Invasive Sacroiliac Joint Fusion Research Articles

Double-center observational study of minimally invasive sacroiliac joint fusion for sacroiliac joint dysfunction: one-year results

BackgroundFor a substantial part of patients with chronic low back pain, the origin is located in the sacroiliac joint (SIJ). Minimally invasive sacroiliac joint fusion (MISJF) is increasingly being implemented as a treatment option in SIJ dysfunction. Despite remaining controversy, evidence continues to increase. This study evaluates the clinical results and safety of MISJF in a double-center consecutive case series in patients with SIJ dysfunction over a one-year observation period.MethodsSIJ complaints were diagnosed after history taking, physical examination and least a 50% reduction of SIJ pain 30–60 min following image-guided injection. Primary outcome measures were patient reported outcome measurements (PROMs), consisting of Visual Analogue Scale (VAS) pain score and EuroQol 5-dimensions 3-levels (EQ-5D-3L). Patients’ perspectives on the effects of surgery were collected through questionnaires. Secondary outcome measures were implant positioning and (serious) adverse events ((S)AE’s).ResultsA total of 29 patients were included. In 44.8% of patients, SIJ dysfunction was of postpartum origin. The mean VAS-pain score improved from 7.83 (± 1.71) to 4.97 (± 2.63) postoperatively (p < 0.001). EQ-5D-3L score improved from 0.266 (± 0.129) to 0.499 (± 0.260) postoperatively (p < 0.001). Opioid consumption decreased from 44.8 to 24.1% postoperatively (p = 0.026). In 13.7% of patients, an (S)AE occurred.ConclusionMISJF appears to be an effective and safe procedure in this cohort. Statistically significant and clinically relevant improvements in pain and quality of life were observed one-year postoperatively. Future studies should focus on the long-term outcomes to further evaluate the safety and effectiveness of MISJF.

Minimally Invasive Inferior Intra-Articular Sacroiliac Joint Fusion: Successful Application of Osseous Stabilization Using Allograft Bone.

Minimally invasive sacroiliac joint (SIJ) fusion is the preferred surgical method for managing patients with recalcitrant, chronically severe SIJ pain and dysfunction refractory to conservative medical measures. The primary surgical objective of all minimally invasive SIJ fusion procedures is to provide immediate stabilization within the joint space to support osseous consolidation and the development of a mechanically solid arthrodesis. The intra-articular surgical approach to the SIJ with allograft bone placement utilizes a trajectory and easily identifiable landmarks that allow the surgeon to control the risk of violating important neuro-vascular structures. The intra-articular approach can employ a superior or inferior operative trajectory, with the former restricted to allograft placement in the ligamentous portion of the SIJ. The inferior approach utilizes decortication to surgically create a channel originating in the purely articular portion of the joint space allowing for truly intra-articular implant placement within the osseous confines of the ilium and sacrum. Positioning the implant along the natural joint line and securing it within the underlying sub-chondral bone, mortise and tenon fashion provides stabilization and large surface area contact at the bone implant interface. The inferior, intra-articular approach also places the implant perpendicular to the S1 endplate, near the sacral axis of rotation, which addresses the most significant biomechanical forces across the joint. Short-term, post-surgical observational data from a 57 patient multi-center registry using the inferior, intra-articular approach show uniform and statistically significant improvement in all clinical outcomes (p < 0.001 for all comparisons), including an average 3-point improvement in back pain severity from 6.8 preoperatively to 3.8 at 6 months. Further clinical evaluation with longer-term follow-up of the inferior, intra-articular SIJ fusion procedure is encouraged.

Economic Process Behind Surgical Innovation

Objective: To analyze trends in open and minimally invasive (MIS) sacroiliac joint fusion (SIJF) that coincide with changes in compensation models and Current Procedural Terminology (CPT) codes. Design: Database analysis Setting: American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) Database Patients/Participants: Underwent SIJF, based on CPT codes, from 2007-2018 Intervention: Open and MIS SIJF Main Outcome Measurements: Proportion of open versus MISJ SIJF, proportion of inpatient vs outpatient SIJF, relative value units Results: There were 744 total SIJFs performed. Open SIJFs totaled 683, while 65 MIS SIJFs were performed. The number of SIJFs increased yearly, apart from two years, with a similar trend noted when controlling for the number of NSQIP entries per year. From 2014-2018, MIS SIJF made up a significantly larger proportion of total SIJFs (p&lt;0.0001) and the proportion of outpatient SIJFs increased over the entire study period (p=0.0002). Conclusions: SIJF is being increasingly utilized, coinciding with regulatory approval and the American Medical Association’s formal recognition of MIS SIJF. Related changes to coding and compensation serve as a model for the economic processes behind surgical innovation, highlighting the importance of surgeon advocacy along the way. Level of Evidence: III; Retrospective Cohort Study Keywords: Sacroiliac joint; arthrodesis; fusion; minimally invasive; NSQIP, economics, compensation, policy

Surgical and clinical efficacy of minimally invasive sacroiliac joint fusion surgery: a meta-analysis protocol

IntroductionSacroiliac joint (SIJ) dysfunction has been shown to cause significant morbidity. Current treatment includes conservative management and surgical intervention. Previously published data reporting clinical and surgical outcomes reached conflicting conclusions....

Alternative Uses of O-Arm and Stealth Navigation Technology Over 10 Years: The University of Colorado Experience.

Intraoperative computed tomography scanning with O-arm and use of Stealth navigation can improve surgical outcomes in a variety of orthopedic subspecialties. In spine surgery, the accuracy, precision, and safety of pedicle screw and interbody implant placement has improved. This technology is now routinely used in percutaneous pedicle screw placement and minimally invasive sacroiliac joint fusion. Other applications include, but are not limited to, isthmic pars defect repair, lumbosacral pseudoarticulation resection in Bertolotti's syndrome, radiofrequency ablation, and en bloc tumor resection. Intraoperative navigation has numerous applications, and use of this technology should continue to evolve as the technology advances. [Orthopedics. 2023;46(2):e89-e97.].

Minimally Invasive Sacroiliac Joint Fusion vs Conservative Management in Patients With Sacroiliac Joint Dysfunction: A Systematic Review and Meta-Analysis.

The sacroiliac joint (SIJ) is affected in 14% to 22% in individuals presenting with chronic low back or buttock pain. This percentage is even higher in patients who underwent lumbar fusion surgery: 32% to 42%. Currently, there is no standard treatment or surgical indication for SIJ dysfunction. When patients do not respond well to nonsurgical treatment, minimally invasive sacroiliac joint fusion (MISJF) seems to be a reasonable option. This systematic review and meta-analysis evaluates the current literature on the effectiveness of MISJF compared to conservative management in patients with SIJ dysfunction. A systematic search of health-care databases was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Inclusion criteria were randomized controlled trials (RCTs) or prospective and retrospective comparative cohort studies that compared MISJF with conservative management. Primary outcome measures were pain, disability, and patient satisfaction measured by patient-reported outcome measures. Secondary outcomes were adverse events (AEs), serious AEs, financial benefits, and costs. Two RCTs and one retrospective cohort study were included comparing MISJF and conservative management with regard to pain and disability outcome, encompassing 388 patients (207 conservative and 181 surgical). In a pooled mean difference analysis, MISJF demonstrated greater reduction in visual analog scale-pain score compared to conservative management: -37.03 points (95%CI [-43.91, -30.15], P < 0.001). Moreover, MISJF was associated with a greater reduction in Oswestry Disability Index outcome: -21.14 points (95% CI [-24.93, -17.35], P < 0.001). AEs were low among the study groups and comparable across the included studies. One cost-effectiveness analysis was also included and reported that MISJF is more cost-effective than conservative management.001). AEs were low among the study groups and comparable across the included studies. One cost-effectiveness analysis was also included and reported that MISJF is more cost-effective than conservative management. This systematic review and meta-analysis suggest that MISJF, using cannulated triangular, titanium implants, is more effective and cost-effective than conservative management in reducing pain and disability in patients with SIJ dysfunction. Further well-powered, independent research is needed to improve the overall evidence.

Minimally Invasive Sacroiliac Fusion-a Review.

Sacroiliac dysfunction is an important cause of low back pain with significant impact on quality of life and daily activities. Minimally invasive sacroiliac joint fusion (MIS SI fusion) is an effective treatment for patients who failed non-surgical strategies. The purpose of this article is to review the clinical outcomes and complications of this surgical technique. For patients with SI joint dysfunction, MIS SI fusion reduced pain and disability as measured by Visual Analog Scale and Oswestry Index and improved quality of life as measured by Short-Form 36 and EuroQol-5D questionnaires. Satisfaction rates were higher in the SI fusion group when compared to the conservative management. In recent clinical trials, adverse events occurred with a similar rate in the first 6months for patients assigned in the conservative management versus patients assigned to MIS SI fusion. MIS SI fusion is an effective and safe procedure for patients with sacroiliac dysfunction who failed non-surgical strategies. This procedure provides rapid as well as sustained pain relief, improvement in back function, high patient satisfaction, with low rate of complications.

Clinical Outcomes Following Minimally Invasive Sacroiliac Joint Fusion With Decortication: The EVoluSIon Clinical Study.

This report documents 1-year results of 250 patients enrolled in a prospective, multicenter study of a minimally invasive (MI) sacroiliac joint fusion (SIJF) system that uses decortication, graft placement, and joint fixation. The cohort includes all patients enrolled in the EVoluSIon (EVSI) clinical study who had MI SIJF surgery and completed 1-year follow-up. Average age at baseline was 60.5 years, and 70.8% were female. Sacroiliac (SI) joint-related pain duration was ≥2 years in 56% of patients. Visual analog scale (VAS) SI joint pain, Oswestry Disability Index (ODI), quality of life, and opioid use were assessed preoperatively and at 1 year. At 1 year, the mean VAS pain demonstrated a significant reduction of more than 43 points, from 76.4 at baseline to 33.0 (P < 0.0001), with 72.2% of patients attaining the minimal clinically important difference (MCID, ≥20-point improvement). Mean ODI scores also significantly improved from 54.4 at baseline to 30.5 at 1 year (P < 0.0001), with 62.5% of patients achieving the MCID (≥15-point improvement). Prior to surgery, 62.7% (126/201) of patients were taking opioids or other narcotics, but by 1 year postsurgery, only 26.9% (54/201) of patients reported using these medications, representing a significant 57.1% decrease in narcotic/opioid use (P < 0.0001). Fusion of the SI joint was seen in 68.7% of patients. Few procedural complications were reported. In all, there were 8 (8/250) serious procedure-related events, including 1 device malposition observed on the day of surgery that required replacing the superior screw with a shorter screw. Analysis of patients treated with MI SIJF in the EVSI study demonstrated that the procedure can be performed safely and results in significant improvements in pain, quality of life, and opioid use at 1 year as well as causing fusion in the majority of patients. MI SIJF differs from most procedures currently being performed in that it applies true orthopedic principles with decorticating, bone grafting, fusion, and placement of implants perpendicular to the joint for greatest stability. The 12-month data show improvement in functionality, reduction in pain, and, most notably, a reduction in narcotic usage, which is important considering the ongoing opioid epidemic.

Independent double-center observational study of minimally invasive sacroiliac joint fusion for sacroiliac joint dysfunction: one-year results

Independent double-center observational study of minimally invasive sacroiliac joint fusion for sacroiliac joint dysfunction: one-year results

The effect of minimally invasive sacroiliac joint fusion compared with sham operation: study protocol of a prospective double-blinded multicenter randomized controlled trial

Background and purpose — The sacroiliac joint is increasingly recognized as a cause of pain in 15–30% of patients with low back pain. Nonoperative management is not always successful and surgical treatment with fusion of the joint is increasingly recommended. According to the literature, minimally invasive fusion reduces pain and improves function compared with nonoperative treatment. It is, however, unclear to what extent the placebo effect influences these results. Patients and methods — The trial is designed as a prospective multi-center, double-blind, randomized sham-surgery controlled trial with 2 parallel groups. 60 patients with a suspected diagnosis of sacroiliac joint pain confirmed with sacroiliac joint injection are included according to the trial inclusion criteria. Patients are randomized with a 1:1 allocation into 2 groups of 30 patients each. The primary end-point is group difference in sacroiliac joint pain intensity on the operated side at 6 months postoperatively, measured by the Numeric Rating Scale. The main objective is to examine whether there is a difference in pain reduction between patients treated with a minimally invasive fusion of the sacroiliac joint compared with patients undergoing a sham operation. Results — Unblinding occurs after the completed 6-month follow-up. The primary analysis will be performed when all patients have completed 6 months’ follow-up. Follow-ups are continued to at least 2 years postoperatively. Data from the different groups will be compared based on the “intention to treat” principle.

269. Two-year clinical and radiographic outcomes after minimally invasive sacroiliac joint fusion with decortication and none grafting utilizing a threaded implant

269. Two-year clinical and radiographic outcomes after minimally invasive sacroiliac joint fusion with decortication and none grafting utilizing a threaded implant

Trends in Diagnosis and Treatment of Sacroiliac Joint Pathology Over the Past 10 Years: Review of Scientific Evidence for New Devices for Sacroiliac Joint Fusion

Sacroiliac (SI) joint pathology is a newly appreciated contributor to lower back pain. Sacroiliac joint fusion (SIJF) has grown rapidly in popularity in association with the advent of minimally-invasive surgical techniques. This has led to an explosion of new medical devices used for SIJF. The objective of this article is to outline clinical trends, summarize the current data, and categorize novel devices for SIJF. Trends in SI joint pathology and fusion were obtained via the Healthcare Cost and Utilization Project’s (HCUP) National Inpatient Sample (NIS) database and Web of Science. To review literature on devices for SIJF, PubMed was searched using the Boolean phrase “sacroiliac joint AND (fusion OR arthrodesis)” since 2010. To establish a list of SIJF devices not represented in the literature, searches were performed on the FDA 510(k), premarket approval, and de novo databases, as well as Google and LinkedIn. Literature review yielded 11 FDA-approved devices for minimally invasive SIJF. Database query yielded an additional 22 devices for a total of 33 devices. Twenty-one devices used the lateral transiliac approach, six posterior allograft approach, three posterolateral approach, and three combined the lateral transiliac and posterolateral approaches. The evidence for the lateral transiliac approach is the most robust. Many novel devices have been developed for minimally invasive SIJF over the past 10 years. Further randomized comparative trials are warranted to evaluate different surgical approaches and novel devices at this time.

Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants: 24-Month Follow-Up.

BackgroundStrong evidence supports minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction.ObjectiveTo report safety and effectiveness of SIJF using a 3D-printed TTI at 24 months.MethodsSIJF with TTI was performed in 51 subjects. Structured follow-up occurred at 3, 6, 12 and 24 months. Both quality of life questionnaires and functional tests were performed at all study visits.Results84% of subjects were available for 24-month follow-up. Observed were rapid and persistent improvements in dysfunction due to pain (Oswestry Disability Index [ODI], mean 52.8 at baseline and 28.3 at 24 months, p<0.0001) and SIJ pain ratings (mean 78.5 at baseline [0–100 scale] to 21.5 at 24 months). Opioid use for SIJ pain decreased markedly from baseline. Physical function tests impaired by SIJ pain showed persistent improvements compared to baseline. There was no evidence of device breakage, migration or subsidence and few late adverse events occurred attributable to the device.ConclusionIn this prospective study, SIJF using 3D-printed TTI resulted in immediate, marked and persistent improvements in pain and quality of life, with improved physical function, reduced opioid use and a low rate of late device-related adverse events.Level of EvidenceLevel II.

Minimally invasive sacroiliac joint fusion using a novel hydroxyapatite-coated screw: final 2-year clinical and radiographic results.

The proper diagnosis and treatment of sacroiliac joint (SIJ) pain remains a clinical challenge. Dysfunction of the SIJ can produce pain in the lower back, buttocks, and extremities. The present prospective clinical study is a follow-up report on a previous 1-year report on the use of a novel hydroxyapatite (HA)-coated titanium screw for the surgical treatment of SIJ dysfunction. Data were prospectively collected on 32 consecutive patients who underwent minimally invasive SIJ fusion with a novel HA-coated screw. Clinical assessments and radiographs were collected and evaluated at 24 months postoperatively. Mean preoperative visual analog scale (VAS) back, left, and right leg pain scores decreased significantly to 20.0 (±18.4), 5.8 (±8.1), and 11.5 (±20.1) at 24-month follow-up, respectively. Oswestry Disability Index (ODI) scores significantly decreased to 27.5 (±18.8) points at 24 months (P<0.01). Two patients who required revision surgery reported improvement of their symptoms within 3 weeks and did not require subsequent surgery to be performed. This study shows positive clinical and functional outcomes for patients who have undergone fusion using HA-coated screws for SIJ dysfunction. SIJ fusion using a HA-coated screw to treat SIJ dysfunction significantly decreased VAS back and leg pain and ODI scores at 2-year follow-up.

Minimally Invasive Sacroiliac Fusion Revision: A Technique Guide.

A retrospective case-series of revision sacroiliac joint (SIJ) fusions. To provide a technique guide for revision minimally invasive SIJ fusion. SIJ dysfunction is a prevalent, yet underdiagnosed condition. This disparity exists as a result of diagnostic complexity and lack of a viable surgical treatment option. However, the advent of minimally invasive SIJ fusion has created a resurgence of interest in this debilitating condition. Multiple studies have reported on the increased use of minimally invasive SIJ fusion in recent years, but there is a paucity of literature on management in a revision setting. A case series of 5 patients from a single academic tertiary referral center over a 3-year period will serve to highlight technical pearls and considerations in SIJ fusion revision. Revision SIJ fusions were identified through a retrospective review of a surgical database and demographic, surgical, and radiographic data were obtained through review of the electronic medical record. Five patients underwent SIJ fusion revision from 2015 to 2018. There were 3 main modes of failure, with indications for revision including nerve root irritation and SIJ pain recurrence. The mean age at time of revision was 48.8 ± 14.3 years, and the mean follow-up after revision was 2.0 + 0.9 years. Familiarity with SIJ anatomy and use of stereotactic navigation can improve implant position and purchase. Additionally, bone graft and bone morphogenetic protein can be used to fill in old implant tracks and to augment bony ingrowth and ongrowth of new implants. Increased use of SIJ fusion creates a demand for comprehensive revision strategies and necessitates familiarity with SIJ anatomy. Preoperative planning to determine causes of failure and use of intraoperative navigation are essential to help surgeons better understand the preferential trajectory for each implant. 4.

Enhancing perioperative landmark detection during sacroiliac joint fusion in patients suffering from low back pain

Over the past decade, minimally invasive sacroiliac joint (SIJ) fusion has become an effective treatment for patients suffering from low back pain (LBP) originating from the SIJ. Perioperative C-arm fluoroscopy-assisted surgical navigation during SIJ fusion remains challenging due to the lack of 3D spatial information. This study developed and assessed a 3D CT/2D fluoroscopy integration approach based on digitally reconstructed radiographs (DRRs) obtained from pre-operative CT scans. Development of this approach proved feasible and landmarks were successfully translated, in retrospect, to perioperatively acquired fluoroscopies. Further expansion of and research into the proposed approach to increase perioperative navigation is indicated and additional validation should be performed.

Minimally invasive sacroiliac joint fusion versus conservative treatment in patients with sacroiliac joint dysfunction: A systematic review and meta-analysis

Minimally invasive sacroiliac joint fusion versus conservative treatment in patients with sacroiliac joint dysfunction: A systematic review and meta-analysis

Patient Reported Clinical Outcomes of Minimally Invasive Sacroiliac Joint Arthrodesis.

ObjectiveTo report patient‐reported outcomes of minimally invasive sacroiliac (SI) joint fusion as a case series.MethodsThis study was a retrospective cohort study of patients 18 years of age and older who underwent a minimally invasive SI joint fusion by a single surgeon between 1 January 2013 and 31 December 2015. Routine demographic data, characteristics, and relevant surgical and clinical data were all collected for this group. In addition, patients completed preoperative and postoperative visual analog scale (VAS) and Short Form 36 (SF‐36) questionnaires to assess outcomes. Patient selection for SI fusion was based on short‐term resolution of symptoms (80% or greater relief) with an image‐guided intra‐articular injection of local anesthetic. Routine statistical analysis was performed using the Wilcoxon signed rank test, Fisher's exact test, or χ2 analysis as appropriate.ResultsThis study included 19 patients comprising 24 SI fusions, with a mean follow‐up of 58 months. The average patient age was 50 years and the average surgical blood loss was 25 cc. Men comprised 79% of the cohort. The VAS score improved from 7 to 3 (P = 0.0001). SF‐36 physical function, role limitations due to physical health, and role limitations due to emotional health improved to a statistically significant extent. General health was not significantly changed. Every patient showed improvement in their SF‐36 physical function scores (mean 40 preoperatively to 55 at final follow up) and 18 of 19 showed improvement in the VAS score (mean 7 preoperatively to 3 at final follow‐up).ConclusionIn appropriately selected patients, minimally invasive SI joint fusion results in decreased pain and improved physical functioning of patients, which is sustained for more than 4 years post‐procedure.

Minimally Invasive Sacroiliac Joint Fusion with Decortication and Bone Grafting

Minimally Invasive Sacroiliac Joint Fusion with Decortication and Bone Grafting

Minimally Invasive Sacroiliac Joint Fusion with Triangular Titanium Implants: Cost-Utility Analysis from NHS Perspective.

ObjectiveThe aim was to identify the cost-effectiveness of minimally invasive sacroiliac joint fusion (MI SIJF) surgery with titanium triangular implants for patients with sacroiliac joint (SIJ) pain who have failed conservative management, compared to non-surgical management (NSM) from a National Health Service (NHS) England perspective.MethodsOver a time horizon of 5 years, a cohort state transition model compared the costs and outcomes of treating patients with MI SIJF to those of traditional NSM treatment pathways. The NSM arm included two treatments: grouped physical therapy and corticosteroid injections (PTSI) or radiofrequency ablation (RFA). Three different strategies were considered: (1) a stepped pathway, (2) patients split between PTSI and RFA, and (3) RFA only. The outcome measure was incremental cost-effectiveness ratio (ICER), reported in 2018 British pounds per quality-adjusted life year (QALY) gained. One-way and probabilistic sensitivity analyses were used to test the robustness of the model results.ResultsPatients undergoing MI SIJF accrued total procedure-related and pain-management costs of £8358, while NSM treatment strategy 1 had total costs of £6880. The MI SIJF cohort had 2.98 QALYs compared to strategy 1 with 2.30 QALYs. This resulted in an ICER for MI SIJF versus strategy 1 of £2164/QALY gained. Strategy 2 of the NSM arm had lower costs than strategy 1 (£6564) and 2.26 QALYs, and this resulted in an ICER of £2468/QALY gained for MI SIJF. Strategy 3 of the NSM arm had lower costs than strategy 1 (£6580), and this resulted in 2.28 QALYs and an ICER of £2518/QALY gained for MI SIJF. Probabilistic sensitivity analysis shows that at a threshold of £20,000/QALY gained, MI SIJF has a probability of being cost-effective versus NSM strategies of 96%, 97%, and 91% for strategies 1, 2, and 3, respectively.ConclusionMI SIJF appears to be cost-effective over a 5-year time horizon when compared to traditional NSM pathways in an NHS context.Electronic supplementary materialThe online version of this article (10.1007/s41669-020-00236-5) contains supplementary material, which is available to authorized users.