{
  "FullStudy":{
    "Rank":218035,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513577",
          "OrgStudyIdInfo":{
            "OrgStudyId":"ON-07-009-RAS"
          },
          "Organization":{
            "OrgFullName":"Northern Orthopaedic Division, Denmark",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Percutaneous Minimal Invasive Pedicular Screw and Rod Insertion in Circumferential Lumbar Fusion",
          "OfficialTitle":"Percutaneous Minimal Invasive Pedicular Screw and Rod Insertion Reduces Hospital Stay and Morbidity Compared to Open Midline Approach in Circumferential Lumbar Fusion. A Randomized Study With 2 Years Follow-up"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2003"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2004",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2006",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 14, 2011",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 12, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 15, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Northern Orthopaedic Division, Denmark",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Convalescence after lumbar surgery is dependent on the extensiveness of the surgical procedure. Minimal invasive techniques in lumbar spine surgery are reported to achieve excellent clinical results with less pain, morbidity and disability.",
          "DetailedDescription":"To achieve lumbar fusion when there is no need for decompression of the neural structures a posterior midline approach and a left anterior retroperitoneal approach is used. The retroperitoneal anterior approach to the lumbar spine offers some benefits compared with the posterior approach. Dural injury and epidural scarring can be avoided, and an interbody fusion graft can be placed with minimal risk to the nerve roots. However, the extensive posterior midline approach with extensive muscle dissection is necessary to place the pedicular screws.\n\nA report of a follow-up period of 2 years of a randomized trial of minimal invasive insertion of pedicular screws and rods in lumbar fusion."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Degenerative Disc Disease"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Lumbar fusion",
              "Pedicular screws",
              "Minimal invasive technique",
              "Randomized controlled trial"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"16",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Minimal invasive pedicular screw",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Pedicle screws"
                  ]
                }
              },{
                "ArmGroupLabel":"Standard open insertion",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Percutaneous stab incisions"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Pedicle screws",
                "InterventionDescription":"The control group received posterior fixation with pedicle screws through a midline approach. Through the approach bone was harvested from the right posterior iliac crest. Before closure of the posterior approach an epidural catheter and a drain was placed.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Minimal invasive pedicular screw"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Percutaneous stab incisions",
                "InterventionDescription":"The intervention group received posterior fixation through 6 percutaneous stab incisions with the use of the sextant system. Through a separate 3-4 cm long incision, bone was harvested from the right posterior iliac crest. After decorticating the transverse processes through the stab wounds, the bone graft was placed with a 10 ml cut syringe. An epidural catheter was placed at the end of the posterior procedure.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Standard open insertion"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Percutaneous technique versus conventional open technique.",
                "PrimaryOutcomeDescription":"The investigators want to assess the effects of percutaneous posterior technique versus conventional open posterior technique on post-fusion pain, mobilization, convalescence, disability and bony fusion in 360 degree lumbar fusion.",
                "PrimaryOutcomeTimeFrame":"Two years"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Improvements of recovery and convalescence.",
                "SecondaryOutcomeDescription":"To investigate operative time, blood loss, use of analgesic, days until ambulation without aids, hospitalization, Oswestry Disability Index.",
                "SecondaryOutcomeTimeFrame":"Two years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion criteria:\n\nDegenerative disc disease in one of the three lower lumbar levels.\n\nExclusion criteria:\n\nPrevious fusion, metabolic bone disease, co-morbidity or psychological instability.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Sten Rasmussen, M.D.",
                "OverallOfficialAffiliation":"Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Henrik Kehlet, M.D.",
                "OverallOfficialAffiliation":"Department of Orthopaedic Surgery, Vejle and Give Hospital",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000055959",
                "ConditionMeshTerm":"Intervertebral Disc Degeneration"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000013122",
                "ConditionAncestorTerm":"Spinal Diseases"
              },{
                "ConditionAncestorId":"D000001847",
                "ConditionAncestorTerm":"Bone Diseases"
              },{
                "ConditionAncestorId":"D000009140",
                "ConditionAncestorTerm":"Musculoskeletal Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M26992",
                "ConditionBrowseLeafName":"Intervertebral Disc Degeneration",
                "ConditionBrowseLeafAsFound":"Degenerative Disc Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14502",
                "ConditionBrowseLeafName":"Spinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3708",
                "ConditionBrowseLeafName":"Bone Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10680",
                "ConditionBrowseLeafName":"Musculoskeletal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC05",
                "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}