<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/NCT03773341</url>
  </required_header>
  <id_info>
    <org_study_id>ACL injuries</org_study_id>
    <nct_id>NCT03773341</nct_id>
  </id_info>
  <brief_title>Causes and Patterns of Anterior Cruciate Ligament Injuries Among Egyptian Population</brief_title>
  <official_title>Causes and Patterns of ACL Injuries Among Egyptian People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of work is to detect the patterns and the causes of ACL injury among Egyptian&#xD;
      population and to identify its risk factors. Identify the male to female ratio of injuries in&#xD;
      our community. To document the patterns and frequencies of associated injuries&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ACL (Anterior Cruciate ligament) is one of the most frequently injured ligaments of the&#xD;
      knee, with a prevalence estimated to be 1 in 3000 in the US (greater than 120000 cases&#xD;
      annually). ACL injury frequently affects young, active individuals. It is also frequently&#xD;
      associated with other structural injuries in the Knee joint like meniscal tears and&#xD;
      multi-ligamentous injuries. ACL injury leads to increased laxity in the knee, predispose the&#xD;
      knee to subsequent injuries and early onset osteoarthritis of the knee.&#xD;
&#xD;
      Sports related trauma is the commonest cause of ACL rupture. Females are reported to have 2&#xD;
      to 10-fold higher risk of injury than males playing the same sport. According to previous&#xD;
      studies at Assuit University Hospital the impression was that the ACL injuries are more&#xD;
      common in males than females. Additionally, non-sports injuries like motor cycle accidents&#xD;
      and domestic injuries are expected to be a major cause of ACL rupture, besides sports&#xD;
      injuries, among Egyptian population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patterns of ACL injuries among Egyptian population</measure>
    <time_frame>one year</time_frame>
    <description>Detection of patterns of ACL injuries among 500 Egyptian patient older than 18 years old and younger than 60 years old e.g valgus stress, faulty landing and whether the injury is sport related or not through a validated research questionnaire</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>ACL Injury</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>research questionnaire</intervention_name>
    <description>Patient personal data History taking clinical knee examination</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Egyptian patients with confirmed ACL injury by clinical and radio logical diagnoses older&#xD;
        than 18 years old and younger than 60 years old&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with confirmed ACL injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with ACL injury associated with fracture at the same limb&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ali Soliman Ali, MBBCh</last_name>
    <phone>00201097038046</phone>
    <email>alisuliaman-noman@outlook.com</email>
  </overall_contact>
  <reference>
    <citation>Levine JW, Kiapour AM, Quatman CE, Wordeman SC, Goel VK, Hewett TE, Demetropoulos CK. Clinically relevant injury patterns after an anterior cruciate ligament injury provide insight into injury mechanisms. Am J Sports Med. 2013 Feb;41(2):385-95. doi: 10.1177/0363546512465167. Epub 2012 Nov 9.</citation>
    <PMID>23144366</PMID>
  </reference>
  <reference>
    <citation>Arendt E, Dick R. Knee injury patterns among men and women in collegiate basketball and soccer. NCAA data and review of literature. Am J Sports Med. 1995 Nov-Dec;23(6):694-701. doi: 10.1177/036354659502300611.</citation>
    <PMID>8600737</PMID>
  </reference>
  <reference>
    <citation>Anderson AF, Dome DC, Gautam S, Awh MH, Rennirt GW. Correlation of anthropometric measurements, strength, anterior cruciate ligament size, and intercondylar notch characteristics to sex differences in anterior cruciate ligament tear rates. Am J Sports Med. 2001 Jan-Feb;29(1):58-66. doi: 10.1177/03635465010290011501.</citation>
    <PMID>11206258</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ali Soliman Ali</investigator_full_name>
    <investigator_title>MBBCh principle investigator</investigator_title>
  </responsible_party>
  <keyword>ACL injury</keyword>
  <keyword>non sport causes</keyword>
  <keyword>Egyptians</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Anterior Cruciate Ligament Injuries</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/NCT03773341
org study id: ACL injuries
nct id: NCT03773341
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of work is to detect the patterns and the causes of ACL injury among Egyptian
      population and to identify its risk factors. Identify the male to female ratio of injuries in
      our community. To document the patterns and frequencies of associated injuries
The ACL (Anterior Cruciate ligament) is one of the most frequently injured ligaments of the
      knee, with a prevalence estimated to be 1 in 3000 in the US (greater than 120000 cases
      annually). ACL injury frequently affects young, active individuals. It is also frequently
      associated with other structural injuries in the Knee joint like meniscal tears and
      multi-ligamentous injuries. ACL injury leads to increased laxity in the knee, predispose the
      knee to subsequent injuries and early onset osteoarthritis of the knee.

      Sports related trauma is the commonest cause of ACL rupture. Females are reported to have 2
      to 10-fold higher risk of injury than males playing the same sport. According to previous
      studies at Assuit University Hospital the impression was that the ACL injuries are more
      common in males than females. Additionally, non-sports injuries like motor cycle accidents
      and domestic injuries are expected to be a major cause of ACL rupture, besides sports
      injuries, among Egyptian population.
observational model: Ecologic or Community
time perspective: Prospective
measure: Patterns of ACL injuries among Egyptian population
time frame: one year
description: Detection of patterns of ACL injuries among 500 Egyptian patient older than 18 years old and younger than 60 years old e.g valgus stress, faulty landing and whether the injury is sport related or not through a validated research questionnaire
intervention type: Other
intervention name: research questionnaire
description: Patient personal data History taking clinical knee examination
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ali Soliman Ali, MBBCh
phone: 00201097038046
email: alisuliaman-noman@outlook.com
citation: Levine JW, Kiapour AM, Quatman CE, Wordeman SC, Goel VK, Hewett TE, Demetropoulos CK. Clinically relevant injury patterns after an anterior cruciate ligament injury provide insight into injury mechanisms. Am J Sports Med. 2013 Feb;41(2):385-95. doi: 10.1177/0363546512465167. Epub 2012 Nov 9.
PMID: 23144366
citation: Arendt E, Dick R. Knee injury patterns among men and women in collegiate basketball and soccer. NCAA data and review of literature. Am J Sports Med. 1995 Nov-Dec;23(6):694-701. doi: 10.1177/036354659502300611.
PMID: 8600737
citation: Anderson AF, Dome DC, Gautam S, Awh MH, Rennirt GW. Correlation of anthropometric measurements, strength, anterior cruciate ligament size, and intercondylar notch characteristics to sex differences in anterior cruciate ligament tear rates. Am J Sports Med. 2001 Jan-Feb;29(1):58-66. doi: 10.1177/03635465010290011501.
PMID: 11206258
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ali Soliman Ali
investigator title: MBBCh principle investigator
mesh term: Wounds and Injuries
mesh term: Anterior Cruciate Ligament Injuries