{
  "FullStudy":{
    "Rank":217657,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518543",
          "OrgStudyIdInfo":{
            "OrgStudyId":"RECON-EMEA-04"
          },
          "Organization":{
            "OrgFullName":"Integra LifeSciences Services",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Follow-up of Patient Implanted With the Staple ASTUS®",
          "OfficialTitle":"Follow-up of Patient Implanted With the Staple ASTUS®"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2014",
          "OverallStatus":"Terminated",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"April 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"June 20, 2011",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 10, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 11, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Integra LifeSciences Services",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"There are many ways of performing arthrodesis in the foot and ankle. Dowel fusion is one of them.\n\nThe in situ technique was first described by Ottolenghi et al. (1970) and was taken up by Baciu and Filibiu (1979). In the technique, they did take the dowel out before turning it. The healing process takes place between surfaces of spongious bone. They showed excellent results with early weight bearing and healing within 12.5 weeks. Stranks et al. (1994) combined the dowel technique with screw fixation and claimed 95 % healing rate within 12.5 weeks. Others have not found this technique satisfactory in rheumatoid arthritis patients (Belt et al. 2001). The results were not compatible to common fusion techniques. The reason may be the circular bone gap of at least 1 mm left by the saw blade.\n\nA new instrumentation and a new staple with a central wedge (ASTUS) avoid this gap and allow the dowel to be turned in situ without leaving in position. The staple is introduced into the joint line and will compress the dowel surfaces against the surrounding bone. Instruments are available to ensure the correct position and length of the dowel, and to rotate it in situ before the special wedge staple is introduced.\n\nDr Kofoed, the surgeon designer of the ASTUS Staple, has communicated on his first series with 83 arthrodesis. The purpose of this study is now to collect and publish data from several centers, several users.\n\nThe objective of this study is to obtain the percentage of healing 3 months after an implantation of the staple ASTUS."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Arthrodesis"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "arthrodesis",
              "arthrodesis in the following joints:Ankle, 1st MTP, Metatarso - Cuneiform (1st), Navicular - Cuneiform, Talo-Navicular, Calcaneum - Cuboid;"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Only"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"5",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"ASTUS",
                "ArmGroupDescription":"Patient candidate for an arthrodesis in the following joints:Ankle,1st MTP, Metatarso - Cuneiform (1st), Navicular - Cuneiform, Talo-Navicular, Calcaneum - Cuboid, and whose surgeon has recommended the implantation of an ASTUS Staple from Newdeal-INTEGRA."
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Rate of healing at 3 month",
                "PrimaryOutcomeTimeFrame":"3 month post implantation"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Complications rate",
                "SecondaryOutcomeDescription":"Number of patients with an adverse event related to the device",
                "SecondaryOutcomeTimeFrame":"12 month follow-up"
              },{
                "SecondaryOutcomeMeasure":"Length of the surgery",
                "SecondaryOutcomeDescription":"We collect the information of the length of the surgery for the implantation of the Astus Device",
                "SecondaryOutcomeTimeFrame":"The time is the day of the surgery, the day the implantation of the device is done"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAge ≥ 18 years;\nHave willingness to give his/her data transfer authorisation;\nPatient candidate for an arthrodesis in the following joints (Ankle, 1st MTP, Metatarso - Cuneiform (1st), Navicular - Cuneiform, Talo-Navicular, calcaneum - Cuboid) and whose surgeon has recommended the implantation of an ASTUS Staple from Newdeal-INTEGRA.\n\nExclusion Criteria:\n\nPatient candidate for an arthrodesis not listed in the inclusion criteria (as Subtalar arthrodesis and Metatarso-cuboid arthrodesis) will not be included in this study;\nPatient re-operated due to a previous failed of fusion of the same joint will not be also included;\nPatients will be excluded from the study if they have an history of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Patient candidate for an arthrodesis in the following joints (Ankle, 1st MTP, Metatarso - Cuneiform (1st), Navicular - Cuneiform, Talo-Navicular, calcaneum - Cuboid) and whose surgeon has recommended the implantation of an ASTUS Staple from Newdeal-INTEGRA can be enrolled in this study",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Cappagh National Orthopaedic Hospital",
                "LocationCity":"Dublin",
                "LocationZip":"11",
                "LocationCountry":"Ireland"
              },{
                "LocationFacility":"Clatterbridge General Hospital",
                "LocationCity":"Wirral",
                "LocationCountry":"United Kingdom"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}