Therapieop)onbeim chronischenISG-Syndrom S.Becker S. Becker 2015 Disclosure • ConsultantSI-Bone S. Becker 2015 IstdasISGein Schmerzgenerator? ISG–Schmerzen-Pa0entenbelastung Schlimmerals COPD KHK Asthma LeichteHerzinsuffizienz Ungefährwie • • • • Coxarthrose Degenera)veSpondylose SPK-Stenose Gonarthrose ChronischeDepression Etwasweniger SchwererM.Parkinson M.Bechterewim Endstadium Dekomp.Leberzirrhose SchwereCOPD Cher et al. Med Devices (Auckl). 2014 S. Becker 2015 PrävalenzdesISGals SchmerzursachebeiLWSSchmerz • ~22%von1,200pa)entshaUenprimärISG Schmerzen–Kirkaldy-Willis1987 • 13-30%InzidenzbeiLWSSchmerzenSchwarzer1995 • 18.5%InzidenzbeiLWSSchmerzenMaigne1996 • “~25%ofLBPisSIJinorigin,butdiagnosisofSIJ diseasefrequentlyoverlooked”Cohen2005 • “~15%ofpa)entswithLBPhavesignificantpain comingfromtheirSIJoints”Sembrano,Polly2009 S. Becker 2015 4 PrävalenzdesISGnach FusionderLWS • 43%SchmerzennachLWS–Fusionsinddurchdas ISGbedingt.“Thesacroiliacjointisthemostlikely sourceoflowbackpainaferlumbarfusion”DePalma 2011 • “SIJissignificantsourceofcon)nuedpainafer lumbarfusion”(35-40%)Liliang2011 S. Becker 2015 5 ProblemAnschlussdegenera)on nachFusion • InzidenzISG–Arthrose5JahrenachFusion 75%,Kontrollgruppe38.2% • MonosegmentaleFusion:91%ISGArthrose. Doppellevel:67%ISGArthrose • Unabhängig,obFusionaufSacrumodernicht Ha, et al. Degeneration of Sacroiliac Joint After Instrumented Lumbar or Lumbosacral Fusion, Spine. 2008; 33 (11): 1192-1198 S. S. Becker 2015 Becker 2012 Diagnosestellung courtesy SI - Bone S. Becker 2015 SISAppzurDiagnosefindung S. Becker 2015 Konserva)ve Therapieop)onen • NSAR • Rö/CT/USgezielteISGInfiltra)on • Physiotherapie/Chirotherapie/Gürtel/ Tapes • Prolotherapie(fehlendeEvidenz) • RFAbla)on(3Mo/6MoErgebnisse,fehlende Evidenz) Kim SR et al.Critical review of prolotherapy for osteoarthritis, low back pain, and other musculoskeletal conditions: a physiatric perspective. Am J Phys Med Rehabil. 2004 May;83(5):379-89. Leggett LE et al. Radiofrequency ablation for chronic low back pain: a systematic review of randomized controlled trials.Pain Res Manag. 2014 SepS. Becker 2015 Oct;19(5):e146-53 MISFusionISG • IFuse courtesy SI - Bone S. Becker 2015 SafetyProfile FDAZulassungseit2008,CEseit2010: 18000Opera)onen,1000Chirurgen ComplaintsAnalysis RevisionRate Miller–MedDevices(Auckl)2013 (Publica9onSubmi>ed–InReview,courtesyofSI-Bone) 5,319pa)ents(Apr2009–Jan2013) ~16,000implants(US&Europe) 487differentphysicians 11,417pa)ents(Apr2009–Aug2014) 19,387pa)ent-years 239revisions Results Results • 3.8%OverallComplaintRate • 96.6%survivorship,freefromrevision (adjusted4-yearrate) • 1.8%RevisionRate courtesy SI - Bone • Likelihoodofrevisionhasdecreased annuallysince2009 Comparison LumbarSurgery:4-yearrates(DevoJBJS2011,Mar)n Spine,2007) 10-12%Decompression 12-14%Fusion Revisionratesinpa)ents>80J.:50%(EurSpineJ2015) S. Becker 2015 iFuseSystem KlinischeEvidenz LOE Type Pubs Descrip0on I RCT 2 INSITE6mo(102iFusevs.46NSM) INSITE12mofollow-up II/IIb Prospec)ve 3 SIFI6mointerimanalysis SIFI12mofollow-up Systema)cReview III Comparison Openvs.MIS 3 MISprovidedbeUeropera)vemeasures&clinical outcomesthanopenprocedures IV Retrospec)ve 10 MostRecentPubs: Sachs2014(mul)center,12mofollow-up) Rudolf2014(5yrfollow-up) Vanaclocha2014(follow-upfrom1-4.5yr) OtherClinical 2 Complaintsanalysis(Apr2009–Jan2013) Intraopera)veneuromonitoring 1submiUed Survivorshipanalysis(Apr2009–Aug2014) 2 Stabilityachieved&maintainedpost-cycles Comparisonofimplantplacementtechnique 1inprogress FEAmodels(implantlength&number,lumbaraffect) Biomechanics S. Becker 2015 Courtesy C. Reckling, MD Prospek)verandomisierte Mul)centerstudieINSITE (n=102) Procedure Time, minutes: mean (range) 44.9 (14-140) Fluoroscopy Time, minutes: mean (range) 2.5 (0.13-25) Estimated Blood Loss, cc: mean (range) 32.7 (0.5-250) Hospital Length of Stay Mean days (range) Discharged same day, subjects (%) 0.78 (0-7) 42 (41.2%) Polly et al. Neurosurgery 2015 S. Becker 2015 INSITE:VAS Crossedover 80% der Fälle NSM SI Joint Fusion ProbabilityiFuse superiortoNSM >0.9999 Months after Randomization Polly et al. Neurosurgery 2015 S. Becker 2015 INSITE:ODI Crossedover 80% der Fälle ODI, mean (SE) NSM SI Joint Fusion ProbabilityiFuse superiortoNSM >0.9999 Months after Randomization Polly et al. Neurosurgery 2015 S. Becker 2015 Metaanalyse lateralerZugangverschiedeneSysteme90%IFuse VAS =HMAscrewcohorts =iFusecohorts Whang et al. Int J Spine 2015 S. Becker 2015 1 Metaanalyse lateralerZugangverschiedeneSysteme90%IFuse ODI =HMAscrewcohorts =iFusecohorts Whang et al. Int J Spine 2015 S. Becker 2015 1 Langzeitdaten Rudolf 20121 50 iFuse nach 2 Jahren Rudolf 20142 17 nach 5 Jahren Vanaclocha 20143 24 nach 4,5 Jahren Fusionsraten: 87% 2 1. Rudolf L. Open Orthop J. 2012. 2. Rudolf L, et al. Open Orthop J. 2014. 3. Vanaclocha-Vanaclocha V, et al. J Spine. 2014. S. Becker 2015 Pa)entenzufriedenheit ! 91% courtesy SI - Bone S. Becker 2015
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