<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/NCT04467099</url>
  </required_header>
  <id_info>
    <org_study_id>1453238</org_study_id>
    <nct_id>NCT04467099</nct_id>
  </id_info>
  <brief_title>Prevalence of Flexor Hallucis Longus Tears, Associated Os Trigonum Excision, and Return to Play</brief_title>
  <official_title>Prevalence of Flexor Hallucis Longus Tears, Associated Os Trigonum Excision, and Return to Play</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Forte Sports Medicine and Orthopedics</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Forte Sports Medicine and Orthopedics</source>
  <oversight_info>
    <has_dmc>Yes</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 study's aim is to determine the incidence of flexor hallucis tendon tears associated with&#xD;
      os trigonum excision. The study will then compare the length until functional return to play&#xD;
      of the patients who had flexor hallucis tendon tears with concomitant os trigonum excision&#xD;
      versus those without flexor hallucis tendon tears who underwent os trigonum excision. Lastly,&#xD;
      the study will be evaluating the patient complaints and physical exam findings before and&#xD;
      after surgery and compare those without flexor hallucis tendon tears to those with flexor&#xD;
      hallucis tendon repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Posterior ankle pain syndrome has many etiologies. Two main causes of this are flexor&#xD;
      hallucis tendon tear and os trigonum impingement. The current teaching is that patients with&#xD;
      flexor hallucis longus tear complain of posterior medial ankle pain and those with posterior&#xD;
      lateral ankle pain have an os trigonum impingement. It is also classically understood that&#xD;
      patients with flexor hallucis tendon tears take longer to return to their pre-injury level of&#xD;
      function. Our clinical experience refutes these reports and our study looks to further&#xD;
      evaluate it.&#xD;
&#xD;
      This study brings back patients who were treated by the study doctor. The patient's&#xD;
      preoperative evaluation will be reviewed including clinic notes and imaging. The operative&#xD;
      reports for these patients will be reviewed to verify the surgery procedure performed. These&#xD;
      patients will be included in the study and we will utilize the American Academy of Orthopedic&#xD;
      Surgeons Foot, Ankle, and Lower Limb module that they have completed postoperatively. This&#xD;
      measure of patient's functional and subjective satisfaction has already been completed by&#xD;
      patients at their regularly scheduled follow up appointments and is available for review.&#xD;
&#xD;
      Prospectively, patients will be asked to return to the clinic for a follow-up evaluation,&#xD;
      which includes a standard x-ray. All patients will be consented prior to data collection,&#xD;
      minors included in this study will be asked to sign an assent as well. Many factors will be&#xD;
      assessed such as; a range of motion test of the ankle utilizing goniometric technique, nerve&#xD;
      path and function, stability ankle grading, radiologic findings, and patient-reported&#xD;
      outcomes filled out pre and postoperatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">March 2, 2020</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of flexor hallucis longus tears associated with os trigonum excision</measure>
    <time_frame>Less than or equal to 30 days</time_frame>
    <description>How many participants had a tear.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length until return to play</measure>
    <time_frame>Less than or equal to 30 days</time_frame>
    <description>Comparing the length until return to play of the patients who had flexor hallucis longus tears with concomitant os trigonum excision versus those without flexor hallucis longus tears who underwent os trigonum excision.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient responses to American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle questionnaire</measure>
    <time_frame>preoperative; perioperative; intraoperative; Less than or equal to 30 days</time_frame>
    <description>The questionnaire responses will be summarized and compared between os trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using two-sample Student t-tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient responses to American Academy of Orthopaedic Surgeons (AAOS) Lower Limb questionnaire</measure>
    <time_frame>preoperative; perioperative; intraoperative; Less than or equal to 30 days</time_frame>
    <description>The questionnaire responses will be summarized and compared between os trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using two-sample Student t-tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in foot and ankle nerve function</measure>
    <time_frame>preoperative; perioperative; intraoperative; Less than or equal to 30 days</time_frame>
    <description>The comparison includes but is not limited to patient nerve path and function. The findings will be summarized and compared between os trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using chi-square tests or Fisher's exact tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in foot and ankle areas of pain</measure>
    <time_frame>preoperative; perioperative; intraoperative; Less than or equal to 30 days</time_frame>
    <description>The comparison includes but is not limited to posterior pain, plantarflexion pain, os trigonum resection site pain, and other areas of pain upon visit. The findings will be summarized and compared between trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using chi-square tests or Fisher's exact tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in foot and ankle range of motion</measure>
    <time_frame>preoperative; perioperative; intraoperative; Less than or equal to 30 days</time_frame>
    <description>The comparison includes but is not limited to patient range of motion (ROM) test in degrees of the ankle by assessing plantarflexion, dorsiflexion, hindfoot angle, and subtalar motion. The findings will be summarized and compared between trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using two-sample Student t-tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in foot and ankle stability</measure>
    <time_frame>preoperative; perioperative; intraoperative; Less than or equal to 30 days</time_frame>
    <description>The comparison includes but is not limited to patient range of motion (ROM) test of the ankle by assessing plantarflexion, dorsiflexion, hindfoot angle, and subtalar motion. The findings will be summarized and compared between trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using chi-square tests or Fisher's exact tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in foot and ankle imaging for x-ray and magnetic resonance imaging</measure>
    <time_frame>preoperative; perioperative; intraoperative; Less than or equal to 30 days</time_frame>
    <description>The comparison includes but is not limited to how many patients have within and group differences in x-ray and magnetic resonance imaging (MRI). Changes to be compared will include but not limited to ankle alignment, os trigonum, the appearance of posterior talus, osteochondral lesions, fractures or dislocations, stress fractures, plantar and posterior heel spurs and arthritic changes in the ankle or hindfoot.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Ankle Impingement</condition>
  <condition>Tendon Tear</condition>
  <arm_group>
    <arm_group_label>Os Trigonum Excision with Tear</arm_group_label>
    <description>Participants with flexor hallucis tendon tear</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Os Trigonum Excision without Tear</arm_group_label>
    <description>Participants without flexor hallucis tendon tear</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Foot Exam Follow-Up</intervention_name>
    <description>All participants will have a clinical assessment of their surgery foot by the study doctor.</description>
    <arm_group_label>Os Trigonum Excision with Tear</arm_group_label>
    <arm_group_label>Os Trigonum Excision without Tear</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>X-ray</intervention_name>
    <description>Standard x-ray of the foot.</description>
    <arm_group_label>Os Trigonum Excision with Tear</arm_group_label>
    <arm_group_label>Os Trigonum Excision without Tear</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>All participants will complete a questionnaire.</description>
    <arm_group_label>Os Trigonum Excision with Tear</arm_group_label>
    <arm_group_label>Os Trigonum Excision without Tear</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Prior patients of the study doctor from August 1996 to June 2017 that underwent os trigonum&#xD;
        excision and of the athletic population (recreational to competitive).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Os trigonum excision with or without a flexor hallucis longus tear in an athletic&#xD;
             population (recreational to competitive)&#xD;
&#xD;
          -  Males and females ages 11-50 at time of surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other injury that will affect their return to play or recovery process&#xD;
&#xD;
          -  Individuals not actively involved in athletic sport/activity&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Any other concomitant injuries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Porter, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Forte Sports Medicine and Orthopedics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Methodist Sports Medicine Carmel</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46280</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Sports Medicine Greenwood</name>
      <address>
        <city>Greenwood</city>
        <state>Indiana</state>
        <zip>46142</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>September 16, 2021</last_update_submitted>
  <last_update_submitted_qc>September 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Forte Sports Medicine and Orthopedics</investigator_affiliation>
    <investigator_full_name>David Porter</investigator_full_name>
    <investigator_title>Orthopedic Surgeon</investigator_title>
  </responsible_party>
  <keyword>flexor hallucis longus</keyword>
  <keyword>os trigonum</keyword>
  <keyword>return to play</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04467099
org study id: 1453238
nct id: NCT04467099
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study's aim is to determine the incidence of flexor hallucis tendon tears associated with
      os trigonum excision. The study will then compare the length until functional return to play
      of the patients who had flexor hallucis tendon tears with concomitant os trigonum excision
      versus those without flexor hallucis tendon tears who underwent os trigonum excision. Lastly,
      the study will be evaluating the patient complaints and physical exam findings before and
      after surgery and compare those without flexor hallucis tendon tears to those with flexor
      hallucis tendon repair.
Posterior ankle pain syndrome has many etiologies. Two main causes of this are flexor
      hallucis tendon tear and os trigonum impingement. The current teaching is that patients with
      flexor hallucis longus tear complain of posterior medial ankle pain and those with posterior
      lateral ankle pain have an os trigonum impingement. It is also classically understood that
      patients with flexor hallucis tendon tears take longer to return to their pre-injury level of
      function. Our clinical experience refutes these reports and our study looks to further
      evaluate it.

      This study brings back patients who were treated by the study doctor. The patient's
      preoperative evaluation will be reviewed including clinic notes and imaging. The operative
      reports for these patients will be reviewed to verify the surgery procedure performed. These
      patients will be included in the study and we will utilize the American Academy of Orthopedic
      Surgeons Foot, Ankle, and Lower Limb module that they have completed postoperatively. This
      measure of patient's functional and subjective satisfaction has already been completed by
      patients at their regularly scheduled follow up appointments and is available for review.

      Prospectively, patients will be asked to return to the clinic for a follow-up evaluation,
      which includes a standard x-ray. All patients will be consented prior to data collection,
      minors included in this study will be asked to sign an assent as well. Many factors will be
      assessed such as; a range of motion test of the ankle utilizing goniometric technique, nerve
      path and function, stability ankle grading, radiologic findings, and patient-reported
      outcomes filled out pre and postoperatively.
observational model: Cohort
time perspective: Prospective
measure: Incidence of flexor hallucis longus tears associated with os trigonum excision
time frame: Less than or equal to 30 days
description: How many participants had a tear.
measure: Length until return to play
time frame: Less than or equal to 30 days
description: Comparing the length until return to play of the patients who had flexor hallucis longus tears with concomitant os trigonum excision versus those without flexor hallucis longus tears who underwent os trigonum excision.
measure: Patient responses to American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle questionnaire
time frame: preoperative; perioperative; intraoperative; Less than or equal to 30 days
description: The questionnaire responses will be summarized and compared between os trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using two-sample Student t-tests.
measure: Patient responses to American Academy of Orthopaedic Surgeons (AAOS) Lower Limb questionnaire
time frame: preoperative; perioperative; intraoperative; Less than or equal to 30 days
description: The questionnaire responses will be summarized and compared between os trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using two-sample Student t-tests.
measure: Change in foot and ankle nerve function
time frame: preoperative; perioperative; intraoperative; Less than or equal to 30 days
description: The comparison includes but is not limited to patient nerve path and function. The findings will be summarized and compared between os trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using chi-square tests or Fisher's exact tests.
measure: Change in foot and ankle areas of pain
time frame: preoperative; perioperative; intraoperative; Less than or equal to 30 days
description: The comparison includes but is not limited to posterior pain, plantarflexion pain, os trigonum resection site pain, and other areas of pain upon visit. The findings will be summarized and compared between trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using chi-square tests or Fisher's exact tests.
measure: Change in foot and ankle range of motion
time frame: preoperative; perioperative; intraoperative; Less than or equal to 30 days
description: The comparison includes but is not limited to patient range of motion (ROM) test in degrees of the ankle by assessing plantarflexion, dorsiflexion, hindfoot angle, and subtalar motion. The findings will be summarized and compared between trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using two-sample Student t-tests.
measure: Change in foot and ankle stability
time frame: preoperative; perioperative; intraoperative; Less than or equal to 30 days
description: The comparison includes but is not limited to patient range of motion (ROM) test of the ankle by assessing plantarflexion, dorsiflexion, hindfoot angle, and subtalar motion. The findings will be summarized and compared between trigonum excision with a flexor hallucis longus tear and without a flexor hallucis longus tear groups using chi-square tests or Fisher's exact tests.
measure: Change in foot and ankle imaging for x-ray and magnetic resonance imaging
time frame: preoperative; perioperative; intraoperative; Less than or equal to 30 days
description: The comparison includes but is not limited to how many patients have within and group differences in x-ray and magnetic resonance imaging (MRI). Changes to be compared will include but not limited to ankle alignment, os trigonum, the appearance of posterior talus, osteochondral lesions, fractures or dislocations, stress fractures, plantar and posterior heel spurs and arthritic changes in the ankle or hindfoot.
arm group label: Os Trigonum Excision with Tear
description: Participants with flexor hallucis tendon tear
arm group label: Os Trigonum Excision without Tear
description: Participants without flexor hallucis tendon tear
intervention type: Other
intervention name: Foot Exam Follow-Up
description: All participants will have a clinical assessment of their surgery foot by the study doctor.
arm group label: Os Trigonum Excision with Tear
arm group label: Os Trigonum Excision without Tear
intervention type: Radiation
intervention name: X-ray
description: Standard x-ray of the foot.
arm group label: Os Trigonum Excision with Tear
arm group label: Os Trigonum Excision without Tear
intervention type: Other
intervention name: Questionnaire
description: All participants will complete a questionnaire.
arm group label: Os Trigonum Excision with Tear
arm group label: Os Trigonum Excision without Tear
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 11 Years
maximum age: 50 Years
healthy volunteers: No
last name: David Porter, MD, PhD
role: Principal Investigator
affiliation: Forte Sports Medicine and Orthopedics
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Forte Sports Medicine and Orthopedics
investigator full name: David Porter
investigator title: Orthopedic Surgeon
sharing ipd: Undecided