Article Figures & Data
Tables
ICD-10-CM
Diagnosis CodeCode Descriptor M46.1 Sacroiliitis, not elsewhere classified M53.2x8 Spinal instabilities, sacral and sacrococcygeal region M53.3 Disorders of sacrum S33.2xxA Dislocation of sacroiliac and sacrococcygeal joint S33.6xxA Sprain of sacroiliac joint 099.89 Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium 094 Sequelae of complication of pregnancy, childbirth and the puerperium - Table 2
Published literature on minimally invasive SIJ fusion.
Inclusion criteria: indexed in PubMed, English language, fusion of the SIJ described as minimally invasive or percutaneous, and clinical outcomes available. Single patient case reports, imaging studies, and technique reports with no clinical outcomes are excluded. When multiple reports of the same cohort were published, only the most recent (longest follow-up) publication is summarized.
Author, Year Study design N Implant Technique Demographics
Mean (±SD) or (range), unless otherwise specifiedResults
Mean (±SD) or (range) unless otherwise specifiedComplications (n) Sturesson 201618 Prospective, multicenter, randomized controlled trial
(Only surgical arm reported herein)
(iMIA,
ClinicalTrials.gov NCT01741025)52 iFuse
Implant
SystemLateral approach Age: 49.4 (27-70)
years
Sex: 38F/14M Prior lumbar
fusion: 34.6%
Follow-up: 6moLBP VAS: 77.7 pre-op, 34.4 at 6mo for an improvement of 43.3 (25.0)
ODI: 56.6 pre-op; improvement of 25.5 at 6mo
90% very or somewhat satisfied
80% would definitely have the surgery again
Surgical time: 54 (19-107) min
Fluoroscopy time: 2.1 (1.0-4.0) min
Hospital stay: 3 (range 1-28) daysWithin 180 days: 10 AEs in 9 subjects (0.19 events per subject), 8 severe AEs: device-related (0), procedure-related (2, both resolved).
Device- and procedure-related events: postop radicular pain resulting from implant protrusion into foramen (1, resolved), postop hematomas (2, resolved).
No subject has undergone late revision of implants.Polly 201519
(prior pubs from same cohort/trial: Whang 2015 - 6mo results51)Prospective, multicenter, randomized controlled trial
(Only surgical arm reported herein)
(INSITE,
ClinicalTrials.gov NCT01681004)102 iFuse
Implant
SystemLateral approach Age: 50.2 (26-72)
years
Sex: 75F/27M
Prior lumbar
fusion: 39%
Follow-up: 12moVAS: 82.3 (11.9) pre-op, 28.3 (29.3) at 12mo
ODI: 57.2 (12.8) pre-op, 28.1 (20.8) at 12mo
Surgical time: 44.9 (22.3) min
Fluoroscopy time: 2.5 (3.6) min
EBL: 32.7 (32.8) mL
Hospital stay: 0.8 (range 0-7) daysProcedure-related adverse events within the first 6mo (180 days):
neuropathic symptoms (2), postoperative medical problems (4: urinary retention, nausea/vomiting, atrial fibrillation), SIJ pain or trochanteric bursitis (4), surgical wound problems (4), iliac fracture (1), asymptomatic physical examination
finding (1)35 of 44
(NSM patients
that crossed over after 6mo visit)iFuse
Implant
SystemLateral approach Age: 53.0 (11.5)
years
Sex: 20F/15M
Prior lumbar
fusion: 39%
Follow-up: 6mo post-fusionVAS: 83.9 pre- op, 35.8 at 6mo post MIS SIJ fusion
ODI: 58.3 pre- op, 30.2 at 6mo post MIS SIJ fusionDuhon 201631
(Prior pubs from same cohort/trial: Duhon 2015 - 12mo results52, Duhon 2013 - 6mo interim results53)Prospective, multicenter
(SIFI,
ClinicalTrials.gov NCT01640353)172 iFuse
Implant
SystemLateral approach Age: 50.9 (24-72) years
Sex: 120F/52M
Prior lumbar fusion: 44%
Follow-up: 24moVAS SI joint pain: 79.8 (12.8) pre-op, 30.4 (27.6) at 12mo, 26.0 (26.7) at 24mo
ODI: 55.2 (11.5) pre-op, 31.5 (19.2) at 12mo, 30.9 (20.5) at 24mo
SF-36 PCS: 31.7 (5.6) pre-op, 40.5 (9.6) at 12mo, 40.7 (10.3) at 24mo
SF-36 MCS: 38.5 (11.3) pre-op, 48.2 (12.3) at 12mo, 49.0 (11.5) at 24mo
EQ-5D TTO: 0.43 (0.18) pre-op, 0.71 (0.20) at 12mo, 0.71 (0.22) at 24mo
Surgical time: 46.6 (16.1) min Fluoroscopy time: 2.7 (1.8) min
EBL: 51.0 (75.8) mL
Hospital stay: median 1 (range 0-7) dayDevice-related:
Neuropathic pain related to device malposition (3), SI joint or buttock pain (2), SI joint pain after fall associated with inadequate device placement (1), Hip pain related to periosteal bone growth around implant (1)
Procedure-related:
Wound drainage/irritation/infection (6), SI joint pain (5), SI joint pain (inadequate stabilization) (3), implant impingement (3), nausea/vomiting (3), buttock pain (2), foot weakness related to anesthesia (1), urinary retention (1), vascular injury (1), wound numbness (1)Capobianco 201554 Prospective, multicenter
(SIFI, ClinicalTrials.gov NCT01640353)
Subsets20
(Females with PPGP)iFuse
Implant
SystemLateral approach Age: 43.3 (9.0)
years
Sex: 20F
Prior lumbar
fusion: 30%
Follow-up: 12moVAS SI joint pain: 81.9 (10.0) pre-op, 21.3 (17.6) at 6mo, 31.4 (30.9) at 12mo
ODI: 52.2 (12.7) pre-op, 30.4 (20.0) at 6mo, 32.8 (21.4) at 12mo
SF-36 PCS: 32.0 (5.6) pre-op, 40.0 (11.1) at 6mo, 41.6 (10.8) at 12mo
SF-36 MCS: 42.2 (12.4) pre-op, 49.7 (9.6) at 6mo, 49.0 (10.8) at 12mo
EQ-5D TTO: 0.42 (0.14) pre-op, 0.72 (0.23) at 6mo, 0.72 (0.21) at 12mo
100% very or somewhat satisfied37 total adverse events (1.8 event rate per subject)
4 device/procedure-related: wound infection (2), numbness around wound (1), fall causing SI joint pain (1)100
(Females with No
PPGP)iFuse
Implant
SystemLateral approach Age: 52.5 (11.1)
years
Sex: 100F
Prior lumbar
fusion: 42.2%
Follow-up: 12moVAS SI joint pain: 79.9 (13.3) pre-op, 31.5 (27.0) at 6mo, 32.7 (28.5) at 12mo
ODI: 55.0 (11.2) pre-op, 31.0 (18.7) at 6mo, 30.8 (19.1) at 12mo
SF-36 PCS: 31.1 (5.6) pre-op, 40.5 (9.2) at 6mo, 40.0 (9.6) at 12mo
SF-36 MCS: 37.7 (11.6) pre-op, 48.8 (10.8) at 6mo, 47.7 (12.9) at 12mo
EQ-5D TTO: 0.43 (0.18) pre-op, 0.70 (0.19) at 6mo, 0.70 (0.20) at 12mo
84% very or sovmewhat satisfied158 total adverse events (1.6 event rate per subject)
10 device/procedure-related: buttock pain (2), post-op neuropathy (1), post-op nausea/vomiting (3), intraop hemorrhage (1), neuropathy after contralateral SIJ fusion revision (1), urinary retention (1), would drainage (1)52
(Men)iFuse
Implant
SystemLateral approach Age: 50.7 (11.4)
years
Sex: 52M
Prior lumbar fusion: 51.6%
Follow-up: 12moVAS SI joint pain: 78.9 (12.9) pre-op, 30.2 (28.0) at 6mo, 25.0 (24.0) at 12mo
ODI: 56.7 (11.5) pre-op, 36.4 (21.4) at 6mo, 31.9 (18.9) at 12mo
SF-36 PCS: 32.7 (5.5) pre-op, 39.8 (10.1) at 6mo, 40.5 (8.9) at 12mo
SF-36 MCS: 38.6 (10.3) pre-op, 45.1 (13.2) at 6mo, 48.0 (12.1) at 12mo
EQ-5D TTO: 0.45 (0.19) pre-op, 0.64 (0.25) at 6mo, 0.72 (0.19) at 12mo
91.3% very or somewhat satisfied88 total adverse events (1.7 event rate per subject)
7 device/procedure-related: wound infection (2), buttock pain (1), post-op neuropathy (1), SI joint pain (2), staple irritation (1)Vanaclocha 201430 Single center case series 24 iFuse
Implant
SystemLateral approach Age: 47.4 (3271) years
Sex: 15F/9M
Prior lumbar fusion: 2
Follow-up: 23 mo (1-4.5 years)VAS: 8.7 pre-op, 1.7 at 1yr, 2.1 at 4.5yrs
ODI: 54.1 pre- op, 14.3 at 1yr, 16.3 at 4.5yrs
Surgical time: 48 (range 40-65) min
EBL: 58 (range 40-70) mLImmediate post-op pain (4-resolved), temporary post-op radicular pain (2) Rudolf 201433 Single center case series 17 iFuse
Implant
SystemLateral approach Age: 58 (36-85)
years
Sex: 13F/4M
Prior lumbar
fusion: 8 (47%)
Follow-up: 60 mo
Bridging bone: 87% (13/15)VAS: 8.3 (1.4) pre-op, 3.4 (2.4) at 1yr, 1.4 (2.6) at 2yrs, 2.4 (2.2) at
5yrs
ODI: 21.5 (22.7) at 5yrs
Surgical time: 65 (18) minNo intraoperative complications, hematoma (1), cellulitis (2), deep wound infection secondary to diverticulitis (1) Sachs 201432 Multicenter, retrospective 144 iFuse Implant
SystemLateral approach Age: 58 (30-89)
years
Sex: 30F/10M
Prior lumbar fusion: 62%
Follow-up: 16
(12-26) moVAS: 8.6 pre-op, 2.7 at follow-up
91% Very or somewhat satisfied
91.7% would have surgery again
Surgical time: 73min
EBL: 31mL
Hospital stay: 0.8 daysNo intraoperative complications.
28 post-op complications, most common: fall (5), trochanteric bursitis (4), piriformis syndrome (3), facet pain (3).
1 implant revision (1-year revision rate 0.7%),Sachs 201355 Single center, retrospective case series 40 iFuse
Implant
SystemLateral approach Age: 58 (30-81) years
Sex: 30F/10M Prior lumbar
fusion: 30%
Follow-up: 12 moVAS: 8.7 (1.5) pre-op, 0.9 (1.6) at 12mo
98% reached MCID
100% patient satisfactionPiriformis syndrome (1), new LBP (1), facet joint pain (8), trochanteric bursitis (2) Cummings 201343 Single center, retrospective case series 18 iFuse
Implant
SystemLateral approach Age: 64 (39-81)
years
Sex: 12F/6M
Prior lumbar fusion: 61%
Follow-up: 12 moVAS: 8.9 (1.9) pre-op, 2.3 (2.1) at 12mo
90% reached MCID
ODI: 52.6 (18.8) pre-op, 13.2 (12.6) at 12mo
SF-12 PCS: 37.8 (10.4) pre-op, 44.6 (10.5) at 12moTrochanteric bursitis (3), hematoma (1), fluid retention (1), toe numbness (1), implant malposition (1) Gaetani 201329 Single center, retrospective case series 10 iFuse
Implant
SystemLateral approach Age: 53.2 (36-71)
years
Sex: 12F Prior
lumbar fusion: 8.3%
Follow-up: 10
(8-18) moVAS: 7.7 (1.3) pre-op, 3 (1.2) at
follow-up
ODI: 31.4 (6.3) pre-op, 12 (3.5) at follow-up
RDQ: 17.6 (1) pre-op, 3 (4.1) at follow-up
Surgical time: 65 (16) min
EBL: <45 mL
3 month CT scans show initial fusionLocal hematoma (2), low back pain (1) Schroeder 201344 Single center, retrospective case series 6 iFuse
Implant
SystemLateral approach Age: 50 (25-60)
years
Sex: 6F/0M Prior
lumbar fusion: 100% (deformity correction) Follow-up: 10.25
(4-15) moVAS: 7.83 pre- op, 2.67 at follow-up
ODI: 22.1 pre- op, 10.5 at follow-up
Hospital stay: 2 days (range 1-4) Bony bridging seen in 4 patientsNo intraoperative or post-operative complications. Rudolf 201341 Single center, sub-group analysis 40 iFuse
Implant
SystemLateral approach Subgroup analysis from Rudolf 2012 to assess effect of prior lumbar fusion or lumbar treatment on outcomes. Follow up: 12 and 24 months 18 (no prior fusion) iFuse
Implant
SystemLateral approach Age: 49 (12)
Sex: 12F/6MVAS decrease at 12mo: -5.94 (3.3)
VAS decrease at 24mo: -5.47 (2.88)
Surgical time: 60 (19) minSuperficial cellulitis (2), wound infection (1), revision for implant malposition (1) 15 (prior fusion) iFuse
Implant
SystemLateral approach Age: 58 (11)
Sex: 11F/4MVAS decrease at 12mo: -3.50 (3.46)
VAS decrease at 24mo: -5.81 (2.88)
Surgical time: 64 (19) minSuperficial cellulitis (2), buttock hematoma (1), revision for implant malposition (1) 7 (prior concomitant lumbar pathology treated non-surgically iFuse
Implant
SystemLateral approach Age: 58 (17)
Sex: 3F/4MVAS decrease at 12mo:
-3.71 (3.11)
VAS decrease at 24mo:
-4.79 (4.28)
Surgical time: 64 (19) minNone Endres 201338 Single center, Retrospective case series 19 DIANA
cage
[Product not
approved for use in the US]Posterior, longitudinally inserted into SI joint Age: 60.9 (36-76)
years
Sex: 5F/14M
Prior lumbar
fusion: 100%
Follow-up: 13.2
(6-24) moVAS: 8.5 (7.5-9) pre-op to 6.0 (2.2-9) at follow-up
ODI: 64.1 (40-82) pre-op to 56.97 (8-82) at follow-up
EBL: <150mL
Hospital stay: 7.3 (3-10) days
Fusion rate: 78.9% (15/19 joints), defined as lack of loosening and evidence of bone bridging around the implantNo neurovascular complications Mason 201336 Retrospective case series 55 HMA screw packed with DBM Lateral approach Age: 57 years
Sex: 46F/9M
Prior lumbar fusion: 40%
Follow-up: 36
(12-84) moVAS: 8.05 (1.9) pre-op, 4.48 (2.81) at follow-up
SF-36PCS: 26.6 (15.2) pre-op, 43 (22.68) follow-up
Majeed scoring: 36.18 (15.08) pre- op, 64.78 (20.18) follow-upPost-op nerve pain requiring reoperation (2) Rudolf 201228 Single center, retrospective case series 50 iFuse
Implant
SystemLateral approach Age: 54 (24-85)
years
Sex: 34F/16M
Prior lumbar fusion: 44%
Follow-up: 40 (24-56) moVAS: 7.6 pre- op, 2.0 at follow-up
82% reached MCID
82% patient satisfaction
Surgical time: 65 (26) minSuperficial cellulitis (3), deep wound infection (1), hematoma (2), reoperation (3) Sachs 201242 Single center, retrospective case series 11 iFuse
Implant
SystemLateral approach Age: 65 (45-82) years
Sex: 10F/1M
Prior lumbar
fusion: 18%
Follow-up: 12 moVAS: 7.9 (2.2) pre-op, 2.3 (3.1) at 12mo
Surgical time: 77.5 (31.8) min
EBL: 21.8 (18.9) mLPiriformis syndrome (1), low back pain (1) McGuire 201221 Retrospective case series 37 Fibular allograft dowels Posterior, longitudinally inserted into
SI jointAge: 42.5 (23-63)
Years
Sex: 34F/3M
Follow-up: 39.6 (8-62) moBaseline VAS: 9.1 Final VAS: 3.4
Fusion rate: 89.5%Nonunion requiring revision (4) (10.5%) Khurana 200935 Retrospective case series 15 HMA screw packed with DBM Lateral approach Age: 48.7 (37.3-62.6) years
Sex: 11F/4M
Prior lumbar fusion: 40%
Follow-up: 17
(9-39) moSF-36 PF: 37.15 (14.28) pre- op, 79.33 (12.52) at follow-up
Majeed's: 37 (18-54) pre- op, 79 (63-96) at follow-up
Good to excellent results: 13/15 (87%) EBL: < 50 ml
Hospital stay: 2.7 (1-7) daysNo post-operative neurological or wound complications. Al-Khayer 200834 Retrospective case series 9 HMA screw packed with DBM Lateral approach Age: 42 (35-56)
years
Sex: 9F
Follow-up: 40 (24-70) moVAS decreased: 8.1 (7-9) to 4.6 (3-7)
ODI decreased: 59 (34-70) to 45 (28-60)
EBL: <50 ml
Hospital stay: 6.9 (2-11) days Return to work: 44.44%Deep wound infection requiring debridement and IV antibiotics (1) Wise 200837 Single center
Prospective
cohort13 Titanium
cage
packed
with BMPPosterior, Longitudinally inserted into SIJ Age: 53.1 (45-62)
years
Sex: 12F/1M
Prior lumbar fusion: 61.5%
Follow-up: 29.5
(24-35) moBack VAS improved by 4.9 pts Leg VAS improved by 2.4 pts
EBL: < 100 ml
Hospital stay: 1.7 days
Fusion rate: 89% (17/19 joints) on CT at 6moReoperation via open arthrodesis secondary to nonunion and persistent pain (1) Comparative cohort studies of open surgery vs MIS Ledonio 201445 Single center, retrospective, comparative cohort study 22 iFuse
Implant
SystemLateral approach MIS Cohort
Age: 47.9 (13.1)
years
Sex: 17F/5M
Prior lumbar fusion: 64%
Follow-up: median 15
(12-26) moODI: 61.5 (12.5) pre-op, 52 (16.9) at follow-up
Surgical time: 68.3(26.8) min
EBL: 40.5 (31.4) mL
Hospital Stay: 2.0 (1.5) daysPulmonary embolism that resolved with treatment (1), revisions due to halo formation on the sacral side with recurring sacroiliac joint pain (2) 22 3 hole, 4.5mm plate, autograft packed within joint Anterior approach through an ilioinguinal incision Open Cohort
Age: 51 (9.4)
years
Sex:13F/9M
Prior lumbar
fusion: 50%
Follow-up: median 13 (11-33) moODI: 61.8 (10.8) pre-op, 47.4 (21.7) at follow-up
Surgical time: 128 (27.9) min
EBL: 168.8 (479.0) mL
Hospital Stay: 3.3 (1.1) daysPulmonary embolism (1), revision due to failed implant and nerve root irritation (2) Ledonio 201446 Multicenter, retrospective, comparative cohort study 17 iFuse
Implant
SystemLateral approach MIS Cohort
Age: median 66 (39-82) years
Sex: 11F/6M
Prior lumbar fusion: 82%
Follow-up: 12 moValues reported as median (range)
ODI: 53 (14-84) pre-op, 13 (0-38) at 12 mo
Surgical time: 27 (18-72) min
Hospital Stay: 1 (1-2) daysTransient trochanteric bursitis (3), hematoma (1), transient toe numbness (1), revision due to malpositioned implant (1) 22 3 hole, 4.5mm plate, autograft packed within joint Anterior approach through an ilioinguinal incision Open Cohort
Age: median 51 (34-74) years
Sex: 82F/32M
Prior lumbar fusion: 47%
Follow-up: 24 moValues reported as median (range)
ODI: 64 (44-78) pre-op, 46 (10-80) at 12 mo
Surgical time: 128 (73-180) min
Hospital Stay: 3 (2-6) daysPulmonary embolism (1), revision due to failed implant and nerve root irritation (2) Graham- Smith 201326 Multicenter, retrospective comparative cohort study 114 iFuse
Implant
SystemLateral approach MIS Cohort
Age: 57.4 (14.0)
years
Sex: 82F/32M
Prior lumbar fusion: 47.4%
Follow-up: 24 moVAS: 8.3 (1.6) pre-op, 2.3 (2.6) at 12mo, 1.7 (2.9) at 24mo
MCID: 86% reached at 12mo, 82% at 24mo
Surgical time: 70 (24) min
EBL: 33 (27) mL
Hospital stay: 1.3 (0.5)
DaysNo intraoperative.
Postop repositioning of implants (4), 3.5% (4/114).149 Screws, plates Open posterior approach Open Cohort
Age: 45.8 (11.3)
years
Sex: 103F/46M
Prior lumbar fusion: 23.5%
Follow-up: 24 moVAS: 7.1 (1.9) pre-op, 4.6 (3.0) at 12mo, 5.6 (2.9) at 24mo
MCID: 61% reached at 12mo, 50% at 24mo
Surgical time: 163 (25) min
EBL: 288 (182) mL
Hospital stay: 5.1 (1.9)
DaysNo intraoperative.
Postop removal of implants (66), 44% (66/149).NOTE: The table excludes 3 systematic reviews:
Zaidi - J Neurosurg Spine 201549: systematic review of studies on SIJ fusion, includes open and MIS.
Heiney - Int J Spine Surg 201548: systematic review and meta-analysis of MIS SIJ fusion utilizing a lateral transarticular technique.
Lingutla - Eur Spine J 201656: Systematic review and meta-analysis of observational studies describing outcome of SIJ fusion in patients with LBP.
Abbreviations: SIJ: sacroiliac joint; MIS: minimally invasive surgery/surgical; F: female; M: male; EBL: estimated blood loss; mo: month; ODI: Oswestry Disability Index; VAS: Visual Analog Scale; NSM: Non-surgical management;
DBM: demineralized bone matrix; HMA: hollow modular anchorage; BMP: bone morphogenic protein.