MD Distinguished Professor and Chair Department of Orthopaedic Surgery UCSD Disclosures AO Spine Benvenue Medical EBI Globus Medical Intrinsic Therapy Johnson amp Johnson DePuy Spine ID: 785053
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Slide1
SI Joint Dysfunciton
Steven Garfin,
M.D.
Distinguished Professor and Chair
Department of Orthopaedic Surgery, UCSD
Slide2DisclosuresAO SpineBenvenue
Medical
EBI
Globus MedicalIntrinsic TherapyJohnson & Johnson, DePuy SpineMagnifi Group
MedtronicNuVasive, Inc.SamumedSI Bone, Inc.Spinal KineticsStrykerSymmetryVertiflex
Slide3Burden of Disease: Utility Values
SI Joint Pain
Hip osteoarthritis
Lumbar stenosis
Degenerative spondyKnee osteoarthritisLumbar spondylosis
Quality of Life
Low
High
Cher D, Polly D, Berven S
Med Devices Evid Res 2014
Severe Parkinson's
Ankylosing Spondylitis
Asthma
HIV+
Type 2 Diabetes
SIJ Pain
Slide4FunctionConnects spine and pelvisTransfers forceOpens during pregnancy (so it is “mobile”)
Slide5SI JointLarge surface area1/4 – 1/3 synovial (anterior)
Cartilaginous surfaces
Strong ligaments
+ Motions (multi-directions) < 4⁰
Can
be
arthritic
Slide6SI Joint – with ageSurfaces flat until puberty
Then ridges appear
3
RD and 4TH decade: elevations and depressions appearArticular surfaces erode
“Arthritic changes”
Slide7InnervationSynovium and capsule contain unmyelinated nerve endings for pain and temperature
Anteriorly from L2-S2 ventral rami and sacral plexus
Posteriorly from L4-S4 dorsal rami
Solomen, 1957Nakegawa 1966Ikeda, 1991
Grob, 1995
Could “sense” pain
Slide8Prevalence of SI Joint Degenerationin Asymptomatic AdultsEno, et al JBJS 2015500 consecutive pelvic CTs(no back or SI pain)
65% SI DJD
30%
Substantial SI DJD(91% by 80 yrs old)
Slide9Prevalence of SI Joint Pain
15-30%
Component of LBP
Slide10Adjacent Segment Disease (ASD)75% 5-years post-fusion had radiographic SIJ degeneration1
Post-L-S fusion
2,3
32% definite SIJ pain29% likely SIJ pain
32-43%Symptomatic Post-Lumbar FusionHa – Spine 2008Katz – J Spine Disord Tech 2003Maigne – Eur Spine J 2005
32% Katz 2003
35% Maigne 2005
43
% DePalma
2011
40% Liliang
2011
DePalma –
Pain Med
2011
Slide11Patient EvaluationClinical History is Subtle
Pain usually inferior to L-5
At or caudal to PSIS
Specific trauma or positional pain is rare
Pain with prolonged sitting (also with DDD)
40%
60%
Slide12DISTRACTION
PATRICK’S
THIGH THRUST
GAENSLEN’S
COMPRESSION
SACRAL THRUST
Exam
At least 3 +
Slide13Radiologic TestingX-rays, CT, MRI for abnormalities/asymmetry (often not helpful)
Fluoroscopic or CT guided SI Joint injection
(pain relief)
Slide14SIJ Dx InjectionOne injection that
↓↓
’
s at least 75% of pain2 injections where both
↓↓ at least 50% of pain
Slide15Non-Op RXPhysical therapy, manipulations/modalitiesNSAIDs
Muscle relaxants
“Pelvic belt”
SI steroid injection
No data to support
Slide16“Fusion” CandidateSI Joint pain = chronic
SI Joint = primary pain generator (other primary causes ruled out)
+ response to diagnostic injection(s)
Slide17Evidence Mixed for Open FusionAll Level IV
Published Clinical Evidence
12 Articles
Describe a wide variety of proceduresFibular allograft dowelsScrews, rods, platesAnterior/posterior exposureAll retrospective case seriesTotal of 261 patientsMixed results
Article
Pts
Results
*
McGuire 2012
37
Good pain relief; Fusion = 89.5%
+
Kibsgard 2012
50
1yr = 48% good, 28% poor, 24% fair;
No sig diff in ODI, VAS, SF-36 between surgery and non-surgery.
-
Schutz 2006
17
LOS 25.2 days; Satisfaction = 18%; Fusion = 35%
-
Buchowski 2005
20
LOS 5.2 days; SF-36 sig improve; 60% would do surgery again.
+
Giannikas 2004
5
Pain relief in 4 out of 5
+
Belanger 2001
4
All fused, returned to work, satisfied.
+
Moore 1997
77
80.5% success.
+
Keating 1995
26
Pain decreased, improved work status.
+
Waisbrod 1987
21
52% (11/21) satisfactory results.
-
Slide18Key MIS SI Joint Fusion Articles
Article
N
Design
Results
Product
Polly, Neurosurgery
Whang
,
IJSS 2015
148
Prospective,
multi-center, fusion vs non-op, 6 & 12
mo
results
Improvement in pain, function, QOL
iFuse
Capofranco
2015
20
Post-posterior F, prospective, follow-up 1 & 12
mos
Heiney
, IJSS 2015
Systematic Review,
6 & 12
mos
Improvement in back
& leg pain, ODI, & scoliosis questionnaire
iFuse
Duhon – Med Device
Evid
Res 2013
94 (safe &
eff
)
32 (outcomes)
Single arm, prospective, multi-center
Improvement
in pain, back function (ODI) and QOL (SF-36, EQ-5D)
iFuse
Schroeder –
Hosp
Spec
Surg
J 2013
6
Retrospective,
single-center, spine deformity adults w/prior long-fusion; post-op MIS SIJ fusion results, 4-15 mo (10-avg)
Improvement in back
& leg pain, ODI, & scoliosis questionnaire
iFuse
Gaetani
- J
Neurosurg
Sci
2013
12
Retrospective, single-center,
8-18 mo f/u.
Improvement in pain, back function (ODI) and QOL (SF-36)
iFuse
Graham Smith – Ann
Surg
Innov
Res 2013
149 Open
114 MIS
Retrospective, Open
vs. MIS, 24-mo f/u
MIS significantly better than open
Open vs. iFuse
Mason –
Eur
Spine J 2013
55
Prospective,
single-center, 36-mo avg f/u
Improvement in pain,
QOL, and pelvic
specific questionnaire
Bone
substitute filled screws
Endres – Indian J Orthop 201319Prospective analysis, single center, 13.2 mo f/u (6-24)Improvement pain and ODIDIANA cage into SIJCummings - Ann Surg Innov Res 201318Retrospective, single-center, 12-mo f/u.Improvement in pain and back functioniFuseSachs - Adv Orthop 201340Retrospective, single-center, 12-mo f/u.Improvement in painiFuse
Level IIb
Post Long Fusion
Open vs. MIS
Level I
Level II
Level
II
Slide19Key MIS SI Joint Fusion Articles (cont.)
Article
N
Design
Results
Product
Miller
- Med Dev
Evid
Res 2013
5319
Retrospective analysis, complaint database 4/2009 – 1/2013
Low overall complaint and revision rate
iFuse
Rudolf
- Open
Orthop
J 2013
40
Retrospective, single-center, compares outcomes
of patients with and without prior lumbar fusion,
24-mo f/u.
Significant pain reduction in
all groups, but no prior fusion better
iFuse
Sachs
- Ann
Surg
Innov
Res 2012
11
Retrospective,
single-center,
12-mo f/u.
Improved pain, high
patient satisfaction
iFuse
McGuire –
Evid
Based
Spine Care J 2012
37
Retrospective, single-center, 40-mo
mean f/u.
Improvement in pain, most
achieved fusion
Allograft
dowels longitudinally in SIJ
Rudolf
- Open
Orthop
J 2012
50
Retrospective, single-center, 24-mo f/u.
Rapid & sustained (mean 40mo
f/u)
improvement
in
pain, high
patient satisfaction
iFuse
Khurana
– JBJS
Br 2009
15
Prospective,
single-center, 17-mo mean f/u.
Improved QOL and pelvic scores
Hollow screws across SIJ
Wise – J Spinal
Disord
Tech 2008
13
Prospective, single-center,
24-mo f/u.
Improvement
in pain, fusion at 6mo shown by CT
Threaded cages packed
with BMP
Al-
khayer
– J Spinal
Disord
Tech 2008
9
Retrospective, single center, 12-mo
f/u.
Improvement in pain and ODI
Hollow modular screwsSafety
Slide20Prospective, multi-center, RCT (INSITE) 2-year Results
Polly, et al
–
Int J Spine Surg
2016(39/44 crossed over)
(39/44 crossed over)
Slide21INSITE 2-year Results
iFuse
% subjects
NSM
% subjects
Primary Endpoint
*
Success
82%
26%
Patient
Satisfaction
Very or somewhat satisfied
90%
(6
mo
)
88%
(2
yr
)
61%
(6
mo
)
Clinical Improvement
(Minimum Clinically
Important
Difference)
VAS improvement ≥ 20pt
83%
(2
yr
)
10%
(2
yr
)
ODI improvement ≥ 15pt
68%
(2
yr
)
7.5%
(2
yr
)
Opioid
Use
% change in number of
subjects taking opioids
30%
(
baseline to 2
yr
)
7.5%
(
baseline to 6
mo
)
Polly –
Int
J Spine
Surg
2016
* Binary
success/failure
composite measure
.
Success if all criteria met: VAS SI joint
pain
reduction
≥
20
points,
no device-related SAEs, no neurological worsening, and no surgical re-intervention
for
SI joint
pain.
Slide22Device- or Procedure-Related Adverse Event
22
events: neuropathy (1), urinary retention (1), nausea/vomiting
(
2), atrial
fibrillation (
1), ipsilateral
or
contralateral SIJ
pain and trochanteric bursitis
(9
),
surgical wound
problems
(5),
iliac fracture
(1) and asymptomatic physical exam or radiographic findings (2).
Revision
Surgery
3 iFuse subjects (3%) had a revision surgery through 2 years.
Adverse Events per Subject Frequency (first 180 days)
1.5 iFuse
vs
. 1.3 NSM per subject (
p=0.2253)
INSITE 2-year Results
Safety Profile
Polly –
I
nt
J Spine
Surg
2016
Slide23European Randomized TrialiFuse vs NSM103 pts/9 sites
SIJ fusion
CM
SIJ fusion
CM
VAS
ODI
Slide24(SIFI) Prospective, Single Arm, Multicenter 2-yr Results
172 patients, 26 US sites
Sustained clinical outcomes (VAS, ODI, QOL)Radiographs show high rate (97%) of bony apposition (on at least 2 implants on
both the iliac and sacral sides)Duhon – Int J Spine Surg 2016
53
pt
mean improvement
24
pt
mean improvement
VAS SI Joint Pain
ODI
Slide25Quality of Life (QOL)via Short Form 36 (SF-36)
PCS = Physical Component Summary
MCS = Mental Component Summary
p
< 0.0001for both PCS and MCSPatient Satisfaction(somewhat or very satisfied)93.8%
Opioid Use Reduction
(% subjects using opioids, baseline to 2 year)
28.2%
Effectiveness Outcomes
Duhon
et al.
2-year
Results
QOL and Effectiveness
Slide26Procedure-related 26 events
Buttock pain (2), foot pain related to anesthesia (1), iFuse impingement (3), nausea/vomiting,
SI joint pain (5), SI joint pain due to inadequate stabilization (3), urinary retention (1), vascular injury (1),
wound drainage/irritation/infection (6), wound numbness (1)
Revision Surgery
8
cases
(4.7%)
2
– immediate postop new onset leg pain
due to implant malposition.
Resolved
with slight
repositioning.
4 – minimal pain improvement, CT scan showed suboptimal implant placement (lower implants not sufficiently in the sacrum). Resolved with additional implants.
1 – bilateral SIJ fusion, recurrent pain 6mo later; resolved with open SIJ fusion and additional implant.
1 – subject had L4-S1 fusion 13mo post SIJ fusion, recurrent pain showed S1 screw touching implant. Resolved with additional non-iFuse device put across SI joint.
Device-related
7 events
3
Neuropathy related to
malposition
2 SI joint or buttock pain
1
SI joint pain after fall assoc. with
inadequate
device placement
1
Hip pain related to periosteal bone growth around
implant
SIFI 24-month
Results
Safety Profile
Duhon
et al.
Slide27Consistent Prospective Study ResultsINSITE, iMIA, SIFI
Sturesson –
Eur
Spine J
2016 (iMIA 6mo
)
Polly –
I
nt
J Spine
Surg
2016 (INSITE
2yr)
Duhon –
Int
J Spine
Surg
2016 (
SIFI 2yr)
Slide2811 Studies: Rapid and Sustained Pain Relief
VAS
Slide29Systematic ReviewAll published cohorts of lateral approach joint-transfixing SIJ fusion
Most cohorts
(85%*) were
treated with iFuse Implant System* 368 of 432 unique patients
Heiney – Int J Spine Surg 2015Gray line shows regression fit
Slide30Slide31SI Joint Fusion: SummarySI joint is pain generator with relatively high prevalenceCorrect diagnosis key (thorough SI joint exam, provocative tests, injections)
Treatment options
Conservative care
MIS SIJ Fusion option when conservative care failsSI Joint pathology is an economic burden, cost effective options needed
Slide32In properly selected patients, MIS SI joint fusions have strong clinical evidence we are not doing enoughThere is data Level I
→
IV
Peer review journalsPresentations – Academic SocietiesJust because we have not paid attention to this in the pastThe literature strongly supports getting our head out of the sand
Slide33Thank You