<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/NCT02190188</url>
  </required_header>
  <id_info>
    <org_study_id>602010072014</org_study_id>
    <secondary_id>602011072014</secondary_id>
    <nct_id>NCT02190188</nct_id>
  </id_info>
  <brief_title>The Influence of Wedge Insoles After Partial Meniscectomy</brief_title>
  <official_title>Effect of Orthotic Devices in the Recovery After Partial Meniscectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University Innsbruck</source>
  <brief_summary>
    <textblock>
      Research on the implications of orthotic devices and the recovery after knee arthroscopy are&#xD;
      widely known. But only a handful of specific issues have been studied to date. However, the&#xD;
      effect of orthotic devices on the recovery after partial meniscectomy are largely unknown. To&#xD;
      our best knowledge, there are no studies that deal with the treatment of partial medial or&#xD;
      lateral meniscectomy with wedge insoles, valgus or varus knee braces. The purpose of this&#xD;
      study is to find out if using wedge inserts or knee orthoses improve the outcomes after&#xD;
      partial meniscectomy.&#xD;
&#xD;
      We therefore verify the following hypothesis: In patients with partial meniscectomy can be by&#xD;
      the postoperative use of exculpatory wedge deposits or relieving knee brace achieve a&#xD;
      significantly better clinical outcome than without specific treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 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>Knee-specific questionnaires which combine an activity and a quality of life score.</measure>
    <time_frame>Two years</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Partial Meniscectomy</condition>
  <arm_group>
    <arm_group_label>No specific treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No specific treatment after partial meniscectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wedge Insole with 5mm wedge angel</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants wear a wedge insole after partial meniscectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Knee Brace</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants wear a knee brace after partial meniscectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wedge Insole 5mm</intervention_name>
    <arm_group_label>Wedge Insole with 5mm wedge angel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Knee Brace</intervention_name>
    <arm_group_label>Knee Brace</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  full leg x-ray to measure the leg axis&#xD;
&#xD;
          -  undersigned Informed Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  at the same time conducted or within one year subsequent corrective osteotomies of the&#xD;
             leg axis&#xD;
&#xD;
          -  medial meniscectomy combination and valgus&#xD;
&#xD;
          -  combination of lateral meniscectomy and varus&#xD;
&#xD;
          -  psychiatric or neurological comorbidities that produce a poor compliance&#xD;
&#xD;
          -  forth degree cartilage lesions or evident osteoarthritis&#xD;
&#xD;
          -  concomitant lesion of the collateral ligaments&#xD;
&#xD;
          -  insufficient knowledge of the study language&#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>Michael Liebensteiner, Priv. Doz. Mag. Dr. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthopedic, Medical University of Innsbruck</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Orthopedic; Medical University of Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <state>Tyrol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>March 21, 2018</last_update_submitted>
  <last_update_submitted_qc>March 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University Innsbruck</investigator_affiliation>
    <investigator_full_name>Dammerer Dietmar, MD</investigator_full_name>
    <investigator_title>MD, MSc, PhD</investigator_title>
  </responsible_party>
  <keyword>wedge insoles,</keyword>
  <keyword>knee brace,</keyword>
  <keyword>orthotic device</keyword>
  <keyword>goal</keyword>
  <!-- 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/NCT02190188
org study id: 602010072014
secondary id: 602011072014
nct id: NCT02190188
lead sponsor: 
Research on the implications of orthotic devices and the recovery after knee arthroscopy are
      widely known. But only a handful of specific issues have been studied to date. However, the
      effect of orthotic devices on the recovery after partial meniscectomy are largely unknown. To
      our best knowledge, there are no studies that deal with the treatment of partial medial or
      lateral meniscectomy with wedge insoles, valgus or varus knee braces. The purpose of this
      study is to find out if using wedge inserts or knee orthoses improve the outcomes after
      partial meniscectomy.

      We therefore verify the following hypothesis: In patients with partial meniscectomy can be by
      the postoperative use of exculpatory wedge deposits or relieving knee brace achieve a
      significantly better clinical outcome than without specific treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Knee-specific questionnaires which combine an activity and a quality of life score.
time frame: Two years
arm group label: No specific treatment
arm group type: No Intervention
description: No specific treatment after partial meniscectomy
arm group label: Wedge Insole with 5mm wedge angel
arm group type: Other
description: Participants wear a wedge insole after partial meniscectomy
arm group label: Knee Brace
arm group type: Other
description: Participants wear a knee brace after partial meniscectomy
intervention type: Device
intervention name: Wedge Insole 5mm
arm group label: Wedge Insole with 5mm wedge angel
intervention type: Device
intervention name: Knee Brace
arm group label: Knee Brace
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Liebensteiner, Priv. Doz. Mag. Dr. PhD
role: Principal Investigator
affiliation: Department of Orthopedic, Medical University of Innsbruck
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University Innsbruck
investigator full name: Dammerer Dietmar, MD
investigator title: MD, MSc, PhD