<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/NCT03798496</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-GAL-2018-75</org_study_id>
    <nct_id>NCT03798496</nct_id>
  </id_info>
  <brief_title>Anatomical and Biomechanical Study About Stability in Galeazzi´s Fracture</brief_title>
  <acronym>Galeazzi</acronym>
  <official_title>Role of the Interosseous Membrane and TFCC in DRUJ Stability in Galeazzi´s Fracture: Anatomical and Biomechanical Study</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>
      Most Galeazzi fractures can be treated adequately with open reduction and internal fixation&#xD;
      (ORIF) of the radius alone, but some will remain unstable at the DRUJ and require repair of&#xD;
      the TFCC.The purpose of this anatomical and biomechanical study was to define and measure&#xD;
      DRUJ dislocation, displacement and instability associated with the sequential sectioning of&#xD;
      the different bands in the interosseous membrane (IOM) and TFCC in the simulation of a&#xD;
      Galeazzi fracture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Instability of the DRUJ is a common clinical problem associated with Galeazzi fracture.&#xD;
      Stability of the DRUJ is primarily provided by both the bony anatomy of the sigmoid notch of&#xD;
      the radius and ulnar head and the soft tissues surrounding the joint. The interosseous&#xD;
      membrane plays an important role in DRUJ stability but the TFCC is the major soft tissue&#xD;
      stabilizer of the DRUJ. The Central Band works as a restraint on the radius from proximal&#xD;
      migration in cooperation with the radial head and the TFCC and also works as a load&#xD;
      transmitter between the radius and ulnar to redistribute load. Some investigators suggested&#xD;
      that the distal membranous portion and DOB stabilizes the DRUJ when TFCC is disrupted.&#xD;
      Watanabe et al. (2005) insisted on the importance of DOB, which constrained volar and dorsal&#xD;
      instability of the radius at the DRUJ in all forearm rotation positions. The purpose of this&#xD;
      anatomical and biomechanical study was to define and measure DRUJ dislocation in the&#xD;
      simulation of a Galeazzi fracture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Displacement in distal radius fracture</measure>
    <time_frame>12 months</time_frame>
    <description>The investigators will mesure the degree of displacement (mm) in a simulate distal radius fracture with a biomechanical device named Medmesin with a especific computer software that applies newtons (from 0 to 100N) in the radius in each especimen.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stability in the DRU joint</measure>
    <time_frame>12 months</time_frame>
    <description>Dislocation of the ulnar in the wrist. In the retrospective clinical reports the investigators evaluate the x-rays before and after the surgery and the radioulnar ratio in the CT scan (congruency method, Mino criteria and the epicenter method).</description>
  </primary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Galeazzi's Fracture</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open reduction and internal fixation</intervention_name>
    <description>Open reduction of the Galeazzi fracture dislocation with a plate.</description>
    <other_name>DRUJ reduction with Kirschner wire</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Anatomical and biomechanical study: Twelve specimens from the Human Anatomy Department.&#xD;
&#xD;
        Clinical study: Review of reports (X-rays) about patients with Galeazzi&#xD;
        fracture-dislocation treated with ORIF.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adults patients(18-85 years old) with Galeazzi fracture-dislocation treated with open&#xD;
        reduction and internal fixation (ORIF).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children&#xD;
&#xD;
          -  Other types of forearms fractures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 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>Farr LD, Werner FW, McGrattan ML, Zwerling SR, Harley BJ. Anatomy and biomechanics of the forearm interosseous membrane. J Hand Surg Am. 2015 Jun;40(6):1145-51.e2. doi: 10.1016/j.jhsa.2014.12.025. Epub 2015 Feb 20.</citation>
    <PMID>25703865</PMID>
  </reference>
  <reference>
    <citation>Kitamura T, Moritomo H, Arimitsu S, Berglund LJ, Zhao KD, An KN, Rizzo M. The biomechanical effect of the distal interosseous membrane on distal radioulnar joint stability: a preliminary anatomic study. J Hand Surg Am. 2011 Oct;36(10):1626-30. doi: 10.1016/j.jhsa.2011.07.016. Epub 2011 Aug 26.</citation>
    <PMID>21872404</PMID>
  </reference>
  <reference>
    <citation>Loeffler BJ, Green JB, Zelouf DS. Forearm instability. J Hand Surg Am. 2014 Jan;39(1):156-67. doi: 10.1016/j.jhsa.2013.07.010. Epub 2013 Dec 6.</citation>
    <PMID>24315636</PMID>
  </reference>
  <reference>
    <citation>Moritomo H. The distal interosseous membrane: current concepts in wrist anatomy and biomechanics. J Hand Surg Am. 2012 Jul;37(7):1501-7. doi: 10.1016/j.jhsa.2012.04.037.</citation>
    <PMID>22721462</PMID>
  </reference>
  <reference>
    <citation>Noda K, Goto A, Murase T, Sugamoto K, Yoshikawa H, Moritomo H. Interosseous membrane of the forearm: an anatomical study of ligament attachment locations. J Hand Surg Am. 2009 Mar;34(3):415-22. doi: 10.1016/j.jhsa.2008.10.025. Epub 2009 Feb 11.</citation>
    <PMID>19211201</PMID>
  </reference>
  <reference>
    <citation>Petersen MS, Adams BD. Biomechanical evaluation of distal radioulnar reconstructions. J Hand Surg Am. 1993 Mar;18(2):328-34. doi: 10.1016/0363-5023(93)90370-I.</citation>
    <PMID>8463602</PMID>
  </reference>
  <reference>
    <citation>Riggenbach MD, Conrad BP, Wright TW, Dell PC. Distal oblique bundle reconstruction and distal radioulnar joint instability. J Wrist Surg. 2013 Nov;2(4):330-6. doi: 10.1055/s-0033-1358546.</citation>
    <PMID>24436838</PMID>
  </reference>
  <reference>
    <citation>Riggenbach MD, Wright TW, Dell PC. Reconstruction of the Distal Oblique Bundle of the Interosseous Membrane: A Technique to Restore Distal Radioulnar Joint Stability. J Hand Surg Am. 2015 Nov;40(11):2279-82. doi: 10.1016/j.jhsa.2015.08.019.</citation>
    <PMID>26518322</PMID>
  </reference>
  <reference>
    <citation>Werner FW, LeVasseur MR, Harley BJ, Anderson A. Role of the Interosseous Membrane in Preventing Distal Radioulnar Gapping. J Wrist Surg. 2017 May;6(2):97-101. doi: 10.1055/s-0036-1584545. Epub 2016 Jun 20.</citation>
    <PMID>28428910</PMID>
  </reference>
  <reference>
    <citation>Werner FW, Taormina JL, Sutton LG, Harley BJ. Structural properties of 6 forearm ligaments. J Hand Surg Am. 2011 Dec;36(12):1981-7. doi: 10.1016/j.jhsa.2011.09.026. Epub 2011 Nov 17.</citation>
    <PMID>22100813</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>July 12, 2021</last_update_submitted>
  <last_update_submitted_qc>July 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Radius Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>After the results were obtained we send the results to the statistical department to correlate the outcomes.</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/NCT03798496
org study id: IIBSP-GAL-2018-75
nct id: NCT03798496
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Most Galeazzi fractures can be treated adequately with open reduction and internal fixation
      (ORIF) of the radius alone, but some will remain unstable at the DRUJ and require repair of
      the TFCC.The purpose of this anatomical and biomechanical study was to define and measure
      DRUJ dislocation, displacement and instability associated with the sequential sectioning of
      the different bands in the interosseous membrane (IOM) and TFCC in the simulation of a
      Galeazzi fracture.
Instability of the DRUJ is a common clinical problem associated with Galeazzi fracture.
      Stability of the DRUJ is primarily provided by both the bony anatomy of the sigmoid notch of
      the radius and ulnar head and the soft tissues surrounding the joint. The interosseous
      membrane plays an important role in DRUJ stability but the TFCC is the major soft tissue
      stabilizer of the DRUJ. The Central Band works as a restraint on the radius from proximal
      migration in cooperation with the radial head and the TFCC and also works as a load
      transmitter between the radius and ulnar to redistribute load. Some investigators suggested
      that the distal membranous portion and DOB stabilizes the DRUJ when TFCC is disrupted.
      Watanabe et al. (2005) insisted on the importance of DOB, which constrained volar and dorsal
      instability of the radius at the DRUJ in all forearm rotation positions. The purpose of this
      anatomical and biomechanical study was to define and measure DRUJ dislocation in the
      simulation of a Galeazzi fracture.
observational model: Cohort
time perspective: Other
measure: Displacement in distal radius fracture
time frame: 12 months
description: The investigators will mesure the degree of displacement (mm) in a simulate distal radius fracture with a biomechanical device named Medmesin with a especific computer software that applies newtons (from 0 to 100N) in the radius in each especimen.
measure: Stability in the DRU joint
time frame: 12 months
description: Dislocation of the ulnar in the wrist. In the retrospective clinical reports the investigators evaluate the x-rays before and after the surgery and the radioulnar ratio in the CT scan (congruency method, Mino criteria and the epicenter method).
intervention type: Procedure
intervention name: Open reduction and internal fixation
description: Open reduction of the Galeazzi fracture dislocation with a plate.
other name: DRUJ reduction with Kirschner wire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 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: Farr LD, Werner FW, McGrattan ML, Zwerling SR, Harley BJ. Anatomy and biomechanics of the forearm interosseous membrane. J Hand Surg Am. 2015 Jun;40(6):1145-51.e2. doi: 10.1016/j.jhsa.2014.12.025. Epub 2015 Feb 20.
PMID: 25703865
citation: Kitamura T, Moritomo H, Arimitsu S, Berglund LJ, Zhao KD, An KN, Rizzo M. The biomechanical effect of the distal interosseous membrane on distal radioulnar joint stability: a preliminary anatomic study. J Hand Surg Am. 2011 Oct;36(10):1626-30. doi: 10.1016/j.jhsa.2011.07.016. Epub 2011 Aug 26.
PMID: 21872404
citation: Loeffler BJ, Green JB, Zelouf DS. Forearm instability. J Hand Surg Am. 2014 Jan;39(1):156-67. doi: 10.1016/j.jhsa.2013.07.010. Epub 2013 Dec 6.
PMID: 24315636
citation: Moritomo H. The distal interosseous membrane: current concepts in wrist anatomy and biomechanics. J Hand Surg Am. 2012 Jul;37(7):1501-7. doi: 10.1016/j.jhsa.2012.04.037.
PMID: 22721462
citation: Noda K, Goto A, Murase T, Sugamoto K, Yoshikawa H, Moritomo H. Interosseous membrane of the forearm: an anatomical study of ligament attachment locations. J Hand Surg Am. 2009 Mar;34(3):415-22. doi: 10.1016/j.jhsa.2008.10.025. Epub 2009 Feb 11.
PMID: 19211201
citation: Petersen MS, Adams BD. Biomechanical evaluation of distal radioulnar reconstructions. J Hand Surg Am. 1993 Mar;18(2):328-34. doi: 10.1016/0363-5023(93)90370-I.
PMID: 8463602
citation: Riggenbach MD, Conrad BP, Wright TW, Dell PC. Distal oblique bundle reconstruction and distal radioulnar joint instability. J Wrist Surg. 2013 Nov;2(4):330-6. doi: 10.1055/s-0033-1358546.
PMID: 24436838
citation: Riggenbach MD, Wright TW, Dell PC. Reconstruction of the Distal Oblique Bundle of the Interosseous Membrane: A Technique to Restore Distal Radioulnar Joint Stability. J Hand Surg Am. 2015 Nov;40(11):2279-82. doi: 10.1016/j.jhsa.2015.08.019.
PMID: 26518322
citation: Werner FW, LeVasseur MR, Harley BJ, Anderson A. Role of the Interosseous Membrane in Preventing Distal Radioulnar Gapping. J Wrist Surg. 2017 May;6(2):97-101. doi: 10.1055/s-0036-1584545. Epub 2016 Jun 20.
PMID: 28428910
citation: Werner FW, Taormina JL, Sutton LG, Harley BJ. Structural properties of 6 forearm ligaments. J Hand Surg Am. 2011 Dec;36(12):1981-7. doi: 10.1016/j.jhsa.2011.09.026. Epub 2011 Nov 17.
PMID: 22100813
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Radius Fractures
sharing ipd: No
ipd description: After the results were obtained we send the results to the statistical department to correlate the outcomes.