<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/NCT01725997</url>
  </required_header>
  <id_info>
    <org_study_id>AC-lux</org_study_id>
    <nct_id>NCT01725997</nct_id>
  </id_info>
  <brief_title>Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation</brief_title>
  <official_title>Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation Rockwood Grade III and V - a Prospective Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St Goran's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St Goran's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to answer if surgery with hook plate for acute dislocation of the&#xD;
      acromioclavicular joint (AC joint) grade III and V according to Rockwood is superior to&#xD;
      conservative treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2012</start_date>
  <completion_date type="Actual">June 5, 2019</completion_date>
  <primary_completion_date type="Actual">June 5, 2019</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Constant Score</measure>
    <time_frame>change from Baseline in Constant Score at 24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disabilities of Arm, Shoulder and Hand function (QuickDASH)</measure>
    <time_frame>change from Baseline in QuickDASH at 24 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Shoulder Pain and Disability Index (SPADI)</measure>
    <time_frame>Change from baseline in SPADI at 24 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Radiographs with and without weight</measure>
    <time_frame>Change in the position of the AC-joint from baseline to at 24 months</time_frame>
    <description>Position of the AC-joint will be measured at standard radiographs and weighted radiographs</description>
  </other_outcome>
  <other_outcome>
    <measure>European Quality of Life - 5 dimensions (EQ5D)</measure>
    <time_frame>Change from baseline in EQ-5D at 24 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Pain rated with Visual Analogue Scale (VAS)</measure>
    <time_frame>Change from baseline in VAS at 24 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Computed Tomography</measure>
    <time_frame>Change in the position of the AC-joint from baseline to at 24 months</time_frame>
    <description>Position of the AC-joint</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Acromioclavicular Joint Dislocation</condition>
  <arm_group>
    <arm_group_label>Operative treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Operative treatment with hook plate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conservative treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Physiotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>hook plate</intervention_name>
    <description>Surgery with hook plate followed by physiotherapy</description>
    <arm_group_label>Operative treatment</arm_group_label>
    <other_name>hook plate by Synthes</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiotherapy</intervention_name>
    <description>Patients will be following a program specific for AC joint dislocations</description>
    <arm_group_label>Conservative treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AC joint dislocation grade III according to Rockwood with at least half a clavicular&#xD;
             bone width above the acromion or grade V according to Rockwood&#xD;
&#xD;
          -  men and women 18-65 years and able to work&#xD;
&#xD;
          -  understand spoken and/or written Swedish or English language&#xD;
&#xD;
          -  be able to start treatment within 3 weeks from trauma&#xD;
&#xD;
          -  consent form signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  earlier injury to, or surgery of either of the shoulders&#xD;
&#xD;
          -  simultaneous fracture of the clavicle or acromion&#xD;
&#xD;
          -  associates neurovascular injury&#xD;
&#xD;
          -  severe osteoporosis&#xD;
&#xD;
          -  open dislocation&#xD;
&#xD;
          -  open growth plate of the acromion&#xD;
&#xD;
          -  local skin damage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helena Boström Windhamre</last_name>
    <role>Principal Investigator</role>
    <affiliation>Capio St Gorans hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Capio St Gorans Hospital AB</name>
      <address>
        <city>Stockholm</city>
        <zip>SE-11281</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>January 26, 2020</last_update_submitted>
  <last_update_submitted_qc>January 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St Goran's Hospital</investigator_affiliation>
    <investigator_full_name>Helena Boström Windhamre</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>acromioclavicular joint dislocation</keyword>
  <keyword>ac joint dislocation</keyword>
  <keyword>acromioclavicular joint separation</keyword>
  <keyword>hook plate</keyword>
  <keyword>Rockwood</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/NCT01725997
org study id: AC-lux
nct id: NCT01725997
lead sponsor: 
has dmc: No
The study aims to answer if surgery with hook plate for acute dislocation of the
      acromioclavicular joint (AC joint) grade III and V according to Rockwood is superior to
      conservative treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Constant Score
time frame: change from Baseline in Constant Score at 24 months
measure: Disabilities of Arm, Shoulder and Hand function (QuickDASH)
time frame: change from Baseline in QuickDASH at 24 months
measure: Shoulder Pain and Disability Index (SPADI)
time frame: Change from baseline in SPADI at 24 months
measure: Radiographs with and without weight
time frame: Change in the position of the AC-joint from baseline to at 24 months
description: Position of the AC-joint will be measured at standard radiographs and weighted radiographs
measure: European Quality of Life - 5 dimensions (EQ5D)
time frame: Change from baseline in EQ-5D at 24 months
measure: Pain rated with Visual Analogue Scale (VAS)
time frame: Change from baseline in VAS at 24 months
measure: Computed Tomography
time frame: Change in the position of the AC-joint from baseline to at 24 months
description: Position of the AC-joint
arm group label: Operative treatment
arm group type: Active Comparator
description: Operative treatment with hook plate.
arm group label: Conservative treatment
arm group type: Active Comparator
description: Physiotherapy
intervention type: Procedure
intervention name: hook plate
description: Surgery with hook plate followed by physiotherapy
arm group label: Operative treatment
other name: hook plate by Synthes
intervention type: Other
intervention name: Physiotherapy
description: Patients will be following a program specific for AC joint dislocations
arm group label: Conservative treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Helena Boström Windhamre
role: Principal Investigator
affiliation: Capio St Gorans hospital
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: St Goran's Hospital
investigator full name: Helena Boström Windhamre
investigator title: MD
mesh term: Joint Dislocations