinical trial and cooperate with follow-up&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The patient has a more appropriate treatment alternative to single intramedullary nail&#xD;
               fixation as determined by the multidisciplinary decision, such as,&#xD;
  &#xD;
                 -  The metastatic lesions involved the femur head&#xD;
  &#xD;
                 -  The metastatic lesions involved the pelvis&#xD;
  &#xD;
                 -  The metastatic lesions compromised the greater or lesser trochanter to a certain&#xD;
                    extent that arthroplasty was indicated&#xD;
  &#xD;
                 -  The metastatic lesions involved/occurred more distal than the intertrochanteric&#xD;
                    line&#xD;
  &#xD;
            -  There are justified, clinically significant rationales that either long or short&#xD;
               intramedullary nails be a more appropriate treatment during pre-operative assessment&#xD;
  &#xD;
            -  The patient has imaging-confirmed distant femoral metastases before treatment&#xD;
  &#xD;
            -  Patient has renal cell carcinoma or sarcoma&#xD;
  &#xD;
            -  Patient is unable to cooperate with follow-up or to understand the trial protocol&#xD;
  &#xD;
            -  Patient is unable to communicate in Chinese&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hsiang Chieh Hsieh, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Department of Orthopaedic Surgery, National Taiwan University Hospital, Hsin-Chu branch</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hsiang Chieh Hsieh, MD</last_name>
      <phone>+886 972654075</phone>
      <email>D08528020@ntu.edu.tw</email>
    </overall_contact>
    <results_reference>
      <citation>Alvi HM, Damron TA. Prophylactic stabilization for bone metastases, myeloma, or lymphoma: do we need to protect the entire bone? Clin Orthop Relat Res. 2013 Mar;471(3):706-14. doi: 10.1007/s11999-012-2656-1. Epub 2012 Oct 27.</citation>
      <PMID>23104043</PMID>
    </results_reference>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>May 9, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Long Intramedullary Nails</keyword>
    <keyword>Short Intramedullary Nails</keyword>
    <keyword>Bone Metastases</keyword>
    <keyword>Pathological Fracture of Femur</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasm Metastasis</mesh_term>
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Fractures, Spontaneous</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05969470
  org study id: 202301173DINA
  nct id: NCT05969470
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The goal of this interventional randomized controlled trial is to compare the clinical
        outcomes in treating extremities pathological fractures (fractures of limbs caused by
        metastatic tumors) or impending pathological fractures with short or long intramedullary
        nails. The main questions it aims to answer are:
  
          1. What is the rate of developing new distant metastasis of the operated extremities?
  
          2. Does treating extremities (impending) pathological fractures with long intramedullary
             nails have lower or similar reoperation rate than the short nails?
  
          3. Are there any differences when comparing the surgical-related complication, functional
             outcomes and life quality assessment between treating extremities (impending)
             pathological fractures with long or short intramedullary nails.
  
        Participants who meet surgical indication will be randomized into either the long or short
        intramedullary nail group after informed consent. The patient will receive bone fixation with
        the corresponding prosthesis.
  Participants will be randomized into either long or short intramedullary nail groups.
        Participants in the long intramedullary nail group will be fixed with a longer intramedullary
        nail (defined as greater than 2/3 of the patient's femur) for proximal femoral (impending)
        pathological fractures, while patients in the short intramedullary nail group will be fixed
        with a shorter intramedullary nail (defined as less than 2/3 of the patient's femur) for
        proximal femoral (impending) pathological fractures. Follow-up will be performed at 1, 3, 6,
        and 12 months after surgery to analyze the patient's function, blood sampling values, and
        imaging follow-up. The functional capacity will be evaluated by PROMIS questionnaire.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Reoperation rate
  time frame: Up to 1 year after the intervention
  description: Percentage of patients receiving revision surgery within 1 year after the intervention. The primary outcome should be compared using non-inferior tests. The non-inferior margin was pre-specified at 25.4%.
  measure: Change from baseline in functional outcome on the Patient-Reported Outcomes Measurement Information System-29 scoring at 1,3,6,12 months after the intervention
  time frame: At 1,3,6,12 months after the intervention
  description: The Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluates physical, mental, and social health in adults and children. It's used to measure symptoms and other aspects of health status in a wide variety of chronic diseases. PROMIS-29 is a particular version of this system that covers multiple domains of health and function. It consists of 29 items in total, spanning seven domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference. Each domain has four questions, with the exception of the pain interference domain, which has five. Each question is scored from 1-5, the higher score indicates better function or quality of life. The sum of the PROMIS results in the raw score, which lies between 4 and 20. There's also a single question evaluating pain intensity, as assessed by pain intensity numeric rating scale.
  measure: Cardiopulmonary complication rate within 30 days after the intervention
  time frame: Up to 30 days after the intervention
  description: Cardiopulmonary complication includes the following events developing within 30 days after the intervention: O2 desaturation, shock, embolic event, or coma and death.
  measure: Mortality rate at 1,3,6,12 months after the intervention
  time frame: At 1,3,6,12 months after the intervention
  description: Percentage of demise at 1,3,6,12 months after the intervention
  measure: Percentage of of participants with distant femoral metastasis
  time frame: Up to 1 year after the intervention
  description: Newly formed metastatic lesions on the same limb distant to the operation site within 1 year after the intervention
  measure: Cost-effectiveness analysis
  time frame: Up to 2 year after the intervention
  description: Utility comparison using Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) questionnaire
  arm group label: Short intramedullary nails
  arm group type: Experimental
  description: The patients receives bone fixation with short intramedullary nails for extremity metastases.
  arm group label: Long intramedullary nails
  arm group type: Active Comparator
  description: The patients receives bone fixation with long intramedullary nails for extremity metastases.
  intervention type: Device
  intervention name: Internal fixation with short intramedullary nails
  description: Intramedullary nailing is a method of internal fixation used to treat fractures. An intramedullary nail is a metal rod forced into the marrow canal of a bone to stabilize and align fractures. Participants in this group will be fixed with a shorter intramedullary nail (defined as defined as less than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures.
  arm group label: Short intramedullary nails
  intervention type: Device
  intervention name: Internal fixation with long intramedullary nails
  description: Intramedullary nailing is a method of internal fixation used to treat fractures. An intramedullary nail is a metal rod forced into the marrow canal of a bone to stabilize and align fractures. Participants in this group will be fixed with a longer intramedullary nail (defined as greater than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures.
  arm group label: Long intramedullary nails
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hsiang Chieh Hsieh, MD
  role: Study Chair
  affiliation: Department of Orthopaedic Surgery, National Taiwan University Hospital, Hsin-Chu branch
  last name: Hsiang Chieh Hsieh, MD
  phone: +886 972654075
  email: D08528020@ntu.edu.tw
  citation: Alvi HM, Damron TA. Prophylactic stabilization for bone metastases, myeloma, or lymphoma: do we need to protect the entire bone? Clin Orthop Relat Res. 2013 Mar;471(3):706-14. doi: 10.1007/s11999-012-2656-1. Epub 2012 Oct 27.
  PMID: 23104043
  responsible party type: Sponsor
  mesh term: Neoplasm Metastasis
  mesh term: Fractures, Bone
  mesh term: Fractures, Spontaneous
  sharing ipd: No