American Society of Pain and Neuroscience Best Practice (ASPN) Guideline for the Treatment of Sacroiliac Disorders.

Clinical management of sacroiliac disease has proven challenging from both diagnostic and therapeutic perspectives. Although it is widely regarded as a common source of low back pain, little consensus exists on the appropriate clinical management of sacroiliac joint pain and dysfunction. Understanding the biomechanics, innervation, and function of this complex load bearing joint is critical to formulating appropriate treatment algorithms for SI joint disorders. ASPN has developed this comprehensive practice guideline to serve as a foundational reference on the appropriate management of SI joint disorders utilizing the best available evidence and serve as a foundational guide for the treatment of adult patients in the United States and globally.

Safety, Efficacy, and Durability of Outcomes: Results from SECURE: A Single Arm, Multicenter, Prospective, Clinical Study on a Minimally Invasive Posterior Sacroiliac Fusion Allograft Implant.

Introduction: Research suggests that sacroiliac joint (SIJ) dysfunction is responsible for 15% to 30% of reported low back pain cases. Recently, there has been an increasing interest in SIJ fusion using minimally invasive surgery (MIS) due to safety. Initially, devices designed for MIS were intended for lateral approaches. A minimally invasive sacroiliac fusion implant for use with a posterior approach has been developed and is regulated for clinical use under the regulatory framework required for human cells, tissues, or cellular or tissue-based products (HCT/Ps). Methods: A multi-center, prospective, single-arm study was launched after initial studies provided preliminary data to support safety, efficacy, and durability of this minimally invasive sacroiliac posterior fusion LinQ allograft implant (NCT04423120). Preliminary results were reported previously. Final results for the full participant cohort are presented here. Results: One-hundred and fifty-nine (159) participants were enrolled across 16 investigational sites in the US between January 2020 and March 2022. One-hundred and twenty-two (122) participants were implanted. At the 1-month follow-up, 82 participants satisfied all criteria for the composite responder endpoint, representing 73.2% of the study cohort. These results stayed consistent across the remaining study timepoints with 66.0%, 74.4%, and 73.5% of participants classified as responders at the 3-, 6- and 12-month follow-up visits, respectively. VAS scores were significantly reduced (p < 0.0001) and ODI scores were significantly improved (p < 0.0001). All domains of the PROMIS-29 were also significantly improved (all p's <0.0001). Only one procedure-related serious AE was reported in the study. Conclusion: These results suggest that the posterior approach LinQ Implant System is a safe and effective treatment for sacroiliac joint dysfunction at 12 months, with results that are favorable compared to outcomes reported for an FDA-cleared lateral approach.

Six Month Interim Outcomes from SECURE: A Single arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device.

INTRODUCTION: Sacroiliac joint disease is a prominent diagnosis across the world. A novel fixation technique employing a posterior approach, single point, bone allograft transfixation has proven to be helpful anecdotally. The purpose of this is study is to investigate prospectively the safety and efficacy of this approach. METHODS: A multicenter, prospective, single arm study was performed after patient identification and treatment with the novel posterior fusion, single-point transfixation system and followed for 24 months. Target enrollment is 100 patients. Interim results on the first 69 consecutive patients at 6 months is presented. Primary endpoint at 6-month analysis was Pain Intensity reduction by visual analogue scale and functional improvement by Oswestry Disability Index. Adverse events were assessed for safety analysis. RESULTS: In total, 69 patients were identified for this analysis. At 6 months, a mean improvement of 34.9 was identified by a reduction in VAS and functional improvement was demonstrated by a mean reduction in ODI of 17.7. There were three adverse events, all unrelated to the device. CONCLUSION: The posterior single point transfixation is safe and efficacious for the treatment of sacroiliac joint dysfunction with statistical improvements in pain and function.

Salvage of Failed Lateral Sacroiliac Joint Fusion with a Novel Posterior Sacroiliac Fusion Device: Diagnostic Approach, Surgical Technique, and Multicenter Case Series.

Background: Studies have found that up to one-third of patients with LBP have sacroiliac joint (SIJ) dysfunction as a contributing cause. Historically, the management of SIJ dysfunction has been plagued by ineffectiveness or significant morbidity. In 2008, minimally invasive lateral SIJ fusion was developed. While this procedure is a safe and effective treatment, there is still a significant proportion of patients who will not experience therapeutic success. There is a paucity of data in the literature regarding the management of these patients. Recently, a novel posterior sacroiliac joint fusion device has been developed which minimizes complications compared to lateral approaches and may serve to salvage therapeutic failures in this patient population. Objective: Determine the efficacy and feasibility of a posterior SIJ fusion device as a salvage technique in patients who have not experienced therapeutic success following lateral SIJ fusion. Design: Multi-center retrospective observational study. Methods: Patients who had previously undergone lateral SIJ fusion and had persistent LBP were evaluated and diagnosed to have persistent primary SIJ pathology. All patients underwent posterior SIJ fusion utilizing a machined allograft transfixing sacroiliac fusion device. Demographic data and patient reported pain scores were collected. Results: A total of 7 patients who had undergone lateral SIJ fusion were included in the study and underwent posterior SIJ fusion. The mean patient reported pain improvement following posterior fusion was 80% with an average follow-up time of 10 months. Median morphine milliequivalents were 20 pre-procedure and 0 post-procedure. Conclusion: We were able to show significant reductions in pain scores and opioid consumption, which suggests that minimally invasive posterior SIJ utilizing a novel implant and technique may be a viable treatment option to salvage pain relief in this patient population. Further, the favorable safety profile of this posterior technique uniquely positions it to be an appropriate first-line surgical therapy.

Successful Diagnosis of Sacroiliac Joint Dysfunction.

BACKGROUND: Sacroiliac joint (SIJ) pain is one of the most common causes of low back pain, accounting for 15 to 30% of all cases. Although SIJ dysfunction accounts for a large portion of chronic low back pain prevalence, it is often overlooked or under diagnosed and subsequently under treated. The purpose of this review was to establish a best practices model to effectively diagnose SIJ pain through detailed history, physical exam, review of imaging, and diagnostic block. METHODS: A literature search was performed on the diagnosis of sacroiliac joint pain and sacroiliac joint dysfunction. The authors proposed diagnostic recommendations based upon the available literature and a detailed understanding of diagnosing SIJ pain. RESULTS: The practitioner must focus on the history, location of pain, observed gait pattern, and perform key points of the physical exam including sacroiliac provocative maneuvers. If the patient exhibits at least three provocative maneuvers then the SIJ may be considered as a possible source of pain. Additionally, a thorough review of the imaging should be performed to rule out other etiologies of low back pain. In the absence of any pathognomonic tests or examination findings, diagnostic SIJ blocks have evolved as the diagnostic standard. CONCLUSION: The diagnosis of SIJ pain is a multifaceted process that involves a careful assessment including differentiating other pain generators in the region. This involves careful history taking, appropriate physical examination including provocative maneuvers and diagnostic injections. Once the diagnosis is confirmed, long-term solutions may be considered, including recent advances in sacral lateral branch denervation and sacroiliac joint fusion.

Pain Relief Salvage with a Novel Minimally Invasive Posterior Sacroiliac Joint Fusion Device in Patients with Previously Implanted Pain Devices and Therapies.

BACKGROUND: Sacroiliac joint (SIJ) pain is a common cause of low back pain, a problem experienced by two-thirds of adults in the United States population. Traditionally, the management of persistent SIJ-related pain has involved conservative therapies (physical therapy, topical medications, oral anti-inflammatory medications), interventional therapies (SIJ steroid injections or ablation), and surgery (SIJ fusion; open and lateral approach). Recent advancements in technology have paved the way for SIJ fusion via a posterior approach, which aims to minimize complications and enhance recovery. OBJECTIVE: The purpose of this study is to introduce the concept of the posterior approach to SIJ fusion as a feasible adjunct and salvage technique for patients with inadequate pain relief from other minimally invasive surgical procedures, and to validate its efficacy through a retrospective multicenter data analysis. DESIGN: Multicenter retrospective observational study. METHODS: Patients with refractory SIJ pain were treated by interventional pain physicians at one of the eight different pain management centers. All patients underwent posterior SIJ fusion via the LinQTM sacroiliac fusion procedure. Demographical data were collected, in addition to patient-reported pain relief. RESULTS: A total of 111 patients were included in the study and underwent posterior SIJ fusion for refractory SIJ-related pain following the use of spinal cord stimulation (SCS), interspinous spacer (ISS), intrathecal drug delivery (IDDS), and/or minimally invasive lumbar decompression (MILD). Overall, the mean patient reported pain relief following posterior SIJ fusion was 67.6%. In patients with a history of failed back surgery syndrome, the mean patient reported pain relief was 76.5%. CONCLUSION: In this retrospective case series of patients with continued intolerable pain following SCS, ISS, IDDS, or MILD, a novel posterior SIJ fusion device provided significant pain relief in a salvage manner. These early results suggest that this intervention may be a therapeutic option to consider in these patients.

Amelioration of lower limb pain and foot drop with 10 kHz spinal cord stimulation: A case series.

There are limited treatment options for patients with foot drop and associated lower back and/or leg pain. We present a case series of three patients who received permanent implantation of 10 kHz spinal cord stimulation (10 kHz SCS) devices. Following treatment, all patients reported sustained improvements in lower back and leg pain, foot mechanics and function which resulted in increased mobility and cessation of opioid use for pain management. Patients were followed up for approximately four years. Treatment with 10 kHz SCS may be a promising alternative to other interventional procedures commonly used for these patients.

Disruption of CCR5 signaling to treat COVID-19-associated cytokine storm: Case series of four critically ill patients treated with leronlimab.

Coronavirus disease 2019 (COVID-19) is associated with considerable morbidity and mortality. The number of confirmed cases of infection with SARS-CoV-2, the virus causing COVID-19 continues to escalate with over 70 million confirmed cases and over 1.6 million confirmed deaths. Severe-to-critical COVID-19 is associated with a dysregulated host immune response to the virus, which is thought to lead to pathogenic immune dysregulation and end-organ damage. Presently few effective treatment options are available to treat COVID-19. Leronlimab is a humanized IgG4, kappa monoclonal antibody that blocks C-C chemokine receptor type 5 (CCR5). It has been shown that in patients with severe COVID-19 treatment with leronlimab reduces elevated plasma IL-6 and chemokine ligand 5 (CCL5), and normalized CD4/CD8 ratios. We administered leronlimab to 4 critically ill COVID-19 patients in intensive care. All 4 of these patients improved clinically as measured by vasopressor support, and discontinuation of hemodialysis and mechanical ventilation. Following administration of leronlimab there was a statistically significant decrease in IL-6 observed in patient A (p=0.034) from day 0-7 and patient D (p=0.027) from day 0-14. This corresponds to restoration of the immune function as measured by CD4+/CD8+ T cell ratio. Although two of the patients went on to survive the other two subsequently died of surgical complications after an initial recovery from SARS-CoV-2 infection.