<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/NCT04438109</url>
  </required_header>
  <id_info>
    <org_study_id>8262_BO_K_2019</org_study_id>
    <nct_id>NCT04438109</nct_id>
  </id_info>
  <brief_title>Clinical Outcome of the Dynamic Reconstruction of the Medial Patellofemoral Ligament (MPFL)</brief_title>
  <official_title>Clinical Outcome of the Dynamic Reconstruction of the Medial Patellofemoral Ligament (MPFL) - a Retrospective Case Series</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hannover Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hannover Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In a single surgical center, 213 consecutive patients with 221 knees were surgically treated&#xD;
      for recurrent lateral patellar dislocation between 07/2010 and 12/2016. All patients obtained&#xD;
      dynamic reconstruction of the MPFL with detachment of the gracilis tendon at the pes&#xD;
      anserinus while maintaining the proximal origin at the gracilis muscle. Patellar fixation was&#xD;
      performed by oblique transpatellar tunnel transfer and tenodesis screw. Follow-up data&#xD;
      including Kujala-, BANFF- and Norwich patellar instability score as well as Return-to-Sport&#xD;
      and pain level were collected at a minimum follow-up of 2 years&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients were identified through the hospitals database using OPS-Codes for MPFL&#xD;
      reconstruction. The included surgeries were performed from 07/2010 to 12/2016 in a single&#xD;
      orthopedic hospital.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        -  Dynamic MPFL-reconstruction (primary and revision surgery) including cartilage procedure&#xD;
&#xD;
        -  Age of 18 years or older at a minimum of 24 months follow up&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        -  Diagnosis of connective tissue disease&#xD;
&#xD;
        -  Neurological diseases including patella associated spasticity and&#xD;
&#xD;
        -  Concomitant alignment correction surgery including femoral/tibial osteotomy,&#xD;
           trochleoplasty and tibial tubercle transfer&#xD;
&#xD;
           213 Patients with 221 knees (8 bilateral) met the inclusion criteria. All patients were&#xD;
           contacted by mail or phone to independently answer questionnaires.&#xD;
&#xD;
      Surgical technique:&#xD;
&#xD;
      The technique was performed according to the description by Ostermeier et al.. Briefly, the&#xD;
      gracilis tendon is detached at its insertion site at the pes anserinus after opening the&#xD;
      sartorius fascia. Instead of transferring the tendon through a subligamentous tunnel of the&#xD;
      medial collateral ligament, as detailed in the original description of the technique, the&#xD;
      tendon was passed around the incised sartorius fascia. From around the sartorius fascia the&#xD;
      gracilis tendon is shuttled subcutaneously to the medial patellar margin, allowing the&#xD;
      sartorius fascia to act as a pulley for the transferred tendon. Due to the dynamic&#xD;
      reconstruction technique, the course of the graft appears to be more oblique compared to the&#xD;
      static technique with femoral fixation at Schöttle's point. Fixation of the tendon is&#xD;
      achieved by passing it through a transpatellar drill hole extending from the proximal medial&#xD;
      patellar margin to the lateral patellar margin. The tendon is then tensioned with the knee in&#xD;
      30 degrees of flexion and fixed with a bioabsorbable tenodesis screw.&#xD;
&#xD;
      Data collection was performed by self-administered questionnaires, which were sent to the&#xD;
      patients.&#xD;
&#xD;
      The medical records and radiographs of all patients were reviewed for demographic information&#xD;
      (age, sex) and to identify complications related to the surgical procedure. Complications&#xD;
      were categorized as major if the patient returned to the operating room or required&#xD;
      hospitalization after the index procedure. Complications were categorized as minor&#xD;
      complications if they were treated on an outpatient basis.&#xD;
&#xD;
      Rating of the results was performed using the Kujala score, the Norwich Patellar Instability&#xD;
      Score and the BANFF Score.&#xD;
&#xD;
      Pain level was recorded using the visual analogue scale (VAS, 0 = no pain, 10 = severe pain).&#xD;
      General satisfaction with treatment outcomes was evaluated by questionnaire (1 = excellent, 2&#xD;
      = very good, 3 = good, 4 = fair, 5 = poor, 6 = very poor) and by asking patients whether they&#xD;
      would undergo the procedure again. Furthermore, information on patient characteristics,&#xD;
      recurrence of dislocation, revision surgery, and other postoperative complications were&#xD;
      recorded.&#xD;
&#xD;
      Postoperative x-rays were analyzed concerning intraoperative complications (e.g. fractures or&#xD;
      patellar drill hole malpositioning).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 12, 2019</start_date>
  <completion_date type="Actual">February 27, 2021</completion_date>
  <primary_completion_date type="Actual">April 12, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Kujala score</measure>
    <time_frame>24 months postoperative</time_frame>
    <description>The Kujala Anterior Knee Pain Scale is a patient reported assessment of patellofemoral disorders that assesses subjective symptoms and functional limitations.&#xD;
The score consists of 13 questions that add up to a total of 100 points. Minimum: 0 (worst), Maximum: 100 (best)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Norwich Patellar Instability Score (NPI Score)</measure>
    <time_frame>24 months postoperative</time_frame>
    <description>The Norwich Patellar Instability Score is a patient reported assessment of patellofemoral instability.&#xD;
The score consists of 19 questions with a special weighting for every question. The results are presented in percent. Range: 0% (best) to 100% (worst)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BANFF Score</measure>
    <time_frame>24 months postoperative</time_frame>
    <description>The Banff Score is a patient reported assessment of patellofemoral disorders that assesses patella instability.&#xD;
The score consists of 23 questions. Minimum: 0 (worst), Maximum: 100 (best)</description>
  </primary_outcome>
  <enrollment type="Actual">152</enrollment>
  <condition>Patellar Luxation</condition>
  <condition>Patellar Instability</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients were identified through the hospitals database using OPS-Codes for MPFL&#xD;
        reconstruction.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with MPFL reconstruction and possible accompanying interventions&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hereditary connective tissue diseases (e.g. Ehlers-Danlos syndrome)&#xD;
&#xD;
          -  Known neurogenic diseases&#xD;
&#xD;
          -  Significant further musculoskeletal disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift</name>
      <address>
        <city>Hanover</city>
        <state>Niedersachsen</state>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>March 18, 2021</last_update_submitted>
  <last_update_submitted_qc>March 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>knee</keyword>
  <keyword>MPFL reconstruction</keyword>
  <keyword>patella instability</keyword>
  <keyword>patella dislocation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04438109
org study id: 8262_BO_K_2019
nct id: NCT04438109
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In a single surgical center, 213 consecutive patients with 221 knees were surgically treated
      for recurrent lateral patellar dislocation between 07/2010 and 12/2016. All patients obtained
      dynamic reconstruction of the MPFL with detachment of the gracilis tendon at the pes
      anserinus while maintaining the proximal origin at the gracilis muscle. Patellar fixation was
      performed by oblique transpatellar tunnel transfer and tenodesis screw. Follow-up data
      including Kujala-, BANFF- and Norwich patellar instability score as well as Return-to-Sport
      and pain level were collected at a minimum follow-up of 2 years
Patients were identified through the hospitals database using OPS-Codes for MPFL
      reconstruction. The included surgeries were performed from 07/2010 to 12/2016 in a single
      orthopedic hospital.

      Inclusion criteria:

        -  Dynamic MPFL-reconstruction (primary and revision surgery) including cartilage procedure

        -  Age of 18 years or older at a minimum of 24 months follow up

      Exclusion criteria:

        -  Diagnosis of connective tissue disease

        -  Neurological diseases including patella associated spasticity and

        -  Concomitant alignment correction surgery including femoral/tibial osteotomy,
           trochleoplasty and tibial tubercle transfer

           213 Patients with 221 knees (8 bilateral) met the inclusion criteria. All patients were
           contacted by mail or phone to independently answer questionnaires.

      Surgical technique:

      The technique was performed according to the description by Ostermeier et al.. Briefly, the
      gracilis tendon is detached at its insertion site at the pes anserinus after opening the
      sartorius fascia. Instead of transferring the tendon through a subligamentous tunnel of the
      medial collateral ligament, as detailed in the original description of the technique, the
      tendon was passed around the incised sartorius fascia. From around the sartorius fascia the
      gracilis tendon is shuttled subcutaneously to the medial patellar margin, allowing the
      sartorius fascia to act as a pulley for the transferred tendon. Due to the dynamic
      reconstruction technique, the course of the graft appears to be more oblique compared to the
      static technique with femoral fixation at Schöttle's point. Fixation of the tendon is
      achieved by passing it through a transpatellar drill hole extending from the proximal medial
      patellar margin to the lateral patellar margin. The tendon is then tensioned with the knee in
      30 degrees of flexion and fixed with a bioabsorbable tenodesis screw.

      Data collection was performed by self-administered questionnaires, which were sent to the
      patients.

      The medical records and radiographs of all patients were reviewed for demographic information
      (age, sex) and to identify complications related to the surgical procedure. Complications
      were categorized as major if the patient returned to the operating room or required
      hospitalization after the index procedure. Complications were categorized as minor
      complications if they were treated on an outpatient basis.

      Rating of the results was performed using the Kujala score, the Norwich Patellar Instability
      Score and the BANFF Score.

      Pain level was recorded using the visual analogue scale (VAS, 0 = no pain, 10 = severe pain).
      General satisfaction with treatment outcomes was evaluated by questionnaire (1 = excellent, 2
      = very good, 3 = good, 4 = fair, 5 = poor, 6 = very poor) and by asking patients whether they
      would undergo the procedure again. Furthermore, information on patient characteristics,
      recurrence of dislocation, revision surgery, and other postoperative complications were
      recorded.

      Postoperative x-rays were analyzed concerning intraoperative complications (e.g. fractures or
      patellar drill hole malpositioning).
observational model: Case-Only
time perspective: Retrospective
measure: Kujala score
time frame: 24 months postoperative
description: The Kujala Anterior Knee Pain Scale is a patient reported assessment of patellofemoral disorders that assesses subjective symptoms and functional limitations.
The score consists of 13 questions that add up to a total of 100 points. Minimum: 0 (worst), Maximum: 100 (best)
measure: Norwich Patellar Instability Score (NPI Score)
time frame: 24 months postoperative
description: The Norwich Patellar Instability Score is a patient reported assessment of patellofemoral instability.
The score consists of 19 questions with a special weighting for every question. The results are presented in percent. Range: 0% (best) to 100% (worst)
measure: BANFF Score
time frame: 24 months postoperative
description: The Banff Score is a patient reported assessment of patellofemoral disorders that assesses patella instability.
The score consists of 23 questions. Minimum: 0 (worst), Maximum: 100 (best)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Patellar Dislocation