{
  "FullStudy":{
    "Rank":217654,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518582",
          "OrgStudyIdInfo":{
            "OrgStudyId":"#0802"
          },
          "Organization":{
            "OrgFullName":"Medicrea International",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study",
          "OfficialTitle":"The GRANVIA®-C Cervical Disc Prosthesis to Treat Symptomatic Degenerative Disc Diseases"
        },
        "StatusModule":{
          "StatusVerifiedDate":"June 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2016",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2016",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 5, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"June 27, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"June 28, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Medicrea International",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This is a prospective clinical study to assess the performance of the prosthesis according to a composite success criterion. The clinical and functional results and the patient's quality of life up to 24 months of follow-up will also be recorded.\n\nGranvia-c is a device NOT FDA-approved and NOT under investigation in the USA.",
          "DetailedDescription":"Anterior cervical arthrodesis has been widely used to treat the degenerative cervical spine. Although the results of ACDF are generally in the good to excellent range, interbody fusion of the cervical spine after cervical discectomy, aside from causing restriction of neck movements, also accelerates degeneration of adjacent disc levels because of the increased stress from fusion. Long-term radiographic follow-up of patients with anterior cervical fusion has demonstrated degenerative changes in the non-fused segments of the spine including disc space narrowing and osteophyte formation.\n\nTo conclude, fusion provokes a functional overload of the discs bordering the fusion that is directly correlated to the number of fused levels. Radiographic observations show a greater mechanical stress on the discs, especially in the arthrodeses involving more than one level.\n\nArtificial discs were designed to replace the entire intervertebral disc and to preserve the physiological motion of the operated level. Several prostheses with different concepts were commercialized. Published clinical studies reported a preserved motion and improved clinical results (Neck Disability Index, Pain Visual Analogic Scale, Quality of Life).\n\nThe cervical disc prosthesis GRANVIA®-C was designed to replace the intervertebral discs of the cervical spine, to restore the disc height and to restore segmental motion.\n\nA prospective clinical study has been set up to evaluate the performance of the prosthesis\n\nGranvia-c is a device NOT FDA-approved and NOT under investigation in the USA."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Cervicobrachial Neuralgia",
              "Cervical Discopathy"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Cervicobrachial",
              "neuralgia",
              "symptomatic cervical discopathy"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"70",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Radiculopathy Cervical",
                "ArmGroupDescription":"Radiculopathy, Cervical",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Cervical arthroplasty surgery with Granvia-C"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Cervical arthroplasty surgery with Granvia-C",
                "InterventionDescription":"Discectomy and Cervical arthroplasty according to standard practice of the surgeon",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Radiculopathy Cervical"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Composite criterion of success",
                "PrimaryOutcomeDescription":"the success is defined by a composite criterion of 4 points. The surgery will be a success only if there is:\n\nA 15-point improvement in the NDI score from the preoperative baseline score\nMaintenance or improvement of the pre-op baseline neurological status\nAbsence of secondary surgical intervention\nAbsence of serious adverse event",
                "PrimaryOutcomeTimeFrame":"24Months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Radiologic evaluation of the motion",
                "SecondaryOutcomeDescription":"Radiologic evaluation of the motion of the operated level(s) and comparison to the motion of the adjacent levels,",
                "SecondaryOutcomeTimeFrame":"Preop, 3M, 12M and 24M"
              },{
                "SecondaryOutcomeMeasure":"Evaluation of potential peri and post-operative adverse events related or not to prosthesis.",
                "SecondaryOutcomeTimeFrame":"preop, 3M, 12M, 24M"
              },{
                "SecondaryOutcomeMeasure":"Evaluation of satisfaction",
                "SecondaryOutcomeDescription":"Evaluation of satisfaction with Patient Satisfaction Index",
                "SecondaryOutcomeTimeFrame":"Preop, 3M, 12M and 24M"
              },{
                "SecondaryOutcomeMeasure":"Evaluation of the time to return to activities (normal activity, work, sport activity)",
                "SecondaryOutcomeTimeFrame":"preop, 3M, 12M, 24M"
              },{
                "SecondaryOutcomeMeasure":"Evaluation of Pain",
                "SecondaryOutcomeDescription":"Evaluation of pain with Visual Analog Scales",
                "SecondaryOutcomeTimeFrame":"Preop, 3M, 12M and 24M"
              },{
                "SecondaryOutcomeMeasure":"cervical alignment",
                "SecondaryOutcomeDescription":"Radiologic evaluation of the global cervical alignment",
                "SecondaryOutcomeTimeFrame":"Preop, 3M, 12M and 24M"
              },{
                "SecondaryOutcomeMeasure":"disc height",
                "SecondaryOutcomeDescription":"Radiologic evaluation of the disc height of the operated level(s)",
                "SecondaryOutcomeTimeFrame":"Preop, 3M, 12M and 24M"
              },{
                "SecondaryOutcomeMeasure":"Radiologic adverse events",
                "SecondaryOutcomeDescription":"Radiologic evaluation of adverse events such as migration, subsidence",
                "SecondaryOutcomeTimeFrame":"Preop, 3M, 12M and 24M"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nCervicobrachial neuralgia due to symptomatic cervical discopathy\n\nPresence of pain (arm or arm and neck) and/or a neurologic deficit with a radiographic confirmation (by CT, MRI, X-ray, etc.) of any of the following:\n\nHerniated nucleus pulposus\nSpondylosis (defined by the presence of osteophytes)\nDegenerative Disc Disease at a single level or 2-level(s) adjacent or not between C3 and C7\n\nExclusion Criteria (non exhaustive):\n\nAsymptomatic degenerative disc disease (DDD)\nDDD of 3-levels or more\nAxial neck pain as the solitary symptom\nSevere spondylosis at the level to be treated by arthroplasty as\n\nCharacterized by any of the following:\n\nBridging osteophytes\nA loss of disc height greater than 50% (compared to adjacent levels)\nAbsence of motion (<2°)\nAny prior spine surgery at any cervical level, especially fusion procedure; views) for the level operated by arthroplasty\nTumor\nDeformity or fracture of the cervical vertebrae\n\nActive systemic infection or infection at the operative site(s)\n\nPregnant or interested in becoming pregnant in the next three years;\nAdvanced emphysema, Alzheimer's disease or other medical conditions that would interfere with patient self-assessment of function, pain or quality of life",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"21 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          },
          "StudyPopulation":"People with Cervicobrachial neuralgia due to symptomatic cervical discopathy",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"John Yeh, MD",
                "OverallOfficialAffiliation":"Royal London Hospital, UK",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Frédéric Schils, MD",
                "OverallOfficialAffiliation":"CHC Liège, Belgium",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Hans Meisel, MD",
                "OverallOfficialAffiliation":"Halle Klinike, Germany",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Patrick Guérin, MD",
                "OverallOfficialAffiliation":"University Hospital, Bordeaux",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"CHR Namur",
                "LocationCity":"Namur",
                "LocationZip":"5000",
                "LocationCountry":"Belgium"
              },{
                "LocationFacility":"Tripode Hospital",
                "LocationCity":"Bordeaux",
                "LocationZip":"33000",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Clairval hospital",
                "LocationCity":"Marseille",
                "LocationZip":"13009",
                "LocationCountry":"France"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000009437",
                "ConditionMeshTerm":"Neuralgia"
              },{
                "ConditionMeshId":"D000020968",
                "ConditionMeshTerm":"Brachial Plexus Neuritis"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010523",
                "ConditionAncestorTerm":"Peripheral Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000009468",
                "ConditionAncestorTerm":"Neuromuscular Diseases"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000010146",
                "ConditionAncestorTerm":"Pain"
              },{
                "ConditionAncestorId":"D000009461",
                "ConditionAncestorTerm":"Neurologic Manifestations"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              },{
                "ConditionAncestorId":"D000020516",
                "ConditionAncestorTerm":"Brachial Plexus Neuropathies"
              },{
                "ConditionAncestorId":"D000009443",
                "ConditionAncestorTerm":"Neuritis"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M10964",
                "ConditionBrowseLeafName":"Neuralgia",
                "ConditionBrowseLeafAsFound":"Neuralgia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M26992",
                "ConditionBrowseLeafName":"Intervertebral Disc Degeneration",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10970",
                "ConditionBrowseLeafName":"Neuritis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M21283",
                "ConditionBrowseLeafName":"Brachial Plexus Neuritis",
                "ConditionBrowseLeafAsFound":"Cervicobrachial Neuralgia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M12015",
                "ConditionBrowseLeafName":"Peripheral Nervous System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10994",
                "ConditionBrowseLeafName":"Neuromuscular Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11649",
                "ConditionBrowseLeafName":"Pain",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10987",
                "ConditionBrowseLeafName":"Neurologic Manifestations",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20885",
                "ConditionBrowseLeafName":"Brachial Plexus Neuropathies",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T4468",
                "ConditionBrowseLeafName":"Parsonage Turner Syndrome",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC05",
                "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}