<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/NCT03816436</url>
  </required_header>
  <id_info>
    <org_study_id>2018-00120; ch19Mueller</org_study_id>
    <nct_id>NCT03816436</nct_id>
  </id_info>
  <brief_title>The Impact of Clavicular Length Restoration in the Treatment of Non-unions of Clavicular Midshaft and Lateral Fractures</brief_title>
  <official_title>The Impact of Clavicular Length Restoration in the Treatment of Non-unions of Clavicular Midshaft and Lateral Fractures</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>
      Evaluating the impact of plate treatment and cortical bone grafting of clavicular midshaft&#xD;
      and lateral non- unions on restoration of clavicular length and bony healing and its&#xD;
      association with functional outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2018</start_date>
  <completion_date type="Actual">September 25, 2018</completion_date>
  <primary_completion_date type="Actual">September 25, 2018</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>Clavicula shortening (cm)</measure>
    <time_frame>one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting</time_frame>
    <description>Clavicula shortening (cm) based on Imaging assessment (x-ray, ultrasound), dichotomous outcome with shortening less or equal 2 cm (yes/no).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Constant Murley score (CS)</measure>
    <time_frame>one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting</time_frame>
    <description>tool for assessment of shoulder function: Range of Motion (ROM) of shoulder (degree), abduction strength (kg), Quality of Life (QoL) questionnaire. The different scales are summed and normalized to 0=worst to 100=best.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective shoulder pain (NRS)</measure>
    <time_frame>one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting</time_frame>
    <description>Patient rates pain at rest and at motion of the treated shoulder on numeric scale ranging from 0 (no pain) to 10 (maximum possible pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective shoulder value (SSV)</measure>
    <time_frame>one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting</time_frame>
    <description>based on a single question answered subjectively by Patient: &quot;What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simple shoulder test (SST)</measure>
    <time_frame>one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting</time_frame>
    <description>12 items questionnaire to assess restrictions in activities of daily living (ADL) related to impaired shoulder function; response in dichotomous manner (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL)</measure>
    <time_frame>one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting</time_frame>
    <description>assessed by Quality of Life EuroQoL 5D-5L Instrument (EQ-5D-5L); the descriptive system comprises 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. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">46</enrollment>
  <condition>Clavicular Length</condition>
  <arm_group>
    <arm_group_label>Follow- up (FU) assessment on clavicular non- union</arm_group_label>
    <description>clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Follow- up (FU) assessment</intervention_name>
    <description>Follow- up (FU) assessment (clinical examination and patient questionnaires) at least 24 months after surgery (clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting)</description>
    <arm_group_label>Follow- up (FU) assessment on clavicular non- union</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients surgically treated at the Schulthess Clinic (KWS) and at the University Hospital&#xD;
        Basel (USB) for internal fixation with a plate and using iliac bone graft of clavicular&#xD;
        non- unions.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clavicular midshaft and lateral non- union treated by plate and iliac crest bone&#xD;
             grafting&#xD;
&#xD;
          -  minimal follow- up of two years after surgery&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  legal incompetence&#xD;
&#xD;
          -  non- union of pathologic fractures&#xD;
&#xD;
          -  current pregnancy&#xD;
&#xD;
          -  German language barrier to complete questionnaires&#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>Andreas Mueller, PD Dr. med</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orthopädische Universitätsklinik Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Orthopaedics</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schulthess Klinik Zürich</name>
      <address>
        <city>Zürich</city>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>April 23, 2019</last_update_submitted>
  <last_update_submitted_qc>April 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>clavicle non-unions</keyword>
  <keyword>plate treatment of clavicular fractures</keyword>
  <keyword>cortical bone grafting of clavicular fractures</keyword>
  <keyword>clavicular midshaft non- union</keyword>
  <keyword>clavicular lateral non- union</keyword>
  <keyword>clavicular shortening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</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/NCT03816436
org study id: 2018-00120; ch19Mueller
nct id: NCT03816436
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluating the impact of plate treatment and cortical bone grafting of clavicular midshaft
      and lateral non- unions on restoration of clavicular length and bony healing and its
      association with functional outcome.
observational model: Cohort
time perspective: Retrospective
measure: Clavicula shortening (cm)
time frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
description: Clavicula shortening (cm) based on Imaging assessment (x-ray, ultrasound), dichotomous outcome with shortening less or equal 2 cm (yes/no).
measure: Constant Murley score (CS)
time frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
description: tool for assessment of shoulder function: Range of Motion (ROM) of shoulder (degree), abduction strength (kg), Quality of Life (QoL) questionnaire. The different scales are summed and normalized to 0=worst to 100=best.
measure: Subjective shoulder pain (NRS)
time frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
description: Patient rates pain at rest and at motion of the treated shoulder on numeric scale ranging from 0 (no pain) to 10 (maximum possible pain)
measure: Subjective shoulder value (SSV)
time frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
description: based on a single question answered subjectively by Patient: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?"
measure: Simple shoulder test (SST)
time frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
description: 12 items questionnaire to assess restrictions in activities of daily living (ADL) related to impaired shoulder function; response in dichotomous manner (yes/no)
measure: Quality of Life (QoL)
time frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
description: assessed by Quality of Life EuroQoL 5D-5L Instrument (EQ-5D-5L); the descriptive system comprises 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. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
arm group label: Follow- up (FU) assessment on clavicular non- union
description: clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting
intervention type: Other
intervention name: Follow- up (FU) assessment
description: Follow- up (FU) assessment (clinical examination and patient questionnaires) at least 24 months after surgery (clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting)
arm group label: Follow- up (FU) assessment on clavicular non- union
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas Mueller, PD Dr. med
role: Principal Investigator
affiliation: Orthopädische Universitätsklinik Basel
facility: 
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Fractures, Bone