<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/NCT04453592</url>
  </required_header>
  <id_info>
    <org_study_id>ALTBKFO</org_study_id>
    <nct_id>NCT04453592</nct_id>
  </id_info>
  <brief_title>Adductor Longus Tenotomy &amp; the BKFO Test</brief_title>
  <official_title>The Effect of an Adductor Longus Tenotomy on the Bent Knee Fall Out Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aspetar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clinique du sport</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aspetar</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>
      The bent knee fall out test (BKFO) is a common test for hip adductor flexibility. It is&#xD;
      unknown whether the BKFO actually tests the the adductors or potentially hip range of motion&#xD;
      instead.&#xD;
&#xD;
      In this study, the BKFO test is performed in the operating theater before and after an&#xD;
      adductor longus tenotomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adductor-related groin pain is the most common type of groin pain in athletes, and pain at&#xD;
      the proximal adductor longus insertion is a key finding in the diagnosis of longstanding&#xD;
      groin pain. &quot;Tightness&quot; or &quot;shortening&quot; of the adductor longus is considered both a cause and&#xD;
      effect of pain, that can lead to increased tension at the proximal insertion, thus playing a&#xD;
      role in the persistence of longstanding adductor-related pain. For patients who do not&#xD;
      respond sufficiently to non-surgical procedures, an adductor longus tenotomy is a surgical&#xD;
      option that is considered to reduce tension at the proximal adductor longus insertion&#xD;
      assisting in reduction of pain and return to sport.&#xD;
&#xD;
      The bent knee fall out test (BKFO) is one of the most commonly used tests to test adductor&#xD;
      flexibility. This test involves a combined hip movement with hip flexion, abduction, and&#xD;
      external rotation, and a high result is generally considered to be related to adductor muscle&#xD;
      &quot;tightness&quot;, specifically that of the adductor longus. It is uncertain whether the BKFO test&#xD;
      is actually measuring adductor muscle flexibility or hip joint range of motion, as the test&#xD;
      results may also be affected by a femoral head cam morphology. A slightly different test,&#xD;
      called the Patrick FABER's test, involves a similar movement and is mainly used as a hip&#xD;
      joint pain provocation test.&#xD;
&#xD;
      By cutting the adductor longus tendon, thereby removing the effect of potential adductor&#xD;
      longus &quot;tightness&quot;, it will be possible to show if and how much the flexibility of this&#xD;
      muscle affects the BKFO test results. This will assist in future considerations of what this&#xD;
      test is actually testing.&#xD;
&#xD;
      The aim of this study is to investigate the immediate effect of an adductor longus tenotomy&#xD;
      on the results of the bent knee fall out test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 22, 2019</start_date>
  <completion_date type="Actual">January 18, 2021</completion_date>
  <primary_completion_date type="Actual">May 22, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Bent Knee Fall Out test</measure>
    <time_frame>Baseline pre-surgery and immediately after the surgery.</time_frame>
    <description>The patient lies supine on the surgical table with app. 90° knee flexion, 45° hip flexion, and the feet together and the hips in external rotation (also known as the frog-leg position. Standardization of position is achieved by flexing one leg first, so the medial malleolus is placed next to the medial knee joint line of the contra-lateral leg. The knee is then moved laterally, externally rotating the hip with the plantar surface placed towards the contra-lateral leg. The contra-lateral leg is then flexed, and the plantar surfaces of the feet are aligned. The distance between the most distal point on the head of the fibula and the surface of the surgical table is measured using a rigid tape measure and distance is recorded in cm to the nearest 0.5 cm</description>
  </primary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Adductor Tendinitis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention assigned as part of this study.</intervention_name>
    <description>The intervention included in this study is part of routine medical care, and not assigned as a result of study participation. This study includes only the addition of a measurement; the bent knee fall out test. Therefore, we believe this study design is observational, and in line with the provided observation study design definition: &quot;Observational: studies in human beings in which biomedical and/or health outcomes are assessed in predefined groups of individuals. Participants in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the study participants. This includes when participants receive interventions as part of routine medical care, and a researcher studies the effect of the intervention.&quot;&#xD;
See uploaded study protocol for further details.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Athletes with groin pain are consecutively recruited from two clinics of a visceral surgeon&#xD;
        specialized in groin pain in athletes. The clinics are located in Bordeaux and Paris,&#xD;
        France, and patient population includes athletes from all over France.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults (&gt;18 years old)&#xD;
&#xD;
          -  athletes (recreational or elite)&#xD;
&#xD;
          -  clinical diagnosis of adductor-related groin pain&#xD;
&#xD;
          -  patients undergoing unilateral or bilateral adductor longus tenotomy by one general&#xD;
             surgeon.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No specific exclusion criteria were present other than refusal to participate in the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinique du sport Bordeaux - Mérignac</name>
      <address>
        <city>Merignac</city>
        <zip>33700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>There are currently no IPD plans. IPD data be obtained upon reasonable request</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT04453592/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>August 8, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04453592
org study id: ALTBKFO
nct id: NCT04453592
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The bent knee fall out test (BKFO) is a common test for hip adductor flexibility. It is
      unknown whether the BKFO actually tests the the adductors or potentially hip range of motion
      instead.

      In this study, the BKFO test is performed in the operating theater before and after an
      adductor longus tenotomy.
Adductor-related groin pain is the most common type of groin pain in athletes, and pain at
      the proximal adductor longus insertion is a key finding in the diagnosis of longstanding
      groin pain. "Tightness" or "shortening" of the adductor longus is considered both a cause and
      effect of pain, that can lead to increased tension at the proximal insertion, thus playing a
      role in the persistence of longstanding adductor-related pain. For patients who do not
      respond sufficiently to non-surgical procedures, an adductor longus tenotomy is a surgical
      option that is considered to reduce tension at the proximal adductor longus insertion
      assisting in reduction of pain and return to sport.

      The bent knee fall out test (BKFO) is one of the most commonly used tests to test adductor
      flexibility. This test involves a combined hip movement with hip flexion, abduction, and
      external rotation, and a high result is generally considered to be related to adductor muscle
      "tightness", specifically that of the adductor longus. It is uncertain whether the BKFO test
      is actually measuring adductor muscle flexibility or hip joint range of motion, as the test
      results may also be affected by a femoral head cam morphology. A slightly different test,
      called the Patrick FABER's test, involves a similar movement and is mainly used as a hip
      joint pain provocation test.

      By cutting the adductor longus tendon, thereby removing the effect of potential adductor
      longus "tightness", it will be possible to show if and how much the flexibility of this
      muscle affects the BKFO test results. This will assist in future considerations of what this
      test is actually testing.

      The aim of this study is to investigate the immediate effect of an adductor longus tenotomy
      on the results of the bent knee fall out test.
observational model: Case-Only
time perspective: Prospective
measure: Change in the Bent Knee Fall Out test
time frame: Baseline pre-surgery and immediately after the surgery.
description: The patient lies supine on the surgical table with app. 90° knee flexion, 45° hip flexion, and the feet together and the hips in external rotation (also known as the frog-leg position. Standardization of position is achieved by flexing one leg first, so the medial malleolus is placed next to the medial knee joint line of the contra-lateral leg. The knee is then moved laterally, externally rotating the hip with the plantar surface placed towards the contra-lateral leg. The contra-lateral leg is then flexed, and the plantar surfaces of the feet are aligned. The distance between the most distal point on the head of the fibula and the surface of the surgical table is measured using a rigid tape measure and distance is recorded in cm to the nearest 0.5 cm
intervention type: Other
intervention name: No intervention assigned as part of this study.
description: The intervention included in this study is part of routine medical care, and not assigned as a result of study participation. This study includes only the addition of a measurement; the bent knee fall out test. Therefore, we believe this study design is observational, and in line with the provided observation study design definition: "Observational: studies in human beings in which biomedical and/or health outcomes are assessed in predefined groups of individuals. Participants in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the study participants. This includes when participants receive interventions as part of routine medical care, and a researcher studies the effect of the intervention."
See uploaded study protocol for further details.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Tendinopathy
sharing ipd: Undecided
ipd description: There are currently no IPD plans. IPD data be obtained upon reasonable request
provided document: 
submitted: August 8, 2023