<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/NCT02261701</url>
  </required_header>
  <id_info>
    <org_study_id>LTV-426521</org_study_id>
    <secondary_id>ACJCKFVästerås</secondary_id>
    <nct_id>NCT02261701</nct_id>
  </id_info>
  <brief_title>Rehabilitation After Rotator Cuff Repair</brief_title>
  <official_title>Rehabilitation After Rotator Cuff Repair a Randomised Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uppsala University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uppsala University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A new postoperative regimen with a new bandage technique after surgery results in a better&#xD;
      shoulder function and quality of life after surgery - than traditional postoperative regimen&#xD;
      with shoulder lock and abductor cushion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A new postoperative regimen , with a new bandage technique with shorter immobilization time&#xD;
      and without shoulder lock, is supposed to results in a better shoulder function 6 and 12&#xD;
      months after surgery. Function is measured by Constant score, pain with VAS and quality of&#xD;
      life with EQ5D, 3 and 12 months after surgery. The two treatment groups are compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">October 30, 2017</completion_date>
  <primary_completion_date type="Actual">August 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>Shoulder function</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Shoulder function is assessed by Constant score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Visual analogue scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>EQ-5D</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Quality of life</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life shoulder specific</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Western Ontario Rotator Cuff Index (WORC)</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Visual analogue scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Euro quality of Life 5D</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Quality of life</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life shoulder specific</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Western Ontario Rotator Cuff Index (WORC)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Rotator Cuff Injury</condition>
  <arm_group>
    <arm_group_label>Early mobilization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention is early mobilization, four weeks immobilization postsurgery with collar´n cuff only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post surgery shoulder lock</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Post surgery shoulder lock with abduction cushion 3 weeks and after this period collar´n cuff 3 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early mobilization</intervention_name>
    <description>Early mobilization, collar´n cuff 4 weeks post surgery and after this light exercises start and no further bandage.</description>
    <arm_group_label>Early mobilization</arm_group_label>
    <other_name>Collar´n cuff 4 weeks post surgery and early mobilization</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Post surgery shoulder lock</intervention_name>
    <description>Post surgery: Shoulder lock with abduction cushion, additionally 3 weeks with collar´n cuff, and after this period light exercises are allowed and nu further bandage.</description>
    <arm_group_label>Post surgery shoulder lock</arm_group_label>
    <other_name>Shoulder lock three weeks post surgery</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  planned shoulder surgery, rotator cuff repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not swedish speaking&#xD;
&#xD;
          -  reoperation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ann Christin Johansson, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Center for Clinical Research County Västmanland, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Orthopaedic surgery, Physiotherapy</name>
      <address>
        <city>Västerås</city>
        <state>Västmanland</state>
        <zip>721 89</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>May 3, 2018</last_update_submitted>
  <last_update_submitted_qc>May 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>shoulder surgery</keyword>
  <keyword>rotator cuff injury</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>function</keyword>
  <keyword>pain</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02261701
org study id: LTV-426521
secondary id: ACJCKFVästerås
nct id: NCT02261701
lead sponsor: 
has dmc: No
A new postoperative regimen with a new bandage technique after surgery results in a better
      shoulder function and quality of life after surgery - than traditional postoperative regimen
      with shoulder lock and abductor cushion.
A new postoperative regimen , with a new bandage technique with shorter immobilization time
      and without shoulder lock, is supposed to results in a better shoulder function 6 and 12
      months after surgery. Function is measured by Constant score, pain with VAS and quality of
      life with EQ5D, 3 and 12 months after surgery. The two treatment groups are compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Shoulder function
time frame: 6 months after surgery
description: Shoulder function is assessed by Constant score
measure: Pain
time frame: 6 months after surgery
description: Visual analogue scale
measure: EQ-5D
time frame: 6 months after surgery
description: Quality of life
measure: Quality of life shoulder specific
time frame: 6 months after surgery
description: Western Ontario Rotator Cuff Index (WORC)
measure: Pain
time frame: 12 months after surgery
description: Visual analogue scale
measure: Euro quality of Life 5D
time frame: 12 months after surgery
description: Quality of life
measure: Quality of life shoulder specific
time frame: 12 months after surgery
description: Western Ontario Rotator Cuff Index (WORC)
arm group label: Early mobilization
arm group type: Experimental
description: Intervention is early mobilization, four weeks immobilization postsurgery with collar´n cuff only.
arm group label: Post surgery shoulder lock
arm group type: Other
description: Post surgery shoulder lock with abduction cushion 3 weeks and after this period collar´n cuff 3 weeks
intervention type: Other
intervention name: Early mobilization
description: Early mobilization, collar´n cuff 4 weeks post surgery and after this light exercises start and no further bandage.
arm group label: Early mobilization
other name: Collar´n cuff 4 weeks post surgery and early mobilization
intervention type: Other
intervention name: Post surgery shoulder lock
description: Post surgery: Shoulder lock with abduction cushion, additionally 3 weeks with collar´n cuff, and after this period light exercises are allowed and nu further bandage.
arm group label: Post surgery shoulder lock
other name: Shoulder lock three weeks post surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ann Christin Johansson, PhD
role: Study Chair
affiliation: Center for Clinical Research County Västmanland, Sweden
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Rotator Cuff Injuries
sharing ipd: No