{
  "FullStudy":{
    "Rank":218046,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513434",
          "OrgStudyIdInfo":{
            "OrgStudyId":"NPH2008-004"
          },
          "Organization":{
            "OrgFullName":"National Police Hospital",
            "OrgClass":"OTHER_GOV"
          },
          "BriefTitle":"Femoral Tunnel Position on Conventional MRI After Anterior Cruciate Ligament Reconstruction-Transtibial Technique Versus Transportal Technique"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"July 2008"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 2011",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 19, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 20, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Jung Ho Noh",
            "ResponsiblePartyInvestigatorTitle":"Principal investigator",
            "ResponsiblePartyInvestigatorAffiliation":"National Police Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"National Police Hospital",
            "LeadSponsorClass":"OTHER_GOV"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The position of the femoral tunnel in anterior cruciate ligament (ACL) reconstruction has been assessed on three dimensional CT (3D-CT) scan or in cadaveric study. However, these methods have some issues; 3D-CT scan has a concern on radiation exposure and cadaveric study is not easily available nor an in vivo test. The purpose of this study is to compare the position of the femoral tunnel aperture on conventional MRI and the outcomes after single bundle ACL reconstruction using free tendon Achilles allograft between transportal technique and transtibial technique in active young men."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Anterior Cruciate Ligament Rupture"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"64",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"transtibial technique",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"In anterior cruciate ligament reconstruction, femoral tunnel was made via tibial tunnel.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: transtibial technique",
                    "Procedure: anterior cruciate ligament reconstruction"
                  ]
                }
              },{
                "ArmGroupLabel":"Transportal technique",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"In anterior cruciate ligament reconstruction, femoral tunnel was made via anteromedial portal.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Transportal technique",
                    "Procedure: anterior cruciate ligament reconstruction"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"transtibial technique",
                "InterventionDescription":"Femoral tunnel was made via tibial tunnel in anterior cruciate ligament reconstruction.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "transtibial technique"
                  ]
                }
              },{
                "InterventionType":"Procedure",
                "InterventionName":"Transportal technique",
                "InterventionDescription":"Femoral tunnel was made via anteromedial portal in anterior cruciate ligament reconstruction.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Transportal technique"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "anteromedial portal technique"
                  ]
                }
              },{
                "InterventionType":"Procedure",
                "InterventionName":"anterior cruciate ligament reconstruction",
                "InterventionDescription":"femoral and tibial tunneling graft fixation on the femoral side with endobutton and on the tibial side with post-tie and interference screw",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Transportal technique",
                    "transtibial technique"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Lysholm score",
                "PrimaryOutcomeDescription":"Lysholm score was superior in transportal technique to transtibial technique.",
                "PrimaryOutcomeTimeFrame":"at least two years after surgery"
              },{
                "PrimaryOutcomeMeasure":"Position of femoral tunnel aperture",
                "PrimaryOutcomeDescription":"The position of the femoral tunnel aperture with transportal technique was more posterior than that of transtibial technique.",
                "PrimaryOutcomeTimeFrame":"within one week after surgery"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\ndiagnosis of anterior cruciate ligament rupture\n\nExclusion Criteria:\n\nfemale\nover 45 years old\nthe subjects who had ACL reconstruction with graft other than Achilles allograft\nthe subjects who had concomitant other ligament injuries on the same knee needing surgical treatment\nrevision ACL reconstruction\ndouble bundle ACL reconstruction\nconcomitant full thickness cartilage injury needing cartilage repairing surgery",
          "HealthyVolunteers":"No",
          "Gender":"Male",
          "MinimumAge":"17 Years",
          "MaximumAge":"45 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"National Police Hospital",
                "LocationCity":"Seoul",
                "LocationZip":"138-708",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000012421",
                "ConditionMeshTerm":"Rupture"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000014947",
                "ConditionAncestorTerm":"Wounds and Injuries"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M13824",
                "ConditionBrowseLeafName":"Rupture",
                "ConditionBrowseLeafAsFound":"Rupture",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M16268",
                "ConditionBrowseLeafName":"Wounds and Injuries",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC26",
                "ConditionBrowseBranchName":"Wounds and Injuries"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}