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Debraj Mukherjee, Kaisorn L. Chaichana, Ziya L. Gokaslan, Oran Aaronson, Joseph S. Cheng and Matthew J. McGirt

Object

Malignant primary osseous spinal neoplasms are aggressive tumors that remain associated with poor outcomes despite aggressive multidisciplinary treatment measures. To date, prognosis for patients with these tumors is based on results from small single-center patient series and controlled trials. Large population-based observational studies are lacking. To assess national trends in histology-specific survival, the authors reviewed patient survival data spanning 30 years (1973–2003) from the Surveillance, Epidemiology, and End Results (SEER) registry, a US population-based cancer registry.

Methods

The SEER registry was queried to identify cases of histologically confirmed primary spinal chordoma, chondrosarcoma, osteosarcoma, or Ewing sarcoma using coding from the International Classification of Disease for Oncology, Third Edition. Association of survival with histology, metastasis status, tumor site, and year of diagnosis was assessed using Cox proportional-hazards regression analysis.

Results

A total of 1892 patients were identified with primary osseous spinal neoplasms (414 with chordomas, 579 with chondrosarcomas, 430 with osteosarcomas, and 469 with Ewing sarcomas). Chordomas presented in older patients (60 ± 17 years; p < 0.01) whereas Ewing sarcoma presented in younger patients (19 ± 11 years; p < 0.01) compared with patients with all other tumors. The relative incidence of each tumor type remained similar per decade from 1973 to 2003. African Americans comprised a significantly greater proportion of patients with osteosarcomas than other tumors (9.6% vs 3.5%, respectively; p < 0.01). Compared with the sacrum, the mobile spine was more likely to be the site of tumor location for chordomas than for all other tumors (47% vs 23%, respectively; p < 0.05). Osteosarcoma and Ewing sarcoma were 3 times more likely than chondrosarcoma and chordoma to present with metastasis (31% vs 8%, respectively). Resection was performed more frequently for chordoma (88%) and chondrosarcoma (89%) than for osteosarcoma (61%) and Ewing sarcoma (53%). Overall median survival was histology-specific (osteosarcoma, 11 months; Ewing sarcoma, 26 months; chondrosarcoma, 37 months; chordoma, 50 months) and significantly worse in patients with metastasis at presentation for all tumor types. Survival did not significantly differ as a function of site (mobile spine vs sacrum/pelvis) for any tumor type, but more recent year of diagnosis was associated with improved survival for isolated spinal Ewing sarcoma (hazard ration [HR] 0.95; p = 0.001), chondrosarcoma (HR 0.98; p = 0.009), and chordoma (HR 0.98; p = 0.10), but not osteosarcoma.

Conclusions

In this analysis of a 30-year, US population-based cancer registry (SEER), the authors provide nationally representative prognosis and survival data for patients with malignant primary spinal osseous neoplasms. Overall patient survival has improved for isolated spine tumors with advancements in care over the past 4 decades. These results may be helpful in providing historical controls for understanding the efficacy of new treatment paradigms, patient education, and guiding level of aggressiveness in treatment strategies.

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Matthew J. McGirt, Beril Gok, Starane Shepherd, Joseph Noggle, Giannina L. Garcés Ambrossi, Ali Bydon and Ziya L. Gokaslan

Object

Hyperglycemia has been shown to potentiate ischemic injury of the spinal cord by quenching vasodilators and potentiating tissue acidosis and free radical production. Steroid-induced hyperglycemia is a common event in the surgical management of metastatic epidural spinal cord compression (MESCC). The goal in this study was to determine whether experimentally induced hyperglycemia accelerates neurological decline in an established animal model of MESCC.

Methods

Sixteen Fischer 344 rats underwent a transabdominal approach for implantation of a CRL-1666 breast adenocarcinoma cell line within the vertebral body of L-6. After 72 hours of recovery from tumor implantation, the animals received intraperitoneal injections every 12 hours of either 2 g/kg dextrose in 5 ml 0.09% saline (hyperglycemia, 8 rats) or 5 ml 0.09% saline alone (normoglycemia, 8 rats). Weights were taken daily, and the hindlimb function was tested daily after tumor implantation by using the Basso-Beattie-Bresnahan (BBB) scale (score range 1–21). Animals were killed at time of paralysis (BBB Score < 7), and the volume of epidural tumor growth within the spinal canal was measured. To determine the degree of hyperglycemia induced by this dextrose regimen, a surrogate group of 10 Fischer 344 rats underwent intraperitoneal injections of 2 g/kg dextrose (5 rats) or 0.09% saline (5 rats) every 12 hours, and serum glucose levels were assessed 1, 3, 6, 8, 10, and 12 hours after injections for 24 hours.

Results

Dextrose versus saline injections resulted in elevated mean serum glucose at 3 (259 vs 103 μg/dl), 6 (219 vs 102 μg/dl), 8 (169 vs 102 μg/dl), and 10 hours (118 vs 99 μg/dl) after injection, returning to normal levels by 12 hours (96 vs 103 μg/dl) just prior to subsequent injection. All rats had normal hindlimb function for the first 8 days after tumor implantation. Hyperglycemic versus normoglycemic rats demonstrated a worsened median BBB score by postimplantation Day 9 (Score 20 vs 21, p = 0.023) through Day 16 (Score 8 vs 12, p = 0.047). Epidural tumor volume demonstrated a near-linear growth rate across both groups; however, hyperglycemic rats developed paralysis earlier (median 15.5 vs 17.5 days, p = 0.0035), with significantly less epidural tumor volume (2.75 ± 0.38 cm3 vs 4 ± 0.41 cm3, p < 0.001) at time of paralysis.

Conclusions

In a rat model of metastatic epidural spinal cord compression, rats maintained in a hyperglycemic state experienced accelerated time to paralysis. Also, less epidural tumor volume was required to cause paralysis in hyperglycemic rats. These results suggest that hyperglycemic states may contribute to decreased spinal cord tolerance to compression resulting from MESCC. Clinical studies evaluating the effect of aggressive glucose control in patients with MESCC may be warranted.

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Owoicho Adogwa, Scott L. Parker, David Shau, Stephen K. Mendelhall, Joseph Cheng, Oran Aaronson, Clinton J. Devin and Matthew J. McGirt

Object

The number of low-back fusion procedures for the treatment of spine disorders has increased steadily over the past 10 years. Lumbar pseudarthrosis is a potential complication of lumbar arthrodesis and can be associated with significant pain and disability. The aim of this study was to assess, using validated patient-reported outcomes measures, the long-term effectiveness of revision arthrodesis in the treatment of symptomatic pseudarthrosis.

Methods

This is a retrospective study of 47 patients who underwent revision lumbar arthrodesis for pseudarthrosis-associated back pain. Baseline 2-year outcomes were assessed using the following: visual analog scale (VAS) for back pain, Oswestry Disability Index (ODI), Zung Self-Rating Depression Scale, time to narcotic independence, time to return to work, EuroQol health-state utility, and physical and mental quality of life (Short Form [SF]–12 Physical and Mental Component Summary scores).

Results

The mean duration of time between prior fusion and development of symptomatic pseudarthrosis was 2.69 years. Bone morphogenetic protein was used in 4 cases (8.5%) of revision arthrodesis. A significant improvement in VAS back pain (7.31 ± 0.81 vs 5.06 ± 2.64, p = 0.001), ODI (29.74 ± 5.35 vs 25.42 ± 6.0, p = 0.001), and physical health SF-12 (23.83 ± 6.89 vs 27.85 ± 8.90, p = 0.001) scores was observed when comparing baseline and 2-year post–revision arthrodesis scores, respectively, with a mean cumulative 2-year gain of 0.35 quality-adjusted life years. The median time to narcotics independence was 12.16 (interquartile range 1.5–24.0) months and the median time to return to work was 4 months (interquartile range 3–5 months). By 2 years after revision surgery, no patients had experienced pseudarthrosis. The SF-12 Mental Component Summary (44.72 ± 7.90 vs 43.46 ± 7.51, p = 0.43) and Zung Self-Rating Depression Scale scores (39.36 ± 7.48 vs 41.39 ± 10.72, p = 0.37) were not significantly improved by 2 years.

Conclusions

The authors' study suggests that revision lumbar arthrodesis for symptomatic pseudarthrosis provides improvement in low-back pain, disability, and quality of life. Revision lumbar arthrodesis should be considered a viable treatment option for patients with pseudarthrosis-related back pain. Mental health symptoms from pseudarthrosis-associated back pain may be more refractory to revision surgery.

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Owoicho Adogwa, Scott L. Parker, David N. Shau, Stephen K. Mendenhall, Clinton J. Devin, Joseph S. Cheng and Matthew J. McGirt

Object

Over the past decade, there has been a dramatic increase in the number of spinal fusions performed in the US and a corresponding increase in the incidence of adjacent-segment disease (ASD). Surgical management of symptomatic ASD consists of decompression of neural elements and extension of fusion. It has been shown to have favorable long-term outcomes, but the cost-effectiveness remains unclear. In this study, the authors set out to assess the cost-effectiveness of revision surgery in the treatment of ASD over a 2-year period.

Methods

Fifty patients undergoing neural decompression and extension of fusion construct for ASD-associated back and leg pain were included in the study. Two-year total back-related medical resource utilization, missed work, and health state values (quality-adjusted life years [QALYs], calculated from the EQ-5D with US valuation) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost), and patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). Mean total 2-year cost per QALY gained after revision surgery was assessed.

Results

The mean (± SD) interval between prior fusion and revision surgery for ASD was 3.07 ± 2.02 years. A mean cumulative 2-year gain of 0.76 QALYs was observed after revision surgery. The mean total 2-year cost of extension of fusion constructs was $47,846 ± $32,712 (surgery cost: $24,063 ± $300; outpatient resource utilization cost: $4175 ± $3368; indirect cost: $19,607 ± $32,187). Revision decompression and extension of fusion was associated with a mean 2-year cost per QALY gained of $62,955.

Conclusions

In the authors' practice, revision decompression and extension of fusion provided a significant gain in health state utility for patients with symptomatic ASD, with a 2-year cost per QALY gained of $62,995. When indicated, revision surgery for ASD is a valuable treatment option for patients experiencing back and leg pain secondary to ASD. The findings provide a value measure of surgery that can be compared with future cost-per-QALY-gained studies of medical management or alternative surgical approaches.

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Daniel M. Sciubba, Joseph C. Noggle, Ananth K. Vellimana, Hassan Alosh, Matthew J. McGirt, Ziya L. Gokaslan and Jean-Paul Wolinsky

Object

Stabilization of the cervical spine can be challenging when instrumentation involves the axis. Fixation with C1–2 transarticular screws combined with posterior wiring and bone graft placement has yielded excellent fusion rates, but the technique is technically demanding and places the vertebral arteries (VAs) at risk. Placement of screws in the pars interarticularis of C-2 as described by Harms and Melcher has allowed rigid fixation with greater ease and theoretically decreases the risk to the VA. However, fluoroscopy is suggested to avoid penetration laterally, medially, and superiorly to avoid damage to the VA, spinal cord, and C1–2 joint, respectively. The authors describe how, after meticulous dissection of the C-2 pars interarticularis, such screws can be placed accurately and safely without the use of fluoroscopy.

Methods

Prospective follow-up was performed in 55 consecutive patients who underwent instrumented fusion of C-2 by a single surgeon. The causes of spinal instability and type and extent of instrumentation were documented. All patients underwent preoperative CT or MR imaging scans to determine the suitability of C-2 screw placement. Intraoperatively, screws were placed following dissection of the posterior pars interarticularis. Postoperative CT scans were performed to determine the extent of cortical breach. Patients underwent clinical follow-up, and complications were recorded as vascular or neurological. A CT-based grading system was created to characterize such breaches objectively by location and magnitude via percentage of screw diameter beyond the cortical edge (0 = none; I = < 25% of screw diameter; II = 26–50%; III = 51–75%; IV = 76–100%).

Results

One-hundred consecutive screws were placed in the pedicle of the axis by a single surgeon using external landmarks only. In 10 cases, only 1 screw was placed because of a preexisting VA anatomy or bone abnormality noted preoperatively. In no case was screw placement aborted because of complications noted during drilling. Early complications occurred in 2 patients and were limited to 1 wound infection and 1 transient C-2 radiculopathy. There were 15 total breaches (15%), 2 of which occurred in the same patient. Twelve breaches were lateral (80%), and 3 were superior (20%). There were no medial breaches. The magnitude of the breach was classified as I in 10 cases (66.7% of breaches), II in 3 cases (20% of breaches), III in 1 case (6.7%), and IV in 1 case (6.7%).

Conclusions

Free-hand placement of screws in the C-2 pedicle can be done safely and effectively without the use of intraoperative fluoroscopy or navigation when the pars interarticularis/pedicle is assessed preoperatively with CT or MR imaging and found to be suitable for screw placement. When breaches do occur, they are overwhelmingly lateral in location, breach < 50% of the screw diameter, and in the authors' experience, are not clinically significant.

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Kaisorn L. Chaichana, Debraj Mukherjee, Owoicho Adogwa, Joseph S. Cheng and Matthew J. McGirt

Object

Lumbar discectomy is the most common surgical procedure performed in the US for patients experiencing back and leg pain from herniated lumbar discs. However, not all patients will benefit from lumbar discectomy. Patients with certain psychological predispositions may be especially vulnerable to poor clinical outcomes.

The goal of this study was therefore to determine the role that preoperative depression and somatic anxiety have on long-term back and leg pain, disability, and quality of life (QOL) for patients undergoing single-level lumbar discectomy.

Methods

In 67 adults undergoing discectomy for a single-level herniated lumbar disc, the authors determined quantitative measurements of leg and back pain (visual analog scale [VAS]), quality of life (36-Item Short Form Health Survey [SF-36]), and disease-specific disability (Oswestry Disability Index) preoperatively and at 6 weeks, 3, 6, and 12 months after surgery. The degree of preoperative depression and somatization was assessed using the Zung Self-Rating Depression Scale and a modified somatic perception questionnaire (MSPQ). Multivariate regression analyses were performed to assess associations between Zung Scale and MSPQ scores with achievement of a minimum clinical important difference (MCID) in each outcome measure by 12 months postoperatively.

Results

All patients completed 12 months of follow-up. Overall, a significant improvement in VAS leg pain, VAS back pain, Oswestry Disability Index, and SF-36 Physical Component Summary scores was observed by 6 weeks after surgery. Improvements in all outcomes were maintained throughout the 12-month follow-up period. Increasing preoperative depression (measured using the Zung Scale) was associated with a decreased likelihood of achieving an MCID in disability (p = 0.006) and QOL (p = 0.04) but was not associated with VAS leg pain (p = 0.96) or back pain (p = 0.85) by 12 months. Increasing preoperative somatic anxiety (measured using the MSPQ) was associated with decreased likelihood of achieving an MCID in disability (p = 0.002) and QOL (p = 0.03) but was not associated with leg pain (p = 0.64) or back pain (p = 0.77) by 12 months.

Conclusions

The Zung Scale and MSPQ are valuable tools for stratifying risk in patients who may not experience clinically relevant improvement in disability and QOL after discectomy. Efforts to address these confounding and underlying contributors of depression and heightened somatic anxiety may improve overall outcomes after lumbar discectomy.

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Owoicho Adogwa, Scott L. Parker, Brandon J. Davis, Oran Aaronson, Clinton Devin, Joseph S. Cheng and Matthew J. McGirt

Object

Transforaminal lumbar interbody fusion (TLIF) for spondylolisthesis-associated back and leg pain is associated with improvement in pain, disability, and quality of life. However, given the rising health care costs associated with spinal fusion procedures and varying results of recent cost-utility studies, the cost-effectiveness of TLIF remains unclear. The authors set out to assess the comprehensive costs of TLIF at their institution and to determine its cost-effectiveness in the treatment of degenerative spondylolisthesis.

Methods

Forty-five patients undergoing TLIF for Grade I degenerative spondylolisthesis–associated back and leg pain after 6–12 months of conservative therapy were included. The authors assessed the 2-year back pain visual analog scale (VAS) score, leg pain VAS score, Oswestry Disability Index, and total back-related medical resource utilization, missed work, and health-state values (quality-adjusted life years [QALYs], calculated from EQ-5D with US valuation). Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost), and patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). The mean total 2-year cost per QALY gained after TLIF was assessed.

Results

Compared with preoperative health states reported after at least 6 months of medical management, a significant improvement in back pain VAS score, leg pain VAS score, and Oswestry Disability Index was observed 2 years after TLIF, with a mean 2-year gain of 0.86 QALYs. The mean ± SD total 2-year cost of TLIF was $36,836 ± $11,800 (surgery cost, $21,311 ± $2800; outpatient resource utilization cost, $3940 ± $2720; indirect cost, $11,584 ± $11,363). Transforaminal lumbar interbody fusion was associated with a mean 2-year cost per QALY gained of $42,854.

Conclusions

Transforaminal lumbar interbody fusion improved pain, disability, and quality of life in patients with degenerative spondylolisthesis–associated back and leg pain. The total cost per QALY gained for TLIF was $42,854 when evaluated 2 years after surgery with Medicare fees, suggesting that TLIF is a cost-effective treatment of lumbar spondylolisthesis.

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Matthew J. McGirt, Theodore Speroff, Saniya Siraj Godil, Joseph S. Cheng, Nathan R. Selden and Anthony L. Asher

In terms of policy, research, quality improvement, and practice-based learning, there are essential principles—namely, quality, effectiveness, and value of care—needed to navigate changes in the current and future US health care environment. Patient-centered outcome measurement lies at the core of all 3 principles. Multiple measures of disease-specific disability, generic health-related quality of life, and preference-based health state have been introduced to quantify disease impact and define effectiveness of care. This paper reviews the basic principles of patient outcome measurement and commonly used outcome instruments. The authors provide examples of how utilization of outcome measurement tools in everyday neurosurgical practice can facilitate practice-based learning, quality improvement, and real-world comparative effectiveness research, as well as promote the value of neurosurgical care.

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Scott L. Parker, Owoicho Adogwa, Alexandra R. Paul, William N. Anderson, Oran Aaronson, Joseph S. Cheng and Matthew J. McGirt

Object

Outcome studies for spine surgery rely on patient-reported outcomes (PROs) to assess treatment effects. Commonly used health-related quality-of-life questionnaires include the following scales: back pain and leg pain visual analog scale (BP-VAS and LP-VAS); the Oswestry Disability Index (ODI); and the EuroQol-5D health survey (EQ-5D). A shortcoming of these questionnaires is that their numerical scores lack a direct meaning or clinical significance. Because of this, the concept of the minimum clinically important difference (MCID) has been put forth as a measure for the critical threshold needed to achieve treatment effectiveness. By this measure, treatment effects reaching the MCID threshold value imply clinical significance and justification for implementation into clinical practice.

Methods

In 45 consecutive patients undergoing transforaminal lumbar interbody fusion (TLIF) for low-grade degenerative lumbar spondylolisthesis-associated back and leg pain, PRO questionnaires measuring BP-VAS, LPVAS, ODI, and EQ-5D were administered preoperatively and at 2 years postoperatively, and 2-year change scores were calculated. Four established anchor-based MCID calculation methods were used to calculate MCID, as follows: 1) average change; 2) minimum detectable change (MDC); 3) change difference; and 4) receiver operating characteristic curve analysis for two separate anchors (the health transition index [HTI] of the 36-Item Short Form Health Survey [SF-36], and the satisfaction index).

Results

All patients were available at the 2-year follow-up. The 2-year improvements in BP-VAS, LP-VAS, ODI, and EQ-5D scores were 4.3 ± 2.9, 3.8 ± 3.4, 19.5 ± 11.3, and 0.43 ± 0.44, respectively (mean ± SD). The 4 MCID calculation methods generated a range of MCID values for each of the PROs (BP-VAS, 2.1–5.3; LP-VAS, 2.1–4.7; ODI, 11–22.9; and EQ-5D, 0.15–0.54). The mean area under the curve (AUC) for the receiver operating characteristic curve from the 4 PRO-specific calculations was greater for the HTI versus satisfaction anchor (HTI [AUC 0.73] vs satisfaction [AUC 0.69]), suggesting HTI as a more accurate anchor.

Conclusions

The TLIF-specific MCID is highly variable based on calculation technique. The MDC approach with the SF-36 HTI anchor appears to be most appropriate for calculating MCID because it provided a threshold above the 95% CI of the unimproved cohort (greater than the measurement error), was closest to the mean change score reported by improved and satisfied patients, and was least affected by the choice of anchor. Based on the MDC method with HTI anchor, MCID scores following TLIF are 2.1 points for BP-VAS, 2.8 points for LP-VAS, 14.9 points for ODI, and 0.46 quality-adjusted life years for EQ-5D.