{
  "FullStudy":{
    "Rank":218004,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514006",
          "OrgStudyIdInfo":{
            "OrgStudyId":"H-4-2011-117"
          },
          "Organization":{
            "OrgFullName":"Rigshospitalet, Denmark",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Postoperative Anemia and Functional Outcomes After Fast-track Primary Hip Arthroplasty",
          "OfficialTitle":"Postoperative Anemia and Functional Outcomes After Fast-track Primary Hip Arthroplasty - a Prospective Observational Study"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 6, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 9, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Oeivind Jans",
            "ResponsiblePartyInvestigatorTitle":"MD., Research Fellow",
            "ResponsiblePartyInvestigatorAffiliation":"Rigshospitalet, Denmark"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Rigshospitalet, Denmark",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"University Hospital, Gentofte, Copenhagen",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Vejle Hospital",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to evaluate the possible association between postoperative anaemia and functional outcomes the first 2 weeks after primary hip arthroplasty.\n\nThe investigators hypothesise that patients with a higher degree of postoperative anaemia have impaired postoperative rehabilitation as measured by standardized functional outcome tests.",
          "DetailedDescription":"Postoperative anemia may impair postoperative rehabilitation due to anemia related symptoms such as fatigue or dizziness. Although, the impact of postoperative anemia on postoperative rehabilitation and function has previously been examined the results are conflicting.\n\nPatients undergoing fast-track hip arthroplasty (THA) are mobilized early and participate in physiotherapy during the admission but are discharged early (2-3) days postoperative. However, the ability to rehabilitate early after discharge has not been evaluated in relation to postoperative anemia.\n\nThe purpose of this observational study is to evaluate the possible association between postoperative anaemia and functional outcomes the first 2 weeks after primary hip arthroplasty.\n\nThe investigators hypothesise that patients with a higher degree of postoperative anaemia have impaired postoperative rehabilitation as measured by standardized functional outcome tests. Hb concentrations and functional outcome measurements will be performed preoperatively, at the day of hospital discharge and during a postoperative visit 12-16 days after surgery."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Arthroplasty, Hip Replacement",
              "Anemia"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Primary hip arthroplasty",
              "postoperative anemia",
              "functional outcomes"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"125",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Study Cohort",
                "ArmGroupDescription":"Patients, aged 65 or above, undergoing elective primary unilateral hip arthroplasty in a fast-track setting."
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"6 Minute walking test (6MWT)",
                "PrimaryOutcomeDescription":"6MWT is a standardized functional test which determines the walking distance covered during a timed period of 6 minutes.",
                "PrimaryOutcomeTimeFrame":"2 weeks after surgery"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"FACT-Anemia Scale",
                "SecondaryOutcomeDescription":"FACT-Anemia scale is a validated questionare based score addressing anaemia related symptoms.",
                "SecondaryOutcomeTimeFrame":"2 weeks after surgery"
              },{
                "SecondaryOutcomeMeasure":"Timed up and go test (TUG)",
                "SecondaryOutcomeTimeFrame":"2 weeks after surgery"
              },{
                "SecondaryOutcomeMeasure":"At home activity by ActivPal",
                "SecondaryOutcomeDescription":"Activity measures using accelerometer based activity monitor",
                "SecondaryOutcomeTimeFrame":"1 week after surgery"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients undergoing primary unilateral THA\nAge 65 or older\n\nExclusion Criteria:\n\nNot able to give consent\nNot able to walk prior to surgery\nChronic need for RBC transfusion",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Older Adult"
            ]
          },
          "StudyPopulation":"All patients aged 65 or above undergoing primary hip arhtroplasty",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Oeivind Jans, MD.",
                "OverallOfficialAffiliation":"Rigshospitalet, Denmark",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Gentofte Hospital, Department of orthopedic surgery",
                "LocationCity":"Gentofte",
                "LocationCountry":"Denmark"
              },{
                "LocationFacility":"Vejle Sygehus, Department of orthopedic surgery",
                "LocationCity":"Vejle",
                "LocationCountry":"Denmark"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000000740",
                "ConditionMeshTerm":"Anemia"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000006402",
                "ConditionAncestorTerm":"Hematologic Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M2651",
                "ConditionBrowseLeafName":"Anemia",
                "ConditionBrowseLeafAsFound":"Anemia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8073",
                "ConditionBrowseLeafName":"Hematologic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC15",
                "ConditionBrowseBranchName":"Blood and Lymph Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}