<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/NCT01693757</url>
  </required_header>
  <id_info>
    <org_study_id>3</org_study_id>
    <secondary_id>USWR</secondary_id>
    <nct_id>NCT01693757</nct_id>
  </id_info>
  <brief_title>Functional Outcome Anterior Cruciate Ligament Reconstruction</brief_title>
  <official_title>Comparison of Functional Outcome Measures of Anterior Cruciate Ligament Reconstruction Using Either Patellar Tendon or Hamstring Tendon Grafts and Controls in Competitive Soccer Players: A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Social Welfare and Rehabilitation Science</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Social Welfare and Rehabilitation Science</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare hop performance and jump landing strategy in soccer&#xD;
      players with higher level sports activities after ACLR using either BPTB or STG and controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The choice of graft for anterior cruciate ligament reconstruction (ACLR) remains&#xD;
      controversial. Despite the need for outcome studies comparing bone-patellar tendon-bone&#xD;
      (BPTB) with semitendinosus and gracilis tendon (STG), few studies have evaluated functional&#xD;
      outcomes. The objective of the current study was to compare hop performance and jump landing&#xD;
      strategy in soccer players with higher level sports activities after ACLR using either BPTB&#xD;
      or STG and controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">March 2011</completion_date>
  <primary_completion_date type="Actual">January 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hop values for the both legs in Single, 6-m, Cross-over and Triple hops</measure>
    <time_frame>Patients were followed up to 8 months post-surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Landing and Take-off Ground Reaction Forces</measure>
    <time_frame>Patients were followed up to 8 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength of Quadriceps and Hamstrings</measure>
    <time_frame>Patients were followed up to 8 months post-surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">63</enrollment>
  <condition>Complications of Surgical Procedures or Medical Care</condition>
  <arm_group>
    <arm_group_label>BPTB group</arm_group_label>
    <description>Bone-patellar tendon-bone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>STG group</arm_group_label>
    <description>Semitendinosus and gracilis tendon</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Healthy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The patients with ACL deficiency were invited to participate in a randomized trial&#xD;
        comparing ACLR with either a BPTB or STG graft.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ACLR and controls.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Musculoskeletal injuries&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahyar Salavati, Professor</last_name>
    <role>Study Director</role>
    <affiliation>USWR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USWR</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>May 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 24, 2012</last_update_submitted>
  <last_update_submitted_qc>September 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Social Welfare and Rehabilitation Science</investigator_affiliation>
    <investigator_full_name>Farshid Mohammadi</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Anterior Cruciate Ligament</keyword>
  <keyword>Hamstrings versus patellar tendon</keyword>
  <keyword>Hop test</keyword>
  <keyword>Return to sports</keyword>
  <!-- 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/NCT01693757
org study id: 3
secondary id: USWR
nct id: NCT01693757
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare hop performance and jump landing strategy in soccer
      players with higher level sports activities after ACLR using either BPTB or STG and controls.
The choice of graft for anterior cruciate ligament reconstruction (ACLR) remains
      controversial. Despite the need for outcome studies comparing bone-patellar tendon-bone
      (BPTB) with semitendinosus and gracilis tendon (STG), few studies have evaluated functional
      outcomes. The objective of the current study was to compare hop performance and jump landing
      strategy in soccer players with higher level sports activities after ACLR using either BPTB
      or STG and controls.
observational model: Case-Control
time perspective: Prospective
measure: Hop values for the both legs in Single, 6-m, Cross-over and Triple hops
time frame: Patients were followed up to 8 months post-surgery
measure: Landing and Take-off Ground Reaction Forces
time frame: Patients were followed up to 8 months post-surgery
measure: Strength of Quadriceps and Hamstrings
time frame: Patients were followed up to 8 months post-surgery
arm group label: BPTB group
description: Bone-patellar tendon-bone
arm group label: STG group
description: Semitendinosus and gracilis tendon
arm group label: Control
description: Healthy
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mahyar Salavati, Professor
role: Study Director
affiliation: USWR
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: University of Social Welfare and Rehabilitation Science
investigator full name: Farshid Mohammadi
investigator title: Director