<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/NCT03786679</url>
  </required_header>
  <id_info>
    <org_study_id>06000836</org_study_id>
    <nct_id>NCT03786679</nct_id>
  </id_info>
  <brief_title>Non-operative Treatment in Sweden of Proximal Humeral Fractures</brief_title>
  <acronym>NOSWEPH</acronym>
  <official_title>Non-operative Treatment in Sweden of Proximal Humeral Fratures, a Randomised Multicenter Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lars Adolfsson</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Linkoeping University</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>
      Proximal humeral fractures are common especially in the elderly population. The majority of&#xD;
      these fractures are minimally displaced and may be treated non-operatively. There is however&#xD;
      a controversy about which fractures that need surgery and randomised trials have not been&#xD;
      able to show a clinically important advantage in patient reported outcome measures for those&#xD;
      operated. The trend is therefore that also displaced and comminute fractures are treated&#xD;
      non-operatively. There is however very little scientific support for how the non-operative&#xD;
      treatment should be designed and performed. Therefore this prospective multicenter study is&#xD;
      aiming at investigating the benefit of a four week immobilisation orthosis as compared to&#xD;
      early range of motion exercises for those patients not assigned for surgery one week after&#xD;
      the trauma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Anticipated">February 25, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 25, 2024</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>
    <intervention_model_description>Parallel assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The assessors are not involved in the treatment and the radiological assessment of images will be assessed with anonymyized images.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Union of fracture</measure>
    <time_frame>Followed 12 months</time_frame>
    <description>recording of fracture union on radiological images</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxford shoulder score</measure>
    <time_frame>12 months</time_frame>
    <description>Shoulder specific patient reported outcome measure, PROM, with a maximum score of 48 points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical pain reporting scale</measure>
    <time_frame>12 months</time_frame>
    <description>Patient reported outcome measure of pain at rest, at night and during activity in scales with 10 steps grading subjective assessment of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quick DASH</measure>
    <time_frame>12 months</time_frame>
    <description>Patient reported outcome measure of shoulder function in a 11-item PROM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of improvement</measure>
    <time_frame>12 months</time_frame>
    <description>Patient rated assessment of global improvement in a numeric scale with 7 steps</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder range of motion</measure>
    <time_frame>12 months</time_frame>
    <description>The elevation, abduction, internal and external rotation of the injured shoulder</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Proximal Humeral Fracture</condition>
  <arm_group>
    <arm_group_label>Orthosis group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An orthosis with the broken arm in neutral position fixed for four weeks. After these four weeks the patient is instructed to start rehabilitation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early rehabilitation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patient is instructed to start early rehabilitation about one week after the trauma.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasling ER III orthosis</intervention_name>
    <description>Application of orthosis and start of rehabilitation after four weeks.</description>
    <arm_group_label>Early rehabilitation group</arm_group_label>
    <arm_group_label>Orthosis group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A proximal humeral fracture verified on radiology no older than 7-10 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Surgically treated proximal humeral fracture&#xD;
&#xD;
          -  Fracture only involving the greater tuberosity&#xD;
&#xD;
          -  Previous surgery in the fractured shoulder&#xD;
&#xD;
          -  Ongoing malignancy in the fractured shoulder&#xD;
&#xD;
          -  Neurologic disease&#xD;
&#xD;
          -  Radiating pain from the neck in the affected arm&#xD;
&#xD;
          -  Associated vascular or nerve injuries&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Alcohol abuse&#xD;
&#xD;
          -  Unwilling to participate in the trial&#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>Lars E Adolfsson, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Linkoeping University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hanna C Björnsson Hallgren, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Linkoeping University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hanna C Björnsson Hallgren, MD, PhD</last_name>
    <phone>0046709473276</phone>
    <email>hanna.bjornsson.hallgren@regionostergotland.se</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lars Adolfsson</name>
      <address>
        <city>Linköping</city>
        <zip>58185</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hanna C Björnsson Hallgren, MD, PhD</last_name>
      <phone>+46101031000</phone>
      <email>hanna.bjornsson.hallgren@regionostergotland.se</email>
    </contact>
    <contact_backup>
      <last_name>lars e adolfsson, MD, PhD</last_name>
      <phone>+46101031000</phone>
      <email>lars.adolfsonb@regionostergotland.se</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>March 7, 2023</last_update_submitted>
  <last_update_submitted_qc>March 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Linkoeping University</investigator_affiliation>
    <investigator_full_name>Lars Adolfsson</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Non-operative treatment, orthosis, healing, rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Humeral Fractures</mesh_term>
    <mesh_term>Shoulder Fractures</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/NCT03786679
org study id: 06000836
nct id: NCT03786679
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Proximal humeral fractures are common especially in the elderly population. The majority of
      these fractures are minimally displaced and may be treated non-operatively. There is however
      a controversy about which fractures that need surgery and randomised trials have not been
      able to show a clinically important advantage in patient reported outcome measures for those
      operated. The trend is therefore that also displaced and comminute fractures are treated
      non-operatively. There is however very little scientific support for how the non-operative
      treatment should be designed and performed. Therefore this prospective multicenter study is
      aiming at investigating the benefit of a four week immobilisation orthosis as compared to
      early range of motion exercises for those patients not assigned for surgery one week after
      the trauma.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The assessors are not involved in the treatment and the radiological assessment of images will be assessed with anonymyized images.
measure: Union of fracture
time frame: Followed 12 months
description: recording of fracture union on radiological images
measure: Oxford shoulder score
time frame: 12 months
description: Shoulder specific patient reported outcome measure, PROM, with a maximum score of 48 points
measure: Numerical pain reporting scale
time frame: 12 months
description: Patient reported outcome measure of pain at rest, at night and during activity in scales with 10 steps grading subjective assessment of pain
measure: Quick DASH
time frame: 12 months
description: Patient reported outcome measure of shoulder function in a 11-item PROM
measure: Global assessment of improvement
time frame: 12 months
description: Patient rated assessment of global improvement in a numeric scale with 7 steps
measure: Shoulder range of motion
time frame: 12 months
description: The elevation, abduction, internal and external rotation of the injured shoulder
arm group label: Orthosis group
arm group type: Active Comparator
description: An orthosis with the broken arm in neutral position fixed for four weeks. After these four weeks the patient is instructed to start rehabilitation.
arm group label: Early rehabilitation group
arm group type: Active Comparator
description: The patient is instructed to start early rehabilitation about one week after the trauma.
intervention type: Device
intervention name: Ultrasling ER III orthosis
description: Application of orthosis and start of rehabilitation after four weeks.
arm group label: Early rehabilitation group
arm group label: Orthosis group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lars E Adolfsson, Professor
role: Principal Investigator
affiliation: Linkoeping University
last name: Hanna C Björnsson Hallgren, MD, PhD
role: Principal Investigator
affiliation: Linkoeping University
last name: Hanna C Björnsson Hallgren, MD, PhD
phone: 0046709473276
email: hanna.bjornsson.hallgren@regionostergotland.se
facility: 
status: Recruiting
contact: 
contact backup: 
country: Sweden
responsible party type: Sponsor-Investigator
investigator affiliation: Linkoeping University
investigator full name: Lars Adolfsson
investigator title: Professor
mesh term: Humeral Fractures
mesh term: Shoulder Fractures
sharing ipd: No