Determining minimal clinically important difference estimates following surgery for degenerative conditions of the lumbar spine: analysis of the Canadian Spine Outcomes and Research Network (CSORN) registry.

BACKGROUND CONTEXT: There is significant variability in minimal clinically important difference (MCID) criteria for lumbar spine surgery that suggests population and primary pathology specific thresholds may be required to help determine surgical success when using patient reported outcome measures (PROMs). PURPOSE: The purpose of this study was to estimate MCID thresholds for 3 commonly used PROMs after surgical intervention for each of 4 common lumbar spine pathologies. STUDY DESIGN/SETTING: Observational longitudinal study of patients from the Canadian Spine Outcomes and Research Network (CSORN) national registry. PATIENT SAMPLE: Patients undergoing surgery from 2015 to 2018 for lumbar spinal stenosis (LSS; n = 856), degenerative spondylolisthesis (DS; n = 591), disc herniation (DH; n = 520) or degenerative disc disease (DDD n = 185) were included. OUTCOME MEASURES: PROMs were collected presurgery and 1-year postsurgery: the Oswestry Disability Index (ODI), and back and leg Numeric Pain Rating Scales (NPRS). At 1-year, patients reported whether they were 'Much better'/'Better'/'Same'/'Worse'/'Much worse' compared to before their surgery. Responses to this item were used as the anchor in analyses to determine surgical MCIDs for benefit ('Much better'/'Better') and substantial benefit ('Much better'). METHODS: MCIDs for absolute and percentage change for each of the 3 PROMs were estimated using a receiving operating curve (ROC) approach, with maximization of Youden's index as primary criterion. Area under the curve (AUC) estimates, sensitivity, specificity and correct classification rates were determined. All analyses were conducted separately by pathology group. RESULTS: MCIDs for ODI change ranged from -10.0 (DDD) to -16.9 (DH) for benefit, and -13.8 (LSS) to -22.0 (DS,DH) for substantial benefit. MCID for back and leg NPRS change were -2 to -3 for each group for benefit and -4.0 for substantial benefit for all groups on back NPRS. MCID estimates for percentage change varied by PROM and pathology group, ranging from -11.1% (ODI for DDD) to -50.0% (leg NPRS for DH) for benefit and from -40.0% (ODI for DDD) to -66.6% (leg NPRS for DH) for substantial benefit. Correct classification rates for all MCID thresholds ranged from 71% to 89% and were relatively lower for absolute vs percent change for those with high or low presurgical scores. CONCLUSIONS: Our findings suggest that the use of generic MCID thresholds across pathologies in lumbar spine surgery is not recommended. For patients with relatively low or high presurgery PROM scores, MCIDs based on percentage change, rather than absolute change, appear generally preferable. These findings have applicability in clinical and research settings, and are important for future surgical prognostic work.

Cost consequence analysis of waiting for lumbar disc herniation surgery.

The economic repercussions of waiting for lumbar disc surgery have not been well studied. The primary goal of this study was to perform a cost-consequence analysis of patients receiving early vs late surgery for symptomatic disc herniation from a societal perspective. Secondarily, we compared patient factors and patient-reported outcomes. This is a retrospective analysis of prospectively collected data from the CSORN registry. A cost-consequence analysis was performed where direct and indirect costs were compared, and different outcomes were listed separately. Comparisons were made on an observational cohort of patients receiving surgery less than 60 days after consent (short wait) or 60 days or more after consent (long wait). This study included 493 patients with surgery between January 2015 and October 2021 with 272 patients (55.2%) in the short wait group and 221 patients (44.8%) classified as long wait. There was no difference in proportions of patients who returned to work at 3 and 12-months. Time from surgery to return to work was similar between both groups (34.0 vs 34.9 days, p = 0.804). Time from consent to return to work was longer in the longer wait group corresponding to an additional $11,753.10 mean indirect cost per patient. The short wait group showed increased healthcare usage at 3 months with more emergency department visits (52.6% vs 25.0%, p < 0.032), more physiotherapy (84.6% vs 72.0%, p < 0.001) and more MRI (65.2% vs 41.4%, p < 0.043). This corresponded to an additional direct cost of $518.21 per patient. Secondarily, the short wait group had higher baseline NRS leg, ODI, and lower EQ5D and PCS. The long wait group had more patients with symptoms over 2 years duration (57.6% vs 34.1%, p < 0.001). A higher proportion of patients reached MCID in terms of NRS leg pain at 3-month follow up in the short wait group (84.0% vs 75.9%, p < 0.040). This cost-consequence analysis of an observational cohort showed decreased costs associated with early surgery of $11,234.89 per patient when compared to late surgery for lumbar disc herniation. The early surgery group had more severe symptoms with higher healthcare utilization. This is counterbalanced by the additional productivity loss in the long wait group, which likely have a more chronic disease. From a societal economic perspective, early surgery seems beneficial and should be promoted.

Patient, clinical, surgical, and institutional factors associated with length of stay in scheduled degenerative thoracolumbar spine surgery: National Multicenter Cohort Analysis from the Canadian Spine Outcomes and Research Network.

OBJECTIVE: Length of stay (LOS) is a contributor to costs and resource utilization. The primary goal of this study was to identify patient, clinical, surgical, and institutional variables that influence LOS after elective surgery for thoracolumbar degenerative pathology. The secondary objective was to examine variability in LOS and institutional strategies used to decrease LOS. METHODS: This is a retrospective study of prospectively collected data from a multicentric cohort enrolled in the Canadian Spine Outcomes and Research Network (CSORN) between January 2015 and October 2020 who underwent elective thoracolumbar surgery (discectomy [1 or 2 levels], laminectomy [1 or 2 levels], and posterior instrumented fusion [up to 5 levels]). Prolonged LOS was defined as LOS greater than the median. Logistic regression models were used to determine factors associated with prolonged LOS for each procedure. A survey was sent to the principal investigators of the participating healthcare institutions to understand institutional practices that are used to decrease LOS. RESULTS: A total of 3700 patients were included (967 discectomies, 1094 laminectomies, and 1639 fusions). The median LOSs for discectomy, laminectomy, and fusion were 0.0 (IQR 1.0), 1.0 (IQR 2.0), and 4.0 (IQR 2.0) days, respectively. On multivariable analysis, predictors of prolonged LOS for discectomy were having more leg pain, higher Oswestry Disability Index (ODI) scores, symptom duration more than 2 years, having undergone an open procedure, occurrence of an adverse event (AE), and treatment at an institution without protocols to reduce LOS (p < 0.05). Predictors of prolonged LOS for laminectomy were increased age, living alone, higher ODI scores, higher BMI, open procedures, longer operative time, AEs, and treatment at an institution without protocols to reduce LOS (p < 0.05). For posterior instrumented fusion, predictors of prolonged LOS were older age, living alone, more comorbidities, higher ODI scores, longer operative time, AEs, and treatment at an institution without protocols to reduce LOS (p < 0.05). The laminectomy group had the largest variability in LOS (SD 4.4 days, range 0-133 days). Three hundred fifty-four patients (22%) had an LOS above the 75th percentile. Ten institutions (53%) had either Enhanced Recovery After Surgery or standardized protocols in place. CONCLUSIONS: Among the factors identified in this study, worse baseline ODI scores, experiencing AEs, and treatment at an institution without protocols aimed at reducing LOS were predictive of prolonged LOS in all surgical groups. The laminectomy group had the largest variability in LOS.

Minimally Invasive Tubular Lumbar Discectomy Versus Conventional Open Lumbar Discectomy: An Observational Study From the Canadian Spine Outcomes and Research Network.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: We evaluated the effectiveness of minimally invasive (MIS) tubular discectomy in comparison to conventional open surgery among patients enrolled in the Canadian Spine Outcomes and Research Network (CSORN). METHODS: We performed an observational analysis of data that was prospectively collected. We implemented Minimum Clinically Important Differences (MCIDs), and we adjusted for potential confounders with multiple logistic regression. Adverse events were collected according to the Spinal Adverse Events Severity (SAVES) protocol. RESULTS: Three hundred thirty-nine (62%) patients underwent MIS tubular discectomy and 211 (38%) underwent conventional open discectomy. There were no significant differences between groups for improvement of leg pain and disability, but the MIS technique was associated with reduced odds of achieving the MCID for back pain (OR 0.66, 95% CI 0.44 to 0.99, P < 0.05). We identified statistically significant differences in favor of MIS for each of operating time (MIS mean (SD) 72.2 minutes (30.0) vs open 93.5 (40.9)), estimated blood loss (MIS 37.9 mL (36.7) vs open 76.8 (71.4)), length of stay in hospital (MIS 73% same-day discharge vs open 40%), rates of incidental durotomy (MIS 4% vs open 8%), and wound-related complications (MIS 3% vs open 9%); but not for overall rates of reoperation. CONCLUSIONS: Open and MIS techniques yielded similar improvements of leg pain and disability at up to 12 months of follow-up, but MIS patients were less likely to experience improvement of associated back pain. Small differences favored MIS for operating time, blood loss, and adverse events but may have limited clinical importance.

Minimally Invasive vs. Open Surgery for Lumbar Spinal Stenosis in Patients with Diabetes - A Canadian Spine Outcomes and Research Network Study.

STUDY DESIGN: Retrospective cohort. OBJECTIVES: To compare outcomes of minimally invasive surgery (MIS) vs open surgery (OPEN) for lumbar spinal stenosis (LSS) in patients with diabetes. METHODS: Patients with diabetes who underwent spinal decompression alone or with fusion for LSS within the Canadian Spine Outcomes and Research Network (CSORN) database were included. MIS vs OPEN outcomes were compared for 2 cohorts: (1) patients with diabetes who underwent decompression alone (N = 116; MIS n = 58 and OPEN n = 58), (2) patients with diabetes who underwent decompression with fusion (N = 108; MIS n = 54 and OPEN n = 54). Modified Oswestry Disability Index (mODI) and back and leg pain were compared at baseline, 6-18 weeks, and 1-year post-operation. The number of patients meeting minimum clinically important difference (MCID) or minimum pain/disability at 1-year was compared. RESULTS: MIS approaches had less blood loss (decompression alone difference 100 mL, P = .002; with fusion difference 244 mL, P < .001) and shorter length of stay (LOS) (decompression alone difference 1.2 days, P = .008; with fusion difference 1.2 days, P = .026). MIS compared to OPEN decompression with fusion had less patients experiencing adverse events (AEs) (difference 13 patients, P = .007). The MIS decompression with fusion group had lower 1-year mODI (difference 14.5, 95% CI [7.5, 21.0], P < .001) and back pain (difference 1.6, 95% CI [.6, 2.7], P = .002) compared to OPEN. More patients in the MIS decompression with fusion group exceeded MCID at 1-year for mODI (MIS 75.9% vs OPEN 53.7%, P = .028) and back pain (MIS 85.2% vs OPEN 70.4%, P = .017). CONCLUSIONS: MIS approaches were associated with more favorable outcomes for patients with diabetes undergoing decompression with fusion for LSS.

Practice Variation between Salaried and Fee-for-Service Surgeons for Lumbar Surgery.

OBJECTIVE: To examine differences in surgical practices between salaried and fee-for-service (FFS) surgeons for two common degenerative spine conditions. Surgeons may offer different treatments for similar conditions on the basis of their compensation mechanism. METHODS: The study assessed the practices of 63 spine surgeons across eight Canadian provinces (39 FFS surgeons and 24 salaried) who performed surgery for two lumbar conditions: stable spinal stenosis and degenerative spondylolisthesis. The study included a multicenter, ambispective review of consecutive spine surgery patients enrolled in the Canadian Spine Outcomes and Research Network registry between October 2012 and July 2018. The primary outcome was the difference in type of procedures performed between the two groups. Secondary study variables included surgical characteristics, baseline patient factors, and patient-reported outcome. RESULTS: For stable spinal stenosis (n = 2234), salaried surgeons performed statistically fewer uninstrumented fusion (p < 0.05) than FFS surgeons. For degenerative spondylolisthesis (n = 1292), salaried surgeons performed significantly more instrumentation plus interbody fusions (p < 0.05). There were no statistical differences in patient-reported outcomes between the two groups. CONCLUSIONS: Surgeon compensation was associated with different approaches to stable lumbar spinal stenosis and degenerative lumbar spondylolisthesis. Salaried surgeons chose a more conservative approach to spinal stenosis and a more aggressive approach to degenerative spondylolisthesis, which highlights that remuneration is likely a minor determinant in the differences in practice of spinal surgery in Canada. Further research is needed to further elucidate which variables, other than patient demographics and financial incentives, influence surgical decision-making.

Outcome of spine surgery in patients with depressed mental states: a Canadian spine outcome research network study.

BACKGROUND CONTEXT: Depression is higher among spine patients than among the general population. Some small studies, but not others, have suggested that depression may be a predictor of worse outcome after surgery. PURPOSE: Determination whether there is an association between depression and worse response to surgery among spine patients. STUDY DESIGN/SETTING: The national, prospective, Canadian Spine Outcome Research Network (CSORN) surgical outcome registry. PATIENT SAMPLE: All patients in the CSORN registry who received surgery for thoracic or lumbar degenerative deformity, stenosis, spondylolisthesis, disc disease, or disc herniation with a minimum of 12 months follow-up postoperation (n = 2310). OUTCOME MEASURES: Oswestry Disability Index (ODI), SF12 Physical Component Score (PCS), European Quality of Life (EuroQoL), and pain scales. METHODS: Change in preoperative to 12-month postoperative ODI, and secondary measures, were compared to assess if there was an association between preoperative depression, as measured by PHQ9, and smaller response to surgery. Multivariate regression analysis was used to search for preoperative factors which might interact with PHQ9 to predict ODI outcome. RESULTS: Patients with PHQ9<5, associated with minimal to no depression, had the smallest ODI improvement (-16.8 [95%CI -18.1 to -15.3]) and patients with severe preoperative depression (PHQ9 ≥ 10) had the largest ODI improvement (-22.8 [95%CI -24.1 to -21.5]; p<.00001). Similar findings were found in the EQ5D and PCS. Pain improvement was not different between depression levels. Multivariate modeling found worse baseline PHQ9 and ODI, greater age, nicotine use, more operative levels, and worse American Society of Anesthesiology score was predictive of worse ODI outcomes. CONCLUSIONS: Depressed patients have similar or better relative improvements in disability, quality of life, and pain, when compared to nondepressed patients, although their preoperative and postoperative levels of disability are higher. Surgeons should not be concerned that depression will reduce the patient-reported beneficial response to surgical intervention.

Effects of Workload on Return to Work After Elective Lumbar Spine Surgery.

STUDY DESIGN: Retrospective analysis was performed of a multi-center Canadian Spine Outcomes and Research Network (CSORN) surgical database. OBJECTIVE: To determine the rate and time to return to work (RTW) based on workload intensity after elective degenerative lumbar spine surgery. METHODS: Patients working pre-operatively, aged greater than 18, who underwent a primary one- or two-level elective lumbar spine surgery for degenerative conditions between January 2015 and October 2020 were evaluated. The percentage of patients who returned to work at 1 year and the time to RTW post-operatively were analyzed based on workload intensity. RESULTS: Of the 1290 patients included in the analysis, the overall rate of RTW was 82% at 1 year. Based on workload there was no significant difference in time to RTW after a fusion procedure, with median time to RTW being 10 weeks. For non-fusion procedure, the sedentary group had a statistically significantly quicker time to RTW than the light-moderate (P < .005) and heavy-very heavy (<.027) groups. CONCLUSIONS: The rate of RTW ranged between 84% for patients with sedentary work to 77% for patient with a heavy-very heavy workload. Median time to resumption of work was about 10 weeks following a fusion regardless of work intensity. There was more variability following non-fusion surgeries such as laminectomy and discectomy reflecting the patient's job demands.

Time to return to work after elective lumbar spine surgery.

OBJECTIVE: Time to return to work (RTW) after elective lumbar spine surgery is variable and dependent on many factors including patient, work-related, and surgical factors. The primary objective of this study was to describe the time and rate of RTW after elective lumbar spine surgery. Secondary objectives were to determine predictors of early RTW (< 90 days) and no RTW in this population. METHODS: A retrospective analysis of prospectively collected data from the multicenter Canadian Spine Outcomes and Research Network (CSORN) surgical registry was performed to identify patients who were employed and underwent elective 1- or 2-level discectomy, laminectomy, and/or fusion procedures between January 2015 and December 2019. The percentage of patients who returned to work and the time to RTW postoperatively were calculated. Predictors of early RTW and not returning to work were determined using a multivariable Cox regression model and a multivariable logistic regression model, respectively. RESULTS: Of the 1805 employed patients included in this analysis, 71% returned to work at a median of 61 days. The median RTW after a discectomy, laminectomy, or fusion procedure was 51, 46, and 90 days, respectively. Predictors of early RTW included male gender, higher education level (high school or above), higher preoperative Physical Component Summary score, working preoperatively, a nonfusion procedure, and surgery in a western Canadian province (p < 0.05). Patients who were working preoperatively were twice as likely to RTW within 90 days (HR 1.984, 95% CI 1.680-2.344, p < 0.001) than those who were employed but not working. Predictors of not returning to work included symptoms lasting more than 2 years, an increased number of comorbidities, an education level below high school, and an active workers' compensation claim (p < 0.05). There were fourfold odds of not returning to work for patients who had not been working preoperatively (OR 4.076, 95% CI 3.087-5.383, p < 0.001). CONCLUSIONS: In the Canadian population, 71% of a preoperatively employed segment returned to work after 1- or 2-level lumbar spine surgery. Most patients who undergo a nonfusion procedure RTW after 6 to 8 weeks, whereas patients undergoing a fusion procedure RTW at 12 weeks. Working preoperatively significantly increased the likelihood of early RTW.

Topical tranexamic acid in hip fractures: a randomized, placebo-controlled double-blinded study.

BACKGROUND: Tranexamic acid (TXA) has been shown to reduce perioperative blood loss in elective orthopedic surgery. The safety of intravenous TXA in nonelective hip fracture surgery is uncertain. The purpose of this study was to evaluate the efficacy and safety of topical TXA in hip fracture surgery. METHODS: Adult patients presenting to a community hospital with a hip fracture requiring surgery were randomly assigned to receive topical TXA or placebo. Hemoglobin and troponin I levels were measured preoperatively and on postoperative days 1, 2 and 3. All postoperative blood transfusions were recorded. Complications, including acute coronary syndrome (ACS), venous thromboembolism (VTE), cerebrovascular accidents (CVA), surgical site infections (SSI) and 90-day mortality, were recorded. RESULTS: Data were analyzed for 65 patients (31 in the TXA group, 34 in the control group). Hemogloblin level was significantly higher on postoperative days 1 and 2 in the TXA group than in the control group. The difference in hemoglobin level between the groups was not statistically significant by postoperative day 3. Significantly fewer units of packed red blood cells were transfused in the TXA group (2 units v. 8 units); however, 2 of the units in the control group were given intraoperatively, and when these were excluded the difference was not significant. The incidence of ACS, CVA, VTE, SSI, transfusion and all-cause mortality at 90 days did not differ significantly between the groups. CONCLUSION: Topical TXA reduces early postoperative blood loss after hip fracture surgery without increased patient risk. TRIAL REGISTRATION: Clinicaltrials.gov, no. NCT02993341.

Adverse events in surgically treated cervical spondylopathic myelopathy: a prospective validated observational study.

STUDY DESIGN: Prospective observational study. OBJECTIVE: Using validated tools to accurately identify and quantify incidence of and risks for inpatient adverse events (AEs) associated with surgical management of cervical spondylopathic myelopathy (CSM) with the goal of assisting physicians and patients in decision making. To identify patient-/disease-/technique-specific, independent risk factors for developing AEs perioperatively and affecting length of stay for patients treated surgically for CSM. SUMMARY OF BACKGROUND DATA: Previous studies have reported an overall perioperative complication rate between 15.6% and 18.52%. METHODS: A total of 104 patients underwent surgery for CSM in our academic quaternary referral center. The average age was 60.3 years (range, 34-86 yr) with a male preponderance (n = 77, 74%). The severity of myelopathy and significant comorbidities was measured and was in keeping with previously assessed populations. Surgical approach was anterior-alone (39.4%), posterior-alone (55.8%), or combined (4.8%) surgery. Inpatient AE data were collected in a rigorous, contemporaneous fashion using the previously validated Spine Adverse Events Severity System (SAVES) tool. RESULTS: A total AE rate of 42.3% was documented in surgically managed patients with CSM (intraoperative = 13.5%, postoperative = 37.5%). Statistically significant risk factors for postoperative AEs were identified, including number of comorbidities (P = 0.012), anterior surgical approach (P = 0.003), and number of levels operated on (P = 0.031). Multiple risk factors for length of stay were also identified, including number of AEs (P < 0.0001), Nurick Score (P < 0.0001), number of levels operated on (P = 0.006), and occurrence of deep wound infection (P < 0.0001). CONCLUSION: We report higher perioperative AE rates than previously recognized, due to the use of a validated, rigorous data collection tool. Multiple novel patient/disease severity/surgical factors with high statistical significance on perioperative AEs have been identified. LEVEL OF EVIDENCE: 3.

Characterization of the behavior of a novel low-stiffness posterior spinal implant under anterior shear loading on a degenerative spinal model.

PURPOSE: Dynamic implants have been developed to address potential adjacent level effects due to rigid instrumentation. Rates of revision surgeries may be reduced by using improved implants in the primary surgery. Prior to clinical use, implants should be rigorously tested ex vivo. The objective of our study was to characterize the load-sharing and kinematic behavior of a novel low-stiffness spinal implant. METHODS: A human cadaveric model of degenerative spondylolisthesis was tested in shear. Lumbar functional spinal units (N = 15) were tested under a static 300 N axial compression force and a cyclic anterior shear force (5-250 N). Translation was tracked with a motion capture system. A novel implant was compared to three standard implants with shear stiffness ranging from low to high. All implants were instrumented with strain gauges to measure the supported shear force. Each implant was affixed to each specimen, and the specimens were tested intact and in two progressively destabilized states. RESULTS: Specimen condition and implant type affected implant load-sharing and specimen translation (p < 0.0001). Implant load-sharing increased across all degeneration-simulating specimen conditions and decreased across the three standard implants (high- to low-stiffness). Translation increased with the three standard implants (trend). The novel implant behaved similarly to the medium-stiffness implant (p > 0.2). CONCLUSIONS: The novel implant behaved similarly to the medium-stiffness implant in both load-sharing and translation despite having a different design and stiffness. Complex implant design and specimen-implant interaction necessitate pre-clinical testing of novel implants. Further in vitro testing in axial rotation and flexion-extension is recommended as they are highly relevant loading directions for non-rigid implants.

The effect of disc degeneration on anterior shear translation in the lumbar spine.

Many pathologies involving disc degeneration are treated with surgery and spinal implants. It is important to understand how the spine behaves mechanically as a function of disc degeneration. Shear loading is especially relevant in the natural and surgically stabilized lumbar spine. The objective of our study was to determine the effect of disc degeneration on anterior translation of the lumbar spine under shear loading. We tested 30 human cadaveric functional spinal units (L3-4 and L4-5) in anterior shear loading. First, the specimens were imaged in a 1.5 T magnetic resonance scanner. The discs were graded according to the Pfirrmann classification. The specimens were then loaded up to 250 N in anterior shear with an axial compression force of 300 N. Motion of the vertebrae was captured with an optoelectronic camera system. Inter- and intra-observer reliability for disc grading was determined (Cohen's and Fleiss' Kappa), and a non-parametric test was performed on the translation data to characterize the effect of disc degeneration on this parameter. We found fair to moderate agreement between and within observers for the disc grading. We found no significant effect of disc degeneration on anterior shear translation (Kruskal-Wallis ANOVA). Our results indicate that disc degeneration, as classified with the Pfirrmann scale, does not predict lumbar spinal motion in shear.

Adverse events in emergency oncological spine surgery: a prospective analysis.

OBJECT: Most descriptions of spine surgery morbidity and mortality in the literature are retrospective. Emerging prospective analyses of adverse events (AEs) demonstrate significantly higher rates, suggesting underreporting in retrospective and prospective studies that do not include AEs as a targeted outcome. Emergency oncological spine surgeries are generally palliative to reduce pain and improve patients' neurology and health-related quality of life. In individuals with limited life expectancy, AEs can have catastrophic implications; therefore, an accurate AE incidence must be considered in the surgical decision-making process. The purpose of this study was to determine the true incidence of AEs associated with emergency oncological spine surgery. METHODS: The authors carried out a prospective cohort study in a quaternary care referral center that included consecutive patients admitted between January 1, 2009, and December 31, 2012. Inclusion criteria were all patients undergoing emergency surgery for metastatic spine disease. AE data were reported and collected on standardized AE forms (Spine AdVerse Events Severity System, version 2 [SAVES V2] forms) at weekly dedicated morbidity and mortality rounds attended by attending surgeons, residents, fellows, and nursing staff. RESULTS: A total of 101 patients (50 males, 51 females) met the inclusion criteria and had complete data. Seventy-six patients (76.2%) had at least 1 AE, and 11 patients (10.9%) died during their admission. Intraoperative surgical AEs were observed in 32% of patients (9.9% incidental durotomy, 16.8% blood loss > 2 L). Transient neurological deterioration occurred in 6 patients (5.9%). Infectious complications in this patient population were significant (surgical site 6%, other 50.5%). Delirium complicated the postoperative period in 20.8% of cases. CONCLUSIONS: When evaluated in a rigorous prospective manner, metastatic spine surgery is associated with a higher morbidity rate than previously reported. This AE incidence must be considered by the patient, oncologist, and surgeon to determine appropriate management and preventative strategies to reduce AEs in this fragile patient population.

Prospective analysis of adverse events in surgical treatment of degenerative spondylolisthesis.

BACKGROUND CONTEXT: Surgical adverse event (AE) monitoring is imprecise, of uncertain validity, and tends toward underreporting. Reports focus on specific procedures rather than outcomes in the context of presenting diagnosis. Specific intraoperative (intraop) or postoperative (postop) AEs that may be independently associated with degenerative spondylolisthesis (DS) have never been reported. PURPOSE: The primary purpose was to assess the AE profile of surgically treated patients with L4-L5 DS. The secondary goal was to identify potential risk factors that correlate with those AEs. STUDY DESIGN/SETTING: Prospective cohort and academic quaternary spine center. PATIENT SAMPLE: Ninety-two patients with L4-L5 DS were treated surgically, discharged from Vancouver General Hospital between January 1, 2009 and December 31, 2010. OUTCOME MEASURES: Incidence rates and odds ratios. METHODS: Prospective AE data were analyzed using univariate analyses, forward selection regression models, and Spearman correlation coefficients. Results were compared with outcomes reported in the Spine Patient Outcomes Research Trial. RESULTS: No AEs were seen in 57.6% of patients, one AE in 17.4%, and two or more AEs in 17.4%. Dural tears (6.5%) and intraop bone-implant interface failure requiring revision (3.3%) were the most common intraop AEs. Postoperatively, the most frequent AEs were urinary tract infection (10.9%), delirium (5.4%), neuropathic pain (4.4%), deep wound infection (3.3%), and superficial wound infection (3.3%). The odds of an intraop AE increased by 9% (95% confidence interval [CI] 1-18) per year of age at admission. Adjusted Charlson comorbidity index (CCI) did not correlate with number of AEs experienced. The odds of postop delirium correlated with CCI (odds ratio [OR] 3.39, 95% CI 1.12-10.24) and dural tear (OR 35.84, 95% CI 1.72-747.45). Length of stay was statistically significant and was influenced by two or more AEs, CCI, postop loss of correction, cerebrospinal fluid leak, deep wound infection, noninfected wound drainage, and gender. CONCLUSIONS: Risk of intraop AEs, but not postop AEs, increased with increasing age. Having multiple comorbidities does not predispose to more AEs. Infections predominate among the postop AEs. Patients at increased risk of delirium or of having an increased length of hospital stay may more easily be predicted. Studies specifically designed to prospectively assess AEs have the potential to more accurately identify postop AE rates.