<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/NCT02250144</url>
  </required_header>
  <id_info>
    <org_study_id>5832</org_study_id>
    <nct_id>NCT02250144</nct_id>
  </id_info>
  <brief_title>Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses</brief_title>
  <official_title>Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is&#xD;
      defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to&#xD;
      patellofemoral malalignment and soft tissue overload.&#xD;
&#xD;
      A few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral&#xD;
      pain syndrome, alone or in association with rehabilitation. However, no one has analyzed the&#xD;
      outcome of morpho-specific foot orthoses in a prospective randomized study.&#xD;
&#xD;
      The purpose of this prospective randomized study is to compare clinical outcomes in daily&#xD;
      living and in sports activities, between morpho-specific and placebo foot orthoses.&#xD;
&#xD;
      Morpho-specific foot orthoses are designed according to the patient's morphotype. They are&#xD;
      intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to&#xD;
      correct abnormal overload during patellofemoral tracking.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2015</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Item Pain of the KOOS Score</measure>
    <time_frame>Twice : at inclusion and at 10 weeks follow-up with feet orthoses</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>KOOS Score (items Symptoms, Activities of daily living, Sport and recreation function, Knee-related quality of life)</measure>
    <time_frame>Twice : at inclusion and at 10 weeks follow-up with feet orthoses</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kujala Score</measure>
    <time_frame>Twice : at inclusion and at 10 weeks follow-up with feet orthoses</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain level</measure>
    <time_frame>Twice : at inclusion and at 10 weeks follow-up with feet orthoses</time_frame>
    <description>Visual Analog Scale (VAS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Patellofemoral Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Morpho-specific foot orthoses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Morpho-specific thermo-molded foot orthoses are designed according to the patient's morphotype.&#xD;
Orthoses are custom-molded from different materials such as BIOFLUX resin, Covercuir MF, EVA300/60, EVA400/70, PE255/55, ABSORB Dur and CAPITON PU.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo foot orthoses</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo foot orthoses will be made with the same principle of molding and with the same materials as for the experimental group. The only difference is that they involve no active corrective insert element : they will be made without morphotype correction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Foot orthoses</intervention_name>
    <arm_group_label>Morpho-specific foot orthoses</arm_group_label>
    <arm_group_label>Placebo foot orthoses</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged 12-40 years&#xD;
&#xD;
          -  Patellofemoral pain syndrome&#xD;
&#xD;
          -  Patient affiliated to a social protection regime&#xD;
&#xD;
          -  Patient who signed an informed consent&#xD;
&#xD;
          -  For teenagers with no complete growth and muscular maturation, failure of appropriate&#xD;
             rehabilitation during minimum 2 months&#xD;
&#xD;
          -  Patient informed of the results of the prior medical examination&#xD;
&#xD;
          -  Normality (no sign of osteoarthritis) of the knee radiographs&#xD;
&#xD;
          -  Ability to read and understand French&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Knee osteoarthritis&#xD;
&#xD;
          -  Systemic disease&#xD;
&#xD;
          -  Inflammatory rheumatism disease&#xD;
&#xD;
          -  Unstable knee&#xD;
&#xD;
          -  Prior patellofemoral dislocation&#xD;
&#xD;
          -  Osteochondrosis&#xD;
&#xD;
          -  Referred pain from a hip or spine disease (particularly proximal femoral&#xD;
             epiphysiolysis in the teenagers)&#xD;
&#xD;
          -  A history of patellar trauma&#xD;
&#xD;
          -  A history of knee surgery&#xD;
&#xD;
          -  Meniscus, ligament or osteochondral pathology&#xD;
&#xD;
          -  Knee tendinitis or bursitis&#xD;
&#xD;
          -  Neurologic disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Antidepressant therapy or behavioral disorder&#xD;
&#xD;
          -  Patient unable to comply the required maximum observance&#xD;
&#xD;
          -  Impossibility to give enlightened information to the patient&#xD;
&#xD;
          -  Patient under guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yann DIESINGER, MD</last_name>
    <phone>388552310</phone>
    <phone_ext>0033</phone_ext>
    <email>yann.diesinger@chru-strasbourg.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cabinet libéral - 12, rue du Puits</name>
      <address>
        <city>Haguenau</city>
        <zip>67500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joseph ARNDT, MD</last_name>
      <email>joseph.arndt@hotmail.fr</email>
    </contact>
    <investigator>
      <last_name>Joseph ARNDT, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Service de Chirurgie Orthopédique - Hôpital CCOM - Hôpitaux Universitaires de Strasbourg</name>
      <address>
        <city>Illkirch Graffenstaden</city>
        <zip>67400</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yann DIESINGER, MD</last_name>
      <phone>388552310</phone>
      <phone_ext>0033</phone_ext>
      <email>yann.diesinger@chru-strasbourg.fr</email>
    </contact>
    <investigator>
      <last_name>Yann DIESINGER, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cabinet libéral - 50, avenue des Vosges</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian LUTZ, MD</last_name>
      <email>lutzortho@wanadoo.fr</email>
    </contact>
    <investigator>
      <last_name>Christian LUTZ, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>August 6, 2015</last_update_submitted>
  <last_update_submitted_qc>August 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patellofemoral pain syndrome</keyword>
  <keyword>Feet orthoses</keyword>
  <keyword>KOOS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Patellofemoral Pain Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Somatoform Disorders</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/NCT02250144
org study id: 5832
nct id: NCT02250144
lead sponsor: 
has dmc: No
Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is
      defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to
      patellofemoral malalignment and soft tissue overload.

      A few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral
      pain syndrome, alone or in association with rehabilitation. However, no one has analyzed the
      outcome of morpho-specific foot orthoses in a prospective randomized study.

      The purpose of this prospective randomized study is to compare clinical outcomes in daily
      living and in sports activities, between morpho-specific and placebo foot orthoses.

      Morpho-specific foot orthoses are designed according to the patient's morphotype. They are
      intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to
      correct abnormal overload during patellofemoral tracking.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Item Pain of the KOOS Score
time frame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
measure: KOOS Score (items Symptoms, Activities of daily living, Sport and recreation function, Knee-related quality of life)
time frame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
measure: Kujala Score
time frame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
measure: Pain level
time frame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
description: Visual Analog Scale (VAS)
arm group label: Morpho-specific foot orthoses
arm group type: Experimental
description: Morpho-specific thermo-molded foot orthoses are designed according to the patient's morphotype.
Orthoses are custom-molded from different materials such as BIOFLUX resin, Covercuir MF, EVA300/60, EVA400/70, PE255/55, ABSORB Dur and CAPITON PU.
arm group label: Placebo foot orthoses
arm group type: Placebo Comparator
description: The placebo foot orthoses will be made with the same principle of molding and with the same materials as for the experimental group. The only difference is that they involve no active corrective insert element : they will be made without morphotype correction.
intervention type: Device
intervention name: Foot orthoses
arm group label: Morpho-specific foot orthoses
arm group label: Placebo foot orthoses
criteria: 
gender: All
minimum age: 12 Years
maximum age: 40 Years
healthy volunteers: No
last name: Yann DIESINGER, MD
phone: 388552310
phone ext: 0033
email: yann.diesinger@chru-strasbourg.fr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Patellofemoral Pain Syndrome
mesh term: Syndrome
mesh term: Somatoform Disorders