<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/NCT03015415</url>
  </required_header>
  <id_info>
    <org_study_id>Clbguglielmetti</org_study_id>
    <nct_id>NCT03015415</nct_id>
  </id_info>
  <brief_title>The Posttraumatic Elbow Stiffness Treatment</brief_title>
  <official_title>A Prospective Randomized Controlled Trial of Open Arthrolysis Versus Non-surgical Treatment for Elbow Stiffness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares patients with post traumatic elbow stiffness and evaluate the range of&#xD;
      motion improvement with two types of treatment: surgical release versus non-surgical&#xD;
      rehabilitation protocol with orthoses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study of the treatment of post-traumatic stiffness of the elbow presents numerous&#xD;
      challenges. Due to the great variability of the types of lesions, causes and symptomatology,&#xD;
      there are great difficulties in the homogenization of protocols and in the comparison of&#xD;
      results between the different treatments. Patients with different levels of severity and time&#xD;
      of stiffness, presence of arthrosis or not, and significant symptoms such as pain.&#xD;
&#xD;
      For patients with elbow stiffness without vicious consolidation, pseudoarthrosis,&#xD;
      intra-articular synthesis material or heterotopic ossification, and who have already failed&#xD;
      conventional therapy, basically have two treatment options. Which will be the subject of this&#xD;
      study: surgical release or non-surgical rehabilitation protocols with orthoses.&#xD;
&#xD;
      In meta-analysis, evaluating the elbow range of motion gain with rehabilitation protocols&#xD;
      associated with orthoses, the mean gain varies from 20º to 40º, depending on the type of&#xD;
      orthosis used. On the other hand a systematic review evaluated movement gain with different&#xD;
      surgical techniques. Observed a mean gain of 51º for open releases, but with higher&#xD;
      complication rates. However, there are no comparative studies in the literature comparing&#xD;
      this 2 types of treatment for post traumatic elbow stiffness: surgical release and&#xD;
      non-surgical rehabilitation protocol with orthoses in patients who have already performed&#xD;
      conventional physiotherapy with no success.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2013</start_date>
  <completion_date type="Actual">October 12, 2018</completion_date>
  <primary_completion_date type="Actual">September 20, 2018</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>Elbow range of motion improvement in degrees</measure>
    <time_frame>6 months</time_frame>
    <description>The gain will be measured with a goniometer centered on the axis of rotation of the elbow by a external examiner.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Elbow Joint Contracture</condition>
  <condition>Elbow Flexion Contractures</condition>
  <condition>Elbow Injury</condition>
  <condition>Elbow Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>surgical</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing surgical elbow arthrolysis. Elbow Open Arthrolyses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-surgical</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients submitted to a non-surgical rehabilitation protocol using splints Non-surgical intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Elbow Open Arthrolyses</intervention_name>
    <description>Elbow arthrolysis by posterior access</description>
    <arm_group_label>surgical</arm_group_label>
    <other_name>surgical</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-surgical intervention</intervention_name>
    <description>Rehabilitation with splinting protocols</description>
    <arm_group_label>non-surgical</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previous history of trauma that evolved with joint stiffness at the elbow&#xD;
&#xD;
          -  Range of movement of the elbow less than 100º or extension deficit greater than 30º or&#xD;
             flexion less than 130º&#xD;
&#xD;
          -  More than six months from the initial trauma;&#xD;
&#xD;
          -  Skeletal maturity;&#xD;
&#xD;
          -  Have had previous physical therapy without the use of orthotics or continuous passive&#xD;
             motion for at least 4 months;&#xD;
&#xD;
          -  Absence of the following findings:&#xD;
&#xD;
          -  Joint block, with range of motion equal to 0º;&#xD;
&#xD;
          -  Neurological limb injury;&#xD;
&#xD;
          -  Mental illness or inability to understand preoperative questionnaires;&#xD;
&#xD;
          -  Active infection;&#xD;
&#xD;
          -  Anterior infection at the elbow;&#xD;
&#xD;
          -  Systemic autoimmune diseases. (Eg, systemic lupus erythematosus, rheumatoid arthritis,&#xD;
             joint psoriasis, etc.).&#xD;
&#xD;
          -  Absence of the following radiographic changes:&#xD;
&#xD;
          -  Intra-articular synthesis material;&#xD;
&#xD;
          -  Presence of vicious consolidation of the distal articular surface of the humerus and&#xD;
             proximal ulna;&#xD;
&#xD;
          -  Heterotopic ossification;&#xD;
&#xD;
          -  Pseudoarthrosis of previous elbow fracture;&#xD;
&#xD;
          -  Elbow incongruity;&#xD;
&#xD;
          -  Grade III and IV arthrosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-collaboration with rehabilitation program and postoperative follow-up;&#xD;
&#xD;
          -  Need to use external fixator after surgical release due to joint instability;&#xD;
&#xD;
          -  Death from non-intervention causes or loss of follow-up before the first functional&#xD;
             evaluation (3 months).&#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>Rames M Junior, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto de Ortopedia e Traumatologia</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>May 16, 2020</last_update_submitted>
  <last_update_submitted_qc>May 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>César Luiz Betoni Guglielmetti</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>elbow</keyword>
  <keyword>posttraumatic stiffness</keyword>
  <keyword>elbow contractures</keyword>
  <keyword>stiff elbow</keyword>
  <keyword>dynamic orthoses</keyword>
  <keyword>Dynamic splint</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Splint</keyword>
  <keyword>Effectiveness of bracing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Contracture</mesh_term>
    <mesh_term>Elbow 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/NCT03015415
org study id: Clbguglielmetti
nct id: NCT03015415
lead sponsor: 
has dmc: Yes
This study compares patients with post traumatic elbow stiffness and evaluate the range of
      motion improvement with two types of treatment: surgical release versus non-surgical
      rehabilitation protocol with orthoses.
The study of the treatment of post-traumatic stiffness of the elbow presents numerous
      challenges. Due to the great variability of the types of lesions, causes and symptomatology,
      there are great difficulties in the homogenization of protocols and in the comparison of
      results between the different treatments. Patients with different levels of severity and time
      of stiffness, presence of arthrosis or not, and significant symptoms such as pain.

      For patients with elbow stiffness without vicious consolidation, pseudoarthrosis,
      intra-articular synthesis material or heterotopic ossification, and who have already failed
      conventional therapy, basically have two treatment options. Which will be the subject of this
      study: surgical release or non-surgical rehabilitation protocols with orthoses.

      In meta-analysis, evaluating the elbow range of motion gain with rehabilitation protocols
      associated with orthoses, the mean gain varies from 20º to 40º, depending on the type of
      orthosis used. On the other hand a systematic review evaluated movement gain with different
      surgical techniques. Observed a mean gain of 51º for open releases, but with higher
      complication rates. However, there are no comparative studies in the literature comparing
      this 2 types of treatment for post traumatic elbow stiffness: surgical release and
      non-surgical rehabilitation protocol with orthoses in patients who have already performed
      conventional physiotherapy with no success.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Elbow range of motion improvement in degrees
time frame: 6 months
description: The gain will be measured with a goniometer centered on the axis of rotation of the elbow by a external examiner.
arm group label: surgical
arm group type: Experimental
description: Patients undergoing surgical elbow arthrolysis. Elbow Open Arthrolyses
arm group label: non-surgical
arm group type: Experimental
description: Patients submitted to a non-surgical rehabilitation protocol using splints Non-surgical intervention
intervention type: Procedure
intervention name: Elbow Open Arthrolyses
description: Elbow arthrolysis by posterior access
arm group label: surgical
other name: surgical
intervention type: Procedure
intervention name: Non-surgical intervention
description: Rehabilitation with splinting protocols
arm group label: non-surgical
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rames M Junior, Professor
role: Study Chair
affiliation: University of São Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: César Luiz Betoni Guglielmetti
investigator title: Principal Investigator
mesh term: Contracture
mesh term: Elbow Injuries
sharing ipd: No