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Study Design: Retrospective review. Objectives: This study investigates the prevalence of adverse postsurgical events, or osteoporosis-related complications (ORCs), following spinal fusion. Methods: Patients undergoing primary posterior thoracolumbar or lumbar fusion by 1 of 2 surgeons practicing at a single institution were analyzed from 2007 to 2014. ORCs were defined in one of the following categories: revision surgery, compression fracture, proximal junctional kyphosis, pseudarthrosis, or failure of instrumentation. Patients with a bone mineral density of the hips and/or spine performed within 1 year of the index procedure were included. Patients were stratified into normal bone density, osteopenia, and osteoporosis using WHO guidelines. Patients were excluded if they were younger than 18 years at the time of surgery, with infection, malignancy, skeletal dysplasia, neuromuscular disorders, concomitant or staged anterior-posterior procedure, or fusion performed because of trauma. Results: Out of 140 patients included, the prevalence of normal bone density was 31.4% (44/140), osteopenia 58.6% (82/140), and osteoporosis 10.0% (14/140). There were no differences between groups for gender, age, body mass index, and interbody device rate. The overall prevalence of ORCs was 32.1% (45/140). By group, there was a prevalence of 22.7% (10/44), 32.9% (27/82), and 50.0% (7/14) for normal bone density, osteopenia, and osteoporosis, respectively. These differences were significantly higher for both the osteopenia and osteoporosis groups. Conclusions: Patients with T scores below −1.0 undergoing posterior lumbar fusion have an increased prevalence of ORCs. Consideration of bone density plays a crucial role in patient selection, medical management, and counseling patient expectations.

Study Design: Retrospective Study. Objective: To compare methods of assessing pre-operative bone density to predict risk for osteoporosis related complications (ORC), defined as proximal junctional kyphosis, pseudarthrosis, accelerated adjacent segment disease, reoperation, compression fracture, and instrument failure following spine fusions. Methods: Chart review of primary posterior thoracolumbar or lumbar fusion patients during a 7 year period. Inclusion criteria: preoperative dual-energy x-ray absorptiometry (DXA) test within 1 year and lumbar CT scan within 6 months prior to surgery with minimum of 1 year follow-up. Exclusion criteria: <18 years at time of index procedure, infection, trauma, malignancy, skeletal dysplasia, neuromuscular disorders, or anterior-posterior procedures. Results: 140 patients were included. The average age was 67.9 years, 83 (59.3%) were female, and 45 (32%) had an ORC. There were no significant differences in patient characteristics between those with and without an ORC. Multilevel fusions were associated with ORCs (46.7% vs 26.3%, p = 0.02). Patients with ORCs had lower DXA t-scores (-1.62 vs -1.10, p = 0.003) and average Hounsfield units (HU) (112.1 vs 148.1, p ≤ 0.001). Multivariable binary logistic regression analysis showed lower average HU (Adj. OR 0.00 595% CI 0.0001-0.1713, p = 0.001) was an independent predictor of an ORC. The odds of an ORC increased by 1.7-fold for every 25 point decrease in average HU. Conclusions: The gold standard for assessing bone mineral density has been DXA t-scores, but the best predictor of ORC remains unclear. While both lower t-scores and average HU were associated with ORC, only HU was an independent predictor of ORC.

Intrathecal delivery of autologous culture-expanded adipose tissue-derived mesenchymal stem cells (AD-MSC) could be utilized to treat traumatic spinal cord injury (SCI). This Phase I trial (ClinicalTrials.gov: NCT03308565) included 10 patients with American Spinal Injury Association Impairment Scale (AIS) grade A or B at the time of injury. The study’s primary outcome was the safety profile, as captured by the nature and frequency of adverse events. Secondary outcomes included changes in sensory and motor scores, imaging, cerebrospinal fluid markers, and somatosensory evoked potentials. The manufacturing and delivery of the regimen were successful for all patients. The most commonly reported adverse events were headache and musculoskeletal pain, observed in 8 patients. No serious AEs were observed. At final follow-up, seven patients demonstrated improvement in AIS grade from the time of injection. In conclusion, the study met the primary endpoint, demonstrating that AD-MSC harvesting and administration were well-tolerated in patients with traumatic SCI. In the CELLTOP Phase I trial, stem cells were harvested from patients with spinal cord injury and injected into their central nervous system after processing. The procedure was safe, with no reported serious adverse events during the 2-year follow-up period.

Although surgical resection is associated with a complete cure in most cases of spinal dural arteriovenous fistulas (SDAVF), there has been an increasing trend towards embolisation. We performed a systematic review and meta-analysis comparing surgical resection with endovascular treatment in terms of success of treatment, rate of recurrence and complications. A literature search was conducted using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Strength of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation Working Group system. Surgical outcomes such as initial treatment failure, late recurrence, neurological improvement and complications were compared between the two approaches. We included 57 studies with 2029 patients, of which 32 studies with 1341 patients directly compared surgery (n=590) and embolisation (n=751). Surgery was found to be associated with significantly lower odds of initial treatment failure (OR: 0.15, 95% CI 0.09 to 0.24, I2 0%, p<0.001) and late recurrence (OR 0.18, 95% CI 0.09 to 0.39, I2 0%, p<0.001). The odds of neurological improvement following surgery were also significantly higher compared with embolisation alone (OR: 2.73, CI:1.67 to 4.48, I2 :49.5%, p<0.001). No difference in complication rates was observed between the two approaches (OR 1.78, 95% CI 0.97 to 3.26, I2 0%, p=0.063). Onyx was associated with significantly higher odds of initial failure/late recurrence as compared with n-butyl 2-cyanoacrylate (OR: 3.87, CI: 1.73 to 8.68, I2 :0%, p<0.001). Surgery may be associated with superior outcomes for SDAVFs in comparison to endovascular occlusion. Newer embolisation agents like Onyx have not conferred a significant improvement in occlusion rate.

•Spine surgery in obese patients is associated with high complications/reoperations.•Spine surgery may offer obese patients clinical improvement in pain and disability.•MIS may offset the adverse influence of obesity on lumbar spine surgery outcomes. The influence of obesity on spine surgery outcomes is highly controversial with a current clinical equipoise. Several studies suggest higher perioperative morbidity with obesity while other studies suggest otherwise. To address this gap in the literature, we conducted a systematic review and meta-analysis in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines with the objective of better defining the impact of obesity on outcomes following lumbar spine surgery. Risk of bias assessment was performed using the Newcastle-Ottawa Scale. Strength of evidence was assessed using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) Working Group system. Surgical outcomes such as blood loss, operative time, length of stay, complication and reoperation rates and functional outcomes represented by the change in Oswestry Disability Index and Visual Analog Scale-Back Pain were compared between obese and non-obese patients. A total of 32 studies with 23,415 patients were analyzed. Obese patients had slightly higher surgical blood loss (Mean Difference [MD]: 46.15 ml, CI: 20.21–72, p-value< .001, I2 = 85%) and longer operative times (MD: 17.17 min, CI: 9.91–24.43, p-value< .001, I2 = 95%), but similar length of stay as compared to non-obese patients. Higher complication (OR = 1.34, C.I. = 1.13–1.58, p = 0.01, I2 = 45%) and reoperation rates (OR = 1.40, C.I. = 1.19–1.64, p < 0.001, I2 = 20) were observed in obese patients. The differences, however, were not significant for obese patients undergoing MIS surgery. Functional outcomes (change in ODI and VAS-BP) were similar between the two groups. Overall confidence in GRADE estimates was either low or very low for all outcomes. Obesity might be linked to higher adverse events following lumbar spine surgery. Minimally invasive spine surgery, however, might offer comparable outcomes between obese and non-obese patients. However, further studies are needed to evaluate whether these findings remain valid for morbidly obese (BMI > 40) patients as well.

Spinal cord injury (SCI) is a devastating condition with limited pharmacological treatment options to restore function. Regenerative approaches have recently attracted interest as an adjuvant to current standard of care. Adipose tissue–derived (AD) mesenchymal stem cells (MSCs) represent a readily accessible cell source with high proliferative capacity. The CELLTOP study, an ongoing multidisciplinary phase 1 clinical trial conducted at Mayo Clinic (ClinicalTrials.gov Identifier: NCT03308565), is investigating the safety and efficacy of intrathecal autologous AD-MSCs in patients with blunt, traumatic SCI. In this initial report, we describe the outcome of the first treated patient, a 53-year-old survivor of a surfing accident who sustained a high cervical American Spinal Injury Association Impairment Scale grade A SCI with subsequent neurologic improvement that plateaued within 6 months following injury. Although he improved to an American Spinal Injury Association grade C impairement classification, the individual continued to be wheelchair bound and severely debilitated. After study enrollment, an adipose tissue biopsy was performed and MSCs were isolated, expanded, and cryopreserved. Per protocol, the patient received an intrathecal injection of 100 million autologous AD-MSCs infused after a standard lumbar puncture at the L3-4 level 11 months after the injury. The patient tolerated the procedure well and did not experience any severe adverse events. Clinical signs of efficacy were observed at 3, 6, 12, and 18 months following the injection in both motor and sensory scores based on International Standards for Neurological Classification of Spinal Cord Injury. Thus, in this treated individual with SCI, intrathecal administration of AD-MSCs was feasible and safe and suggested meaningful signs of improved, rather than stabilized, neurologic status warranting further clinical evaluation.

ObjectiveThere is a paucity of literature investigating the clinical course of patients with spinal intramedullary cavernous malformations (ISCMs). We present a large case series of ISCMs to describe clinical presentation, natural history and outcomes of both surgical and conservative management.MethodsWe retrospectively reviewed the clinical course of patients diagnosed with ISCMs at our institution between 1995 and 2016. Haemorrhage was defined as clinical worsening in tandem with imaging changes visualised on follow-up MRI. Outcomes assessed included neurological status and annual haemorrhage rates.ResultsA total of 107 patients met inclusion criteria. Follow-up data were available for 85 patients. While 21 (24.7%) patients underwent immediate surgical resection, 64 (75.3%) were initially managed conservatively. Among this latter group, 16 (25.0%) suffered a haemorrhage during follow-up and 11 (17.2%) required surgical resection due to interval bleeding or neurological worsening. The overall annual risk of haemorrhage was 5.5% per person year. The rate among patients who were symptomatic and asymptomatic on presentation was 9.5% and 0.8%, respectively. Median time to haemorrhage was 2.3 years (0.1–12.3). Univariate analysis identified higher ISCM size (p=0.024), history of prior haemorrhage (p=0.013) and presence of symptoms (p=0.003) as risk factors for subsequent haemorrhage. Multivariable proportional hazards analysis revealed presence of symptoms to be independently associated with haemorrhage during follow-up (HR 9.39, CI 1.86 to 170.8, p=0.013).ConclusionLarge, symptomatic ISCMs appear to be at increased risk for subsequent haemorrhage. Surgery may be considered in such lesions to prevent rebleeding and subsequent neurological worsening.

PurposeThis study aims to determine whether outcomes following vertebroplasty with high viscosity cement are superior to low viscosity cement and non-inferior to kyphoplasty in the setting of vertebral compression fractures. MethodsWe searched for randomized controlled trials and cohort studies assessing cement leakage rate in adult patients with VCFs who underwent vertebroplasty with high (HVCV) or low viscosity cement (LVCV) augmentation, or kyphoplasty (KP) in PubMed, Embase, Ovid, The Cochrane Library, and Web of Science from inception up to December 2019. Two authors extracted data and appraised risk of bias. We performed pairwise meta-analyses in R to compare differences between three treatments and network meta-analysis using frequentist random-effects models for indirect comparison. We used P-score to rate the overall certainty of evidence. The primary outcome was cement leakage rate. ResultsFive RCTs and eight cohort studies with 840 patients and a total of 1280 vertebral bodies were included in the systematic review and network meta-analysis. Compared to LVCV, the relative risk for cement leakage following HVCV and KP was 0.42 (95% CI 0.28–0.61) and 0.83 (95% CI 0.40–1.68), respectively. Our pooled results suggested that HVCV (P-score = 0.99) was better than KP (P-score = 0.36) in cement leakage rate. ConclusionsThe present network meta-analysis demonstrated that HVCV may be associated with lower risk of cement leakage among patients with VCFs as compared to other augmentation techniques. Future prospective studies will validate the findings of this analysis and further elucidate the risk of symptomatic cement leakage.

BackgroundEn bloc spondylectomy is the gold standard for surgical resection of sacral chordomas (CHO), but the effect of extent of resection on recurrence and survival in patients with CHO of the cervical spine remains elusive.MethodsMEDLINE, Embase, Scopus, and Cochrane were systematically reviewed. Patients with cervical CHO treated at three tertiary-care academic institutions were reviewed for inclusion. We performed an individual participant data meta-analysis to assess the overall survival (OS) and progression free survival (PFS) after en bloc-gross total resection (GTR) and intralesional-GTR compared to subtotal resection (STR). We then performed an intention-to-treat analysis including all patients with attempted en bloc resection in the en bloc group, regardless of the surgical margins.ResultsThere was a total of 13 series including 161 patients with cervical CHO, including our current series of 22 patients. GTR (en bloc-GTR + intralesional-GTR) was associated with a significant decrease in the risk of local progression (pooled hazard ratio (PHR) = 0.22; 95% CI 0.08–0.59; p = 0.003) and risk of death (PHR 0.31; 95%; CI 0.12–0.83; p = 0.020). A meta-regression analyses determined that intralesional-GTR improved PFS (PHR 0.35; 95% CI 0.16–0.76; p = 0.009) as well as OS (PHR 0.25; 95% CI 0.08–0.79; p = 0.019) when compared to STR. En bloc-GTR was associated with a significant reduction in the risk of local progression (PHR 0.06; 95% CI 0.01–0.77; p = 0.030), but not a decreased OS (PHR 0.50; 95% CI 0.19–1.27; p = 0.145). Our intention-to-treat analyses revealed a near significant improvement in OS for the en bloc group (PHR: 0.15; 95% CI 0.02–1.22; p = 0.054), and nearly identical improvement in PFS. Radiation data was not available for the studies included in the meta-analysis.ConclusionThis is the first and only meta-analysis of patients with cervical CHO. We found that both en bloc-GTR and intralesional-GTR resulted in improved local tumor control when compared to STR.

PurposeGlioblastoma multiforme (GBM) is a common and aggressive malignancy associated with poor prognosis. Characteristics and treatment of long-term survivors are of particular interest in efforts to improve outcomes. Therefore, the objective of this study was to examine trends and prognostic factors for 3-year survival from a national database.MethodsThe National Cancer Database (NCDB) was queried for patients diagnosed with cranial GBM from 2004 to 2013 and with 3-year follow-up. Trends in 3-year and overall survival, patient characteristics, tumor properties, and treatment modalities were examined. Multivariable logistic regression was utilized to investigate the association of these factors with 3-year survival. Predictor importance analysis was conducted using a metric defined as Wald χ2 penalized by degrees of freedom.ResultsA total of 88,919 GBM patients with 3-year follow-up were identified. Overall, 8757 (9.8%) patients survived ≥ 3 years. Three-year survival significantly improved from 8.0 to 10.5% (p < 0.001) from 2004 to 2013. Trimodal treatment administration also significantly increased from 38.7 to 55.9% (p < 0.001). During this span, patients increasingly presented as older (p = 0.040), without private insurance (p < 0.001), and with a higher comorbidity index (p < 0.001). On multivariable regression, factors such as trimodal treatment (p < 0.001), younger age (p < 0.001), and MGMT methylation (p < 0.001) were significantly associated with increased odds of 3-year survival. Predictor importance analysis indicated that MGMT methylation, age, and treatment modality were the most significant relative determinants of 3-year survival.ConclusionThese findings illustrate an improved 3-year survival rate for GBM patients from 2004 to 2013 with a concurrent increase in trimodal treatment administration despite more adverse patient presenting characteristics.