Therapieoption beim chronischen ISG

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
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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