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Signe Elmose, Mikkel Ø. Andersen, Else Bay Andresen and Leah Yacat Carreon

OBJECTIVE

The purpose of this study was to investigate the effect of tranexamic acid (TXA) compared to placebo in low-risk adult patients undergoing elective minor lumbar spine surgery—specifically with respect to operative time, estimated blood loss, and complications. Studies have shown that TXA reduces blood loss during major spine surgery. There have been no previous studies on the effect of TXA in minor lumbar spine surgery in which these variables have been evaluated.

METHODS

The authors enrolled patients with ASA grades 1 to 2 scheduled to undergo lumbar decompressive surgery at Middelfart Hospital into a double-blind, randomized, placebo-controlled, parallel-group study. Patients with thromboembolic disease, coagulopathy, hypersensitivity to TXA, or a history of convulsion were excluded. Patients were randomly assigned, in blocks of 10, to one of 2 groups, TXA or placebo. Anticoagulation therapy was discontinued 2–7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10 mg/kg) or an equivalent volume of saline solution (placebo). Independent t-tests were used to compare differences between the 2 groups, with statistical significance set at p < 0.05.

RESULTS

Of the 250 patients enrolled, 17 patients were excluded, leaving 233 cases for analysis (117 in the TXA group and 116 in the placebo group). The demographics of the 2 groups were similar, except for a higher proportion of women in the TXA group (TXA 50% vs placebo 32%, p = 0.017). There was no significant between-groups difference in operative time (49.53 ± 18.26 vs 54.74 ± 24.49 minutes for TXA and placebo, respectively; p = 0.108) or intraoperative blood loss (55.87 ± 48.48 vs 69.14 ± 83.47 ml for TXA and placebo, respectively; p = 0.702). Postoperative blood loss measured from drain output was 62% significantly lower in the TXA group (13.03 ± 21.82 ml) than in the placebo group (34.61 ± 44.38 ml) (p < 0.001). There was no significant difference in number of dural lesions or postoperative spinal epidural hematomas, and there were no thromboembolic events.

CONCLUSIONS

Tranexamic acid did not have a statistically significant effect on operative time, intraoperative blood loss, or complications. This study gives no evidence to support the routine use of TXA during minor lumbar decompressive surgery.

Clinical trial registration no.: NCT03714360 (clinicaltrials.gov)

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Jeffrey L. Gum, Steven D. Glassman and Leah Y. Carreon

Object

Health-related quality of life (HRQOL) measures have become the mainstay for outcome appraisal in spine surgery. Clinically meaningful interpretation of HRQOL improvement has centered on the minimum clinically important difference (MCID). The purpose of this study was to calculate clinically important deterioration (CIDET) thresholds and determine a CIDET value for each HRQOL measure for patients undergoing lumbar fusion.

Methods

Seven hundred twenty-two patients (248 males, 127 smokers, mean age 60.8 years) were identified with complete preoperative and 1-year postoperative HRQOLs including the Oswestry Disability Index (ODI), 36-Item Short Form Health Survey (SF-36), and numeric rating scales (0–10) for back and leg pain following primary, instrumented, posterior lumbar fusion. Anchor-based and distribution-based methods were used to calculate CIDET for each HRQOL. Anchor-based methods included change score, change difference, and receiver operating characteristic curve analysis. The Health Transition Item, an independent item of the SF-36, was used as the external anchor. Patients who responded “somewhat worse” and “much worse” were combined and compared with patients responding “about the same.” Distribution-based methods were minimum detectable change and effect size.

Results

Diagnoses included spondylolisthesis (n = 332), scoliosis (n = 54), instability (n = 37), disc pathology (n = 146), and stenosis (n = 153). There was a statistically significant change (p < 0.0001) for each HRQOL measure from preoperatively to 1-year postoperatively. Only 107 patients (15%) reported being “somewhat worse” (n = 81) or “much worse” (n = 26). Calculation methods yielded a range of CIDET values for ODI (0.17–9.06), SF-36 physical component summary (−0.32 to 4.43), back pain (0.02–1.50), and leg pain (0.02–1.50).

Conclusions

A threshold for clinical deterioration was difficult to identify. This may be due to the small number of patients reporting being worse after surgery and the variability across methods to determine CIDET thresholds. Overall, it appears that patients may interpret the absence of change as deterioration.

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Charles H. Crawford III, Steven D. Glassman, Jeffrey L. Gum and Leah Y. Carreon

Advancements in the understanding of adult spinal deformity have led to a greater awareness of the role of the pelvis in maintaining sagittal balance and alignment. Pelvic incidence has emerged as a key radiographic measure and should closely match lumbar lordosis. As proper measurement of the pelvic incidence requires accurate identification of the S-1 endplate, lumbosacral transitional anatomy may lead to errors. The purpose of this study is to demonstrate how lumbosacral transitional anatomy may lead to errors in the measurement of pelvic parameters. The current case highlights one of the potential complications that can be avoided with awareness.

The authors report the case of a 61-year-old man who had undergone prior lumbar surgeries and then presented with symptomatic lumbar stenosis and sagittal malalignment. Radiographs showed a lumbarized S-1. Prior numbering of the segments in previous surgical and radiology reports led to a pelvic incidence calculation of 61°. Corrected numbering of the segments using the lumbarized S-1 endplate led to a pelvic incidence calculation of 48°. Without recognition of the lumbosacral anatomy, overcorrection of the lumbar lordosis might have led to negative sagittal balance and the propensity to develop proximal junction failure. This case illustrates that improper identification of lumbosacral transitional anatomy may lead to errors that could affect clinical outcome. Awareness of this potential error may help improve patient outcomes.

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Manish P. Lambat, Steven D. Glassman and Leah Y. Carreon

Object

Although lumbar fusion is effective in well-selected patients, it is not without complications associated with short-term morbidity. There is a paucity of literature on the effect of these complications on long-term clinical outcomes. The purpose of this study was to determine whether perioperative complications—that is, those occurring within 30 days after surgery—alter the long-term clinical outcomes after lumbar fusion.

Methods

The authors retrospectively reviewed surgical and clinical databases for the period from 2001 to 2008 to identify patients who had undergone instrumented lumbar spinal fusion and had complete preoperative and 2-year postoperative outcome measures data. Outcome measures included the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary, SF-36 Mental Component Summary, Oswestry Disability Index (ODI), and Numeric Rating Scales (0–10) for back and leg pain.

Three patient groups were created for comparison—one with major complications, one with only minor complications, and another with no complications—using propensity matching techniques based on demographics, baseline clinical outcome scores, and surgical characteristics. Preoperative and 2-year postoperative outcome scores in the groups were compared. One-way ANOVA was used to compare continuous variables, and the Fisher exact test was used to compare categorical variables between the groups. Significance was set at p < 0.001.

Results

In the database with 1144 patients, 81 had a major complication. Of these 81 patients, 78 were propensity matched to a similar group of patients with minor complications and another group with no complications. Comparison of the 3 groups revealed that 2-year postoperative outcomes were not statistically different for any of the measures. Overall ODI at 2 years was better in patients having no complications (39.6) or only minor complications (37.0) than in those having major complications (44.5), but this difference was not statistically significant (p = 0.074). The proportion of patients reaching a minimum clinically important difference (MCID) for ODI was statistically significantly smaller in the major complication group (31%) than in the minor complication (51%) and no complication groups (65%; p < 0.001).

Conclusions

A smaller proportion of patients achieved MCID for ODI 2 years after a major perioperative complication following lumbar fusion than after a minor complication or no complications.

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Zachary G. Ries, Steven D. Glassman, Ivan Vasilyev, Leanne Metcalfe and Leah Y. Carreon

OBJECTIVE

Diagnostic workup for lumbar degenerative disc disease (DDD) includes imaging such as radiography, MRI, and/or CT myelography. If a patient has unsuccessful nonoperative treatment, the surgeon must then decide if obtaining updated images prior to surgery is warranted. The purpose of this study was to investigate whether the timing of preoperative neuroimaging altered clinical outcome, as reflected by the subsequent rate of revision surgery, in patients with degenerative lumbar spinal pathology.

METHODS

From the Health Care Service Corporation administrative claims database, adult patients (minimum age 55 years old) with lumbar DDD who underwent surgery including posterior lumbar decompression with and without fusion (1–2 levels) and at least 5 years of continuous coverage after the index surgery were identified. The chi-square test was used to determine differences in revision rates stratified by timing of each imaging procedure relative to the index procedure (< 6 months, 6–12 months, 12–24 months, or > 24 months).

RESULTS

Of 28,676 cases identified, 5128 (18%) had revision surgery within 5 years. The timing of preoperative MRI or plain radiography was not associated with revision surgery. Among the entire cohort, there was a lower incidence of revision surgery in patients who had a CT myelogram within 1 year prior to the index surgery (p = 0.017). This observation was strongest in patients undergoing decompression only (p = 0.002), but not significant in patients undergoing fusion (p = 0.845).

CONCLUSIONS

Routine reimaging prior to surgery, simply because the existing MRI is 6–12 months old, may not be beneficial, at least as reflected in subsequent revision rates. The study also suggests that there may be a subset of patients for whom preoperative CT myelography reduces revision rates. This topic has important financial implications and deserves further study in a more granular data set.

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Sean M. Jones-Quaidoo, Mladen Djurasovic, R. Kirk Owens II and Leah Y. Carreon

Object

Recent studies have reported the incidence of superior facet joint violation using percutaneous techniques. These techniques have not been compared with the open midline approach. An increased incidence of superior facet violation may lead to adjacent-segment disease. In this paper, the authors' goal is to compare the rate of superior facet violation with the use of percutaneously placed pedicle screws versus midline approach open placement.

Methods

Patients who underwent a single-level fusion using a percutaneous approach from L-1 to S-1 who had undergone CT scanning within 1 year after surgery were identified. A cohort who underwent open fusion matched by level of surgery was identified. All CT scans were reviewed by 3 fellowship-trained spine surgeons to determine the degree of facet violation. The final categorization for each screw was based on the most frequent reading among the 6 evaluations. The Fisher test was used to determine the association of facet violation with approach.

Results

There were 66 patients in each group. Patients in the Percutaneous group were younger (mean 42.5 years) than those in the Open group (mean 57.8 years, p = 0.000). There was no statistically significant difference in sex distribution, surgical levels fused, or time between surgery and CT scan between the groups. Thirty-six (13.6%) of 264 screws in the percutaneous and 16 (6%) of 263 screws in the Open group were in the facet joint (p = 0.005). Of these, 17 (12%) of the 132 proximal screws in the percutaneous and 7 (5%) of the 131 proximal screws in the Open group were in the facet joint (p = 0.052).

Conclusions

The use of a percutaneous method to insert pedicle screws results in a statistically significantly higher incidence of facet joint violation, even if only proximal screws are considered. Further studies are needed to determine if this leads to a higher incidence of symptomatic adjacent-level disease.

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Ian S. Mutchnick, Travis E. Clegg, Leah Y. Carreon and Rolando M. Puno

Object

The current standard of care for symptomatic chronic spondylolysis (SP) is a one-level posterior spinal fusion for defects at L-5 or direct pars repair (motion segment sparing) for more rostral SP in younger patients and if no disc degeneration or listhesis is present. Since many patients with SP undergoing operative repair are young, a procedure with the lowest biomechanical profile is desirable, and direct pars repair is recommended. The authors here explore the limits of direct pars repair.

Methods

A retrospective review of all patients who underwent direct repair of SP between 2002 and 2009 was performed. Data were analyzed for predictors of symptom relief and radiographic fusion failure.

Results

Of 49 patients, only 7 required a reoperation to treat clinical symptoms, and 6 of them were female (p = 0.049). In all cases of treatment failure, the patient had bilateral L-5 SP. Patients with a slip percentage as high as 30% experienced radiographic fusion and symptom relief. Disc degeneration (measured using the Modified Pfirrmann Scale) did not predict symptom persistence or radiographic fusion failure. Patients with high-grade disc disease experienced symptom relief. The authors found no predictors of treatment failure.

Conclusions

The number of patients undergoing motion segment–sparing fusions of symptomatic chronic SP can be safely increased to include patients with Grade I spondylolisthesis as well as high-grade disc disease. Female patients with bilateral L-5 SP and low lordotic angles may be better served by a posterior spinal fusion from L-5 to S-1.

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Charles H. Crawford III, Leah Y. Carreon, Mohamad Bydon, Anthony L. Asher and Steven D. Glassman

OBJECTIVE

Patient satisfaction is a commonly used metric in the current health care environment. While factors that affect patient satisfaction following spine surgery are complex, the authors of this study hypothesized that specific diagnostic groups of patients are more likely to be satisfied after spine surgery and that this is reflected in patient-reported outcome measures. The purpose of this study was to determine if the preoperative diagnosis—disc herniation, stenosis, spondylolisthesis, adjacent segment degeneration, or mechanical disc collapse—would impact patient satisfaction following surgery.

METHODS

Patients enrolled in the Quality Outcomes Database, formerly known as the National Neurosurgery Quality and Outcomes Database (N2QOD), completed patient-reported outcome measures, including the Oswestry Disability Index (ODI) and Numeric Rating Scale (NRS) for back pain (NRS-BP) and leg pain (NRS-LP) preoperatively and 1-year postoperatively. Patients were stratified by diagnosis and by their response to the satisfaction question: 1) surgery met my expectations; 2) I did not improve as much as I hoped, but I would undergo the same operation for the same results; 3) surgery helped, but I would not undergo the same operation for the same results; or 4) I am the same or worse as compared with before surgery.

RESULTS

A greater proportion of patients with primary disc herniation or spondylolisthesis reported that surgery met expectations (66% and 67%, respectively), followed by recurrent disc herniation and stenosis (59% and 60%, respectively). A smaller proportion of patients who underwent surgery for adjacent segment degeneration or mechanical disc collapse had their expectations met (48% and 41%, respectively). The percentage of patients that would undergo the same surgery again, by diagnostic group, was as follows: disc herniation 88%, recurrent disc herniation 79%, spondylolisthesis 86%, stenosis 82%, adjacent segment disease 75%, and mechanical collapse 73%. Regardless of diagnosis, mean improvement and ultimate 1-year postoperative ODI, NRS-BP, and NRS-LP reflected patient satisfaction.

CONCLUSIONS

Preoperative diagnosis was predictive of patient satisfaction following spine surgery. The mean change in and 1-year ODI, NRS-BP, and NRS-LP reflected patient satisfaction regardless of preoperative diagnosis.

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Steven M. Kurtz, Edmund Lau, Kevin L. Ong, Leah Carreon, Heather Watson, Todd Albert and Steven Glassman

Object

This retrospective analysis of Medicare administrative data was performed to evaluate the risk of infection following instrumented lumbar fusion over a 10-year follow-up period in the Medicare population. Although infection can be a devastating complication, due to its rarity it is difficult to characterize infection risk except in large patient populations.

Methods

Using ICD-9-CM and CPT4 procedure codes, the Medicare 5% analytical research files for inpatient, outpatient, and physician carrier claims were checked to identify patients who were treated between 1997 and 2009 with lumbar spine fusion in which cages or posterior instrumentation were used. Patients younger than 65 years old were excluded. Patients were followed continuously by using the matching denominator file until they withdrew from Medicare or died. The authors identified 15,069 patients with primary fusion procedures and 605 with revision of instrumented lumbar fusion. Infections were identified by the related ICD-9 codes (998.59 or 996.67) after fusion. Kaplan-Meier survival analysis and Cox regression were performed to determine adjusted infection risk for each type of spine procedure (primary vs revision) and surgical approach (anterior, posterior, combined anteroposterior), accounting for patient (for example, age, sex, comorbidities/Charlson Comorbidity Index [CCI], and state buy-in) and hospital (census region) characteristics.

Results

At 10 years, the overall infection incidence, including superficial and deep infections, was 8.5% in primary procedures and 12.2% in revisions. Among the factors considered, infection risk within 10 years was most influenced by comorbidities: for a CCI of 5 versus 0, the adjusted hazard ratio (AHR) was 2.48 (95% CI 1.93–3.19, p < 0.001); for ≥ 9 versus 2–3 fused vertebrae, the AHR was 2.39 (95% CI 1.20–4.76, p < 0.001); for revision versus primary fusion procedures, the AHR was 1.66 (95% CI 1.28–2.15, p < 0.001). Other significant predictors of 10-year infection risk included diagnosis of obesity (p < 0.001); state buy-in—a proxy for socioeconomic status (p = 0.02); age (p = 0.003); surgical approach (p = 0.03); census region (p = 0.02); and the year of the index procedure (p = 0.03).

Conclusions

Patient comorbidities were the greatest predictor of infection risk for the Medicare population. The high incidence of infection following instrumented fusion warrants increased focus on infection risk mitigation, especially for patients with comorbid conditions.

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Ikemefuna Onyekwelu, Steven D. Glassman, Anthony L. Asher, Christopher I. Shaffrey, Praveen V. Mummaneni and Leah Y. Carreon

OBJECTIVE

Prior studies have shown obesity to be associated with higher complication rates but equivalent clinical outcomes following lumbar spine surgery. These findings have been reproducible across lumbar spine surgery in general and for lumbar fusion specifically. Nevertheless, surgeons seem inclined to limit the extent of surgery, perhaps opting for decompression alone rather than decompression plus fusion, in obese patients. The purpose of this study was to ascertain any difference in clinical improvement or complication rates between obese and nonobese patients following decompression alone compared with decompression plus fusion for lumbar spinal stenosis (LSS).

METHODS

The Quality Outcomes Database (QOD), formerly known as the National Neurosurgery Quality and Outcomes Database (N2QOD), was queried for patients who had undergone decompression plus fusion (D+F group) versus decompression alone (D+0 group) for LSS and were stratified by a body mass index (BMI) ≥ 30 kg/m2 (obese) or < 30 kg/m2 (nonobese). Demographic, surgical, and health-related quality of life data were compared.

RESULTS

In the nonobese cohort, 947 patients underwent decompression alone and 319 underwent decompression plus fusion. In the obese cohort, 844 patients had decompression alone and 337 had decompression plus fusion. There were no significant differences in the Oswestry Disability Index score or in leg pain improvement at 12 months when comparing decompression with fusion to decompression without fusion in either obese or nonobese cohorts. However, absolute improvement in back pain was less in the obese group when decompression alone had been performed. Blood loss and operative time were lowest in the nonobese D+0 cohort and were higher in obese patients with or without fusion. Obese patients had a longer hospital stay (4.1 days) than the nonobese patients (3.3 days) when fusion had been performed. In-hospital stay was similar in both obese and nonobese D+0 cohorts. No significant differences were seen in 30-day readmission rates among the 4 cohorts.

CONCLUSIONS

Consistent with the prior literature, equivalent clinical outcomes were found among obese and non-obese patients treated for LSS. In addition, no difference in clinical outcomes as related to the extent of the surgical procedure was observed between obese and nonobese patients. Within the D+0 group, the nonobese patients had slightly better back pain scores at 2 years postoperatively. There may be a higher blood product requirement in obese patients following spine surgery, as well as an extended hospital stay, when fusion is performed. While obesity may influence the decision for or against surgery, the data suggest that obesity should not necessarily alter the appropriate procedure for well-selected surgical candidates.