<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/NCT03261778</url>
  </required_header>
  <id_info>
    <org_study_id>2017-00670</org_study_id>
    <nct_id>NCT03261778</nct_id>
  </id_info>
  <brief_title>Comparison of Two Types of Braces in the Treatment of Rockwood Type III AC-dislocations</brief_title>
  <official_title>Conservative Treatment of Rockwood Type III Acromioclavicular Dislocation With Two Different Types of Braces: a Comparative Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bürgerspital Solothurn</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bürgerspital Solothurn</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>
      In a randomised prospective comparative Trial the investigators aim to compare the&#xD;
      conservative Treatment of acromioclavicular dislocations (Rockwood III) with a conventional&#xD;
      sling versus a Acromion 2.0 brace, which exerts a direct Reposition force on the Joint.&#xD;
&#xD;
      The sling/brace will be worn for 6 weeks and the patients will be regularly checked&#xD;
      clinically and radiologically.The investigators are interested in differences of shoulder&#xD;
      function, Patient satisfaction as well as cosmetic and radiological results.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">January 12, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>at 6 weeks</time_frame>
    <description>Constant-Score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>at 12 weeks</time_frame>
    <description>Constant-Score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>at 1 week</time_frame>
    <description>ASES-Score (American Shoulder and Elbow Score)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>at 6 weeks</time_frame>
    <description>ASES-Score (American Shoulder and Elbow Score)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>at 12 weeks</time_frame>
    <description>ASES-Score (American Shoulder and Elbow Score)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>at 1 week</time_frame>
    <description>Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>at 6 weeks</time_frame>
    <description>Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>at 12 weeks</time_frame>
    <description>Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Degree of lateral clavicle dislocation</measure>
    <time_frame>at initial presentation</time_frame>
    <description>Coracoclavicular distance on Panorama view in comparison to healthy side</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of lateral clavicle dislocation</measure>
    <time_frame>at 6 weeks</time_frame>
    <description>Coracoclavicular distance on Panorama view in comparison to healthy side</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of lateral clavicle dislocation</measure>
    <time_frame>at 12 weeks</time_frame>
    <description>Coracoclavicular distance on Panorama view in comparison to healthy side</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Acromioclavicular Joint Dislocation</condition>
  <arm_group>
    <arm_group_label>Acromion 2.0 Brace</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Mitella Sling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acromion 2.0 Brace</intervention_name>
    <description>Acromion 2.0 Brace will be worn for 6 weeks instead of the conventional Mitella sling</description>
    <arm_group_label>Acromion 2.0 Brace</arm_group_label>
    <arm_group_label>Mitella Sling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First acute acromioclavicular dislocation Rockwood Type III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous injury to acromioclavicular Joint&#xD;
&#xD;
          -  Previous surgery of acromioclavicular Joint&#xD;
&#xD;
          -  Known hypersensitivity or allergy to fabric of investigational product&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Known or suspected non-compliance, drug or alcohol abuse&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc. of the participant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Näder Helmy, PD, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Bürgerspital Solothurn, Department of Orthopaedics and Traumatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orthopädische Universitätsklinik Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bürgerspital Solothurn, Department of Orthopaedics and Traumatology</name>
      <address>
        <city>Solothurn</city>
        <zip>4500</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Phillips AM, Smart C, Groom AF. Acromioclavicular dislocation. Conservative or surgical therapy. Clin Orthop Relat Res. 1998 Aug;(353):10-7.</citation>
    <PMID>9728155</PMID>
  </reference>
  <reference>
    <citation>Korsten K, Gunning AC, Leenen LP. Operative or conservative treatment in patients with Rockwood type III acromioclavicular dislocation: a systematic review and update of current literature. Int Orthop. 2014 Apr;38(4):831-8. doi: 10.1007/s00264-013-2143-7. Epub 2013 Oct 31.</citation>
    <PMID>24178060</PMID>
  </reference>
  <reference>
    <citation>Smith TO, Chester R, Pearse EO, Hing CB. Operative versus non-operative management following Rockwood grade III acromioclavicular separation: a meta-analysis of the current evidence base. J Orthop Traumatol. 2011 Mar;12(1):19-27. doi: 10.1007/s10195-011-0127-1. Epub 2011 Feb 23.</citation>
    <PMID>21344264</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bürgerspital Solothurn</investigator_affiliation>
    <investigator_full_name>Michael Finsterwald</investigator_full_name>
    <investigator_title>Dr. med. Michael Finsterwald</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Dislocations</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03261778
org study id: 2017-00670
nct id: NCT03261778
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In a randomised prospective comparative Trial the investigators aim to compare the
      conservative Treatment of acromioclavicular dislocations (Rockwood III) with a conventional
      sling versus a Acromion 2.0 brace, which exerts a direct Reposition force on the Joint.

      The sling/brace will be worn for 6 weeks and the patients will be regularly checked
      clinically and radiologically.The investigators are interested in differences of shoulder
      function, Patient satisfaction as well as cosmetic and radiological results.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Shoulder function
time frame: at 6 weeks
description: Constant-Score
measure: Shoulder function
time frame: at 12 weeks
description: Constant-Score
measure: Shoulder function
time frame: at 1 week
description: ASES-Score (American Shoulder and Elbow Score)
measure: Shoulder function
time frame: at 6 weeks
description: ASES-Score (American Shoulder and Elbow Score)
measure: Shoulder function
time frame: at 12 weeks
description: ASES-Score (American Shoulder and Elbow Score)
measure: Shoulder function
time frame: at 1 week
description: Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
measure: Shoulder function
time frame: at 6 weeks
description: Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
measure: Shoulder function
time frame: at 12 weeks
description: Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
measure: Degree of lateral clavicle dislocation
time frame: at initial presentation
description: Coracoclavicular distance on Panorama view in comparison to healthy side
measure: Degree of lateral clavicle dislocation
time frame: at 6 weeks
description: Coracoclavicular distance on Panorama view in comparison to healthy side
measure: Degree of lateral clavicle dislocation
time frame: at 12 weeks
description: Coracoclavicular distance on Panorama view in comparison to healthy side
arm group label: Acromion 2.0 Brace
arm group type: Experimental
arm group label: Mitella Sling
arm group type: Active Comparator
intervention type: Device
intervention name: Acromion 2.0 Brace
description: Acromion 2.0 Brace will be worn for 6 weeks instead of the conventional Mitella sling
arm group label: Acromion 2.0 Brace
arm group label: Mitella Sling
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Näder Helmy, PD, MD
role: Study Chair
affiliation: Bürgerspital Solothurn, Department of Orthopaedics and Traumatology
facility: 
facility: 
country: Switzerland
citation: Phillips AM, Smart C, Groom AF. Acromioclavicular dislocation. Conservative or surgical therapy. Clin Orthop Relat Res. 1998 Aug;(353):10-7.
PMID: 9728155
citation: Korsten K, Gunning AC, Leenen LP. Operative or conservative treatment in patients with Rockwood type III acromioclavicular dislocation: a systematic review and update of current literature. Int Orthop. 2014 Apr;38(4):831-8. doi: 10.1007/s00264-013-2143-7. Epub 2013 Oct 31.
PMID: 24178060
citation: Smith TO, Chester R, Pearse EO, Hing CB. Operative versus non-operative management following Rockwood grade III acromioclavicular separation: a meta-analysis of the current evidence base. J Orthop Traumatol. 2011 Mar;12(1):19-27. doi: 10.1007/s10195-011-0127-1. Epub 2011 Feb 23.
PMID: 21344264
responsible party type: Principal Investigator
investigator affiliation: Bürgerspital Solothurn
investigator full name: Michael Finsterwald
investigator title: Dr. med. Michael Finsterwald
mesh term: Joint Dislocations
sharing ipd: Undecided