Risk factors of emergency department visits following elective cervical and lumbar surgical procedures: a multi-institution analysis from the Michigan Spine Surgery Improvement Collaborative.

OBJECTIVE: Emergency department visits 90 days after elective spinal surgery are relatively common, with rates ranging from 9% to 29%. Emergency visits are very costly, so their reduction is of importance. This study's objective was to evaluate the reasons for emergency department visits and determine potentially modifiable risk factors. METHODS: This study retrospectively reviewed data queried from the Michigan Spine Surgery Improvement Collaborative (MSSIC) registry from July 2020 to November 2021. MSSIC is a multicenter (28-hospital) registry of patients undergoing cervical and lumbar degenerative spinal surgery. Adult patients treated for elective cervical and/or lumbar spine surgery for degenerative pathology (spondylosis, intervertebral disc disease, low-grade spondylolisthesis) were included. Emergency department visits within 90 days of surgery (outcome measure) were analyzed utilizing univariate and multivariate regression analyses. RESULTS: Of 16,224 patients, 2024 (12.5%) presented to the emergency department during the study period, most commonly for pain related to spinal surgery (31.5%), abdominal problems (15.8%), and pain unrelated to the spinal surgery (12.8%). On multivariate analysis, age (per 5-year increase) (relative risk [RR] 0.94, 95% CI 0.92-0.95), college education (RR 0.82, 95% CI 0.69-0.96), private insurance (RR 0.79, 95% CI 0.70-0.89), and preoperative ambulation status (RR 0.88, 95% CI 0.79-0.97) were associated with decreased emergency visits. Conversely, Black race (RR 1.30, 95% CI 1.13-1.51), current diabetes (RR 1.13, 95% CI 1.01-1.26), history of deep venous thromboembolism (RR 1.28, 95% CI 1.16-1.43), history of depression (RR 1.13, 95% CI 1.03-1.25), history of anxiety (RR 1.32, 95% CI 1.19-1.46), history of osteoporosis (RR 1.21, 95% CI 1.09-1.34), history of chronic obstructive pulmonary disease (RR 1.19, 95% CI 1.06-1.34), American Society of Anesthesiologists class > II (RR 1.18, 95% CI 1.08-1.29), and length of stay > 3 days (RR 1.29, 95% CI 1.16-1.44) were associated with increased emergency visits. CONCLUSIONS: The most common reasons for emergency department visits were surgical pain, abdominal dysfunction, and pain unrelated to index spinal surgery. Increased focus on postoperative pain management and bowel regimen can potentially reduce emergency visits. The risks of diabetes, history of osteoporosis, depression, and anxiety are areas for additional preoperative screening.

Safety and functional outcomes of early antiplatelet therapy within 24 hours following mechanical thrombectomy for secondary prevention in emergent large-vessel occlusion strokes: a registry study.

OBJECTIVE: The aim of this study was to demonstrate the safety and functional outcomes of antiplatelet use within 24 hours following mechanical thrombectomy (MT). METHODS: A retrospective review of prospectively collected data for consecutive patients who underwent MT for acute ischemic stroke (AIS) between 2016 and 2020 was performed. Patient demographics, comorbidities, Alberta Stroke Program Early CT Score (ASPECTS), antiplatelet use, neurological status, and tissue plasminogen activator use were collected. Patients were stratified into two groups, early (< 24 hours) or late (> 24 hours), based on when antiplatelet therapy was initiated post-MT. The primary outcome was safety, determined based on the rate of symptomatic intracranial hemorrhage (sICH) and inpatient mortality. The secondary outcome was functional independence (defined as modified Rankin Scale [mRS] score ≤ 2) at discharge and 30 days and 90 days postoperatively. The two cohorts were compared using univariate analysis. Multiple imputations were used to create complete data sets for missing data. Multivariable analysis was used to identify predictors for sICH and functional outcomes. RESULTS: A total of 190 patients met inclusion criteria (95 per group). Significant differences between the early and late groups included sex, preoperative intravenous thrombolysis, angioplasty, stent placement, and thrombectomy site. ICH (symptomatic and asymptomatic) and inpatient mortality were not significantly different between the groups. The mRS score was significantly lower at discharge (p < 0.001), 30 days (p = 0.011), and 90 days (p = 0.024) following MT in the early group. Functional independence was significantly higher in the early antiplatelet group at discharge (p = 0.015) and at 30 days (p = 0.006). Early antiplatelet use was independently associated with significantly increased odds of achieving functional independence at discharge (OR 3.07, p = 0.007) and 30 days (OR 5.78, p = 0.004). Early antiplatelet therapy was not independently associated with increased odds of sICH. CONCLUSIONS: Early antiplatelet initiation after MT in patients with AIS was independently associated with significantly increased odds of improved postoperative functional outcomes without increased odds of developing sICH.

Fusion and patient-reported outcomes after navigated decortication and direct arthrodesis in minimally invasive sacroiliac joint fusion using cylindrical threaded implants: a case series and literature review.

OBJECTIVE: Sacroiliac joint (SIJ) dysfunction is a significant cause of back pain. Despite recent advances in minimally invasive (MIS) SIJ fusion, the fusion rate remains controversial. This study sought to demonstrate that a navigated decortication and direct arthrodesis technique in MIS SIJ fusion would result in satisfactory fusion rates and patient-reported outcomes (PROs). METHODS: The authors retrospectively reviewed consecutive patients who underwent MIS SIJ fusion from 2018 to 2021. SIJ fusion was performed using cylindrical threaded implants and SIJ decortication employing the O-arm surgical imaging system and StealthStation. The primary outcome was fusion, evaluated using CT at 6, 9, and 12 months postoperatively. Secondary outcomes included revision surgery, time to revision surgery, visual analog scale (VAS) score for back pain, and the Oswestry Disability Index (ODI), measured preoperatively and 6 and 12 months postoperatively. Patient demographics and perioperative data were also collected. PROs over time were analyzed using ANOVA followed by a post hoc analysis. RESULTS: One hundred eighteen patients were included in this study. The mean (± SD) patient age was 58.56 ± 13.12 years, and most patients were female (68.6% vs 31.4% male). There were 19 smokers (16.1%) with an average BMI of 29.92 ± 6.73. One hundred twelve patients (94.9%) underwent successful fusion on CT. The ODI improved significantly from baseline to 6 months (Δ7.73, 95% CI 2.43-13.03, p = 0.002) and from baseline to 12 months (Δ7.54, 95% CI 1.65-13.43, p = 0.008). Similarly, VAS back pain scores improved significantly from baseline to 6 months (Δ2.31, 95% CI 1.07-3.56, p < 0.001) and from baseline to 12 months (Δ1.63, 95% CI 0.25-3.00, p = 0.015). CONCLUSIONS: MIS SIJ fusion with navigated decortication and direct arthrodesis was associated with a high fusion rate and significant improvement in disability and pain scores. Further prospective studies examining this technique are warranted.

Preventing Postoperative Urinary Retention (POUR) in Patients Undergoing Elective Lumbar Surgery: A Quality Improvement Project.

BACKGROUND AND OBJECTIVES: Postoperative urinary retention (POUR) is associated with significant morbidity. Our institution's POUR rate was elevated among patients undergoing elective lumbar spinal surgery. We sought to demonstrate that our quality improvement (QI) intervention would significantly lower our POUR rate and length of stay (LOS). METHODS: A resident-led QI intervention was implemented from October 2017 to 2018 on 422 patients in an academically affiliated community teaching hospital. This consisted of standardized intraoperative indwelling catheter utilization, postoperative catheterization protocol, prophylactic tamsulosin, and early ambulation after surgery. Baseline data on 277 patients were collected retrospectively from October 2015 to September 2016. Primary outcomes were POUR and LOS. The focus, analyze, develop, execute, and evaluate (FADE) model was used. Multivariable analyses were used. P value <.05 was considered significant. RESULTS: We analyzed 699 patients (277 pre-intervention vs 422 post-intervention). The POUR rate (6.9% vs 2.6%, Δ confidence interval [CI] 1.15-8.08, P = .007) and mean LOS (2.94 ± 1.87 days vs 2.56 ± 2.2 days, Δ CI 0.066-0.68, P = .017) were significantly improved following our intervention. Logistic regression demonstrated that the intervention was independently associated with significantly decreased odds for developing POUR (odds ratio [OR] = 0.38, CI 0.17-0.83, P = .015). Diabetes (OR = 2.25, CI 1.03-4.92, P = .04) and longer surgery duration (OR = 1.006, CI 1.002-1.01, P = .002) were independently associated with increased odds of developing POUR. CONCLUSIONS: After implementing our POUR QI project for patients undergoing elective lumbar spine surgery, the institutional POUR rate significantly decreased by 4.3% (62% reduction) and LOS, by 0.37 days. We demonstrated that a standardized POUR care bundle was independently associated with a significant decrease in the odds of developing POUR.

The Effect of Preoperative Symptom Duration on Patient-Reported Outcomes After Anterior Cervical Discectomy and Fusion in Nonmyelopathic Patients: Analyses From the Michigan Spine Surgery Improvement Collaborative (MSSIC).

BACKGROUND: The effect of preoperative symptom duration (PSD) on patient-reported outcomes (PROs) in anterior cervical discectomy and fusion (ACDF) for radiculopathy is unclear. OBJECTIVE: To determine whether PSD is a predictor for PRO after ACDF for radiculopathy. METHODS: The Michigan Spine Surgery Improvement Collaborative registry was queried between March, 2014, and July, 2019, for patients who underwent ACDF without myelopathy and PROs (baseline, 90 days, 1 year, 2 years). PROs were measured by numerical rating scales for neck/arm pain, Patient-Reported Outcomes Measurement Information System Short Form-Physical Function (PROMIS-PF), EuroQol-5D (EQ5D), and North American Spine Society satisfaction. Univariate analyses were used to evaluate the proportion of patients reaching minimal clinically important differences (MCID). PSD was <3 months, 3 month-1 year, or >1 years. Multiple logistic regression models were used to estimate the association between PSD and PRO reaching MCID. The discriminative ability of the model was evaluated by receiver operating characteristic curve. RESULTS: We included 2233 patients who underwent ACDF with PSD <3 months (278, 12.4%), 3 month-1 year (669, 30%), and >1 years (1286, 57.6%). Univariate analyses demonstrated a greater proportion of patients achieving MCID in <3-month cohort for arm numerical rating scales, PROMIS-PF, EQ5D, and North American Spine Society Satisfaction. Multivariable analyses demonstrated using <3 months PSD as a reference, PSD >1 years was associated with decreased odds of achieving MCID for EQ5D (odds ratio 0.5, CI 0.32-0.80, P = .004). Private insurance and increased baseline PRO were associated with significantly higher odds for achieving PROMIS-PF MCID and EQ5D-MCID. CONCLUSION: Preoperative symptom duration greater than 1 year in patients who underwent ACDF for radiculopathy was associated with worse odds of achieving MCID for multiple PROs.

Impact of Interspace Distraction on Fusion and Clinical Outcomes in Anterior Cervical Discectomy and Fusion: A Longitudinal Cohort Study.

STUDY DESIGN: Longitudinal cohort study. PURPOSE: To determine the effect of change in interspace height on fusion and postoperative neck pain. OVERVIEW OF LITERATURE: The optimal height of a cervical interbody device (cage) in anterior cervical discectomy and fusion (ACDF) is not well defined. In addition, the effect of interspace distraction on fusion and postoperative neck pain remains unclear. METHODS: We retrospectively reviewed the charts of consecutive patients who underwent one- or two-level ACDF using polyetheretherketone cages by multiple surgeons from January 2015 to June 2016. We excluded patients younger than 18 years old, patients who had prior surgery at the same level (s), those with two-stage procedures, and those with less than 3 months of followup. Fusion was determined using the "Song" criteria. Ordinal regression was used to determine predictors of fusion. Patient-reported outcomes (PRO) were analyzed. RESULTS: We identified 323 consecutive patients. Twenty-two patients met the exclusion criteria. A total of 435 operative levels were included in the 301 remaining patients. Interspace fusion did not significantly vary by increasing interspace height with fusion rates between 76.2% and 82.8% at a mean follow-up of 17.9±12.6 months. The effect of an increase in interspace height and neck pain PRO was available for 163 patients who underwent one-level ACDF at a mean follow-up period of 16.2±13.1 months. We found no significant difference in fusion rate or neck pain score with increasing interspace height from 1 to 8 mm. Ordinal regression demonstrated no significant predictors of fusion. CONCLUSIONS: Interspace distraction from 1 to 8 mm did not result in significantly different pseudarthrosis rates or postoperative neck pain.

The effect of ketorolac on posterior minimally invasive transforaminal lumbar interbody fusion: an interim analysis from a randomized, double-blinded, placebo-controlled trial.

BACKGROUND CONTEXT: Postoperative pain control following posterior lumbar fusion continues to be challenging and often requires high doses of opioids for pain relief. The use of ketorolac in spinal fusion is limited due to the risk of pseudarthrosis. However, recent literature suggests it may not affect fusion rates with short-term use and low doses. PURPOSE: We sought to demonstrate noninferiority regarding fusion rates in patients who received ketorolac after undergoing minimally invasive (MIS) posterior lumbar interbody fusion. Additionally, we sought to demonstrate ketorolac's opioid-sparing effect on analgesia in the immediate postoperative period. STUDY DESIGN/SETTING: This is a prospective, randomized, double-blinded, placebo-controlled trial. We are reporting our interim analysis. PATIENT SAMPLE: Adults with degenerative spinal conditions eligible to undergo a one to three-level MIS transforaminal lumbar interbody fusion (TLIF). OUTCOME MEASURES: Six-month and 1-year radiographic fusion as determined by Suk criteria, postoperative opioid consumption as measured by intravenous milligram morphine equivalent, length of stay, and drug-related complications. Self-reported and functional measures include validated visual analog scale, short-form 12, and Oswestry Disability Index. METHODS: A double-blinded, randomized placebo-controlled, noninferiority trial of patients undergoing 1- to 3-level MIS TLIF was performed with bone morphogenetic protein (BMP). Patients were randomized to receive a 48-hour scheduled treatment of either intravenous ketorolac (15 mg every 6 hours) or saline in addition to a standardized pain regimen. The primary outcome was fusion. Secondary outcomes included 48-hour and total postoperative opioid use demonstrated as milligram morphine equivalence, pain scores, length of stay (LOS), and quality-of-life outcomes. Univariate analyses were performed. The present study provides results from a planned interim analysis. RESULTS: Two hundred and forty-six patients were analyzed per protocol. Patient characteristics were comparable between the groups. There was no significant difference in 1-year fusion rates between the two treatments (p=.53). The difference in proportion of solid fusion between the ketorolac and placebo groups did not reach inferiority (p=.072, 95% confidence interval, -.07 to .21). There was a significant reduction in total/48-hour mean opioid consumption (p<.001) and LOS (p=.001) for the ketorolac group while demonstrating equivalent mean pain scores in 48 hours postoperative (p=.20). There was no significant difference in rates of perioperative complications. CONCLUSIONS: Short-term use of low-dose ketorolac in patients who have undergone MIS TLIF with BMP demonstrated noninferior fusion rates. Ketorolac safely demonstrated a significant reduction in postoperative opioid use and LOS while maintaining equivalent postoperative pain control.

Age as a Risk Factor for Complications Following Anterior Cervical Discectomy and Fusion: Analysis From the Michigan Spine Surgery Improvement Collaborative (MSSIC).

STUDY DESIGN: Retrospective analysis of prospectively collected registry data using multivariable analyses of imputed data. OBJECTIVE: We sought to demonstrate that age would not be associated with complications in patients undergoing anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA: Elderly patients (≥70 yrs) undergoing ACDF are considered a higher risk for complications. However, conclusive evidence is lacking. The Michigan Spine Surgery Improvement Collaborative (MSSIC) is a quality improvement collaborative with 30 hospitals across Michigan. METHODS: The study included all patients who had 1 to 4 level ACDF (September 2015-August 2019) for 90-day complications. Major and minor complications were defined using a validated classification. Multiple imputations were used to generate complete covariate datasets. Generalized estimating equation model was used to identify associations with complications using the whole cohort and elderly subgroup analyses. Bonferroni correction was used. RESULTS: Nine thousand one hundred thirty five patients (11.1% ≥ 70 yrs and 88.9% <70 yrs) with 2266 complications were analyzed. Comparing elderly versus non-elderly, the elderly had a significantly higher rate of any complications (31.5% vs. 24.0%, P < 0.001) and major complications (14.1% vs. 7.0%, P < 0.001). On multivariable analysis, age was not independently associated with any complication. POD#0 ambulation and preop independent ambulation were independently associated with significantly decreased odds of any complication. In the elderly, independent preoperative ambulation was protective for any complication (odds ratio [OR] 0.53, 0.39-0.73 95% confidence interval [CI]), especially major complications (OR 0.41, 0.27-0.61 95% CI). CONCLUSION: Age was not an independent risk factor for complications in patients that underwent ACDF. In the elderly, independent preoperative ambulation was especially protective for major complications.Level of Evidence: 3.

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

INTRODUCTION: Sacroiliac 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. This protocol aims to conduct a meta-analysis to determine fusion rates and patient-reported outcomes of minimally invasive (MIS) SIJ fusions compared with conservative treatment. METHODS AND ANALYSIS: We drafted our protocol according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. We will search PubMed, Embase and the Cochrane Library, supplemented by manual search when necessary. Two independent reviewers will screen for eligibility by title/abstract, then full text, arbitrated by a third reviewer if necessary. The two reviewers will carry out a risk of bias assessment using the Cochrane Collaboration Risk of Bias tool for randomised controlled trial and the Methodological Index for Non-Randomised Studies tool for observational cohort studies. A third reviewer will arbitrate any disagreement. We will perform data synthesis using Review Manager (RevMan for Windows, V.5.4.1, The Cochrane Collaboration, 2020) and Comprehensive Meta-Analysis (V.3.3.070). Meta-bias will be evaluated and confidence determined using the Grading of Recommendations, Assessment, Development and Evaluation guidelines. ETHICS AND DISSEMINATION: Ethical approval for this review will not be required as no patient data is being collected. The results of this study will be submitted for publication in peer-reviewed journals. PROSPERO REGISTRATION NUMBER: CRD42021273481.

The Effect of Morbid Obesity on Complications, Readmission, and Patient-Reported Outcomes Following Minimally Invasive Transforaminal Lumbar Interbody Fusion: An Inverse Propensity Score Weighted Analysis.

STUDY DESIGN: Retrospective review of prospectively collected data at a single institution. OBJECTIVE: To compare perioperative and clinical outcomes in morbidly obese patients who underwent minimally invasive transforaminal lumbar interbody fusion (MiTLIF). SUMMARY OF BACKGROUND DATA: Obesity remains a serious public health concern. Obese patients who undergo lumbar fusion have historically thought to be at higher risk for complications and fare worse regarding quality-of-life outcomes. However, recent literature may demonstrate comparable risk and outcomes in obese patients. An increasing number of patients are categorized as morbidly obese (body mass index [BMI] ≥ 40 kg/m2). Perioperative and patient-reported outcomes (PROs) are lacking in this patient population. METHODS: The authors retrospectively reviewed a prospectively collected database of all morbidly obese and non-obese patients that underwent MiTLIF between 2015 and 2018 for degenerative conditions who had minimum 1-year follow-up for outcome assessment. An inverse propensity/probability of treatment weighting was utilized to create a synthetic weighted sample in which covariates were independent of obesity designation to adjust for imbalance between groups. Generalized estimating equations (GEE) was used to estimate the association of morbid obesity and complications and 1-year PROs. RESULTS: A total of 292 patients were analyzed with 234 non-obese patients and 58 morbidly obese patients. Multivariate analysis failed to demonstrate any association between morbid obesity and achieving minimal clinically important difference (MCID) for Oswestry disability index (ODI), visual analog scale (VAS), or short form-12 (SF-12) physical component score. However, morbid obesity was associated with significant decrease in odds of achieving MCID for SF-12 mental component score (P = 0.001). Increased surgery duration was significantly associated with morbid obesity (P = 0.001). Morbid obesity exhibited no statistically significant association with postoperative complications, readmission, pseudarthrosis, or adjacent segment disease (ASD). CONCLUSION: Morbidly obese patients who undergo MiTLIF can achieve meaningful clinical improvement comparable to nonobese patients. Morbid obesity was associated with longer surgical times but was not associated with postoperative complications, readmission, or ASD.Level of Evidence: 3.

Age as a Predictor for Complications and Patient-reported Outcomes in Multilevel Transforaminal Lumbar Interbody Fusions: Analyses From the Michigan Spine Surgery Improvement Collaborative (MSSIC).

STUDY DESIGN: Retrospective review of a multi-institutional data registry. OBJECTIVE: The authors sought to determine the association between age and complications & patient-reported outcomes (PRO) in patients undergoing multilevel transforaminal interbody lumbar fusion (MTLIF). SUMMARY OF BACKGROUND DATA: Elderly patients undergoing MTLIF are considered high risk. However, data on complications and PRO are lacking. Additionally, safety of multilevel lumbar fusion in the elderly remains uncertain. METHODS: Patients ≥50-year-old who underwent MTLIF for degenerative lumbar spine conditions were analyzed. Ninety-day complications and PROs (baseline, 90-d, 1-y, 2-y) were queried using the MSSIC database. PROs were measured by back & leg visual analog scale (VAS), Patient-reported Outcomes Measurement Information System (PROMIS), EuroQol-5D (EQ-5D), and North American Spine Society (NASS) Patient Satisfaction Index. Univariate analyses were used to compare among elderly and complication cohorts. Generalized estimating equation (GEE) was used to identify predictors of complications and PROs. RESULTS: A total of 3120 patients analyzed with 961 (31%) ≥ 70-y-o and 2159 (69%) between 50-69. A higher proportion of elderly experienced postoperative complications (P = .003) including urinary retention (P = <.001) and urinary tract infection (P = .002). Multivariate analysis demonstrated that age was not independently associated with complications. Number of operative levels was associated with any (P = .001) and minor (P = .002) complication. Incurring a complication was independently associated with worse leg VAS and PROMIS scores (P = <.001). Preoperative independent ambulation was independently associated with improved PROMIS, and EQ5D (P = <.001). Within the elderly, preoperative independent ambulation and lower BMI were associated with improved PROMIS (P = <.001). Complications had no significant effect on PROs in the elderly. CONCLUSIONS: Age was not associated with complications nor predictive of functional outcomes in patients who underwent MTLIF. Age alone, therefore, may not be an appropriate surrogate for risk. Furthermore, baseline preoperative independent ambulation was associated with better clinical outcomes and should be considered during preoperative surgical counseling.Level of Evidence: 3.

Patient Satisfaction with Neurosurgery Telemedicine Visits During the Coronavirus Disease 2019 Pandemic: A Prospective Cohort Study.

BACKGROUND: Telemedicine refers to various modalities for remote care, including telephone calls, imaging review, and real-time video teleconferencing visits. Although it has not been widely used in outpatient neurosurgery settings, the COVID-19 (coronavirus disease 2019) pandemic has necessitated a broader adoption. Our goal is to show the level of patient satisfaction with their telemedicine care. METHODS: We prospectively studied consecutive telemedicine patients who scheduled outpatient neurosurgery visits from May 15 to June 8, 2020. Patients were seen by the surgeon via real-time video conferencing using Google Meet, and then completed a telemedicine satisfaction survey. Our primary outcome was telemedicine satisfaction scores. We compared satisfaction scores between new and established patients and between patients within and outside of a 15-mile radius of the nearest clinic location. Sensitivity analyses were performed to account for the nonrespondents. Descriptive and univariate analyses were performed. A P value of <0.05 was considered significant. RESULTS: Five-hundred and ninety patients completed a telemedicine visit during the study period. One patient from out of state was excluded. Three-hundred and ten patients (52.6%) responded. The average age was 60.9 ± 13.60 years; 59% were female, 20.6% were new patients; the average distance to the clinic was 28.03 ± 36.09 km (17.42 ± 22.43 miles). The mean overall satisfaction score was 6.32 ± 1.27. Subgroup analyses by new/established patient status and distance from their home to the clinic showed no significant difference in mean satisfaction scores between groups. CONCLUSIONS: Telemedicine provided a viable and satisfactory option for neurosurgical patients in the outpatient setting during the COVID-19 pandemic.

Efficacy and safety of cilostazol-nimodipine combined therapy on delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage: a prospective, randomised, double-blinded, placebo-controlled trial protocol.

INTRODUCTION: Delayed cerebral ischaemia (DCI) due to cerebral vasospasm (cVS) remains the foremost contributor to morbidity and mortality following aneurysmal subarachnoid haemorrhage (aSAH). Past efforts in preventing and treating DCI have failed to make any significant progress. To date, our most effective treatment involves the use of nimodipine, a calcium channel blocker. Recent studies have suggested that cilostazol, a platelet aggregation inhibitor, may prevent cVS. Thus far, no study has evaluated the effect of cilostazol plus nimodipine on the rate of DCI following aSAH. METHODS AND ANALYSIS: This is a multicentre, double-blinded, randomised, placebo-controlled superiority trial investigating the effect of cilostazol on DCI. Data concerning rates of DCI, symptomatic and radiographic vasospasm, length of intensive care unit stay, and long-term functional and quality-of-life (QoL) outcomes will be recorded. All data will be collected with the aim of demonstrating that the use of cilostazol plus nimodipine will safely decrease the incidence of DCI, and decrease the rates of both radiographic and symptomatic vasospasm with subsequent improvement in long-term functional and QoL outcomes when compared with nimodipine alone. ETHICS AND DISSEMINATION: Ethical approval was obtained from all participating hospitals by the Ascension Providence Hospital Institutional Review Board. The results of this study will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04148105.

The minimally effective dose of bone morphogenetic protein in posterior lumbar interbody fusion: a systematic review and meta-analysis.

BACKGROUND CONTENT: The risks and benefits of recombinant human bone morphogenetic protein-2 (BMP) in posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) have been widely reported. However, the BMP dose associated with such reports varied widely. Additionally, data on the location of BMP placement on complications and fusion are lacking. PURPOSE: To determine the minimally effective dose (MED) of BMP which results in optimal fusion rates while minimizing complications; to determine the effects of the location of BMP placement has on fusion rates and complications. STUDY DESIGN: Systematic review and meta-analysis. STUDY SAMPLE: Adult patients undergoing PLIF/TLIF for degenerative indications. OUTCOME MEASURES: Rates of radiculitis, fusion, osteolysis, heterotopic bone formation, and new cancer diagnosis. METHODS: PubMed, Embase, and Cochrane Database were used to identify studies published between January 1, 2011 and April 30, 2019 reporting BMP usage in adult patients who underwent PLIF/TLIF degenerative indications. A qualitative and quantitative synthesis was performed to evaluate the MED of BMP and the effect of location of BMP placement on fusion and complications. Complications were defined as osteolysis, heterotopic bone growth, radiculitis, and rate of new cancer diagnosis. Complications and fusion outcomes were each pooled according to commercially available BMP doses. Additionally, complications and fusion outcomes were pooled according to 4 location groups (interbody cage only, interbody cage + posterolateral gutter [PLG], cage + interspace, and interspace + PLG). Heterogeneity was assessed with Q and I2 statistics. RESULTS: Twenty-two articles, totaling 2,729 patients were included. Sixteen studies reported fusion and 15 reported complications. Among fusion studies, the mean BMP/level ranged from 1.28 to 12 mg/level. Among complication studies, the mean BMP/level ranged from 6.7 to 23.6 mg/level. The pooled overall fusion rate was 94.0% (91.4-95.8 confidence intervals). There was no significant difference in fusion and complication rates between different BMP doses. Thirteen studies included data on the location of BMP placement with 1,823 patients. At each BMP location, the fusion rate was not significantly different across the dose ranges (1.28-12 mg/level). We found the fusion rate to be marginally higher in the interspace + PLG group compared to the other groups. When BMP was placed in the interbody cage there was a mild increase in the rate of osteolysis compared to other placement locations. CONCLUSIONS: Fusion and complication rates did not differ significantly between different doses of BMP with the lowest MED for fusion as low as 1.28 mg/level. The location of BMP placement does not significantly affect fusion or complication rates.

Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium versus Cylindrical Threaded Implants: A Comparison of Patient-Reported Outcomes.

BACKGROUND: Minimally invasive fusion of the sacroiliac (SI) joint has gained popularity for the treatment of refractory dysfunction. The purpose of this study was to compare the clinical outcomes of minimally invasive SI joint fusion between cylindrical threaded implants (CTIs) and triangular dowel implants (TDIs). METHODS: We retrospectively reviewed consecutive patients who underwent SI joint fusions with either CTIs or TDIs. Data collected included patient demographics, perioperative data, and all patient-reported outcomes (PROs) including postoperative visual analog scale (VAS), Oswestry Disability Index, and Short Form-12 at 6 months and 1 year. The change from baseline PROs between the cohorts was analyzed as the primary outcome. Secondary outcomes included revision rates and time to revision between the two cohorts. A P value <0.05 was considered significant. RESULTS: One hundred fifty-six consecutive patients underwent SI joint fusion, 74 patients with CTIs and 82 with TDIs. There was a significant difference in procedure length with CTI averaging 60.0 minutes (confidence interval: 55.7-64.3) and TDI averaging 41.2 minutes (confidence interval: 38.4-43.9, P < 0.0005). In both cohorts, there was a significant improvement in all PROs at 6 months when compared with preoperative values. However, when compared, there was no significant difference between the cohorts at 6-month follow-up or 1-year follow-up for either VAS-back, VAS-leg, Oswestry Disability Index, or Short Form-12. A 6.1% revision rate in the CTI cohort was observed compared with a 2.4% revision rate in the TDI cohort (P = 0.11). CONCLUSIONS: SI joint fusions with TDI or CTI offer a significant improvement in pain, disability, and quality of life. However, no difference was observed between devices to suggest superior clinical outcomes. Increased revision rates in the Rialto group warrants further investigation.

Elderly as a Predictor for Perioperative Complications in Patients Undergoing Multilevel Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Regression Modeling Study.

STUDY DESIGN: This was a single-institute retrospective study. OBJECTIVE: To describe perioperative and postoperative complications in elderly who underwent multilevel minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) while identifying predictors of complications. SUMMARY OF BACKGROUND DATA: The number of elderly patients undergoing spinal fusion is rising. Spinal surgery in the elderly is considered high risk with high rates of complications. Perioperative and postoperative complications in elderly undergoing multilevel MIS TLIF is, however, not known. METHODS: A retrospective analysis was performed on 467 consecutive patients who underwent multilevel MIS TLIF at a single institution from 2013 to 2017. Two cohorts, 70 years or older and 50 to 69 years old were analyzed. Multiple logistic regressions with minor and major complication rates as the dependent variables were performed to identify predictors of complication based on previously cited risk factors. A p-value of 0.008 or less was considered significant. RESULTS: One hundred fifty-two elderly and 315 nonelderly patients underwent multilevel MIS TLIFs. The average age was 76.4 and 60.4 years for the elderly and nonelderly cohorts. We observed 13 major (8.44%) and 72 minor (47.4%) complications in the elderly. No difference was noted in complication rates between the cohorts, except for urinary tract infection (P = .004) and urinary retention (P = .014). There were no myocardial infarctions; hardware complications; visceral, vascular, and neural injuries; or death. Length of stay, comorbidity, and length of surgery were predictive of major and minor complications. CONCLUSION: Elderly may undergo multilevel MIS TLIF with comparable complication rates. Age was not a predictor of complications. Rather, attention should focus on evaluation of comorbidity and limiting operative times. LEVEL OF EVIDENCE: 3.

Repair of Postoperative Cervical Pseudomeningocele with the Use of Bone Morphogenetic Protein.

Recurrent cerebrospinal fluid (CSF) leak carries significant morbidity and mortality. A 25-year-old Caucasian male developed a symptomatic pseudomeningocele eight days after surgical resection of a cervical schwannoma. With no improvement after lumbar drain placement, the dural sleeve defect over the left C3 nerve root was repaired with suturable DuraGen® (Integra LifeSciences, Plainsboro, NJ, USA). Muscle and fat graft were then laid over the repair site and covered by Tisseel® (Baxter Healthcare, Deerfield, IL, USA). Recombinant human bone morphogenetic protein-2 (rhBMP-2) was applied via extra-small sponge laid over the graft. At 15-month clinical and 16-month radiographic follow-up, the patient had complete resolution of symptoms without any evidence of infection, ectopic bone formation, excessive inflammation, neoplasm, or recurrent CSF leak. This case demonstrates the successful use of BMP in the treatment of recurrent symptomatic cervical pseudomeningocele after tumor resection. We believe that the pro-inflammatory effects of rhBMP-2 lead to early scarring of dural defect and resolution of CSF leak.

Aesthetic Comparison between Subcuticular Suture and Staple Closure of Anterior Cervical Decompression and Fusion Incision Scars: A Prospective Controlled Single-blinded Trial.

INTRODUCTION: Anterior cervical decompression and fusion (ACDF) procedures are common and neck scar appearance is important aesthetically. This study compared subcuticular suture closure with staple closure regarding the aesthetics of the neck incision scar. METHODS: A single-blinded comparative prospective study with two cohorts involving one facility and multiple surgeons was done to study all consecutive patients who underwent one/two-level ACDF operations from 2015-2016. We excluded patients with corpectomies, postoperative wound infection, reoperations in the same admission, any previous ACDF operations, non-compliance in follow-up, and inability to give informed consent. We did single-layer skin stapling without platysma closure or subcuticular suture with platysma closure. Patients followed up between 1.5 and six months. We used the Stony Brook Scar Evaluation Scale (SBSES), range 0-5 with five being the best score. Digital images were taken in a standardized manner and saved in a secure database. A blinded plastic surgeon and a blinded neurosurgeon, not involved in the operation, evaluated the scars using SBSES. A priori sample size using a clinically significant difference of one was determined. Wilcoxon rank-sum test was used; a p-value <0.05 was considered statistically significant. RESULTS: We studied 93 staple and 66 suture closures. There is no significant difference between the groups regarding age, sex, the incidence of diabetes, smoking, obesity (body mass index (BMI) >30 kg/m2), chemotherapy or the length of the incision. There is no statistically significant difference regarding SBSES as evaluated by the plastic surgeon (staples vs. sutures, median 2 vs. 2, range 0-5, p = 0.32). There is a statistically significant difference as evaluated by the neurosurgeon (staples vs. sutures, median 4 vs. 3, range 0-5, p = 0.003). Post hoc power analysis was 0.90. CONCLUSION: Using the validated SBSES to assess the aesthetic outcome of ACDF scars, we demonstrated that staples and sutures provide equivalent aesthetic outcomes per plastic surgeon evaluation, and staple closure results in statistically significant better aesthetic outcomes per neurosurgeon evaluation.

The effect of ketorolac on posterior thoracolumbar spinal fusions: a prospective double-blinded randomised placebo-controlled trial protocol.

INTRODUCTION: Ketorolac has been shown to provide quality postoperative pain control and decrease opioid requirement with minimal side effects following spinal surgery. However, the literature addressing its use in spinal fusions is highly variable in both its effectiveness and complications, such as pseudarthrosis. Recent literature postulates that ketorolac may not affect fusion rates and large randomised controlled trials are needed to demonstrate ketorolac as a safe and effective adjuvant treatment to opioids for postoperative pain control. METHODS AND ANALYSIS: This is a multihospital, prospective, double-blinded, randomised placebo-controlled trial. Data concerning fusion rates, postoperative opioid use, pain scores, length of stay will be recorded with the aim of demonstrating that the use of ketorolac does not decrease thoracolumbar spinal fusion rates while identifying possible adverse events related to short-term minimal effective dose compared with placebo. Additionally, this investigation aims to demonstrate a decrease in postoperative opioid use demonstrated by a decrease in morphine equivalence while showing equivalent postoperative pain control and decrease the average length of stay. ETHICS AND DISSEMINATION: Ethical approval was obtained at all participating hospitals by the institutional review board. The results of this study will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03278691.