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.

Radiographic and Patient-Reported Outcomes of Lordotic Versus Non-lordotic Static Interbody Devices in Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Longitudinal Comparative Cohort Study.

Introduction Minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) is increasingly used to treat lumbar degenerative pathology. Its effect on sagittal parameters remains controversial. Static and expandable lordotic interbody devices (cages) were developed to improve segmental and overall lumbar lordosis. This study aimed to compare the radiographic and patient-reported outcomes (PROs) between static lordotic and non-lordotic titanium cages in patients undergoing 1-2 level MI-TLIF for degenerative conditions.  Methods We reviewed consecutive eligible patients who underwent 1-2 level MI-TLIF (7/2017-11/2019) at a single institution by multiple surgeons. Standing X-rays and PROs were collected at preoperative, 1-month, and 6-month postoperative intervals. Using univariate analyses, we compared the two cohorts regarding confounders, radiographic parameters, and proportions of patients reaching minimal clinically important difference (MCID) for PROs. Results One-hundred-twenty-five patients were reviewed. Forty-seven had lordotic and seventy-eight non-lordotic cages. The lordotic cohort was significantly younger than the non-lordotic (55.9 years vs. 60.7 years, p= 0.042). The baseline radiographic parameters were not significantly different between cohorts. At the preoperative-6-month interval, the lordotic cohort had significant improvement in lumbar lordosis versus non-lordotic cohort (2.95° ± 7.2° vs. -0.3° ± 7.1°, p=0.024). Both cohorts showed improvement in segmental lordosis, anterior and posterior interspace height, and low subsidence grade with no significant difference between cohorts at all intervals. Overall, 69.1-83.8% of patients achieved MCID in all PROs with no significant difference between cohorts. Conclusions The use of a static lordotic titanium cage in 1-2 level MI-TLIF did not result in significantly different radiographic improvements or PROs compared with a non-lordotic cage.

Multilevel Stabilization Screws Prevent Proximal Junctional Failure and Kyphosis in Adult Spinal Deformity Surgery: A Comparative Cohort Study.

BACKGROUND: Proximal junctional kyphosis (PJK) and proximal junctional failure (PJF) occurred in up to 40% of patients with adult spinal deformity (ASD) who underwent open thoracolumbar fusion. Proximal stabilization techniques have been investigated to prevent PJK/PJF without conclusive results. OBJECTIVE: To demonstrate reductions in PJK/PJF with multilevel stabilization screws (MLSSs). METHODS: This observational longitudinal cohort study compares MLSSs with standard instrumentation. We reviewed the charts of consecutive patients with ASD undergoing open thoracolumbar fusion (>3 levels, extending cranially above T6 and caudally below L1) from 2009 to 2017 and were followed for >2 yr postoperatively. We defined PJF using the International Spine Study Group criteria and PJK as a Cobb angle increase >10°. We defined the upper instrumented vertebra as the most cephalad vertebral body with bilateral MLSSs. Confounders, MLSS-specific complications, and radiographic outcomes were collected. We evaluated comparability between groups using univariate analyses. We adjusted for covariates by using multivariable regressions modeling PJF and PJK separately with a P-value < .00625 considered significant after the Bonferroni correction. Sensitivity analysis accounted for those lost to follow-up. RESULTS: Seventy-six patients (50 MLSS vs 26 controls) were included. MLSS patients were significantly older (64.5 ± 8.9 vs 54.8 ± 19.9 yr, P = .024) and had significantly lower PJF incidence (10.0% vs 30.8%, P = .023) and less kyphosis (1.3° ± 5.3° vs 5.2° ± 6.3°, P = .014). Multivariable analysis demonstrated a significant independent association between MLSSs and decreased odds of PJF (odds ratio: 0.11, 0.02-0.53, P = .006). Perioperative complications did not significantly differ between cohorts. CONCLUSION: MLSSs are safe and efficacious in reducing PJF/PJK in patients with ASD undergoing open thoracolumbar fusion.

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.

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.

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.

Reconstruction of a Thoracic Spine Epithelioid Hemangioendothelioma with Antibiotic Impregnated Poly-methyl Methacrylate: A Case Report.

A 58-year-old female presented to the hospital with respiratory distress several days after a right hallux amputation. A new lytic lesion within the fourth thoracic (T4) vertebral body and mediastinal lymphadenopathy was noted on chest computed tomography scan. A bone biopsy was performed, revealing bone and collagenous fragments only. Two months later, new imaging revealed approximately 60% lytic destruction of the T4 vertebral body with new right pedicle involvement. Surgical treatment was offered. Intraoperative frozen pathology indicated a hemangioma. An intralesional debulking and stabilization was performed. The right T4 nerve was sacrificed to gain access to the entire vertebral body. Curettage was then used to push the tumor away from the spinal canal into the vertebral body. The spine was reconstructed with 5-10mm beads of Simplex P bone cement (Stryker®, Kalamazoo, MI) which contained 40 grams of poly-methyl methacrylate and 1 gram of tobramycin. Five months after resection, the patient presented with computed tomography and magnetic resonance imaging findings of recurrent disease at T4 and spread to the adjacent T5 vertebral body with lytic changes. At 18 months following her second debulking surgery and radiation treatment, the patient was doing well with no pain or numbness. Long-term imaging compared to the patient's preoperative imaging displayed improvement in spinal debulking with minimal residual enhancement of tumor despite significant artifact.

Bone Morphogenetic Protein in the Repair of Cerebrospinal Fluid Leak after Transsphenoidal Surgery.

BACKGROUND: Recurrent cerebrospinal fluid (CSF) leak carries significant morbidity. We sought to demonstrate that bone morphogenetic protein (BMP) use is effective and safe for the repair of recurrent CSF leak after a transsphenoidal pituitary tumor resection (TSPTR). MATERIALS AND METHODS: We reviewed charts and radiographic data of consecutive patients who underwent BMP repair of recurrent CSF leak after TSPTR from January 2010 to June 2015 and who failed previous multilayer closure. We detailed the technique for constructing and placing a BMP-DuraGen patch for the repair. The primary variables include postoperative computed tomography/magnetic resonance imaging (CT/MRI) evidence of ectopic bone growth or inflammation, newly diagnosed systemic neoplasm within 1 year, and recurrent CSF leak. Secondary outcome is the length of stay after BMP repair. All patients were followed up radiographically and through phone interview. RESULTS: Four patients underwent BMP repair of recurrent CSF leak after TSPTR. The average postoperative CT/MRI interval was 22 months. Postoperative CT/MRI revealed no ectopic bone formation or inflammatory changes around the site of BMP application. There was no recurrence of CSF leak or newly diagnosed neoplasm from both chart review and phone interview. CONCLUSIONS: We demonstrate that the use of BMP is a safe and an effective treatment in the repair of recurrent CSF leaks after TSPTR.

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.