<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/NCT02195219</url>
  </required_header>
  <id_info>
    <org_study_id>ACLUX-3</org_study_id>
    <nct_id>NCT02195219</nct_id>
  </id_info>
  <brief_title>Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Dislocations</brief_title>
  <official_title>Clinical Trial to Compare the Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Grade III Dislocations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General Universitario Gregorio Marañon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario Gregorio Marañon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare two therapeutical procedures for the grade III&#xD;
      acromioclavicular dislocations, either open reduction and internal fixation with a&#xD;
      coracoclavicular device (MINAR-STORZ ) or non operative treatment.&#xD;
&#xD;
      For these purpose we have designed an interventional, prospective, parallel assignment,&#xD;
      opened and randomized study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acromioclavicular dislocations are one of the most frequent traumatic lesions of the scapular&#xD;
      girdle. They represent the 40-50% of the sport related shoulder injuries.&#xD;
&#xD;
      There are different grades of dislocations being classified by Altman- Rockwood in 6 types.&#xD;
      There is consensus for non operative treatment in types 1 and 2 and for surgical treatment in&#xD;
      types 4, 5 and 6.&#xD;
&#xD;
      For type 3 both therapeutic techniques are accepted with no high scientific evidence studies&#xD;
      supporting either of them.&#xD;
&#xD;
      During de 70's, surgical treatment was recommended for all these lesions but in the early&#xD;
      90´s surgeons´s preferences changed into the non-operative treatment. Now a day, treatment is&#xD;
      decided according to the surgeon experience and the functional demands of the patient.&#xD;
&#xD;
      The aim of this study is to compare the results of non-operative treatment and open reduction&#xD;
      and internal fixation with a coracoclavicular reconstruction device (MINAR-STORZ) in grade&#xD;
      III acromioclavicular dislocations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unable reach recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy</measure>
    <time_frame>12 months</time_frame>
    <description>Efficacy will be measured for the AMERICAN SHOULDER AND ELBOW SURGEONS EVALUATION (ASES) and the CONSTANT score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>X-ray evaluation</measure>
    <time_frame>12 months</time_frame>
    <description>X-ray evaluation of the patients who underwent open reduction and internal fixation treatment, comparing the results with the contralateral shoulder and with the preoperative images:&#xD;
Width of the acromioclavicular joint in millimetres, before and after surgery.&#xD;
Coracoclavicular distance, in millimetres, of the injured joint (the closest distance between these two structures) before and after surgery.&#xD;
Vertical displacement distance of the clavicle, in millimetres, to the tangent line along the inferior edge of the acromioclavicular joint, before and after surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Acromioclavicular Joint Dislocation</condition>
  <arm_group>
    <arm_group_label>open reduction internal fixation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>open reduction internal fixation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non operative treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>'sling rest and early functional recovery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>open reduction internal fixation</intervention_name>
    <description>MINAR device allows for reduction of the acromioclavicular joint and the reconstruction of coracoclavicular ligaments with a suture cerclage system. Three weeks after surgery a rehabilitation program will be carried out.</description>
    <arm_group_label>open reduction internal fixation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sling rest and early functional recovery</intervention_name>
    <description>Immobilization with a sling for three weeks and, from this time, the same rehabilitation program will be performed.</description>
    <arm_group_label>non operative treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 50 years.&#xD;
&#xD;
          -  Grade III acromioclavicular dislocation.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition that may impair the functional recovery or the patient collaboration&#xD;
             with the rehabilitation program (cognitive disability, neurological pathology, tumoral&#xD;
             disease…).&#xD;
&#xD;
          -  Previous acromioclavicular osteoarthritis.&#xD;
&#xD;
          -  Previous acromioclavicular lesions.&#xD;
&#xD;
          -  Concomitant lesions in the ipsilateral limb or in the contralateral shoulder.&#xD;
&#xD;
          -  Polytraumatized patients.&#xD;
&#xD;
          -  Any disease or condition the investigator finds decisive for exclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mikel Aburto, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Heneral Universitario Gregorio Maranon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>March 15, 2018</last_update_submitted>
  <last_update_submitted_qc>March 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Gregorio Marañon</investigator_affiliation>
    <investigator_full_name>Carlos Alvarez</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>conservative</keyword>
  <keyword>treatment</keyword>
  <keyword>surgical</keyword>
  <keyword>Acromioclavicular</keyword>
  <keyword>Joint</keyword>
  <keyword>dislocation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Dislocations</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/NCT02195219
org study id: ACLUX-3
nct id: NCT02195219
lead sponsor: 
has dmc: No
The aim of this study is to compare two therapeutical procedures for the grade III
      acromioclavicular dislocations, either open reduction and internal fixation with a
      coracoclavicular device (MINAR-STORZ ) or non operative treatment.

      For these purpose we have designed an interventional, prospective, parallel assignment,
      opened and randomized study.
Acromioclavicular dislocations are one of the most frequent traumatic lesions of the scapular
      girdle. They represent the 40-50% of the sport related shoulder injuries.

      There are different grades of dislocations being classified by Altman- Rockwood in 6 types.
      There is consensus for non operative treatment in types 1 and 2 and for surgical treatment in
      types 4, 5 and 6.

      For type 3 both therapeutic techniques are accepted with no high scientific evidence studies
      supporting either of them.

      During de 70's, surgical treatment was recommended for all these lesions but in the early
      90´s surgeons´s preferences changed into the non-operative treatment. Now a day, treatment is
      decided according to the surgeon experience and the functional demands of the patient.

      The aim of this study is to compare the results of non-operative treatment and open reduction
      and internal fixation with a coracoclavicular reconstruction device (MINAR-STORZ) in grade
      III acromioclavicular dislocations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy
time frame: 12 months
description: Efficacy will be measured for the AMERICAN SHOULDER AND ELBOW SURGEONS EVALUATION (ASES) and the CONSTANT score.
measure: X-ray evaluation
time frame: 12 months
description: X-ray evaluation of the patients who underwent open reduction and internal fixation treatment, comparing the results with the contralateral shoulder and with the preoperative images:
Width of the acromioclavicular joint in millimetres, before and after surgery.
Coracoclavicular distance, in millimetres, of the injured joint (the closest distance between these two structures) before and after surgery.
Vertical displacement distance of the clavicle, in millimetres, to the tangent line along the inferior edge of the acromioclavicular joint, before and after surgery.
arm group label: open reduction internal fixation
arm group type: Experimental
description: open reduction internal fixation
arm group label: non operative treatment
arm group type: Active Comparator
description: 'sling rest and early functional recovery
intervention type: Procedure
intervention name: open reduction internal fixation
description: MINAR device allows for reduction of the acromioclavicular joint and the reconstruction of coracoclavicular ligaments with a suture cerclage system. Three weeks after surgery a rehabilitation program will be carried out.
arm group label: open reduction internal fixation
intervention type: Other
intervention name: sling rest and early functional recovery
description: Immobilization with a sling for three weeks and, from this time, the same rehabilitation program will be performed.
arm group label: non operative treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Mikel Aburto, MD
role: Principal Investigator
affiliation: Hospital Heneral Universitario Gregorio Maranon
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital General Universitario Gregorio Marañon
investigator full name: Carlos Alvarez
investigator title: MD
mesh term: Joint Dislocations