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) | |
| 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) | |
| 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). | |
| 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.