ISASS Policy 2016 Update – Minimally Invasive Sacroiliac Joint Fusion

Morgan P. Lorio

doi:10.14444/3026

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Table 1

ICD-10-CM Diagnosis.

ICD-10-CM Diagnosis Code	Code 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

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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 specified	Results Mean (±SD) or (range) unless otherwise specified	Complications (n)
Sturesson 201618	Prospective, multicenter, randomized controlled trial (Only surgical arm reported herein) (iMIA, ClinicalTrials.gov NCT01741025)	52	iFuse Implant System	Lateral approach	Age: 49.4 (27-70) years Sex: 38F/14M Prior lumbar fusion: 34.6% Follow-up: 6mo	LBP 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) days	Within 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 System	Lateral approach	Age: 50.2 (26-72) years Sex: 75F/27M Prior lumbar fusion: 39% Follow-up: 12mo	VAS: 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) days	Procedure-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 System	Lateral approach	Age: 53.0 (11.5) years Sex: 20F/15M Prior lumbar fusion: 39% Follow-up: 6mo post-fusion	VAS: 83.9 pre- op, 35.8 at 6mo post MIS SIJ fusion ODI: 58.3 pre- op, 30.2 at 6mo post MIS SIJ fusion
Duhon 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 System	Lateral approach	Age: 50.9 (24-72) years Sex: 120F/52M Prior lumbar fusion: 44% Follow-up: 24mo	VAS 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) day	Device-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) Subsets	20 (Females with PPGP)	iFuse Implant System	Lateral approach	Age: 43.3 (9.0) years Sex: 20F Prior lumbar fusion: 30% Follow-up: 12mo	VAS 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 satisfied	37 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 System	Lateral approach	Age: 52.5 (11.1) years Sex: 100F Prior lumbar fusion: 42.2% Follow-up: 12mo	VAS 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 satisfied	158 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 System	Lateral approach	Age: 50.7 (11.4) years Sex: 52M Prior lumbar fusion: 51.6% Follow-up: 12mo	VAS 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 satisfied	88 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 System	Lateral 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) mL	Immediate post-op pain (4-resolved), temporary post-op radicular pain (2)
Rudolf 201433	Single center case series	17	iFuse Implant System	Lateral 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) min	No intraoperative complications, hematoma (1), cellulitis (2), deep wound infection secondary to diverticulitis (1)
Sachs 201432	Multicenter, retrospective	144	iFuse Implant System	Lateral approach	Age: 58 (30-89) years Sex: 30F/10M Prior lumbar fusion: 62% Follow-up: 16 (12-26) mo	VAS: 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 days	No 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 System	Lateral approach	Age: 58 (30-81) years Sex: 30F/10M Prior lumbar fusion: 30% Follow-up: 12 mo	VAS: 8.7 (1.5) pre-op, 0.9 (1.6) at 12mo 98% reached MCID 100% patient satisfaction	Piriformis syndrome (1), new LBP (1), facet joint pain (8), trochanteric bursitis (2)
Cummings 201343	Single center, retrospective case series	18	iFuse Implant System	Lateral approach	Age: 64 (39-81) years Sex: 12F/6M Prior lumbar fusion: 61% Follow-up: 12 mo	VAS: 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 12mo	Trochanteric bursitis (3), hematoma (1), fluid retention (1), toe numbness (1), implant malposition (1)
Gaetani 201329	Single center, retrospective case series	10	iFuse Implant System	Lateral approach	Age: 53.2 (36-71) years Sex: 12F Prior lumbar fusion: 8.3% Follow-up: 10 (8-18) mo	VAS: 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 fusion	Local hematoma (2), low back pain (1)
Schroeder 201344	Single center, retrospective case series	6	iFuse Implant System	Lateral approach	Age: 50 (25-60) years Sex: 6F/0M Prior lumbar fusion: 100% (deformity correction) Follow-up: 10.25 (4-15) mo	VAS: 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 patients	No intraoperative or post-operative complications.
Rudolf 201341	Single center, sub-group analysis	40	iFuse Implant System	Lateral 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 System	Lateral approach	Age: 49 (12) Sex: 12F/6M	VAS decrease at 12mo: -5.94 (3.3) VAS decrease at 24mo: -5.47 (2.88) Surgical time: 60 (19) min	Superficial cellulitis (2), wound infection (1), revision for implant malposition (1)
		15 (prior fusion)	iFuse Implant System	Lateral approach	Age: 58 (11) Sex: 11F/4M	VAS decrease at 12mo: -3.50 (3.46) VAS decrease at 24mo: -5.81 (2.88) Surgical time: 64 (19) min	Superficial cellulitis (2), buttock hematoma (1), revision for implant malposition (1)
		7 (prior concomitant lumbar pathology treated non-surgically	iFuse Implant System	Lateral approach	Age: 58 (17) Sex: 3F/4M	VAS decrease at 12mo: -3.71 (3.11) VAS decrease at 24mo: -4.79 (4.28) Surgical time: 64 (19) min	None
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) mo	VAS: 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 implant	No 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) mo	VAS: 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-up	Post-op nerve pain requiring reoperation (2)
Rudolf 201228	Single center, retrospective case series	50	iFuse Implant System	Lateral approach	Age: 54 (24-85) years Sex: 34F/16M Prior lumbar fusion: 44% Follow-up: 40 (24-56) mo	VAS: 7.6 pre- op, 2.0 at follow-up 82% reached MCID 82% patient satisfaction Surgical time: 65 (26) min	Superficial cellulitis (3), deep wound infection (1), hematoma (2), reoperation (3)
Sachs 201242	Single center, retrospective case series	11	iFuse Implant System	Lateral approach	Age: 65 (45-82) years Sex: 10F/1M Prior lumbar fusion: 18% Follow-up: 12 mo	VAS: 7.9 (2.2) pre-op, 2.3 (3.1) at 12mo Surgical time: 77.5 (31.8) min EBL: 21.8 (18.9) mL	Piriformis syndrome (1), low back pain (1)
McGuire 201221	Retrospective case series	37	Fibular allograft dowels	Posterior, longitudinally inserted into SI joint	Age: 42.5 (23-63) Years Sex: 34F/3M Follow-up: 39.6 (8-62) mo	Baseline 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) mo	SF-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) days	No 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) mo	VAS 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 cohort	13	Titanium cage packed with BMP	Posterior, Longitudinally inserted into SIJ	Age: 53.1 (45-62) years Sex: 12F/1M Prior lumbar fusion: 61.5% Follow-up: 29.5 (24-35) mo	Back 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 6mo	Reoperation 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 System	Lateral approach	MIS Cohort Age: 47.9 (13.1) years Sex: 17F/5M Prior lumbar fusion: 64% Follow-up: median 15 (12-26) mo	ODI: 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) days	Pulmonary embolism that resolved with treatment (1), revisions due to halo formation on the sacral side with recurring sacroiliac joint pain (2)
Ledonio 201445	Single center, retrospective, comparative cohort study	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) mo	ODI: 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) days	Pulmonary embolism (1), revision due to failed implant and nerve root irritation (2)
Ledonio 201446	Multicenter, retrospective, comparative cohort study	17	iFuse Implant System	Lateral approach	MIS Cohort Age: median 66 (39-82) years Sex: 11F/6M Prior lumbar fusion: 82% Follow-up: 12 mo	Values 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) days	Transient trochanteric bursitis (3), hematoma (1), transient toe numbness (1), revision due to malpositioned implant (1)
Ledonio 201446	Multicenter, retrospective, comparative cohort study	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 mo	Values 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) days	Pulmonary embolism (1), revision due to failed implant and nerve root irritation (2)
Graham- Smith 201326	Multicenter, retrospective comparative cohort study	114	iFuse Implant System	Lateral approach	MIS Cohort Age: 57.4 (14.0) years Sex: 82F/32M Prior lumbar fusion: 47.4% Follow-up: 24 mo	VAS: 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) Days	No intraoperative. Postop repositioning of implants (4), 3.5% (4/114).
Graham- Smith 201326	Multicenter, retrospective comparative cohort study	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 mo	VAS: 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) Days	No 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.