Superion® InterSpinous Spacer for treatment of moderate degenerative lumbar spinal stenosis: durable three-year results of a randomized controlled trial
Patel VV, Nunley PD, Whang PG, Haley TR, Bradley WD, Davis RP, Block JE, Geisler FH. Superion® InterSpinous Spacer for treatment of moderate degenerative lumbar spinal stenosis: durable three-year results of a randomized controlled trial. Journal Of Pain Research 2015, Volume 8: 657-662. PMID: 26491369, PMCID: PMC4599047, DOI: 10.2147/jpr.s92633.Peer-Reviewed Original ResearchDegenerative lumbar spinal stenosisLumbar spinal stenosisPrimary composite endpointSpinal stenosisComposite endpointClinical outcomesDrug Administration Investigational Device Exemption trialDisease-specific functional outcomesInvestigational device exemption trialDurable clinical improvementLeg pain severityRandomized study groupsZurich Claudication QuestionnaireProcedure-related complicationsIntermittent neurogenic claudicationTreatment of patientsProportion of subjectsThree-year resultsTreatment of subjectsIndividual patient successNeurogenic claudicationPrimary endpointClinical improvementCorresponding success ratesPain severitySuperion Interspinous Process Spacer for Intermittent Neurogenic Claudication Secondary to Moderate Lumbar Spinal Stenosis
Patel VV, Whang PG, Haley TR, Bradley WD, Nunley PD, Davis RP, Miller LE, Block JE, Geisler FH. Superion Interspinous Process Spacer for Intermittent Neurogenic Claudication Secondary to Moderate Lumbar Spinal Stenosis. Spine 2015, 40: 275-282. PMID: 25494323, DOI: 10.1097/brs.0000000000000735.Peer-Reviewed Original ResearchConceptsLumbar spinal stenosisIntermittent neurogenic claudicationInterspinous process spacerNeurogenic claudicationClinical successSpinal stenosisModerate lumbar spinal stenosisPrimary composite endpointRate of complicationsMajority of patientsInvasive treatment alternativeConservative careLeg painSurgical decompressionControl patientsMost patientsComposite endpointNonsurgical managementHigh quality comparative dataPatient complaintsNoninferiority trialBACKGROUND DATAClaudicationInterspinous spacerPatients