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Todd W. Vitaz, George H. Raque, Christopher B. Shields and Steven D. Glassman

Object. The purpose of this study was to evaluate the safety and efficacy of the surgical treatment of lumbar spinal stenosis in patients older than 75 years of age.

Methods. The authors reviewed the records of 65 patients with lumbar spinal stenosis who were at least 75 years of age at the time of surgery, which was performed between November 1990 and May 1996.

The 65 patients (43 women, 22 men; average age 78 years) underwent a total of 71 operations (one patient underwent three, and four patients underwent two). Fifteen patients (21%) underwent isolated lumbar decompression, and 56 patients (79%) underwent decompression in conjunction with posterior spinal fusion. There was an average of 1.7 levels decompressed per isolated lumbar decompression and 2.6 levels per decompression and fusion procedure. Seven patients (10%) experienced one or more serious postoperative complication, which included wound infection, septicemia, small bowel obstruction, stroke, myocardial infarction, gastrointestinal bleeding, and pulmonary embolus. In addition there was one intraoperative complication (hypotension [1%]) that required modification of the planned surgical procedure. No deaths were documented in the perioperative period.

Conclusions. With appropriate preoperative selection and evaluation, careful intraoperative monitoring, and attentive perioperative care, the surgical treatment of elderly patients with lumbar spinal stenosis can effect significant improvement with acceptable levels of morbidity and mortality.

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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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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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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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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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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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Charles H. Crawford III, Steven D. Glassman, Praveen V. Mummaneni, John J. Knightly and Anthony L. Asher

OBJECTIVE

The relief of leg symptoms by surgical decompression for lumbar stenosis is well supported by the literature. Less is known about the effect on back pain. Some surgeons believe that the relief of back pain should not be an expected outcome of decompression and that substantial back pain may be a contraindication to decompression only; therefore, stabilization may be recommended for patients with substantial preoperative back pain even in the absence of well-accepted indications for stabilization such as spondylolisthesis, scoliosis, or sagittal malalignment. The purpose of this study is to determine if patients with lumbar stenosis and substantial back pain—in the absence of spondylolisthesis, scoliosis, or sagittal malalignment—can obtain significant improvement after decompression without fusion or stabilization.

METHODS

Analysis of the National Neurosurgery Quality and Outcomes Database (N2QOD) identified 726 patients with lumbar stenosis (without spondylolisthesis or scoliosis) and a baseline back pain score ≥ 5 of 10 who underwent surgical decompression only. No patient was reported to have significant spondylolisthesis, scoliosis, or sagittal malalignment. Standard demographic and surgical variables were collected, as well as patient outcomes including back and leg pain scores, Oswestry Disability Index (ODI), and EuroQoL 5D (EQ-5D) at baseline and 3 and 12 months postoperatively.

RESULTS

The mean age of the cohort was 65.6 years, and 407 (56%) patients were male. The mean body mass index was 30.2 kg/m2, and 40% of patients had 2-level decompression, 29% had 3-level decompression, 24% had 1-level decompression, and 6% had 4-level decompression. The mean estimated blood loss was 130 ml. The mean operative time was 100.85 minutes. The vast majority of discharges (88%) were routine home discharges. At 3 and 12 months postoperatively, there were significant improvements from baseline for back pain (7.62 to 3.19 to 3.66), leg pain (7.23 to 2.85 to 3.07), EQ-5D (0.55 to 0.76 to 0.75), and ODI (49.11 to 27.20 to 26.38).

CONCLUSIONS

Through the 1st postoperative year, patients with lumbar stenosis—without spondylolisthesis, scoliosis, or sagittal malalignment—and clinically significant back pain improved after decompression-only surgery.

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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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Zoher Ghogawala, Daniel K. Resnick, Steven D. Glassman, James Dziura, Christopher I. Shaffrey and Praveen V. Mummaneni

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Mladen Djurasovic, Steven D. Glassman, John R. Dimar II, Charles H. Crawford III, Kelly R. Bratcher and Leah Y. Carreon

Object

Clinical studies use both disease-specific and generic health outcomes measures. Disease-specific measures focus on health domains most relevant to the clinical population, while generic measures assess overall health-related quality of life. There is little information about which domains of the Oswestry Disability Index (ODI) are most important in determining improvement in overall health-related quality of life, as measured by the 36-Item Short Form Health Survey (SF-36), after lumbar spinal fusion. The objective of the study is to determine which clinical elements assessed by the ODI most influence improvement of overall health-related quality of life.

Methods

A single tertiary spine center database was used to identify patients undergoing lumbar fusion for standard degenerative indications. Patients with complete preoperative and 2-year outcomes measures were included. Pearson correlation was used to assess the relationship between improvement in each item of the ODI with improvement in the SF-36 physical component summary (PCS) score, as well as achievement of the SF-36 PCS minimum clinically important difference (MCID). Multivariate regression modeling was used to examine which items of the ODI best predicted achievement for the SF-36 PCS MCID. The effect size and standardized response mean were calculated for each of the items of the ODI.

Results

A total of 1104 patients met inclusion criteria (674 female and 430 male patients). The mean age at surgery was 57 years. All items of the ODI showed significant correlations with the change in SF-36 PCS score and achievement of MCID for the SF-36 PCS, but only pain intensity, walking, and social life had r values > 0.4 reflecting moderate correlation. These 3 variables were also the dimensions that were independent predictors of the SF-36 PCS, and they were the only dimensions that had effect sizes and standardized response means that were moderate to large.

Conclusions

Of the health dimensions measured by the ODI, pain intensity, walking, and social life best predicted improvement in overall health-related quality of life, as measured using the SF-36 PCS.