Safety and 6-month effectiveness of minimally invasive sacroiliac joint fusion: a prospective study

Abstract

BackgroundSacroiliac (SI) joint pain is an often overlooked cause of low back pain. SI joint arthrodesis has been reported to relieve pain and improve quality of life in patients suffering from degeneration or disruption of the SI joint who have failed non-surgical care. We report herein early results of a multicenter prospective single-arm cohort of patients with SI joint degeneration or disruption who underwent minimally invasive fusion using the iFuse Implant System®.MethodsThe safety cohort includes 94 subjects at 23 sites with chronic SI joint pain who met study eligibility criteria and underwent minimally invasive SI joint fusion with the iFuse Implant System® between August 2012 and September 2013. Subjects underwent structured assessments preoperatively, immediately postoperatively, and at 1, 3, and 6 months postoperatively, including SI joint and back pain visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form-36 (SF-36), and EuroQoL-5D (EQ-5D). Patient satisfaction with surgery was assessed at 6 months. The effectiveness cohort includes the 32 subjects who have had 6-month follow-up to date.ResultsMean subject age was 51 years (n=94, safety cohort) and 66% of patients were women. Subjects were highly debilitated at baseline (mean VAS pain score 78, mean ODI score 54). Three implants were used in 80% of patients; two patients underwent staged bilateral implants. Twenty-three adverse events occurred within 1 month of surgery and 29 additional events occurred between 30 days and latest follow-up. Six adverse events were severe but none were device-related. Complete 6-month postoperative follow-up was available in 26 subjects. In the effectiveness cohort, mean (± standard deviation) SI joint pain improved from a baseline score of 76 (±16.2) to a 6-month score of 29.3 (±23.3, an improvement of 49 points, P<0.0001), mean ODI improved from 55.3 (±10.7) to 38.9 (±18.5, an improvement of 15.8 points, P<0.0001) and SF-36 PCS improved from 30.7 (±4.3) to 37.0 (±10.7, an improvement of 6.7 points, P=0.003). Ninety percent of subjects who were ambulatory at baseline regained full ambulation by month 6; median time to full ambulation was 30 days. Satisfaction with the procedure was high at 85%.ConclusionMinimally invasive SI joint fusion using the iFuse Implant System® is safe. Mid-term follow-up indicates a high rate of improvement in pain and function with high rates of patient satisfaction.

One-year outcomes after minimally invasive sacroiliac joint fusion with a series of triangular implants: a multicenter, patient-level analysis

“…The type and number of postsurgical adverse events in our study was commensurate with other published studies using this device system 15,24–26. The most commonly reported complications in the cohort reported herein were trochanteric bursitis and piriformis syndrome.…”

A systematic review of minimally invasive sacroiliac joint fusion utilizing a lateral transarticular technique

“…A total of 18 articles were identified. The study design and number of these are as follows: 10 retrospective single-center case series, 12,34,35,37,38,[44][45][46][47][48] 2 prospective single center case series, 36,49 1 multi-center retrospective case series, 50 1 single center, 27 and 2 multicenter 26,28 comparative cohort studies, one prospective single-arm study, 24 and one prospective multicenter randomized controlled trial 39 (Table 1). Two types of implants are represented: 3 studies reported the use of a single hollow modular anchorage (HMA) screw packed with demineralized bone matrix and 15 described the placement of a series (typically 3) of triangular, porous titanium plasma spray (TPS) coated implants.…”

“…non-weight bearing status), open surgical repair is typically reserved for only the most severe cases. 24,25 More recently, minimally invasive surgical (MIS) methods have become available. Compared to open surgery, minimally invasive techniques are typically associated with less blood loss, shorter hospital stay, and less perioperative morbidity; these are likely attributable to smaller surgical incisions and less soft tissue dissection.…”

Sacroiliac Joint Fusion: One Year Clinical and Radiographic Results Following Minimally Invasive Sacroiliac Joint Fusion Surgery

“…Additionally, 15 of 18 patients were discharged on the same day as their procedure using the SImmetry system, resulting in a shorter mean length of stay than other MIS systems [45]. These data are in contrast with other MIS procedures or open fusion, which routinely require a hospital stay of 1 to 5 days [31, 45, 46]. …”