<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/NCT02263807</url>
  </required_header>
  <id_info>
    <org_study_id>2009/2148</org_study_id>
    <nct_id>NCT02263807</nct_id>
  </id_info>
  <brief_title>Knee Function in Patients With Two or More Episodes of Patella Dislocations</brief_title>
  <acronym>MPFL</acronym>
  <official_title>RCT Study:Knee Function in Patients With Two or More Episodes of Patella Dislocations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asbjorn Aroen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Akershus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included&#xD;
      into a randomized prospective study. This study comparess the outcome of two forms of&#xD;
      treatment for recurrent patella dislocation. One group is offered reconstruction of the&#xD;
      medial patellofemoral ligament (MPFL), the second group is offered a standardized training&#xD;
      program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      Patella dislocation is a serious knee injury whose peak incidence occurs in patients aged&#xD;
      10-17 years and is associated with a high rate of re-dislocation. Knee injuries frequently&#xD;
      cause long-term disability and reduced physical activity among adolescents and young persons.&#xD;
      Surgery in this patient group requires a low tolerance for complications, meaning that&#xD;
      physical therapy might offer more successful outcomes in many knee injury cases. The proposed&#xD;
      project studies a particular patient cohort subjected to recurrent dislocation of the&#xD;
      patella.&#xD;
&#xD;
      Aim:&#xD;
&#xD;
      The principal objective of this clinical, randomized controlled trial is to evaluate and&#xD;
      compare knee function and symptoms in patients with recurrent patella dislocation randomized&#xD;
      into treatment with surgical reconstruction of the medial patellofemoral ligament (MPFL) with&#xD;
      those of patients in a standardized physiotherapy program designed to stabilize the patella&#xD;
      and improve patient function.&#xD;
&#xD;
      Materials and methods:&#xD;
&#xD;
      Patients aged 12-30 years who have experienced two or more patella dislocations are&#xD;
      randomized into groups receiving either MPFL reconstruction or physical therapy only.&#xD;
      Follow-ups at 3, 6, 12, and 36 months involve functional tests, validated knee scores,&#xD;
      arthroscopic examination, and cartilage-specific MRI protocols for the knee.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2010</start_date>
  <completion_date type="Actual">January 2022</completion_date>
  <primary_completion_date type="Actual">January 2022</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>Reoperation</measure>
    <time_frame>2011-2022</time_frame>
    <description>Numbers of reoperation in the two treatment groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patella reluxation</measure>
    <time_frame>2011-2022</time_frame>
    <description>Number of reluxation of patella in the two treatment groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Joint Instability</condition>
  <arm_group>
    <arm_group_label>MPFL group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arthroscopy and MPFL reconstruction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arhroscopy and rehabilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MPFL Group</intervention_name>
    <description>MPFL reconstruction or standard treatment followed by physiotherapy</description>
    <arm_group_label>MPFL group</arm_group_label>
    <other_name>MPFL surgery</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Arthroscopy followed by active rehabilitation</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>MPFL group</arm_group_label>
    <other_name>Arthroscopy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  More than one luxation&#xD;
&#xD;
          -  Norwegian citizens&#xD;
&#xD;
          -  Unilateral problems&#xD;
&#xD;
          -  Age range 12-30 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Generalized degenerative changes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asbjørn Årøen, MD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital, Akershus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Akershus University Hospital</name>
      <address>
        <city>Lørenskog</city>
        <zip>1476</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akershus University Hospital</name>
      <address>
        <city>Lørenskog</city>
        <zip>1478</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <results_reference>
    <citation>Straume-Naesheim TM, Randsborg PH, Mikaelsen JR, Sivertsen EA, Devitt B, Granan LP, Aroen A. Recurrent lateral patella dislocation affects knee function as much as ACL deficiency - however patients wait five times longer for treatment. BMC Musculoskelet Disord. 2019 Jul 8;20(1):318. doi: 10.1186/s12891-019-2689-7.</citation>
    <PMID>31286929</PMID>
  </results_reference>
  <results_reference>
    <citation>Straume-Naesheim TM, Randsborg PH, Mikaelsen JR, Aroen A. Medial patellofemoral ligament reconstruction is superior to active rehabilitation in protecting against further patella dislocations. Knee Surg Sports Traumatol Arthrosc. 2022 Oct;30(10):3428-3437. doi: 10.1007/s00167-022-06934-3. Epub 2022 Mar 28.</citation>
    <PMID>35347375</PMID>
  </results_reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 22, 2011</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Akershus</investigator_affiliation>
    <investigator_full_name>Asbjorn Aroen</investigator_full_name>
    <investigator_title>Professor, Orthopaedic Surgeon</investigator_title>
  </responsible_party>
  <keyword>Patella luxation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Instability</mesh_term>
    <mesh_term>Patellar Dislocation</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/NCT02263807
org study id: 2009/2148
nct id: NCT02263807
lead sponsor: 
has dmc: Yes
Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included
      into a randomized prospective study. This study comparess the outcome of two forms of
      treatment for recurrent patella dislocation. One group is offered reconstruction of the
      medial patellofemoral ligament (MPFL), the second group is offered a standardized training
      program.
Introduction:

      Patella dislocation is a serious knee injury whose peak incidence occurs in patients aged
      10-17 years and is associated with a high rate of re-dislocation. Knee injuries frequently
      cause long-term disability and reduced physical activity among adolescents and young persons.
      Surgery in this patient group requires a low tolerance for complications, meaning that
      physical therapy might offer more successful outcomes in many knee injury cases. The proposed
      project studies a particular patient cohort subjected to recurrent dislocation of the
      patella.

      Aim:

      The principal objective of this clinical, randomized controlled trial is to evaluate and
      compare knee function and symptoms in patients with recurrent patella dislocation randomized
      into treatment with surgical reconstruction of the medial patellofemoral ligament (MPFL) with
      those of patients in a standardized physiotherapy program designed to stabilize the patella
      and improve patient function.

      Materials and methods:

      Patients aged 12-30 years who have experienced two or more patella dislocations are
      randomized into groups receiving either MPFL reconstruction or physical therapy only.
      Follow-ups at 3, 6, 12, and 36 months involve functional tests, validated knee scores,
      arthroscopic examination, and cartilage-specific MRI protocols for the knee.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reoperation
time frame: 2011-2022
description: Numbers of reoperation in the two treatment groups
measure: Patella reluxation
time frame: 2011-2022
description: Number of reluxation of patella in the two treatment groups
arm group label: MPFL group
arm group type: Experimental
description: Arthroscopy and MPFL reconstruction
arm group label: Control
arm group type: Active Comparator
description: Arhroscopy and rehabilitation
intervention type: Procedure
intervention name: MPFL Group
description: MPFL reconstruction or standard treatment followed by physiotherapy
arm group label: MPFL group
other name: MPFL surgery
intervention type: Procedure
intervention name: Control
description: Arthroscopy followed by active rehabilitation
arm group label: Control
arm group label: MPFL group
other name: Arthroscopy
criteria: 
gender: All
minimum age: 12 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Asbjørn Årøen, MD,PhD
role: Study Chair
affiliation: University Hospital, Akershus
facility: 
facility: 
country: Norway
citation: Straume-Naesheim TM, Randsborg PH, Mikaelsen JR, Sivertsen EA, Devitt B, Granan LP, Aroen A. Recurrent lateral patella dislocation affects knee function as much as ACL deficiency - however patients wait five times longer for treatment. BMC Musculoskelet Disord. 2019 Jul 8;20(1):318. doi: 10.1186/s12891-019-2689-7.
PMID: 31286929
citation: Straume-Naesheim TM, Randsborg PH, Mikaelsen JR, Aroen A. Medial patellofemoral ligament reconstruction is superior to active rehabilitation in protecting against further patella dislocations. Knee Surg Sports Traumatol Arthrosc. 2022 Oct;30(10):3428-3437. doi: 10.1007/s00167-022-06934-3. Epub 2022 Mar 28.
PMID: 35347375
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Akershus
investigator full name: Asbjorn Aroen
investigator title: Professor, Orthopaedic Surgeon
mesh term: Joint Instability
mesh term: Patellar Dislocation