<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/NCT01719887</url>
  </required_header>
  <id_info>
    <org_study_id>HUS-118/13/03/02/2012</org_study_id>
    <nct_id>NCT01719887</nct_id>
  </id_info>
  <brief_title>Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial</brief_title>
  <official_title>Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Töölö Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tampere University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Finnish Institute for Health and Welfare</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Töölö Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Humeral shaft fractures represent 1-3% of all fractures and 20% of the humeral fractures.&#xD;
      These fractures have historically been treated mainly conservatively with good results.&#xD;
      Recent development in fracture treatment and findings that certain fracture types are more&#xD;
      prone to non-union and bracing-related functional problems of adjacent joints are somewhat&#xD;
      common have caused increasing interest in treating these fractures surgically. Return to&#xD;
      activities is also considered to be quicker among surgically treated patients.&#xD;
&#xD;
      The purpose of this study is to evaluate effectiveness and cost-effectiveness of surgical&#xD;
      treatment of humeral shaft fractures. Patients with an unilateral humeral shaft fracture who&#xD;
      are willing to participate in the study after informed consent are randomly assigned to two&#xD;
      different treatment methods:&#xD;
&#xD;
        1. Surgical treatment with an open reduction and internal fixation with a 4,5mm locking&#xD;
           plate.&#xD;
&#xD;
        2. Conservative treatment with functional bracing&#xD;
&#xD;
      The randomization is done using blocked randomization (block sizes are not known by the&#xD;
      enrolling or assigning physician) and stratification is done according to fracture type&#xD;
      (AO-OTA type A vs. type B/C) and radial nerve status (total/subtotal motor palsy vs. no&#xD;
      palsy).&#xD;
&#xD;
      Standard follow-up visits at 6 weeks, 3, 6 and 12 months are arranged. Later follow-up visits&#xD;
      are arranged at 2, 5 and 10 years for the study purpose. Patients fill evaluation forms and&#xD;
      clinical and radiological assessments are made. The physiotherapist doing objective&#xD;
      functional measurements is blinded to treatment method. Both study groups receive&#xD;
      physiotherapy after the initial treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 4, 2012</start_date>
  <completion_date type="Anticipated">January 2028</completion_date>
  <primary_completion_date type="Actual">January 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>The Disabilities of the Arm, Shoulder and Hand Score (DASH)</measure>
    <time_frame>at 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective assessment of the function of the upper extremity</measure>
    <time_frame>6 wks, 3, 6, 12 mo, 2, 5, 10 years</time_frame>
    <description>Numerical Rating Scale (NRS) 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Constant Score</measure>
    <time_frame>6 wks, 3, 6, 12 mo, 2, 5, 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elbow ROM</measure>
    <time_frame>6 wks, 3, 6, 12 mo, 2, 5, 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life (15D)</measure>
    <time_frame>6 wks, 3, 6, 12 mo, 2, 5, 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>6 wks, 3, 6, 12 mo, 2, 5, 10 years</time_frame>
    <description>Incidence of complications (i.e. non-union, malunion, re-fracture, reoperation, infection and iatrogenic radial palsy) is recorded and compared between study groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>6 wks, 3, 6, 12 mo, 2, 5, 10 years</time_frame>
    <description>Quality-adjusted life years/months measured as a change in 15D tool, pain-NRS and other outcome measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective assessment of the function of the upper extremity</measure>
    <time_frame>6 wks, 3, 6, 12 mo, 2, 5, 10 years</time_frame>
    <description>Likert Scale 1-7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective assessment of the function of the elbow</measure>
    <time_frame>6 wks, 3, 6, 12 mo, 2, 5, 10 years</time_frame>
    <description>Numerical Rating Scale (NRS) 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Disabilities of the Arm, Shoulder and Hand Score (DASH)</measure>
    <time_frame>at 6 wks, 3, 6 mo, 2, 5, 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain at rest and in activity, Numerical Rating Scale (NRS) 0-10</measure>
    <time_frame>at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with acceptable symptom state (PASS)</measure>
    <time_frame>at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Fracture</condition>
  <arm_group>
    <arm_group_label>Conservative treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conservative treatment with functional brace and physiotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Operative treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Operative treatment with open reduction and internal fixation with 4,5mm locking compression plate. Physiotherapy at 3 and 9 wks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conservative treatment</intervention_name>
    <description>Conservative treatment with functional brace.</description>
    <arm_group_label>Conservative treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Operative treatment</intervention_name>
    <description>Operative treatment with open reduction and internal fixation using 4,5mm locking compression plate.</description>
    <arm_group_label>Operative treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiotherapy</intervention_name>
    <description>Physiotherapy is arranged to both groups at 3 and 9 wks.</description>
    <arm_group_label>Conservative treatment</arm_group_label>
    <arm_group_label>Operative treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years old patient who agrees to the consent to participation in this study&#xD;
&#xD;
          -  Unilateral dislocated humeral shaft fracture (dislocation over thickness of the bone&#xD;
             cortex, fracture below the level of insertion of pectoralis major muscle and 5 cm&#xD;
             above the olecranon fossa)&#xD;
&#xD;
          -  Randomization can be done within 10 days and operation within 14 days after the&#xD;
             initial trauma&#xD;
&#xD;
          -  Patient is willing to participate all follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bilateral humeral shaft fracture&#xD;
&#xD;
          -  A significant concomitant trauma of the same upper extremity that warrants operative&#xD;
             treatment (fracture, tendon injury, soft tissue trauma)&#xD;
&#xD;
          -  Other fracture or abdominal/thoracal trauma that warrants operative treatment&#xD;
&#xD;
          -  Open fracture&#xD;
&#xD;
          -  Pathological fracture&#xD;
&#xD;
          -  Multi-trauma patient&#xD;
&#xD;
          -  Vascular injury&#xD;
&#xD;
          -  Plexus injury&#xD;
&#xD;
          -  Previous trauma in the same upper extremity that causes functional deficit&#xD;
&#xD;
          -  Trauma or condition that warrants use of walking aid (crutches, wheelchair etc)&#xD;
&#xD;
          -  Disease that affects significantly general condition of the patient&#xD;
&#xD;
          -  Significantly impaired ability to co-operate for any reason (substance abuse, mental&#xD;
             disorder, dementia)&#xD;
&#xD;
          -  Unwilling to accept both treatment methods&#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>Mika Paavola, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Töölö Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Töölö Hospital, Helsinki University Central Hospital</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampere University Hospital</name>
      <address>
        <city>Tampere</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <link>
    <url>http://bmjopen.bmj.com/content/7/7/e014076</url>
    <description>Protocol article in BMJ Open</description>
  </link>
  <link>
    <url>https://jamanetwork.com/journals/jama/article-abstract/2765728</url>
    <description>1-year results in JAMA</description>
  </link>
  <link>
    <url>https://jamanetwork.com/journals/jamasurgery/article-abstract/2778638</url>
    <description>2-year results in JAMA Surgery</description>
  </link>
  <reference>
    <citation>Ramo L, Taimela S, Lepola V, Malmivaara A, Lahdeoja T, Paavola M. Open reduction and internal fixation of humeral shaft fractures versus conservative treatment with a functional brace: a study protocol of a randomised controlled trial embedded in a cohort. BMJ Open. 2017 Jul 9;7(7):e014076. doi: 10.1136/bmjopen-2016-014076.</citation>
    <PMID>28694341</PMID>
  </reference>
  <results_reference>
    <citation>Ramo L, Sumrein BO, Lepola V, Lahdeoja T, Ranstam J, Paavola M, Jarvinen T, Taimela S; FISH Investigators. Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clinical Trial. JAMA. 2020 May 12;323(18):1792-1801. doi: 10.1001/jama.2020.3182.</citation>
    <PMID>32396179</PMID>
  </results_reference>
  <results_reference>
    <citation>Ramo L, Paavola M, Sumrein BO, Lepola V, Lahdeoja T, Ranstam J, Jarvinen TLN, Taimela S; FISH Investigators. Outcomes With Surgery vs Functional Bracing for Patients With Closed, Displaced Humeral Shaft Fractures and the Need for Secondary Surgery: A Prespecified Secondary Analysis of the FISH Randomized Clinical Trial. JAMA Surg. 2021 Apr 14;156(6):1-9. doi: 10.1001/jamasurg.2021.0906. Online ahead of print.</citation>
    <PMID>33851991</PMID>
  </results_reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>October 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>October 20, 2022</last_update_submitted>
  <last_update_submitted_qc>October 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Töölö Hospital</investigator_affiliation>
    <investigator_full_name>Lasse Rämö</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>humerus</keyword>
  <keyword>humeral</keyword>
  <keyword>shaft</keyword>
  <keyword>diaphysis</keyword>
  <keyword>fracture</keyword>
  <keyword>RCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</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/NCT01719887
org study id: HUS-118/13/03/02/2012
nct id: NCT01719887
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Humeral shaft fractures represent 1-3% of all fractures and 20% of the humeral fractures.
      These fractures have historically been treated mainly conservatively with good results.
      Recent development in fracture treatment and findings that certain fracture types are more
      prone to non-union and bracing-related functional problems of adjacent joints are somewhat
      common have caused increasing interest in treating these fractures surgically. Return to
      activities is also considered to be quicker among surgically treated patients.

      The purpose of this study is to evaluate effectiveness and cost-effectiveness of surgical
      treatment of humeral shaft fractures. Patients with an unilateral humeral shaft fracture who
      are willing to participate in the study after informed consent are randomly assigned to two
      different treatment methods:

        1. Surgical treatment with an open reduction and internal fixation with a 4,5mm locking
           plate.

        2. Conservative treatment with functional bracing

      The randomization is done using blocked randomization (block sizes are not known by the
      enrolling or assigning physician) and stratification is done according to fracture type
      (AO-OTA type A vs. type B/C) and radial nerve status (total/subtotal motor palsy vs. no
      palsy).

      Standard follow-up visits at 6 weeks, 3, 6 and 12 months are arranged. Later follow-up visits
      are arranged at 2, 5 and 10 years for the study purpose. Patients fill evaluation forms and
      clinical and radiological assessments are made. The physiotherapist doing objective
      functional measurements is blinded to treatment method. Both study groups receive
      physiotherapy after the initial treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The Disabilities of the Arm, Shoulder and Hand Score (DASH)
time frame: at 12 months
measure: Subjective assessment of the function of the upper extremity
time frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
description: Numerical Rating Scale (NRS) 0-10
measure: Constant Score
time frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
measure: Elbow ROM
time frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
measure: Health-related quality of life (15D)
time frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
measure: Complications
time frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
description: Incidence of complications (i.e. non-union, malunion, re-fracture, reoperation, infection and iatrogenic radial palsy) is recorded and compared between study groups.
measure: Cost-effectiveness
time frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
description: Quality-adjusted life years/months measured as a change in 15D tool, pain-NRS and other outcome measures.
measure: Subjective assessment of the function of the upper extremity
time frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
description: Likert Scale 1-7
measure: Subjective assessment of the function of the elbow
time frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
description: Numerical Rating Scale (NRS) 0-10
measure: The Disabilities of the Arm, Shoulder and Hand Score (DASH)
time frame: at 6 wks, 3, 6 mo, 2, 5, 10 years
measure: Pain at rest and in activity, Numerical Rating Scale (NRS) 0-10
time frame: at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years
measure: Percentage of patients with acceptable symptom state (PASS)
time frame: at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years
arm group label: Conservative treatment
arm group type: Active Comparator
description: Conservative treatment with functional brace and physiotherapy.
arm group label: Operative treatment
arm group type: Experimental
description: Operative treatment with open reduction and internal fixation with 4,5mm locking compression plate. Physiotherapy at 3 and 9 wks.
intervention type: Device
intervention name: Conservative treatment
description: Conservative treatment with functional brace.
arm group label: Conservative treatment
intervention type: Procedure
intervention name: Operative treatment
description: Operative treatment with open reduction and internal fixation using 4,5mm locking compression plate.
arm group label: Operative treatment
intervention type: Other
intervention name: Physiotherapy
description: Physiotherapy is arranged to both groups at 3 and 9 wks.
arm group label: Conservative treatment
arm group label: Operative treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mika Paavola, MD, PhD
role: Study Director
affiliation: Töölö Hospital
facility: 
facility: 
country: Finland
url: http://bmjopen.bmj.com/content/7/7/e014076
description: Protocol article in BMJ Open
url: https://jamanetwork.com/journals/jama/article-abstract/2765728
description: 1-year results in JAMA
url: https://jamanetwork.com/journals/jamasurgery/article-abstract/2778638
description: 2-year results in JAMA Surgery
citation: Ramo L, Taimela S, Lepola V, Malmivaara A, Lahdeoja T, Paavola M. Open reduction and internal fixation of humeral shaft fractures versus conservative treatment with a functional brace: a study protocol of a randomised controlled trial embedded in a cohort. BMJ Open. 2017 Jul 9;7(7):e014076. doi: 10.1136/bmjopen-2016-014076.
PMID: 28694341
citation: Ramo L, Sumrein BO, Lepola V, Lahdeoja T, Ranstam J, Paavola M, Jarvinen T, Taimela S; FISH Investigators. Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clinical Trial. JAMA. 2020 May 12;323(18):1792-1801. doi: 10.1001/jama.2020.3182.
PMID: 32396179
citation: Ramo L, Paavola M, Sumrein BO, Lepola V, Lahdeoja T, Ranstam J, Jarvinen TLN, Taimela S; FISH Investigators. Outcomes With Surgery vs Functional Bracing for Patients With Closed, Displaced Humeral Shaft Fractures and the Need for Secondary Surgery: A Prespecified Secondary Analysis of the FISH Randomized Clinical Trial. JAMA Surg. 2021 Apr 14;156(6):1-9. doi: 10.1001/jamasurg.2021.0906. Online ahead of print.
PMID: 33851991
responsible party type: Principal Investigator
investigator affiliation: Töölö Hospital
investigator full name: Lasse Rämö
investigator title: MD, PhD
mesh term: Fractures, Bone