Evolving Trends in the Use of Sacroiliac Fusion From 2015 to 2020.

STUDY DESIGN: Retrospective cohort analysis. OBJECTIVE: To assess the evolution of patients undergoing sacroiliac (SI) fusion with minimally invasive surgery (MIS) relative to open approaches. SUMMARY OF BACKGROUND DATA: The SI joint can be a contributor to lumbopelvic symptoms. The MIS approach to SI fusion has been shown to have fewer complications compared with the open approach. Recent trends and evolved patient populations have not been well-characterized. MATERIALS AND METHODS: Data were abstracted from the large, national, multi-insurance, administrative 2015-2020 M151 PearlDiver database. The incidence, trends, and patient characteristics of MIS, as well as open, SI fusions for adult patients with degenerative indications, were determined. Univariable and multivariable analyses were then performed to compare the MIS relative to open populations. The primary outcome was to assess the trends of MIS and open approaches for SI fusions. RESULTS: In total, 11,217 SI fusions were identified (of which 81.7% were MIS), with a clear increase in numbers over the years from 2015 (n=1318, 62.3% of which were MIS) to 2020 (n=3214 86.6% of which were MIS). Independent predictors of MIS (as opposed to open) SI fusion included: older age (odds ratio [OR] 1.09 per decade increase), higher Elixhauser-Comorbidity Index (OR 1.04 per two-point increase), and geographic region (relative to South, Northeast OR 1.20 and West OR 1.64). As might be expected, 90-day adverse events were lower for MIS than open cases (OR 0.73). CONCLUSION: The presented data quantify the increasing incidence of SI fusions over the years, with the increase being driven by MIS cases. This was largely related to an expanded population (those who are older and with greater comorbidity), fitting the definition of disruptive technology with lesser adverse events than open procedures. Nonetheless, geographic variation highlights the differential adoption of this technology.

Minimally Invasive SI Joint Fusion Procedures for Chronic SI Joint Pain: Systematic Review and Meta-Analysis of Safety and Efficacy.

BACKGROUND: Sacroiliac (SI) joint fusion is increasingly used to treat chronic SI joint pain. Multiple surgical approaches are now available. METHODS: Data abstraction and random effects meta-analysis of safety and efficacy outcomes from published patient cohorts. Patient-reported outcomes (PROs) and safety measures were stratified by surgical technique: transiliac, including lateral transiliac (LTI) and posterolateral transiliac (PLTI), and posterior interpositional (PI) procedures. RESULTS: Fifty-seven cohorts of 2851 patients were identified, including 43 cohorts (2126 patients) for LTI, 6 cohorts (228 patients) for PLTI, and 8 cohorts (497 patients) for PI procedures. Randomized trials were only available for LTI. PROs were available for pain (numeric rating scale) in 57 cohorts (2851 patients) and disability (Oswestry Disability Index [ODI]) in 37 cohorts (1978 patients).All studies with PROs showed improvement from baseline after surgery. Meta-analytic improvements in pain scores were highest for LTI (4.8 points [0-10 scale]), slightly lower for PLTI (4.2 points), and lowest for PI procedures (3.8 points, P = 0.1533). Mean improvements in ODI scores were highest for LTI (25.9 points), lowest for PLTI procedures (6.8 points), and intermediate for PI (16.3 points, P = 0.0095).For safety outcomes, acute symptomatic implant malposition was 0.43% for LTI, 0% for PLTI, and 0.2% for PI procedures. Wound infection was reported in 0.15% of LTI, 0% of PLTI, and 0% of PI procedures. Bleeding requiring surgical intervention was reported in 0.04% of LTI procedures and not reported for PLTI or PI. Breakage and migration were not reported for any device. Radiographic imaging evaluation reporting implant placement accuracy and fusion was only available for LTI. DISCUSSION: Literature support for SI joint fusion is growing. The LTI procedure contains the largest body of available evidence and shows the largest improvements in pain and ODI. Only LTI procedures have independent radiographic evidence of fusion and implant placement. The adverse event rate for all procedures was low.

Longitudinal Comparative Analysis of Complications and Subsequent Interventions Following Stand-Alone Interspinous Spacers, Open Decompression, or Fusion for Lumbar Stenosis.

INTRODUCTION: For individuals with lumbar spinal stenosis (LSS), minimally invasive procedures such as an interspinous spacer device without decompression or fusion (ISD) or open surgery (i.e., open decompression or fusion) may relieve symptoms and improve functions when patients fail to respond to conservative therapies. This research compares longitudinal postoperative outcomes and rates of subsequent interventions between LSS patients treated with ISD and those with open decompression or fusion as their first surgical intervention. METHODS: This retrospective, comparative claims analysis identified patients age ≥ 50 years with LSS diagnosis and with a qualifying procedure during 2017-2021 in the Medicare database which includes healthcare encounters in inpatient and outpatient settings. Patients were followed from the qualifying procedure until end of data availability. The outcomes assessed during the follow-up included subsequent surgical interventions, including subsequent fusion and lumbar spine surgeries, long-term complications, and short-term life-threatening events. Additionally, the costs to Medicare during a 3-year follow-up were calculated. Cox proportional hazards, logistic regression, and generalized linear models were used to compare outcomes and costs, adjusted for baseline characteristics. RESULTS: A total of 400,685 patients who received a qualifying procedure were identified (mean age 71.5 years, 50.7% male). Compared to ISD patients, patients receiving open surgery (i.e., decompression and/or fusion) were more likely to have a subsequent fusion [hazard ratio (HR), 95% confidence intervals (CI): 1.49 (1.17, 1.89)-2.54 (2.00, 3.23)] or other lumbar spine surgery [HR (CI): 3.05 (2.18, 4.27)-5.72 (4.08, 8.02)]. Short-term life-threatening events [odds ratio (CI): 2.42 (2.03, 2.88)-6.36 (5.33, 7.57)] and long-term complications [HR (CI): 1:31 (1.13, 1.52)-2.38 (2.05, 2.75)] were more likely among the open surgery cohorts. Adjusted mean index costs were lowest for decompression alone (US$7001) and highest for fusion alone ($33,868). ISD patients had significantly lower 1-year complication-related costs than all surgery cohorts and lower 3-year all-cause costs than fusion cohorts. CONCLUSIONS: ISD resulted in lower risks of short- and long-term complications and lower long-term costs than open decompression and fusion surgeries as a first surgical intervention for LSS.

A comparison of in-hospital outcomes after elective anterior cervical discectomy and fusion in cases with and without Parkinson's Disease.

Background: Following orthopedic surgery, patients with Parkinson's disease (PD) have been shown to have high rates of surgical complications, and some studies suggest that PD may be associated with greater risk for postoperative medical complications. As complication rates are critical to consider for elective surgery planning, the current study aimed to describe the association of PD with medical complications following anterior cervical discectomy and fusion (ACDF), the most commonly performed procedure to treat cervical degenerative pathology. Methods: The 2008-2018 National Inpatient Sample database was queried for cases involving elective ACDF. Demographics and comorbidities were extracted using ICD codes. Cases were propensity matched based on demographic and comorbidity burden, and logistic regression was used to compare in-hospital complications between patients with and without PD. Results: After weighting, a total of 1,273,437 elective ACDF cases were identified, of which 3948 (0.31%) involved cases with PD. After 1:1 propensity score matching by demographic and comorbidity variables, there were no differences between the PD and non-PD cohorts. Logistic regression models constructed for the matched and unmatched populations showed that PD cases have greater odds of in-hospital minor adverse events with no differences in odds of serious adverse events or mortality. Conclusions: After matching for demographics and comorbidity burden, PD cases undergoing elective ACDF had slightly longer length of stay and greater risk for minor adverse events but had similar rates of serious adverse events and mortality. These findings are important for surgeons and patients to consider when making decisions about surgical intervention.

Better Functional Recovery After Single-Level Compared With Two-Level Posterolateral Lumbar Fusion.

Background Multiple studies describe the outcomes of patients undergoing single-level and multilevel posterolateral lumbar fusion (PLF). However, a comparison of outcomes between single-level and two-level PLF is lacking. The aim of this prospective cohort study was to compare outcomes between single-level and two-level instrumented PLF. Methods A total of 42 patients were enrolled at nine US centers between October 2015 and June 2017. Data included radiologic outcomes, visual analog scale (VAS) Back and Leg Pain, disability per the Oswestry Disability Index (ODI), and health-related quality of life (QoL) per 36-Item Short Form Survey version 2.0 (SF-36v2) at six weeks and three, six, 12, and 24 months. Results Twelve-month and 24-month follow-ups were completed by 38 (90.5%) and 32 (76.2%) subjects, respectively. The average age was 67 years, and 54.8% were female. Twenty-six received single-level PLF, and 16 received two-level PLF. In the single-level group, there was one reoperation, two postoperative infections, and one dural tear. In the two-level group, there was one postoperative infection. The surgeon computed tomography (CT)-based evaluation of fusion rate was 67.6% (25/37) at 12-month follow-up and 94.1% (32/34) at 24-month follow-up. The third-party evaluation of fusion rate was 52.8% (19/36) at six months, 81.1% (30/37) at 12 months, and 86.5% (32/37) at 24 months. There was a tendency toward a higher fusion rate in single-level compared with two-level PLF. The ODI, SF-36v2 Mental Component Score (MCS), and VAS Back Pain and Leg Pain outcomes improved by the first follow-up visit in both the single-level and two-level groups. Improvement in the ODI was 5.86 (95% confidence interval (CI): 0.03-11.69) points greater in the single-level group compared with the two-level group. Conclusions Compared with the two-level PLF subjects, single-level PLF subjects had better functional outcomes and reported higher satisfaction with the outcome of surgery but showed similar fusion, pain, and generic health-related quality of life outcomes. Both single-level and two-level PLF subjects demonstrated high fusion rates in association with improvements in pain, functional, and quality of life outcomes, as well as high satisfaction levels.

Cement Augmentation of Vertebral Compression Fractures May Be Safely Considered in the Very Elderly.

OBJECTIVE: The objective of the current study was to perform a retrospective review of a national database to assess the safety of cement augmentation for vertebral compression fractures in geriatric populations in varying age categories. METHODS: The 2005-2016 National Surgical Quality Improvement Program databases were queried to identify patients undergoing kyphoplasty or vertebroplasty in the following age categories: 60-69, 70-79, 80-89, and 90+ years old. Demographic variables, comorbidity status, procedure type, provider specialty, inpatient/outpatient status, number of procedure levels, and periprocedure complications were compared between age categories using chi-square analysis. Multivariate logistic regressions controlling for patient and procedural variables were then performed to assess the relative periprocedure risks of adverse outcomes of patients in the different age categories relative to those who were 60-69 years old. RESULTS: For the 60-69, 70-79, 80-89, and 90+ years old cohorts, 486, 822, 937, and 215 patients were identified, respectively. After controlling for patient and procedural variables, 30-day any adverse events, serious adverse events, reoperation, readmission, and mortality were not different for the respective age categories. Cases in the 80- to 89-year-old cohort were at increased risk of minor adverse events compared to cases in the 60- to 69-year-old cohort. CONCLUSION: As the population ages, cement augmentation is being considered as a treatment for vertebral compression fractures in increasingly older patients. These results suggest that even the very elderly may be appropriately considered for these procedures (level of evidence: 3).

Brain Structure and Function of Chronic Low Back Pain Patients on Long-Term Opioid Analgesic Treatment: A Preliminary Study.

Chronic low back pain (CLBP) is often treated with opioid analgesics (OA), a class of medications associated with a significant risk of misuse. However, little is known about how treatment with OA affect the brain in chronic pain patients. Gaining this knowledge is a necessary first step towards understanding OA associated analgesia and elucidating long-term risk of OA misuse. Here we study CLBP patients chronically medicated with opioids without any evidence of misuse and compare them to CLBP patients not on opioids and to healthy controls using structural and functional brain imaging. CLBP patients medicated with OA showed loss of volume in the nucleus accumbens and thalamus, and an overall significant decrease in signal to noise ratio in their sub-cortical areas. Power spectral density analysis (PSD) of frequency content in the accumbens' resting state activity revealed that both medicated and unmedicated patients showed loss of PSD within the slow-5 frequency band (0.01-0.027 Hz) while only CLBP patients on OA showed additional density loss within the slow-4 frequency band (0.027-0.073 Hz). We conclude that chronic treatment with OA is associated with altered brain structure and function within sensory limbic areas.

Evidence-Based Recommendations for Spine Surgery.

: This next issue of Evidence-Based Recommendations for Spine Surgery examines six articles that seek to address pressing and relevant issues in contemporary spine surgery. These articles explore the safety and efficacy of tranexamic acid during lumbar surgery, the utility of post-operative MRI after spinal decompression surgery, the role of teriparatide for fusion support in osteoporotic patients, sagittal spinopelvic alignment in adults, the comparative effectiveness of lumbar disk arthroplasty and prognostic factors for satisfaction after lumbar decompression surgery. These important publications are examined rigorously - both clinically and methodologically - and recommendations regarding impact on clinical practice are provided.Level of Evidence: N/A.

Loss of nucleus accumbens low-frequency fluctuations is a signature of chronic pain.

Chronic pain is a highly prevalent disease with poorly understood pathophysiology. In particular, the brain mechanisms mediating the transition from acute to chronic pain remain largely unknown. Here, we identify a subcortical signature of back pain. Specifically, subacute back pain patients who are at risk for developing chronic pain exhibit a smaller nucleus accumbens volume, which persists in the chronic phase, compared to healthy controls. The smaller accumbens volume was also observed in a separate cohort of chronic low-back pain patients and was associated with dynamic changes in functional connectivity. At baseline, subacute back pain patients showed altered local nucleus accumbens connectivity between putative shell and core, irrespective of the risk of transition to chronic pain. At follow-up, connectivity changes were observed between nucleus accumbens and rostral anterior cingulate cortex in the patients with persistent pain. Analysis of the power spectral density of nucleus accumbens resting-state activity in the subacute and chronic back pain patients revealed loss of power in the slow-5 frequency band (0.01 to 0.027 Hz) which developed only in the chronic phase of pain. This loss of power was reproducible across two cohorts of chronic low-back pain patients obtained from different sites and accurately classified chronic low-back pain patients in two additional independent datasets. Our results provide evidence that lower nucleus accumbens volume confers risk for developing chronic pain and altered nucleus accumbens activity is a signature of the state of chronic pain.

Long-Term Prospective Clinical And Radiographic Outcomes After Minimally Invasive Lateral Transiliac Sacroiliac Joint Fusion Using Triangular Titanium Implants.

BACKGROUND: Accumulating evidence supports the long-term safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) for sacroiliac joint dysfunction. OBJECTIVE: To report 5-year clinical and radiographic follow-up in patients undergoing SIJF using triangular titanium implants (TTI). METHODS: One hundred and three subjects at 12 centers treated with SIJF using TTI in two prospective clinical trials (NCT01640353 and NCT01681004) were enrolled and followed in the current study (NCT02270203) with clinic visits at 3, 4 and 5 years. CT scans performed at 5 years were compared to prior CT scans (at 1 or 2 years) by an independent radiologist. RESULTS: Compared to baseline scores, SIJ pain scores at 5 years decreased by a mean of 54 points, disability scores (Oswestry Disability Index) decreased by 26 points, and quality of life scores (EuroQOL-5D time trade-off index) increased by 0.29 points (0-1 scale) (all p<0.0001). Satisfaction rates were high and the proportion of subjects taking opioids decreased from 77% at baseline to 41% at 5-year follow-up. Independent radiographic analysis showed a high rate (98%) of bone apposition to implants on both the sacral and iliac sides of the SI joint, with a high rate of bony bridging (87%) and a low rate of radiolucencies suggestive of loosening (5%). CONCLUSION: A 5-year follow-up showed continued excellent clinical responses in patients with SIJ pain treated with SIJF using triangular titanium implants along with a high rate (88%) of joint fusion. LEVEL OF EVIDENCE: Level II.

Practice Patterns and Treatment Challenges in Acute Postoperative Pain Management: A Survey of Practicing Physicians.

INTRODUCTION: The management of acute postoperative pain remains a significant challenge for physicians. Poorly controlled postoperative pain is associated with poorer overall outcomes. METHODS: Between April and May 2017, physicians from an online database who regularly prescribe intravenous (IV) medications for acute postoperative pain completed a 47-question survey on topics such as patient demographics, IV analgesia preferences, factors that influence prescribing decisions, and the challenges and unmet needs for the treatment of acute postoperative pain. RESULTS: Of 501 surveyed physicians, 55% practiced in community hospitals, 60% had been in practice for > 10 years, and 60% were surgeons. The three categories of IV pain medications most likely to be prescribed to patients with moderate-to-severe pain immediately after surgery were morphine, hydromorphone, or fentanyl (95.8% of respondents); COX-2 inhibitors or nonsteroidal anti-inflammatory drugs (73.7%); and acetaminophen (60.5%). Past clinical experience (81.6%), surgery type (78.2%), and onset of analgesia (67.1%) were practice-related factors that most determined their medication choice. Key patient-related risk factors, such as avoidance of medication-related adverse events (AEs), each influenced prescription decisions in > 75.0% of physicians. Nausea and vomiting were among the most common challenges associated with postoperative pain management (76.2 and 60.3%, respectively), and avoidance of analgesic medication-related AEs was among the three most influential patient-related factors that determined prescribing decision (75%). Physicians reported the top unmet need for acute pain management in patients experiencing moderate-to-severe postoperative pain was more medications with fewer side effects (i.e., nausea, vomiting, and respiratory depression; 80.7%). CONCLUSIONS: Opioids remain an integral component of multimodal acute analgesic therapy for acute postoperative pain in hospitalized patients. The use of all IV analgesic medications is limited by concerns over AEs, particularly with opioids and in high-risk patients. There remains a key unmet need for effective analgesic medications that are associated with a lower risk of AEs. FUNDING: Trevena, Inc.

Long-term prospective outcomes after minimally invasive trans-iliac sacroiliac joint fusion using triangular titanium implants.

BACKGROUND: Minimally invasive sacroiliac joint fusion (SIJF) has become an increasingly accepted surgical option for chronic sacroiliac (SI) joint dysfunction, a prevalent cause of unremitting low back/buttock pain. OBJECTIVE: The objective of this study was to report clinical and functional outcomes of SIJF using triangular titanium implants (TTI) in the treatment of chronic SI joint dysfunction due to degenerative sacroiliitis or sacroiliac joint (SIJ) disruption at 3 years postoperatively. METHODS: A total of 103 subjects with SIJ dysfunction at 12 centers were treated with TTI in two prospective clinical trials (NCT01640353 and NCT01681004) and enrolled in this long-term follow-up study (NCT02270203). Subjects were evaluated in study clinics at study start and again at 3, 4, and 5 years. RESULTS: Mean (SD) preoperative SIJ pain score was 81.5, and mean preoperative Oswestry Disability Index (ODI) was 56.3. At 3 years, mean pain SIJ pain score decreased to 26.2 (a 55-point improvement from baseline, p<0.0001). At 3 years, mean ODI was 28.2 (a 28-point improvement from baseline, p<0.0001). In all, 82% of subjects were very satisfied with the procedure at 3 years. EuroQol-5D (EQ-5D) time trade-off index improved by 0.30 points (p<0.0001). No adverse events definitely related to the study device or procedure were reported; one subject underwent revision surgery at year 3.7. SIJ pain contralateral to the originally treated side occurred in 15 subjects of whom four underwent contralateral SIJF. The proportion of subjects who were employed outside the home full- or part-time at 3 years decreased somewhat from baseline (p=0.1814), and the proportion of subjects who would have the procedure again was lower at 3 years compared to earlier time points. CONCLUSION: In long-term (3-year) follow-up, minimally invasive trans-iliac SIJF with TTI was associated with improved pain, disability, and quality of life with relatively high satisfaction rates. LEVEL OF EVIDENCE: Level II. CLINICAL RELEVANCE: SIJF with TTI.