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/NCT06003595</url>
    </required_header>
    <id_info>
      <org_study_id>2023-01191; kt23Lardinois3</org_study_id>
      <nct_id>NCT06003595</nct_id>
    </id_info>
    <brief_title>Long-term Outcome After Removal of Rib Stabilization Hardware in Patients With Blunt Chest Trauma</brief_title>
    <acronym>REMOVE</acronym>
    <official_title>Long-term Outcome After Removal of Rib Stabilization Hardware in Patients With Blunt Chest Trauma</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>
        The main study objective is to evaluate the long-term outcome in a prospective follow-up&#xD;
        visit of patients who underwent hardware removal after surgical stabilization of rib&#xD;
        fractures (SSRF) after a blunt chest trauma .&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Potential of surgical stabilization of rib fractures (SSRF) to improve clinical outcomes in&#xD;
        patients has been demonstrated with increasing interest of surgeons in this procedure and&#xD;
        indications for SSRF expanding. Some reports found signals for hardware removal after SSRF&#xD;
        such as hardware failure, infections and persisting pain. There is currently lack of studies&#xD;
        collecting systematically long-term outcomes after SSRF hardware removal. For that reason,&#xD;
        this project presents the retrospective case series of patients with removal of&#xD;
        osteosynthetic material after rib stabilisation treated at Department of Thoracic Surgery of&#xD;
        the University Hospital Basel (USB). The recovery of these patients will be reviewed and a&#xD;
        prospective evaluation of long-term outcomes will be done. The aim is to provide an insight&#xD;
        and implications for treatment strategies of future patients. Most of the collected patient&#xD;
        data are retrospective data. One prospective follow-up visit inclusive a health survey per&#xD;
        patient will be performed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Health survey of long-term outcome after hardware removal (Quality of life assessment)</measure>
      <time_frame>one time assessment at baseline (prospective Follow up-visit)</time_frame>
      <description>The questions are formulated as an adapted question set of the EuroQol-5 Dimension (EQ-5D-5L) questionnaire followed by additional study specific questions. A numerical rating scale (NRS) will be used for evaluation from 0 - 10. In addition, the patient will be asked to rate the condition now compared to before hardware removal in four categories (less good, no change, slightly better, much better). The analysis of the project data will be done descriptive.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of removed hardware</measure>
      <time_frame>up to 3 years until prospective Follow up-visit</time_frame>
      <description>Number of removed hardware at affected ribs (retrospective analyses)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of broken and fixed ribs</measure>
      <time_frame>up to 3 years until prospective Follow up-visit</time_frame>
      <description>Number of broken and fixed ribs with used hardware (retrospective analyses)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interval between SSRF and hardware failure</measure>
      <time_frame>up to 3 years until prospective Follow up-visit</time_frame>
      <description>Interval between SSRF and hardware failure (retrospective analyses)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interval between SSRF and hardware removal</measure>
      <time_frame>up to 3 years until prospective Follow up-visit</time_frame>
      <description>Interval between SSRF and hardware removal (retrospective analyses)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interval between SSRF and follow-up visit</measure>
      <time_frame>up to 3 years until prospective Follow up-visit</time_frame>
      <description>Interval between SSRF and follow-up visit (retrospective analyses)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of significant complications during and 30 days after SSRF hardware removal</measure>
      <time_frame>up to 3 years until prospective Follow up-visit</time_frame>
      <description>Occurrence of significant complications during and 30 days after SSRF hardware removal (retrospective analyses)</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Rib Fractures</condition>
    <arm_group>
      <arm_group_label>surgical stabilization of rib fractures (SSRF) and subsequent hardware removal</arm_group_label>
      <description>Patients treated at the Department of Thoracic Surgery at the University Hospital Basel between 01.09.2017 and start date Remove Study with a diagnosis of rib fracture and with surgical stabilization of rib fracture and subsequent hardware removal will be identified.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>data collection on patient reported long-term outcome of SSRF hardware removal</intervention_name>
      <description>One prospective follow-up visit will be performed. On this visit the patient reported long-term outcome will be documented through a health survey.</description>
      <arm_group_label>surgical stabilization of rib fractures (SSRF) and subsequent hardware removal</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with blunt chest trauma who underwent hardware removal after rib stabilisation&#xD;
          between September 01, 2017 until start date of the Remove Study. The patients received&#xD;
          hardware implantation and hardware removal at the Department of Thoracic Surgery of the&#xD;
          University Hospital Basel.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient treated at the Department of Thoracic Surgery, USB for implantation and&#xD;
               removal of rib fixation hardware&#xD;
  &#xD;
            -  Blunt chest trauma/injuries to the thorax: Patient with blunt chest trauma (with or&#xD;
               without polytrauma) before SSRF implantation and subsequent hardware removal. Patients&#xD;
               with rib fracture/non-union due to pseudo arthrosis are included.&#xD;
  &#xD;
            -  Rib fracture: At least one rib fracture (unilateral and or bilateral incl. flail&#xD;
               chest) on radiography chest imaging on time of SSRF implantation&#xD;
  &#xD;
            -  Rib fixation material implantation and removal: Patient underwent surgery for rib&#xD;
               fracture and implantation of at least one (partially or complete) rib fixation&#xD;
               material (at any time point) with later hardware removal (partially or complete) (at&#xD;
               any time point between 01.09.2017 and start date Remove Study)&#xD;
  &#xD;
            -  Patients of all gender&#xD;
  &#xD;
            -  Patient ≥18 years at time point of rib stabilization&#xD;
  &#xD;
            -  Signed written informed consent prior to initiation of any protocol-specific&#xD;
               activities/procedure&#xD;
  &#xD;
            -  Patient will be included if a signed USB general research consent approval is&#xD;
               available but patient cannot be reached or disagreed to come to the follow-up visit&#xD;
  &#xD;
            -  Patients who died will be included if a signed USB general research consent approval&#xD;
               is available&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who received re-osteosynthesis on the same day as hardware removal&#xD;
  &#xD;
            -  Patients received conservative therapy or surgery with absorbable plates&#xD;
  &#xD;
            -  On hardware implantation:&#xD;
  &#xD;
                 -  Penetrating chest trauma&#xD;
  &#xD;
                 -  Random findings of rib fractures&#xD;
  &#xD;
                 -  Solitary sternocostal joint fracture, solitary sternum fracture, solitary&#xD;
                    thoracic spine/vertebra fracture, solitary fractures of rib connecting parts&#xD;
  &#xD;
                 -  In-hospital: Patient suffered new rib fracture during a surgery, cardiac surgery&#xD;
  &#xD;
                 -  Rib fractures/non-unions due to malignancy, radiation therapy, chronic&#xD;
                    obstructive pulmonary disease (COPD), coughing&#xD;
  &#xD;
            -  Inability to follow procedures or insufficient knowledge of language (German/French)&#xD;
               or impaired communication or inability to give consent&#xD;
  &#xD;
            -  Patients who have clearly stated that they would not agree in providing their clinical&#xD;
               data for scientific purposes&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Maria Stepankova, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Thoracic Surgery, University Hospital Basel</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maria Stepankova, MD</last_name>
      <phone>+41 61 328 7132</phone>
      <email>maria.stepankova@usb.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Helga Bachmann</last_name>
      <phone>+41 61 32 87170</phone>
      <email>helga.bachmann@usb.ch</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Thoracic Surgery, University Hospital Basel</name>
        <address>
          <city>Basel</city>
          <zip>4031</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <contact>
        <last_name>Maria Stepankova, MD</last_name>
        <phone>+41 61 328 7132</phone>
        <email>maria.stepankova@usb.ch</email>
      </contact>
      <investigator>
        <last_name>Maria Stepankova, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Aljaz Hojski, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>surgical stabilization of rib fractures (SSRF)</keyword>
    <keyword>hardware failure</keyword>
    <keyword>hardware-related complications</keyword>
    <keyword>hardware removal</keyword>
    <keyword>blunt chest trauma</keyword>
    <keyword>rib osteosynthesis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rib Fractures</mesh_term>
      <mesh_term>Thoracic Injuries</mesh_term>
    </condition_browse>
    <!-- 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/NCT06003595
  org study id: 2023-01191; kt23Lardinois3
  nct id: NCT06003595
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The main study objective is to evaluate the long-term outcome in a prospective follow-up
        visit of patients who underwent hardware removal after surgical stabilization of rib
        fractures (SSRF) after a blunt chest trauma .
  Potential of surgical stabilization of rib fractures (SSRF) to improve clinical outcomes in
        patients has been demonstrated with increasing interest of surgeons in this procedure and
        indications for SSRF expanding. Some reports found signals for hardware removal after SSRF
        such as hardware failure, infections and persisting pain. There is currently lack of studies
        collecting systematically long-term outcomes after SSRF hardware removal. For that reason,
        this project presents the retrospective case series of patients with removal of
        osteosynthetic material after rib stabilisation treated at Department of Thoracic Surgery of
        the University Hospital Basel (USB). The recovery of these patients will be reviewed and a
        prospective evaluation of long-term outcomes will be done. The aim is to provide an insight
        and implications for treatment strategies of future patients. Most of the collected patient
        data are retrospective data. One prospective follow-up visit inclusive a health survey per
        patient will be performed.
  observational model: Cohort
  time perspective: Prospective
  measure: Health survey of long-term outcome after hardware removal (Quality of life assessment)
  time frame: one time assessment at baseline (prospective Follow up-visit)
  description: The questions are formulated as an adapted question set of the EuroQol-5 Dimension (EQ-5D-5L) questionnaire followed by additional study specific questions. A numerical rating scale (NRS) will be used for evaluation from 0 - 10. In addition, the patient will be asked to rate the condition now compared to before hardware removal in four categories (less good, no change, slightly better, much better). The analysis of the project data will be done descriptive.
  measure: Number of removed hardware
  time frame: up to 3 years until prospective Follow up-visit
  description: Number of removed hardware at affected ribs (retrospective analyses)
  measure: Number of broken and fixed ribs
  time frame: up to 3 years until prospective Follow up-visit
  description: Number of broken and fixed ribs with used hardware (retrospective analyses)
  measure: Interval between SSRF and hardware failure
  time frame: up to 3 years until prospective Follow up-visit
  description: Interval between SSRF and hardware failure (retrospective analyses)
  measure: Interval between SSRF and hardware removal
  time frame: up to 3 years until prospective Follow up-visit
  description: Interval between SSRF and hardware removal (retrospective analyses)
  measure: Interval between SSRF and follow-up visit
  time frame: up to 3 years until prospective Follow up-visit
  description: Interval between SSRF and follow-up visit (retrospective analyses)
  measure: Occurrence of significant complications during and 30 days after SSRF hardware removal
  time frame: up to 3 years until prospective Follow up-visit
  description: Occurrence of significant complications during and 30 days after SSRF hardware removal (retrospective analyses)
  arm group label: surgical stabilization of rib fractures (SSRF) and subsequent hardware removal
  description: Patients treated at the Department of Thoracic Surgery at the University Hospital Basel between 01.09.2017 and start date Remove Study with a diagnosis of rib fracture and with surgical stabilization of rib fracture and subsequent hardware removal will be identified.
  intervention type: Other
  intervention name: data collection on patient reported long-term outcome of SSRF hardware removal
  description: One prospective follow-up visit will be performed. On this visit the patient reported long-term outcome will be documented through a health survey.
  arm group label: surgical stabilization of rib fractures (SSRF) and subsequent hardware removal
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Maria Stepankova, MD
  role: Principal Investigator
  affiliation: Department of Thoracic Surgery, University Hospital Basel
  last name: Maria Stepankova, MD
  phone: +41 61 328 7132
  email: maria.stepankova@usb.ch
  last name: Helga Bachmann
  phone: +41 61 32 87170
  email: helga.bachmann@usb.ch
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Rib Fractures
  mesh term: Thoracic Injuries