<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/NCT03286270</url>
  </required_header>
  <id_info>
    <org_study_id>002A/BT</org_study_id>
    <nct_id>NCT03286270</nct_id>
  </id_info>
  <brief_title>A mRUS Validation Study for Nail-treated Fractures of Long Bones and a TUS Exploratory Study for Nail and Plate-treated Fractures of Long Bones</brief_title>
  <acronym>mRUSTUS</acronym>
  <official_title>A mRUS Validation Study for Nail-treated Fractures of Long Bones and a TUS Exploratory Study for Nail and Plate-treated Fractures of Long Bones</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bone Therapeutics S.A</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bone Therapeutics S.A</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Early intervention attempts to shorten protracted delayed union (DU) or prevent non-union&#xD;
      (NU) fractures are hampered by lack of validated quantitative assessment tools for bone&#xD;
      fracture healing during normal and delayed healing processes. In actual practice, sequential&#xD;
      X-rays usually follow a pre-determined time interval in patients with fractures.They&#xD;
      constitute the best available state of the art used by surgeons to assess the fracture&#xD;
      healing course.&#xD;
&#xD;
      In an attempt to improve between raters reliability of radiographic assessment of healing,&#xD;
      studies have explored a novel radiographic assessment for tibial shaft fractures, the&#xD;
      Radiographic Union Scale for Tibial Fractures (RUST). The RUST assesses the presence of&#xD;
      bridging callus and a fracture line on each of four cortices (seen on anterior-posterior and&#xD;
      lateral views). This callus based scoring system has been since extended to other bones than&#xD;
      the tibia in a retrospective case series. It has been renamed modified radiological union&#xD;
      score (mRUS) and has shown potential value in bone healing measurement.&#xD;
&#xD;
      Based on an initial retrospective study in nail-treated fractures, the first objective of the&#xD;
      present investigation is to prospectively validate mRUS as a tool to identify patients at&#xD;
      increased risk of DU and NU within the first 75-110 days after fracture occurrence. This&#xD;
      prospective validation will be performed on a retrospective cohort of patients having&#xD;
      sustained long bone fractures, including both upper and lower extremities. A further&#xD;
      objective of the present investigation is to apply the scoring system to tomographic imaging&#xD;
      in case of nail/plate treated fractures, deriving a tomographic union score (TUS) and first&#xD;
      assess its potential value in bone healing for fractures treated by nails/plates.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">April 27, 2018</completion_date>
  <primary_completion_date type="Actual">April 27, 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>mRUS assessed on X-Ray</measure>
    <time_frame>75-110 days after fracture occurrence</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>TUS assessed on CT-scan</measure>
    <time_frame>75-110 days after fracture occurrence</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">173</enrollment>
  <condition>Delayed Union Fracture</condition>
  <condition>CT-scan</condition>
  <condition>X-Ray</condition>
  <condition>Bone Fracture</condition>
  <condition>Fracture Healing</condition>
  <condition>Validation Studies</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Long bone fracture&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female adult patient (&gt;18 and &lt; 80 years old)&#xD;
&#xD;
          -  Patient with nail(s) (for mRUS validation study and TUS exploratory study) or plate(s)&#xD;
             (for TUS exploratory study) treated long bone fractures, corresponding to the&#xD;
             following OA/OTA classification: 11-A, 12-A, -B and -C, 13-A, 21-A, 22-A, -B and -C, ,&#xD;
             31-A3, 32-A, -B and -C, 33-A 41-A2 and A3, 42-A, -B and -C and 43-A&#xD;
&#xD;
          -  Patient for whom outcome of fracture is known&#xD;
&#xD;
          -  For the mRUS validation study, patient with one follow up X-ray imaging performed&#xD;
             75-110 days after fracture occurrence&#xD;
&#xD;
          -  For the TUS exploratory study, patient with one follow up CT-scan imaging performed&#xD;
             75-110 days after the fracture occurrence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bone infection diagnosed between time of the fracture occurrence and the X-Ray or&#xD;
             CT-scan imaging performed 75-110 days after the fracture occurrence&#xD;
&#xD;
          -  Previous fracture and previous surgery on the fractured bone&#xD;
&#xD;
          -  Bone tumour or history of bone tumour&#xD;
&#xD;
          -  Bone metastasis&#xD;
&#xD;
          -  Known evidence for ongoing metabolic bone disease (e.g. chronic renal failure, hyper&#xD;
             or hypoparathyroidism, rickets, Paget's disease of bone, inherited or congenital bone&#xD;
             abnormalities)&#xD;
&#xD;
          -  Patient with current traumatic brain injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Investigating site DE01</name>
      <address>
        <city>Cologne</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigating site DE03</name>
      <address>
        <city>Lübeck</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigating site DE02</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigating site DE04</name>
      <address>
        <city>Würzburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mRUS</keyword>
  <keyword>validation tool</keyword>
  <keyword>Impaired fractures</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/NCT03286270
org study id: 002A/BT
nct id: NCT03286270
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Early intervention attempts to shorten protracted delayed union (DU) or prevent non-union
      (NU) fractures are hampered by lack of validated quantitative assessment tools for bone
      fracture healing during normal and delayed healing processes. In actual practice, sequential
      X-rays usually follow a pre-determined time interval in patients with fractures.They
      constitute the best available state of the art used by surgeons to assess the fracture
      healing course.

      In an attempt to improve between raters reliability of radiographic assessment of healing,
      studies have explored a novel radiographic assessment for tibial shaft fractures, the
      Radiographic Union Scale for Tibial Fractures (RUST). The RUST assesses the presence of
      bridging callus and a fracture line on each of four cortices (seen on anterior-posterior and
      lateral views). This callus based scoring system has been since extended to other bones than
      the tibia in a retrospective case series. It has been renamed modified radiological union
      score (mRUS) and has shown potential value in bone healing measurement.

      Based on an initial retrospective study in nail-treated fractures, the first objective of the
      present investigation is to prospectively validate mRUS as a tool to identify patients at
      increased risk of DU and NU within the first 75-110 days after fracture occurrence. This
      prospective validation will be performed on a retrospective cohort of patients having
      sustained long bone fractures, including both upper and lower extremities. A further
      objective of the present investigation is to apply the scoring system to tomographic imaging
      in case of nail/plate treated fractures, deriving a tomographic union score (TUS) and first
      assess its potential value in bone healing for fractures treated by nails/plates.
observational model: Cohort
time perspective: Retrospective
measure: mRUS assessed on X-Ray
time frame: 75-110 days after fracture occurrence
measure: TUS assessed on CT-scan
time frame: 75-110 days after fracture occurrence
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Fractures, Bone