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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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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, 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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Leah Y. Carreon, Kelly R. Bratcher, Nandita Das, Jacob B. Nienhuis and Steven D. Glassman

Object

The Neck Disability Index (NDI) and numeric rating scales (0 to 10) for neck pain and arm pain are widely used cervical spine disease–specific measures. Recent studies have shown that there is a strong relationship between the SF-6D and the NDI such that using a simple linear regression allows for the estimation of an SF-6D value from the NDI alone. Due to ease of administration and scoring, the EQ-5D is increasingly being used as a measure of utility in the clinical setting. The purpose of this study is to determine if the EQ-5D values can be estimated from commonly available cervical spine disease–specific health-related quality of life measures, much like the SF-6D.

Methods

The EQ-5D, NDI, neck pain score, and arm pain score were prospectively collected in 3732 patients who presented to the authors' clinic with degenerative cervical spine disorders. Correlation coefficients for paired observations from multiple time points between the NDI, neck pain and arm pain scores, and EQ-5D were determined. Regression models were built to estimate the EQ-5D values from the NDI, neck pain, and arm pain scores.

Results

The mean age of the 3732 patients was 53.3 ± 12.2 years, and 43% were male. Correlations between the EQ-5D and the NDI, neck pain score, and arm pain score were statistically significant (p < 0.0001), with correlation coefficients of −0.77, −0.62, and −0.50, respectively. The regression equation 0.98947 + (−0.00705 × NDI) + (−0.00875 × arm pain score) + (−0.00877 × neck pain score) to predict EQ-5D had an R-square of 0.62 and a root mean square error (RMSE) of 0.146. The model using NDI alone had an R-square of 0.59 and a RMSE of 0.150. The model using the individual NDI items had an R-square of 0.46 and an RMSE of 0.172. The correlation coefficient between the observed and estimated EQ-5D scores was 0.79. There was no statistically significant difference between the actual EQ-5D score (0.603 ± 0.235) and the estimated EQ-5D score (0.603 ± 0.185) using the NDI, neck pain score, and arm pain score regression model. However, rounding off the coefficients to fewer than 5 decimal places produced less accurate results.

Conclusions

The regression model estimating the EQ-5D from the NDI, neck pain score, and arm pain score accounted for 60% of the variability of the EQ-5D with a relatively large RMSE. This regression model may not be sufficient to accurately or reliably estimate actual EQ-5D values.

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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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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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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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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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Leah Y. Carreon, Steven D. Glassman, Zoher Ghogawala, Praveen V. Mummaneni, Matthew J. McGirt and Anthony L. Asher

OBJECTIVE

Transforaminal lumbar interbody fusion (TLIF) has become the most commonly used fusion technique for lumbar degenerative disorders. This suggests an expectation of better clinical outcomes with this technique, but this has not been validated consistently. How surgical variables and choice of health utility measures drive the cost-effectiveness of TLIF relative to posterolateral fusion (PSF) has not been established. The authors used health utility values derived from Short Form-6D (SF-6D) and EQ-5D and different cost-effectiveness thresholds to evaluate the relative cost-effectiveness of TLIF compared with PSF.

METHODS

From the National Neurosurgery Quality and Outcomes Database (N2QOD), 101 patients with spondylolisthesis who underwent PSF were propensity matched to patients who underwent TLIF. Health-related quality of life measures and perioperative parameters were compared. Because health utility values derived from the SF-6D and EQ-5D questionnaires have been shown to vary in patients with low-back pain, quality-adjusted life years (QALYs) were derived from both measures. On the basis of these matched cases, a sensitivity analysis for the relative cost per QALY of TLIF versus PSF was performed in a series of cost-assumption models.

RESULTS

Operative time, blood loss, hospital stay, and 30-day and 90-day readmission rates were similar for the TLIF and PSF groups. Both TLIF and PSF significantly improved back and leg pain, Oswestry Disability Index (ODI) scores, and EQ-5D and SF-6D scores at 3 and 12 months postoperatively. At 12 months postoperatively, patients who had undergone TLIF had greater improvements in mean ODI scores (30.4 vs 21.1, p = 0.001) and mean SF-6D scores (0.16 vs 0.11, p = 0.001) but similar improvements in mean EQ-5D scores (0.25 vs 0.22, p = 0.415) as patients treated with PSF. At a cost per QALY threshold of $100,000 and using SF-6D–based QALYs, the authors found that TLIF would be cost-prohibitive compared with PSF at a surgical cost of $4830 above that of PSF. However, with EQ-5D–based QALYs, TLIF would become cost-prohibitive at an increased surgical cost of $2960 relative to that of PSF. With the 2014 US per capita gross domestic product of $53,042 as a more stringent cost-effectiveness threshold, TLIF would become cost-prohibitive at surgical costs $2562 above that of PSF with SF-6D–based QALYs or at a surgical cost exceeding that of PSF by $1570 with EQ-5D–derived QALYs.

CONCLUSIONS

As with all cost-effectiveness studies, cost per QALY depended on the measure of health utility selected, durability of the intervention, readmission rates, and the accuracy of the cost assumptions.

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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.