{
  "FullStudy":{
    "Rank":217894,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515449",
          "OrgStudyIdInfo":{
            "OrgStudyId":"IIS2010002"
          },
          "Organization":{
            "OrgFullName":"NHS Fife",
            "OrgClass":"OTHER_GOV"
          },
          "BriefTitle":"Predictors of Poor Outcomes in 1038 Sigma Knees",
          "OfficialTitle":"Predictors of Poor Outcomes in 1038 Sigma Knees"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 1998"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"October 2008",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"October 2008",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 23, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 24, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Ivan Brenkel",
            "ResponsiblePartyInvestigatorTitle":"Consultant Orthopaedic Surgeon",
            "ResponsiblePartyInvestigatorAffiliation":"NHS Fife"
          },
          "LeadSponsor":{
            "LeadSponsorName":"NHS Fife",
            "LeadSponsorClass":"OTHER_GOV"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"DePuy International",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The aim of the project is to ascertain the pre and intra operative predictors of poor outcomes in total knee replacement.",
          "DetailedDescription":"It is known that surgical outcomes are good in the majority following a Sigma knee at 5 years. 3% have persistent pain. Is it possible to predict these patients? Is it possible to make a determination as to which of the 3 outcome measures ((1) American Knee Society Score; (2) SF12 Oxford 12 and (3) Complications) is most appropriate to use and when is the most appropriate time to use it"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Total Knee Replacement"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"1038",
            "EnrollmentType":"Actual"
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Predictors of poor outcomes using 3 measures",
                "PrimaryOutcomeDescription":"A prospective database was set up in October 1998. Patient details were collected preoperatively, intra operatively and immediately post operatively. Patients are then followed up in a dedicated knee clinic at 6 months, 18 months, 3 years and 5 years. Data such as SF12 and the American Knee Society Score was done at each visit",
                "PrimaryOutcomeTimeFrame":"10 years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAll patients undergoing total knee replacement in Fife",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"All patients undergoing total knee replacement in Fife",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"NHS Fife",
                "LocationCity":"Kirkcaldy",
                "LocationState":"Fife",
                "LocationZip":"KY2 5AH",
                "LocationCountry":"United Kingdom"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}