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.

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.

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.

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.

Two-Level Spontaneous Pedicle Fracture above a Degenerative Spondylolisthesis and Minimally Invasive Treatment.

This is a case report and literature review. The objectives of the study are to describe minimally invasive treatment of pedicle fractures, to show contralateral pedicle changes with pedicle fracture treatment, and to review literature on incidence and mechanism of neural arch fractures. After conservative therapy, there are several options for the treatment of pedicle fractures including pediculoplasty, osteosynthesis, or fusion. As patients' age increases, the incidence of pedicle fracture may rise and minimally invasive pedicle screw treatment represents a good motion-preserving option to stabilize without fusion. We report a patient with spontaneous pedicle fractures above a degenerative spondylolisthesis and evidence of contralateral pedicle changes at L2 and L3. After minimally invasive pedicle screw placement, postoperative imaging demonstrated trabeculation across both L2 and L3 fractures with a resolution of contralateral pedicle sclerotic changes and healing of incompletely fracture contralateral pedicle at L2. Pedicle fractures lead to contralateral pedicle sclerotic changes and potential fracture and may cause significant back pain. Stabilization and healing of the neural arch can be achieved with minimally invasive placement of pedicle screws without need for fusion.

Kyphoplasty patient-centered outcomes via questionnaire.

BACKGROUND: To assess patient centered outcomes among adults with compression fractures treated by kyphoplasty. METHODS: A 3-question survey was administered via telephone to patients who had a kyphoplasty procedure performed from 2008-2011. RESULTS: One hundred fifty-one patients completed the telephone satisfaction survey. Of these, 95.4% of respondents said the procedure was tolerable, 82.8% had full or partial pain relief and 66.2% would have the procedure again. CONCLUSIONS: Large randomized and observational evidence support the use of kyphoplasty in osteoporotic and malignant compression fractures. Based on our survey, patients believe kyphoplasty is a tolerable procedure that produces full or partial pain relief and would undergo the procedure again if needed.