{
  "FullStudy":{
    "Rank":217877,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515670",
          "OrgStudyIdInfo":{
            "OrgStudyId":"RH30-0623"
          },
          "Organization":{
            "OrgFullName":"Rigshospitalet, Denmark",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Length of Stay and Complications in High-risk Patients Receiving Fast-track Total Hip (THA) or Knee- Alloplasty (TKA)",
          "OfficialTitle":"Length of Stay and Complications in High-risk Patients Receiving Fast-track Total Hip (THA) or Knee- Alloplasty (TKA)."
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2018",
          "OverallStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2020",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2020",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 7, 2018",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 11, 2018",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Christoffer Joergensen",
            "ResponsiblePartyInvestigatorTitle":"Research-fellow",
            "ResponsiblePartyInvestigatorAffiliation":"Rigshospitalet, Denmark"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Rigshospitalet, Denmark",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Hvidovre University Hospital",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Aarhus University Hospital",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Vejle Hospital",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Sydvestjysk Hospital",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Regional Hospital Holstebro",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Naestved Hospital",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Bispebjerg Hospital",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Central Jutland Regional Hospital",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Aalborg University Hospital",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of the study is to determine the influence of preoperative co-morbidity in relation to increased length of stay and postoperative complications in patients receiving fast-track hip or knee replacement.",
          "DetailedDescription":"Preoperative risk assessment is well established and repeatedly demonstrated to be related to adverse postoperative outcomes regarding all organ functions. However, all evidence is based upon conventional care programs and none has been done on fast-track surgery, neither in total hip arthroplasty (THA) or total knee arthroplasty (TKA).\n\nThe purpose of this study series is therefore to evaluate the importance of conventional risk factors in an optimised fast-track TKA and THA set-up. These studies will be performed in the Lundbeck Foundation Center for fast-track THA and TKA, based on an established database, but with additional detailed risk information to be included in studies of certain types co-morbidity.\n\nThe Lundbeck Foundation Center Database prospectively registers patient characteristics and co-morbidity in all patients receiving hip and knee arthroplasty. This is done using a questionaire and with dedicated staff available to help in case of doubt regarding specific questions. Additional information is collected by scrutinizing the patients medical charts. Completeness of data has been shown to be about 95%."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Arthroplasty Complications",
              "Co-morbidity",
              "Postoperative Morbidity"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "THA",
              "TKA",
              "Fast-track",
              "Enhanced recovery",
              "preoperative co-morbidity",
              "postoperative morbidity",
              "Arthroplasty",
              "Replacement",
              "Hip",
              "Knee",
              "Morbidity"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "PatientRegistry":"Yes",
          "TargetDuration":"90 Days",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"30000",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Fast-track THA/TKA",
                "ArmGroupDescription":"Any patient receiving THA/TKA in the participating wards"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Length of hospital stay and reasons for length of hospital stay >4days",
                "PrimaryOutcomeDescription":"Number of nights spend in hospital after day of surgery, including transferral between departments.\n\nAny procedure followed by more than 4 days in hospital will have review of discharge papers to determine causes of the \"prolonged\" admission",
                "PrimaryOutcomeTimeFrame":"At discharge"
              },{
                "PrimaryOutcomeMeasure":"Surgically related readmissions",
                "PrimaryOutcomeDescription":"Evaluation of any potentially surgery related readmission 90 days after discharge. Readmissions defined as related are defined as: Revision due to prosthesis problems, deep venous thrombosis (DVT), pulmonary embolism (PE) (verified or disproved), stroke/transitory cerebral ischaemia (TCI), possible wound infection (return to operating theatre, treatment with antibiotics only, no treatment), fractures without known trauma, falls, knee manipulation, hip dislocation, cardiac problems (acute myocardial infarction (AMI), any type of arrhythmia), pneumonia, urinary retention (UR), abdominal complications (gastric ulcer, ileus) and sequelae (rehabilitation, opioid side-effects, pain, other conditions related to surgery). Readmissions due to chronic obstructive lung disease (COPD), syncope and urinary tract infection (UTI) ≤ 30 days of primary admission",
                "PrimaryOutcomeTimeFrame":"90 days after surgery"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Mortality 90 days after surgery",
                "SecondaryOutcomeDescription":"Evaluation of all deaths 90 days after surgery",
                "SecondaryOutcomeTimeFrame":"90 days after surgery"
              }
            ]
          },
          "OtherOutcomeList":{
            "OtherOutcome":[
              {
                "OtherOutcomeMeasure":"Co-morbidity related readmissions",
                "OtherOutcomeDescription":"Depending on the type of co-morbidity investigated, special attention and analysis of readmissions found to be related to the specific type of co-morbidity will be done",
                "OtherOutcomeTimeFrame":"90 days after surgery"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nStandardized elective fast-track THA or TKA\n\nExclusion Criteria:\n\nElective THA or TKA not in regular fast-track setup\nnot a Danish citizen",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"unselected patients receiving THA or TKA",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Christoffer C Joergensen, MD",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"+45 35454616",
                "CentralContactEMail":"christoffer.calov.joergensen@rh.regionh.dk"
              },{
                "CentralContactName":"Henrik Kehlet, Prof,MD,PhD",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"+45 35454074",
                "CentralContactEMail":"henrik.kehlet@rh.dk"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Christoffer C Joergensen, MD",
                "OverallOfficialAffiliation":"Rigshospitalet, Denmark",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Aarhus University Hospital",
                "LocationStatus":"Active, not recruiting",
                "LocationCity":"Aarhus",
                "LocationState":"Judland",
                "LocationZip":"8000",
                "LocationCountry":"Denmark"
              },{
                "LocationFacility":"Himmerland Hospital",
                "LocationStatus":"Recruiting",
                "LocationCity":"Farsoe",
                "LocationState":"Judland",
                "LocationZip":"9640",
                "LocationCountry":"Denmark"
              },{
                "LocationFacility":"Sydvestjydsk hospital Grindsted",
                "LocationStatus":"Recruiting",
                "LocationCity":"Grindsted",
                "LocationState":"Judland",
                "LocationZip":"7200",
                "LocationCountry":"Denmark"
              },{
                "LocationFacility":"Holstebro Regionalhospital",
                "LocationStatus":"Recruiting",
                "LocationCity":"Holstebro",
                "LocationState":"Judland",
                "LocationZip":"7500",
                "LocationCountry":"Denmark"
              },{
                "LocationFacility":"Vejle Hospital",
                "LocationStatus":"Recruiting",
                "LocationCity":"Vejle",
                "LocationState":"Judland",
                "LocationZip":"7100",
                "LocationCountry":"Denmark"
              },{
                "LocationFacility":"Viborg Hospital",
                "LocationStatus":"Recruiting",
                "LocationCity":"Viborg",
                "LocationState":"Judland",
                "LocationZip":"8800",
                "LocationCountry":"Denmark",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Andrea Søe-Larsen, Nurse",
                      "LocationContactRole":"Contact",
                      "LocationContactEMail":"andrsoee@rm.dk"
                    },{
                      "LocationContactName":"Niels Krarup, MD",
                      "LocationContactRole":"Principal Investigator"
                    }
                  ]
                }
              },{
                "LocationFacility":"Hvidovre Hospital",
                "LocationStatus":"Recruiting",
                "LocationCity":"Hvidovre",
                "LocationState":"Seeland",
                "LocationZip":"2650",
                "LocationCountry":"Denmark"
              },{
                "LocationFacility":"Bispebjerg University Hospital",
                "LocationStatus":"Recruiting",
                "LocationCity":"Copenhagen",
                "LocationCountry":"Denmark",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Jens Bagger, MD",
                      "LocationContactRole":"Contact",
                      "LocationContactEMail":"Jens.Bagger@regionh.dk"
                    }
                  ]
                }
              },{
                "LocationFacility":"Gentofte University Hospital",
                "LocationStatus":"Recruiting",
                "LocationCity":"Gentofte",
                "LocationCountry":"Denmark",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Søren Solgaard, MD",
                      "LocationContactRole":"Contact"
                    },{
                      "LocationContactName":"Søren Solgaard, MD",
                      "LocationContactRole":"Principal Investigator"
                    }
                  ]
                }
              },{
                "LocationFacility":"Næstved Hospital",
                "LocationStatus":"Recruiting",
                "LocationCity":"Næstved",
                "LocationCountry":"Denmark",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Henrik M Schroeder, MD",
                      "LocationContactRole":"Contact"
                    }
                  ]
                }
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"31256778",
                "ReferenceType":"derived",
                "ReferenceCitation":"Petersen PB, Jørgensen CC, Kehlet H; Lundbeck Foundation Center for Fast-track Hip and Knee Replacement collaborative group. Temporal trends in length of stay and readmissions after fast-track hip and knee arthroplasty. Dan Med J. 2019 Jul;66(7). pii: A5553."
              },{
                "ReferencePMID":"26758264",
                "ReferenceType":"derived",
                "ReferenceCitation":"Jørgensen CC, Petersen MA, Kehlet H; Lundbeck Foundation Centre for Fast-Track Hip and Knee Replacement Collaborative Group. Preoperative prediction of potentially preventable morbidity after fast-track hip and knee arthroplasty: a detailed descriptive cohort study. BMJ Open. 2016 Jan 12;6(1):e009813. doi: 10.1136/bmjopen-2015-009813."
              }
            ]
          },
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"The Lundbeck Center for Fast-track Hip and Knee replacement",
                "SeeAlsoLinkURL":"http://www.fthk.dk/"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}