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 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.

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.

Big data registries in spine surgery research: the lurking dangers.

Spine surgery research has improved considerably over the last few decades. Its' most recent growth is in large part due to the mounting increase in studies conducted using national databases and registries. With easy access to a large number of patients, the benefit of these registries has become evident. However, as with any research, this type of data must be used responsibly with the appropriate strengths and limitations kept in mind. Inappropriate use of these registries continues to be a growing concern as potentially false or inaccurate conclusions can adversely impact clinical practice. It is, therefore, the author and the readers' responsibility to acknowledge and understand the limitations of this type of data. Knowledge of methodological requirements in the use and analyses of registry data is essential to ensuring quality evidence with proper interpretation.

The Impact of Intraoperative Local Ketorolac on Opioid Use in the Management of Postoperative Pain in Thoracolumbar Spinal Fusions: A Retrospective Cohort Study.

BACKGROUND: The United States is facing an opioid addiction epidemic with >63,600 deaths from drug overdoses in 2016 alone. Ketorolac is a nonsteroidal anti-inflammatory drug that has been shown to decrease postoperative pain in decompressive lumbar laminectomies. We sought to demonstrate that intraoperative intramuscular (IM) ketorolac is associated with decreased opioid use in the management of acute postoperative pain in thoracolumbar spinal fusions. METHODS: A retrospective review of consecutive patients undergoing open and minimally invasive (MIS) thoracolumbar fusions between 2017 and 2018. Ketorolac (30 mg) was injected into the paraspinal muscles adjacent to the operative site before closure. Patients were placed on a standard pain control regimen. All demographic and surgical data were assessed with univariate analysis to assess for differences between groups. Univariate analysis was used to identify significant covariates for the linear regressions with postoperative morphine equivalents, length of stay (LOS), and visual analog scale (VAS) for pain as dependent variables. A P < .025 was considered significant to account for multiple covariates. RESULTS: Two hundred twenty-five consecutive patients were included with 58 patients receiving intraoperative IM ketorolac. The average age of the ketorolac groups was 63.4 years (23-87 years) with an even distribution between genders. There was no significant difference in demographic or surgical data between the 2 cohorts. Postoperative opioid use, when corrected for LOS, showed no significance between cohorts, ketorolac 16.4 mg (95% confidence interval [CI]: 12.3-20.5) and nonketorolac 6.7 mg (95% CI: 14.1-19.4, P = .8729). Other than postoperative day zero VAS (P = .05), ketorolac was not a predictor of opioid use, LOS, or VAS. CONCLUSION: The use of a single dose of intraoperative IM ketorolac did not decrease the overall opioid requirements or shorten the LOS following open or MIS lumbar fusions. However, we did demonstrate benefit in early pain control, which makes this promising for further investigation. LEVEL OF EVIDENCE: 3. CLINICAL RELEVANCE: This article promotes attention to the opioid crisis and the need for multimodal nonopioid based pain management in spine surgery.

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.

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.

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.

Treatment of a Compression Fracture at a Previously Instrumented Lumbar Vertebral Body Using Balloon Kyphoplasty: A Technical Case Report.

Compression fractures are common among osteoporotic patients and can be a significant source of pain and disability. Patients who suffer a compression fracture at an instrumented level of a lumbar fusion are most often treated conservatively. Herein, we demonstrate a safe and effective treatment for a vertebral compression fracture (VCF) at a previous level with instrumented fusion and pedicle screw fixation. An 89-year-old female with a history of multiple osteoporotic compression fractures treated with previous kyphoplasties and a prior instrumented fusion at L4-L5 presented with debilitating lower back pain for one week. After failing conservative management, computed tomography (CT) and magnetic resonance imaging (MRI) study of the lumbar spine revealed an acute VCF of the previously instrumented L5 vertebral body. Under biplanar fluoroscopy, a balloon kyphoplasty was performed at the L5 vertebrae utilizing the Inflatable Vertebral Augmentation System (IVAS) from Stryker® (Kalamazoo, MI, USA). We were able to demonstrate that the treatment of an acute VCF with balloon kyphoplasty is feasible in patients who have a history of previous instrumentation with pedicle screws remaining at the fracture level.

Minimally Effective Dose of Bone Morphogenetic Protein in Minimally Invasive Lumbar Interbody Fusions: Six Hundred Ninety Patients in a Dose-Finding Longitudinal Cohort Study.

STUDY DESIGN: Retrospective longitudinal cohort. OBJECTIVE: We sought to demonstrate the minimally effective bone morphogenetic protein (BMP) dose to achieve fusion in minimally invasive transforaminal lumbar interbody fusions. SUMMARY OF BACKGROUND DATA: Multiple studies have been conducted, which used a wide range of BMP doses for lumbar fusions highlighting associated risks and benefits. There is, however, a paucity in the literature in determining the minimally effective dose. METHODS: Consecutive patients who underwent transforaminal lumbar interbody fusion from 2009 to 2014 were reviewed. Fusion was determined by a combination of computed tomography and dynamic x-ray by independent radiologists. We used backward stepwise multiple logistic regression with fusion as the dependent variable to determine whether BMP dose/level was a significant predictor for fusion. To determine the minimally effective dose of BMP/level, separate logistic regressions for different BMP dose ranges and sensitivity analyses were used. A P value ≤0.025 was considered significant. RESULTS: There were 1102 interspaces among 690 patients. Average BMP dose was 1.28 mg/level. Overall fusion was 95.2% with a mean follow-up of 19 months. BMP dose/level was a significant predictor for fusion. Odds of fusion increased by 2.02 when BMP dose range was increased from (0.16-1 mg/level) to (1.0-2 mg/level), but fusion odds did not increase when BMP dose increased to more than 2 mg/level. CONCLUSION: BMP dose/level was a significant predictor for fusion. There was a significant increase in odds of fusion when BMP dose increased from 0.16 to 1 mg/level to 1.0 to 2 mg/level. No benefit from increasing the dose more than 2 mg/level was found, suggesting 1.0 mg/level to be the minimally effective BMP dose. LEVEL OF EVIDENCE: 3.

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.

Surgical management of penetrating spinal cord injury primarily due to shrapnel and its effect on neurological outcome: a literature review and meta-analysis.

OBJECTIVE This study was performed to determine whether decompression of penetrating spinal cord injury (SCI) due to explosive shrapnel leads to greater neurological recovery than conservative management. METHODS In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a comprehensive literature search using PubMed/MEDLINE, Web of Science, Google Scholar, and the Defense Technical Information Center public site was conducted on May 2, 2016. Studies that described penetrating SCI with shrapnel as an etiology, included surgical and/or conservative management, and demonstrated admission and follow-up neurological status were eligible for inclusion in this study. Odds ratios were calculated for the overall effect of surgical treatment on neurological recovery. Funnel plots were used to evaluate publication bias. RESULTS Five case series (Level IV evidence) met the study criteria, and 2 of them had estimable odds ratios for use in the Forest plot analysis. Among the patients from all 5 studies, 65% were injured by shrapnel, 25% by high-velocity bullet, 8% by low-velocity bullet, and 2% by an unknown cause. A total of 288 patients were included in the overall odds ratio calculations. Patients were stratified by complete and incomplete SCI. The meta-analysis showed no significant difference in outcomes between surgical and conservative management in the complete SCI cohort or the incomplete SCI cohort. Overall rates of improvement for complete SCI were 25% with surgery and 27% with conservative treatment (OR 1.07, 95% CI 0.44-2.61, p = 0.88); for incomplete SCI, 70% with surgery and 81% with conservative treatment (OR 1.67, 95% CI 0.68-4.05, p = 0.26). CONCLUSIONS This study demonstrates no clear benefit to surgical decompression of penetrating SCI due predominantly to shrapnel. There is a considerable need for nonrandomized prospective cohort studies examining decompression and stabilization surgery for secondary and tertiary blast injuries.