<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/NCT03805204</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-CUB-2018-61</org_study_id>
    <nct_id>NCT03805204</nct_id>
  </id_info>
  <brief_title>Vascularity of the Ulna and Its Association With Forearm Nonunion</brief_title>
  <acronym>Nonunion</acronym>
  <official_title>Anatomical Study About the Vascularization of the Ulna: Vascular and Mechanical Risk Factors Associated With Forearm Nonunion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</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>
      Non-union after operative treatment of an ulnar fracture is very uncommon. There are severely&#xD;
      disabling and challenging to treat. Multiple factors have been associated with the&#xD;
      establishment of this non-union. Many non-unions are associated with soft tissue damage,&#xD;
      fracture site vascularity, persistent instability, infection, and the surgical treatment&#xD;
      technique. This study analysed the systemic conditions and local factors associated with the&#xD;
      failure of bone fracture healing The aim of our study was to identify the risk factors for&#xD;
      ulnar nonunion&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the anatomical study we investigated the extraosseous and intraosseous blood supply in&#xD;
      fourteen specimens from the Department of Human Anatomy. We correlated the areas with a low&#xD;
      vascularity with the usual areas that patients have ulnar nonunion.&#xD;
&#xD;
      In the clinical study we retrospectively reviewed a cohort of ulnar fractures treated&#xD;
      surgically with open reduction and internal fixation (ORIF), during a period of 10 years&#xD;
      (2007-2016). We identified 211 ulnar fractures. All patients had a minimum follow-up of 1&#xD;
      year. We defined non-union if there was no radiological consolidation of the fracture after&#xD;
      this period, and we classified them according to Weber classification. We assessed risk&#xD;
      factors like: fracture site vascularity, surgical treatment technique, biological factors of&#xD;
      the patient, and the fracture's mechanism. We correlated data and associated risk factors&#xD;
      from the anatomical and the clinical studies.&#xD;
&#xD;
      Data were analysed using SPSS software system version 21. Multivariate regression analysis&#xD;
      was performed to assess independent risk factors of ulnar non-union. Chi square test or&#xD;
      Fisher exact test was used to compare categorical measurements. Statistical significance was&#xD;
      considered as p less than 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Actual">August 30, 2021</completion_date>
  <primary_completion_date type="Actual">July 29, 2021</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Avascular areas in anatomical study</measure>
    <time_frame>8 months</time_frame>
    <description>The extraossea and intraossea vascularity of the forearms with Spalteholz dissection technique and Tompsett dissection technique will be described. The location, distribution and dimensions of the vessels and the areas without vascularity will be measured with a digital caliper (mm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Epidemiological risk factors for ulnar nonunion</measure>
    <time_frame>8 months</time_frame>
    <description>Epidemiological risks factor such as: smoke, heart problems, rheumatic disorders will be registered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biomechanical risk factors for ulnar nonunion</measure>
    <time_frame>8 months</time_frame>
    <description>Biomechanical risk factors will be evaluated using the OTA/AO classification.</description>
  </primary_outcome>
  <enrollment type="Actual">211</enrollment>
  <condition>Forearm Fracture</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open reduction and internal fixation (ORIF)</intervention_name>
    <description>ORIF with a forearm plate</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Anatomical study: 14 upper extremities from the Department of Human Anatomy. Clinical&#xD;
        study. Records about 211 ulnar fractures. We included only the fractures with the&#xD;
        complication of ulnar nonunion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults from 18 to 90 years old&#xD;
&#xD;
          -  Forearm ulnar nonunion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children&#xD;
&#xD;
          -  Other types of forearm fractures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudia Lamas, Ph D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Kloen P, Wiggers JK, Buijze GA. Treatment of diaphyseal non-unions of the ulna and radius. Arch Orthop Trauma Surg. 2010 Dec;130(12):1439-45. doi: 10.1007/s00402-010-1071-x. Epub 2010 Mar 9.</citation>
    <PMID>20217106</PMID>
  </reference>
  <reference>
    <citation>Kloen P, Buijze GA, Ring D. Management of forearm nonunions: current concepts. Strategies Trauma Limb Reconstr. 2012 Apr;7(1):1-11. doi: 10.1007/s11751-011-0125-0. Epub 2011 Nov 24.</citation>
    <PMID>22113538</PMID>
  </reference>
  <reference>
    <citation>Bartonicek J, Kozanek M, Jupiter JB. History of operative treatment of forearm diaphyseal fractures. J Hand Surg Am. 2014 Feb;39(2):335-42. doi: 10.1016/j.jhsa.2013.06.020. Epub 2013 Dec 11.</citation>
    <PMID>24332651</PMID>
  </reference>
  <reference>
    <citation>Hardy BT, Glowczewskie F Jr, Wright TW. Vascular anatomy of the proximal ulna. J Hand Surg Am. 2011 May;36(5):808-10. doi: 10.1016/j.jhsa.2011.02.011. Epub 2011 Apr 12.</citation>
    <PMID>21489724</PMID>
  </reference>
  <reference>
    <citation>Sheetz KK, Bishop AT, Berger RA. The arterial blood supply of the distal radius and ulna and its potential use in vascularized pedicled bone grafts. J Hand Surg Am. 1995 Nov;20(6):902-14. doi: 10.1016/S0363-5023(05)80136-4.</citation>
    <PMID>8583061</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>October 25, 2021</last_update_submitted>
  <last_update_submitted_qc>October 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>When we have the results we analyse the anatomical and clinical data and association with the differents risks factors in the Department of Statistics.</ipd_description>
  </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/NCT03805204
org study id: IIBSP-CUB-2018-61
nct id: NCT03805204
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Non-union after operative treatment of an ulnar fracture is very uncommon. There are severely
      disabling and challenging to treat. Multiple factors have been associated with the
      establishment of this non-union. Many non-unions are associated with soft tissue damage,
      fracture site vascularity, persistent instability, infection, and the surgical treatment
      technique. This study analysed the systemic conditions and local factors associated with the
      failure of bone fracture healing The aim of our study was to identify the risk factors for
      ulnar nonunion
In the anatomical study we investigated the extraosseous and intraosseous blood supply in
      fourteen specimens from the Department of Human Anatomy. We correlated the areas with a low
      vascularity with the usual areas that patients have ulnar nonunion.

      In the clinical study we retrospectively reviewed a cohort of ulnar fractures treated
      surgically with open reduction and internal fixation (ORIF), during a period of 10 years
      (2007-2016). We identified 211 ulnar fractures. All patients had a minimum follow-up of 1
      year. We defined non-union if there was no radiological consolidation of the fracture after
      this period, and we classified them according to Weber classification. We assessed risk
      factors like: fracture site vascularity, surgical treatment technique, biological factors of
      the patient, and the fracture's mechanism. We correlated data and associated risk factors
      from the anatomical and the clinical studies.

      Data were analysed using SPSS software system version 21. Multivariate regression analysis
      was performed to assess independent risk factors of ulnar non-union. Chi square test or
      Fisher exact test was used to compare categorical measurements. Statistical significance was
      considered as p less than 0.05.
observational model: Cohort
time perspective: Other
measure: Avascular areas in anatomical study
time frame: 8 months
description: The extraossea and intraossea vascularity of the forearms with Spalteholz dissection technique and Tompsett dissection technique will be described. The location, distribution and dimensions of the vessels and the areas without vascularity will be measured with a digital caliper (mm).
measure: Epidemiological risk factors for ulnar nonunion
time frame: 8 months
description: Epidemiological risks factor such as: smoke, heart problems, rheumatic disorders will be registered.
measure: Biomechanical risk factors for ulnar nonunion
time frame: 8 months
description: Biomechanical risk factors will be evaluated using the OTA/AO classification.
intervention type: Procedure
intervention name: Open reduction and internal fixation (ORIF)
description: ORIF with a forearm plate
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Claudia Lamas, Ph D
role: Principal Investigator
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
facility: 
country: Spain
citation: Kloen P, Wiggers JK, Buijze GA. Treatment of diaphyseal non-unions of the ulna and radius. Arch Orthop Trauma Surg. 2010 Dec;130(12):1439-45. doi: 10.1007/s00402-010-1071-x. Epub 2010 Mar 9.
PMID: 20217106
citation: Kloen P, Buijze GA, Ring D. Management of forearm nonunions: current concepts. Strategies Trauma Limb Reconstr. 2012 Apr;7(1):1-11. doi: 10.1007/s11751-011-0125-0. Epub 2011 Nov 24.
PMID: 22113538
citation: Bartonicek J, Kozanek M, Jupiter JB. History of operative treatment of forearm diaphyseal fractures. J Hand Surg Am. 2014 Feb;39(2):335-42. doi: 10.1016/j.jhsa.2013.06.020. Epub 2013 Dec 11.
PMID: 24332651
citation: Hardy BT, Glowczewskie F Jr, Wright TW. Vascular anatomy of the proximal ulna. J Hand Surg Am. 2011 May;36(5):808-10. doi: 10.1016/j.jhsa.2011.02.011. Epub 2011 Apr 12.
PMID: 21489724
citation: Sheetz KK, Bishop AT, Berger RA. The arterial blood supply of the distal radius and ulna and its potential use in vascularized pedicled bone grafts. J Hand Surg Am. 1995 Nov;20(6):902-14. doi: 10.1016/S0363-5023(05)80136-4.
PMID: 8583061
responsible party type: Sponsor
sharing ipd: No
ipd description: When we have the results we analyse the anatomical and clinical data and association with the differents risks factors in the Department of Statistics.