{ "FullStudy":{ "Rank":218199, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511445", "OrgStudyIdInfo":{ "OrgStudyId":"Amedica 2010-1" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"NL36103.098.11", "SecondaryIdType":"Registry Identifier", "SecondaryIdDomain":"Netherlands Trial Registry" } ] }, "Organization":{ "OrgFullName":"Amedica Corporation", "OrgClass":"INDUSTRY" }, "BriefTitle":"Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome", "OfficialTitle":"Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome; a Blinded Randomised Trial of Cancellous Structured Ceramic (CSC) Versus PEEK Cages.", "Acronym":"CASCADE" }, "StatusModule":{ "StatusVerifiedDate":"March 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"January 26, 2017", "ResultsFirstSubmitQCDate":"March 27, 2017", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"May 8, 2017", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"March 27, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 8, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Amedica Corporation", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"This study randomizes neck and arm pain patients being treated with discectomy and anterior interbody fusion into two groups: one to receive a new ceramic implant and a control group with a more traditional plastic implant. The study will measure and compare pain and disability improvement with the two products over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Radiating Pain", "Myelopathy", "Cervicobrachial Syndrome" ] }, "KeywordList":{ "Keyword":[ "Cervicobrachial pain", "radicular pain", "arm pain", "myelopathy", "radiculitis", "Radiating pain with or without signs of myelopathy." ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"100", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"ACDF with PEEK interbody cage", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is to be filled with local autologous bone harvested during the decompression phase of the procedure.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Anterior cervical discectomy and fusion (ACDF) with PEEK Cage" ] } },{ "ArmGroupLabel":"ACDF with Valeo CSC Ceramic Cage", "ArmGroupType":"Experimental", "ArmGroupDescription":"ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage. The center area of the cage is filled with porous silicon nitride. No autologous bone is used; the cage is soaked in patient blood.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"Anterior cervical discectomy and fusion (ACDF) with PEEK Cage", "InterventionDescription":"Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "ACDF with PEEK interbody cage" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Medicrea Manta or similar PEEK cage" ] } },{ "InterventionType":"Device", "InterventionName":"Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage", "InterventionDescription":"Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "ACDF with Valeo CSC Ceramic Cage" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Valeo CSC (Cancellous Structured Ceramic)", "Silicon Nitride ceramic" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Neck Disability Index", "PrimaryOutcomeDescription":"The change in the Neck Disability Index compared to the pre-op value for each group will be compared. Neck disability index is a unitless measure from zero (no disability) to 100 (absolute disability). Change is calculated as the pre-op value minus the 24 month value. A negative difference indicates that the patient is more disabled at 24 months.", "PrimaryOutcomeTimeFrame":"24 months post-op" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Fusion Status", "SecondaryOutcomeDescription":"Dynamic flexion-extension plane film x-rays will be used to assess fusion at all four follow-up periods. The criteria for fusion are rotation motion less than or equal to four degrees and translation less than 1.25 mm. The final fusion judgement will be fusion status at 24 months or the last time point with flexion-extension data available.", "SecondaryOutcomeTimeFrame":"3 mo., 6mo., 12 mo., 24 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAge 18 75 years\nRadicular signs and symptoms in one or both arms (i.e., pain, paraesthesiae or paresis in a specific nerve root distribution) or symptoms and signs of acute or chronic myelopathy.\nAt least 8 weeks prior conservative treatment (i.e., physical therapy, pain medication)\nRadiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level (C3-C4 to C7-T1) in accordance with clinical signs and symptoms\nAbility and willingness to comply with project requirements\nWritten informed consent given by the subject or the subject's legally authorised representative\n\nExclusion Criteria:\n\nPrevious cervical surgery (either anterior or posterior)\nIncreased motion on dynamic studies (> 3 mm)\nSevere segmental kyphosis of the involved disc level (> 7 degrees)\nPatient cannot be imaged with MRI\nNeck pain only (without radicular or medullary symptoms)\nInfection\nMetabolic and bone diseases (osteoporosis, severe osteopenia)\nNeoplasma or trauma of the cervical spine\nSpinal anomaly (Klippel Feil, Bechterew, OPLL)\nSevere mental or psychiatric disorder\nInadequate Dutch language\nPlanned (e)migration abroad in the year after inclusion", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Mark P Arts, MD, PhD", "OverallOfficialAffiliation":"Medical Center Haaglanden", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Medical Center Haaglanden", "LocationCity":"The Hague", "LocationZip":"2501 CK", "LocationCountry":"Netherlands" } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No" } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Four additional patients were randomized when four patients were excluded for protocol violations prior to the primary endpoint. A surgeon who had not been trained as an investigator operated on these four patients, making numerous protocol violations in implant technique. These patients were randomized and had pre-op data in the study.", "FlowRecruitmentDetails":"The study was designed as double-blind randomized trial. The design called for randomizing 100 patients.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"ACDF With Valeo CSC Ceramic Cage", "FlowGroupDescription":"ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage. The center area of the cage is filled with porous silicon nitride. No autologous bone is used; the cage is soaked in patient blood.\n\nAnterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage: Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"ACDF With PEEK Interbody Cage", "FlowGroupDescription":"Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is to be filled with local autologous bone harvested during the decompression phase of the procedure.\n\nAnterior cervical discectomy and fusion (ACDF) with PEEK Cage: Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowMilestoneComment":"Enrollment", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"Patient enrollment started in December, 2011.", "FlowAchievementNumSubjects":"53" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"Patient enrollment started in December, 2011.", "FlowAchievementNumSubjects":"51" } ] } },{ "FlowMilestoneType":"Surgeries Completed", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"All surgeries were completed by October, 2013.", "FlowAchievementNumSubjects":"53" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"All surgeries were completed by October, 2013.", "FlowAchievementNumSubjects":"51" } ] } },{ "FlowMilestoneType":"Primary Completion October, 2014", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"1 was excluded Bechterew's disease. 1 protocol violation. 3 were lost to follow-up.", "FlowAchievementNumSubjects":"48" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"3 protocol violations. 1 lost to follow-up.", "FlowAchievementNumSubjects":"47" } ] } },{ "FlowMilestoneType":"Follow-up Completion", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"Two year follow-up was completed in November, 2015", "FlowAchievementNumSubjects":"48" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"Two year follow-up was completed in November, 2015", "FlowAchievementNumSubjects":"47" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"Data analysis was completed in February, 2016", "FlowAchievementNumSubjects":"48" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"Data analysis was completed in February, 2016", "FlowAchievementNumSubjects":"47" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"5" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"4" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"3" } ] } },{ "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"ACDF With Valeo CSC Ceramic Cage", "BaselineGroupDescription":"ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"ACDF With PEEK Interbody Cage", "BaselineGroupDescription":"Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"53" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"51" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"104" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureDescription":"Age at date of surgery", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"53" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"51" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"104" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"53.3", "BaselineMeasurementSpread":"9.3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"49.6", "BaselineMeasurementSpread":"9.5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"51.3", "BaselineMeasurementSpread":"9.5" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"53" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"51" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"104" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"27" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"25" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"52" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"26" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"26" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"52" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race and Ethnicity Not Collected", "BaselineMeasurePopulationDescription":"Race and Ethnicity were not collected from any participant.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Netherlands", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"53" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"51" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"104" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"53" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"51" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"104" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Use of nicotine products", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"53" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"51" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"104" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"23" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"43" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Symptomatic (operated) spinal level", "BaselineMeasureDescription":"Patients were operated at a single cervical spinal level from C3-C4 to C7-T1", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"53" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"51" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"104" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"C3-C4", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" } ] } },{ "BaselineCategoryTitle":"C4-C5", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"6" } ] } },{ "BaselineCategoryTitle":"C5-C6", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"30" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"30" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"60" } ] } },{ "BaselineCategoryTitle":"C6-C7", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"32" } ] } },{ "BaselineCategoryTitle":"C7-T1", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Neck Disability Index", "OutcomeMeasureDescription":"The change in the Neck Disability Index compared to the pre-op value for each group will be compared. Neck disability index is a unitless measure from zero (no disability) to 100 (absolute disability). Change is calculated as the pre-op value minus the 24 month value. A negative difference indicates that the patient is more disabled at 24 months.", "OutcomeMeasurePopulationDescription":"Patients who had data from 24 month follow-up visit", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale from 0 to 100", "OutcomeMeasureTimeFrame":"24 months post-op", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"ACDF With Valeo CSC Ceramic Cage", "OutcomeGroupDescription":"ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"ACDF With PEEK Interbody Cage", "OutcomeGroupDescription":"Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"47" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"44" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"17.9", "OutcomeMeasurementSpread":"14.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"16.7", "OutcomeMeasurementSpread":"16.1" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"The null hypothesis was that the mean change in NDI scores from pre-op to 24 months was equal in the two study arms.", "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"The noninferiority margin was specified as 15 NDI points (0-100 scale).", "OutcomeAnalysisPValue":"0.641", "OutcomeAnalysisStatisticalMethod":"Fisher Exact", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-1.3", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-7.3", "OutcomeAnalysisCIUpperLimit":"4.5", "OutcomeAnalysisDispersionType":"Standard Error of the Mean", "OutcomeAnalysisDispersionValue":"2.96", "OutcomeAnalysisEstimateComment":"A negative value means that the PEEK change was slightly larger than the silicon nitride study arm." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Fusion Status", "OutcomeMeasureDescription":"Dynamic flexion-extension plane film x-rays will be used to assess fusion at all four follow-up periods. The criteria for fusion are rotation motion less than or equal to four degrees and translation less than 1.25 mm. The final fusion judgement will be fusion status at 24 months or the last time point with flexion-extension data available.", "OutcomeMeasurePopulationDescription":"Patients with 24 month films", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"3 mo., 6mo., 12 mo., 24 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"ACDF With Valeo CSC Ceramic Cage", "OutcomeGroupDescription":"ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"ACDF With PEEK Interbody Cage", "OutcomeGroupDescription":"Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"43" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"41" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"40" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"37" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"The null hypothesis was that the fusion rates would be equal in the two study arms. The comparison includes patients with flexion-extension films at 24 months (as-treated population).", "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"The definition of fusion is rotation on flexion-extension films of less than or equal to four degrees and translation less than 1.25 mm.", "OutcomeAnalysisPValue":"0.710", "OutcomeAnalysisStatisticalMethod":"Fisher Exact" } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsDescription":"Investigators completed adverse event questionnaires and patients were surveyed for adverse events at each interaction with the investigational team", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"ACDF With Valeo CSC Ceramic Cage", "EventGroupDescription":"ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.", "EventGroupSeriousNumAffected":"2", "EventGroupSeriousNumAtRisk":"53", "EventGroupOtherNumAffected":"16", "EventGroupOtherNumAtRisk":"53" },{ "EventGroupId":"EG001", "EventGroupTitle":"ACDF With PEEK Interbody Cage", "EventGroupDescription":"Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"51", "EventGroupOtherNumAffected":"11", "EventGroupOtherNumAtRisk":"51" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Replacement of implant due to subsidence", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventNotes":"Cage subsidence led to symptoms; revised by removing cage and replacing with bone graft and a cervical plate", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"53" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"51" } ] } },{ "SeriousEventTerm":"Debridement of abscess", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventNotes":"The abscess was cleaned in a second surgery without cage removal", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"53" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"51" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Dysphasia", "OtherEventOrganSystem":"Injury, poisoning and procedural complications", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventNotes":"Difficulty swallowing in the immediate post-op period. All cases resolved completely as post-op swelling subsided.", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"9", "OtherEventStatsNumAffected":"9", "OtherEventStatsNumAtRisk":"53" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"8", "OtherEventStatsNumAffected":"8", "OtherEventStatsNumAtRisk":"51" } ] } },{ "OtherEventTerm":"Surgery at additional spinal level", "OtherEventOrganSystem":"Musculoskeletal and connective tissue disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventNotes":"Surgery for development of new or persistent symptoms. More common at lower cervical spine levels.", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"6", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"53" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"51" } ] } },{ "OtherEventTerm":"Removal for restenosis", "OtherEventOrganSystem":"Immune system disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventNotes":"Patient had undiagnosed Becherew's disease (ankylosing spondylitis), an exclusion criterion for the study. A bone spur regrew underneath the cage. The patient had a revision with bone graft and a cervical plate.", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"53" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"51" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Sonny Bal, MD", "PointOfContactOrganization":"Amedica Corporation", "PointOfContactEMail":"SBal@amedica.com", "PointOfContactPhone":"(573) 808-4512" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000012825", "InterventionMeshTerm":"Silicon" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000014131", "InterventionAncestorTerm":"Trace Elements" },{ "InterventionAncestorId":"D000018977", "InterventionAncestorTerm":"Micronutrients" },{ "InterventionAncestorId":"D000078622", "InterventionAncestorTerm":"Nutrients" },{ "InterventionAncestorId":"D000006133", "InterventionAncestorTerm":"Growth Substances" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M14213", "InterventionBrowseLeafName":"Silicon", "InterventionBrowseLeafAsFound":"Silicon", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M15468", "InterventionBrowseLeafName":"Trace Elements", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19593", "InterventionBrowseLeafName":"Micronutrients", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M1986", "InterventionBrowseLeafName":"Nutrients", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Micro", "InterventionBrowseBranchName":"Micronutrients" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000013118", "ConditionMeshTerm":"Spinal Cord Diseases" },{ "ConditionMeshId":"D000001855", "ConditionMeshTerm":"Bone Marrow Diseases" },{ "ConditionMeshId":"D000013577", "ConditionMeshTerm":"Syndrome" },{ "ConditionMeshId":"D000010146", "ConditionMeshTerm":"Pain" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000004194", "ConditionAncestorTerm":"Disease" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000002493", "ConditionAncestorTerm":"Central Nervous System Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" },{ "ConditionAncestorId":"D000006402", "ConditionAncestorTerm":"Hematologic Diseases" },{ "ConditionAncestorId":"D000009461", "ConditionAncestorTerm":"Neurologic Manifestations" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M14938", "ConditionBrowseLeafName":"Syndrome", "ConditionBrowseLeafAsFound":"Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M11649", "ConditionBrowseLeafName":"Pain", "ConditionBrowseLeafAsFound":"Radiating Pain", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3716", "ConditionBrowseLeafName":"Bone Marrow Diseases", "ConditionBrowseLeafAsFound":"Myelopathy", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14498", "ConditionBrowseLeafName":"Spinal Cord Diseases", "ConditionBrowseLeafAsFound":"Myelopathy", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4325", "ConditionBrowseLeafName":"Central Nervous System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8073", "ConditionBrowseLeafName":"Hematologic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10987", "ConditionBrowseLeafName":"Neurologic Manifestations", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC15", "ConditionBrowseBranchName":"Blood and Lymph Conditions" },{ "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" } ] } } } } } }