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Sina Pourtaheri, Akshay Sharma, Jason Savage, Iain Kalfas, Thomas E. Mroz, Edward Benzel and Michael P. Steinmetz

OBJECTIVE

The flexed posture of the proximal (L1–3) or distal (L4–S1) lumbar spine increases the diameter of the spinal canal and neuroforamina and can relieve symptoms of neurogenic claudication. Distal lumbar flexion can result in pelvic retroversion; therefore, in cases of flexible sagittal imbalance, pelvic retroversion may be compensatory for lumbar stenosis and not solely compensatory for the sagittal imbalance as previously thought. The authors investigate underlying causes for pelvic retroversion in patients with flexible sagittal imbalance.

METHODS

One hundred thirty-eight patients with sagittal imbalance who underwent a total of 148 fusion procedures of the thoracolumbar spine were identified from a prospective clinical database. Radiographic parameters were obtained from images preoperatively, intraoperatively, and at 6-month and 2-year follow-up. A cohort of 24 patients with flexible sagittal imbalance was identified and individually matched with a control cohort of 23 patients with fixed deformities. Flexible deformities were defined as a 10° change in lumbar lordosis between weight-bearing and non–weight-bearing images. Pelvic retroversion was quantified as the ratio of pelvic tilt (PT) to pelvic incidence (PI).

RESULTS

The average difference between lumbar lordosis on supine MR images and standing radiographs was 15° in the flexible cohort. Sixty-eight percent of the patients in the flexible cohort were diagnosed preoperatively with lumbar stenosis compared with only 22% in the fixed sagittal imbalance cohort (p = 0.0032). There was no difference between the flexible and fixed cohorts with regard to C-2 sagittal vertical axis (SVA) (p = 0.95) or C-7 SVA (p = 0.43). When assessing for postural compensation by pelvic retroversion in the stenotic patients and nonstenotic patients, the PT/PI ratio was found to be significantly greater in the patients with stenosis (p = 0.019).

CONCLUSIONS

For flexible sagittal imbalance, preoperative attention should be given to the root cause of the sagittal misalignment, which could be compensation for lumbar stenosis. Pelvic retroversion can be compensatory for both the lumbar stenosis as well as for sagittal imbalance.

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Pranay Soni, Ghaith Habboub, Varun R. Kshettry, Richard Schlenk, Frederick Lautzenheiser and Edward C. Benzel

The Cleveland Clinic was established in 1921 under the direction of 4 experienced and iconic physicians: George Crile, Frank Bunts, William Lower, and John Phillips. The Clinic initially employed a staff of only 6 surgeons, 4 internists, 1 radiologist, and 1 biophysicist, but Crile was quick to realize the need for broadening its scope of practice. He asked his close friend, Harvey Cushing, for assistance in finding a suitable candidate to establish a department of neurosurgery at the Cleveland Clinic. With his full endorsement, Cushing recommended Dr. Charles Edward Locke Jr., a former student and burgeoning star in the field of neurosurgery. Unfortunately, Locke’s life and career both ended prematurely in the Cleveland Clinic fire of 1929, but not before he would leave a lasting legacy, both at the Cleveland Clinic and in the field of neurosurgery.

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Jaes C. Jones, Jacob A. Miller, Dattanand M. Sudarshana, Nicolas R. Thompson, Edward C. Benzel and Thomas E. Mroz

OBJECTIVE

In 2009, 2 randomized controlled trials demonstrated no improvement in pain following vertebral augmentation compared with sham surgery. However, a recent randomized trial demonstrated significant pain relief in patients following vertebroplasty compared to controls treated with conservative medical management. This study is a retrospective review of prospectively collected patient-reported quality of life (QOL) outcomes. The authors hypothesized that vertebral augmentation procedures offer a QOL benefit, but that this benefit would be diminished in patients with a history of depression and/or in patients undergoing vertebral augmentation at more than 1 level.

METHODS

Multivariable linear regression was used to identify predictors of postoperative pain assessed using the Pain Disability Questionnaire (PDQ), Patient Health Questionnaire 9 (PHQ-9), and EQ-5D scores. Eleven candidate predictors were selected a priori: age, sex, smoking history, coronary artery disease, depression, diabetes, procedure location (thoracic, lumbar), BMI, prior spine surgery, procedure indication (metastases, osteoporosis/osteopenia, other), and number of levels (1, 2, 3, or more).

RESULTS

A total of 143 patients were included in the study. For each 10-year increase in age, postoperative PDQ scores decreased (improved) by 9.7 points (p < 0.001). Patients with osteoporosis/osteopenia had significantly higher (worse) postoperative PDQ scores (+17.97, p = 0.028) than patients with metastatic lesions. Male sex was associated with higher (worse) postoperative PHQ-9 scores (+2.48, p = 0.010). Compared to single-level augmentation, operations at 2 levels were associated with significantly higher PHQ-9 scores (+2.58, p = 0.017). Current smokers had significantly lower PHQ-9 scores (−1.98, p = 0.023) than never smokers. No predictors were associated with significantly different EQ-5D score.

CONCLUSIONS

Variables associated with worse postoperative PDQ scores included younger age and osteoporosis/osteopenia. Variables associated with decreased (better) postoperative PHQ-9 scores included female sex, single operative vertebral level, and positive smoking status (i.e., current smoker). These clinically relevant predictors may permit identification of patients who may benefit from vertebral augmentation.

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Matthew D. Alvin, Jacob A. Miller, Daniel Lubelski, Benjamin P. Rosenbaum, Kalil G. Abdullah, Robert G. Whitmore, Edward C. Benzel and Thomas E. Mroz

Object

Cost-effectiveness research in spine surgery has been a prominent focus over the last decade. However, there has yet to be a standardized method developed for calculation of costs in such studies. This lack of a standardized costing methodology may lead to conflicting conclusions on the cost-effectiveness of an intervention for a specific diagnosis. The primary objective of this study was to systematically review all cost-effectiveness studies published on spine surgery and compare and contrast various costing methodologies used.

Methods

The authors performed a systematic review of the cost-effectiveness literature related to spine surgery. All cost-effectiveness analyses pertaining to spine surgery were identified using the cost-effectiveness analysis registry database of the Tufts Medical Center Institute for Clinical Research and Health Policy, and the MEDLINE database. Each article was reviewed to determine the study subject, methodology, and results. Data were collected from each study, including costs, interventions, cost calculation method, perspective of cost calculation, and definitions of direct and indirect costs if available.

Results

Thirty-seven cost-effectiveness studies on spine surgery were included in the present study. Twenty-seven (73%) of the studies involved the lumbar spine and the remaining 10 (27%) involved the cervical spine. Of the 37 studies, 13 (35%) used Medicare reimbursements, 12 (32%) used a case-costing database, 3 (8%) used cost-to-charge ratios (CCRs), 2 (5%) used a combination of Medicare reimbursements and CCRs, 3 (8%) used the United Kingdom National Health Service reimbursement system, 2 (5%) used a Dutch reimbursement system, 1 (3%) used the United Kingdom Department of Health data, and 1 (3%) used the Tricare Military Reimbursement system. Nineteen (51%) studies completed their cost analysis from the societal perspective, 11 (30%) from the hospital perspective, and 7 (19%) from the payer perspective. Of those studies with a societal perspective, 14 (38%) reported actual indirect costs.

Conclusions

Changes in cost have a direct impact on the value equation for concluding whether an intervention is cost-effective. It is essential to develop a standardized, accurate means of calculating costs. Comparability and transparency are essential, such that studies can be compared properly and policy makers can be appropriately informed when making decisions for our health care system based on the results of these studies.

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Dara Bakar, Joseph E. Tanenbaum, Kevin Phan, Vincent J. Alentado, Michael P. Steinmetz, Edward C. Benzel and Thomas E. Mroz

OBJECTIVE

The aim of this study was to systematically review the literature on reported outcomes following decompression surgery for spinal metastases.

METHODS

The authors conducted MEDLINE, Scopus, and Web of Science database searches for studies reporting clinical outcomes and complications associated with decompression surgery for metastatic spinal tumors. Both retrospective and prospective studies were included. After meeting inclusion criteria, articles were categorized based on the following reported outcomes: survival, ambulation, surgical technique, neurological function, primary tumor histology, and miscellaneous outcomes.

RESULTS

Of the 4148 articles retrieved from databases, 36 met inclusion criteria. Of those included, 8 were prospective studies and 28 were retrospective studies. The year of publication ranged from 1992 to 2015. Study size ranged from 21 to 711 patients. Three studies found that good preoperative Karnofsky Performance Status (KPS ≥ 80%) was a significant predictor of survival. No study reported a significant effect of time-to-surgery following the onset of spinal cord compression symptoms on survival. Three studies reported improvement in neurological function following surgery. The most commonly cited complication was wound infection or dehiscence (22 studies). Eight studies reported that preoperative ambulatory or preoperative motor status was a significant predictor of postoperative ambulatory status. A wide variety of surgical techniques were reported: posterior decompression and stabilization, posterior decompression without stabilization, and posterior decompression with total or subtotal tumor resection. Although a wide range of functional scales were used to assess neurological outcomes, four studies used the American Spinal Injury Association (ASIA) Impairment Scale to assess neurological function. Four studies reported the effects of radiation therapy and local disease control for spinal metastases. Two studies reported that the type of treatment was not significantly associated with the rate of local control. The most commonly reported primary tumor types included lung cancer, prostate cancer, breast cancer, renal cancer, and gastrointestinal cancer.

CONCLUSIONS

This study reports a systematic review of the literature on decompression surgery for spinal metastases. The results of this study can help educate surgeons on the previously published predictors of outcomes following decompression surgery for metastatic spinal disease. However, the authors also identify significant gaps in the literature and the need for future studies investigating the optimal practice with regard to decompression surgery for spinal metastases.

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Daniel Lubelski, Nilgun Senol, Michael P. Silverstein, Matthew D. Alvin, Edward C. Benzel, Thomas E. Mroz and Richard Schlenk

OBJECT

The authors investigated quality of life (QOL) outcomes after primary versus revision discectomy.

METHODS

A retrospective review was performed for all patients who had undergone a primary or revision discectomy at the Cleveland Clinic Center for Spine Health from January 2008 through December 2011. Among patients in the revision cohort, they identified those who needed a second revision discectomy. Patient QOL measures were recorded before and after surgery. These measures included responses to the EQ-5D health questionnaire, Patient Health Questionnaire–9, Pain and Disability Questionnaire, and quality-adjusted life years (QALYs). Cohorts were compared by using independent-sample t-tests and Fisher exact tests for continuous and categorical variables, respectively. Multivariable logistic regression was performed to adjust for confounding.

RESULTS

A total of 196 patients were identified (116 who underwent primary discectomy and 80 who underwent revision discectomy); average follow-up time was 150 days. There were no preoperative QOL differences between groups. Postoperatively, both groups improved significantly in all QOL measures. For QALYs, the primary cohort improved by 0.25 points (p < 0.001) and the revision cohort improved by 0.18 points (p < 0.001). QALYs improved for significantly more patients in the primary than in the revision cohort (76% vs 59%, respectively; p = 0.02), and improvement exceeded the minimum clinically important difference for more patients in the primary cohort (62% vs 45%, respectively; p = 0.03). Of the 80 patients who underwent revision discectomy, yet another recurrent herniation (third herniation) occurred in 14 (17.5%). Of these, 4 patients (28.6%) chose to undergo a second revision discectomy and the other 10 (71.4%) underwent conservative management. For those who underwent a second revision discectomy, QOL worsened according to all questionnaire scores.

CONCLUSIONS

QOL, pain and disability, and psychosocial outcomes improved after primary and revision discectomy, but the improvement diminished after revision discectomy.

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Lisa A. Ferrara, Illya Gordon, Madeline Coquillette, Ryan Milks, Aaron J. Fleischman, Shuvo Roy, Vijay K. Goel and Edward C. Benzel

Object

A preliminary in vitro biomechanical study was conducted to determine if the pressure at a bone graft–mortise interface and the load transmitted along a ventral cervical plate could be used as parameters to assess fusion status.

Methods

An interbody bone graft and a ventral plate were placed at the C3–4 motion segment in six fresh cadaveric goat spines. Polymethylmethacrylate (PMMA) was used to simulate early bone fusion at the bone graft site. The loads along the plate and the simultaneous pressures induced at the graft–endplate interfaces were monitored during simulated stages of bone healing. Each specimen was nondestructively tested in compression loading while the pressures and loads at the graft site were recorded continuously. Each specimen was tested under five conditions (Disc, Graft, Plate, PMMA, and Removal).

Results

The pressure at the interface of the bone graft and vertebral endplate did not change significantly with the addition of the ventral plate. The interface pressure and segmental stiffness did increase following PMMA augmentation of the bone graft (simulating an intermediate phase of bone fusion). The load transmitted along the ventral plate in compression increased after the addition of the bone graft, but decreased after PMMA augmentation. Thus, there was an increase in pressure at the graft–endplate interface and a decrease in load transferred along the ventral plate after the simulation of bone fusion. Upon removal of the ventral plate, the simulated fusion bore most of the axial load, thus explaining a further increase in graft site pressure.

Conclusions

These observations support the notions of load sharing and the redistribution of loads occurring during and after bone graft incorporation. In the clinical setting, these parameters may be useful in the assessment of fusion after spine surgery. Although feasibility has been demonstrated in this preliminary study, further research is needed.

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Mark N. Hadley

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Jacob A. Miller, Ehsan H. Balagamwala, Camille A. Berriochoa, Lilyana Angelov, John H. Suh, Edward C. Benzel, Alireza M. Mohammadi, Todd Emch, Anthony Magnelli, Andrew Godley, Peng Qi and Samuel T. Chao

OBJECTIVE

Spine stereotactic radiosurgery (SRS) is a safe and effective treatment for spinal metastases. However, it is unknown whether this highly conformal radiation technique is suitable at instrumented sites given the potential for microscopic disease seeding. The authors hypothesized that spinal decompression with instrumentation is not associated with increased local failure (LF) following SRS.

METHODS

A 2:1 propensity-matched retrospective cohort study of patients undergoing SRS for spinal metastasis was conducted. Patients with less than 1 month of radiographic follow-up were excluded. Each SRS treatment with spinal decompression and instrumentation was propensity matched to 2 controls without decompression or instrumentation on the basis of demographic, disease-related, dosimetric, and treatment-site characteristics. Standardized differences were used to assess for balance between matched cohorts.

The primary outcome was the 12-month cumulative incidence of LF, with death as a competing risk. Lesions demonstrating any in-field progression were considered LFs. Secondary outcomes of interest were post-SRS pain flare, vertebral compression fracture, instrumentation failure, and any Grade ≥ 3 toxicity. Cumulative incidences analysis was used to estimate LF in each cohort, which were compared via Gray’s test. Multivariate competing-risks regression was then used to adjust for prespecified covariates.

RESULTS

Of 650 candidates for the control group, 166 were propensity matched to 83 patients with instrumentation. Baseline characteristics were well balanced. The median prescription dose was 16 Gy in each cohort. The 12-month cumulative incidence of LF was not statistically significantly different between cohorts (22.8% [instrumentation] vs 15.8% [control], p = 0.25). After adjusting for the prespecified covariates in a multivariate competing-risks model, decompression with instrumentation did not contribute to a greater risk of LF (HR 1.21, 95% CI 0.74–1.98, p = 0.45). The incidences of post-SRS pain flare (11% vs 14%, p = 0.55), vertebral compression fracture (12% vs 22%, p = 0.04), and Grade ≥ 3 toxicity (1% vs 1%, p = 1.00) were not increased at instrumented sites. No instrumentation failures were observed.

CONCLUSIONS

In this propensity-matched analysis, LF and toxicity were similar among cohorts, suggesting that decompression with instrumentation does not significantly impact the efficacy or safety of spine SRS. Accordingly, spinal instrumentation may not be a contraindication to SRS. Future studies comparing SRS to conventional radiotherapy at instrumented sites in matched populations are warranted.

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Andrew T. Healy, Swetha J. Sundar, Raul J. Cardenas, Prasath Mageswaran, Edward C. Benzel, Thomas E. Mroz and Todd B. Francis

Object

Single-level anterior cervical discectomy and fusion (ACDF) is an established surgical treatment for cervical myelopathy. Within 10 years of undergoing ACDF, 19.2% of patients develop symptomatic adjacent-level degeneration. Performing ACDF adjacent to prior fusion requires exposure and removal of previously placed hardware, which may increase the risk of adverse outcomes. Zero-profile cervical implants combine an interbody spacer with an anterior plate into a single device that does not extend beyond the intervertebral disc space, potentially obviating the need to remove prior hardware. This study compared the biomechanical stability and adjacent-level range of motion (ROM) following placement of a zero-profile device (ZPD) adjacent to a single-level ACDF against a standard 2-level ACDF.

Methods

In this in vitro biomechanical cadaveric study, multidirectional flexibility testing was performed by a robotic spine system that simulates flexion-extension, lateral bending, and axial rotation by applying a continuous pure moment load. Testing conditions were as follows: 1) intact, 2) C5–6 ACDF, 3) C4–5 ZPD supraadjacent to simulated fusion at C5–6, and 4) 2-level ACDF (C4–6). The sequence of the latter 2 test conditions was randomized. An unconstrained pure moment of 1.5 Nm with a 40-N simulated head weight load was applied to the intact condition first in all 3 planes of motion and then using the hybrid test protocol, overall intact kinematics were replicated subsequently for each surgical test condition. Intersegmental rotations were measured optoelectronically. Mean segmental ROM for operated levels and adjacent levels was recorded and normalized to the intact condition and expressed as a percent change from intact. A repeated-measures ANOVA was used to analyze the ROM between test conditions with a 95% level of significance.

Results

No statistically significant differences in immediate construct stability were found between construct Patterns 3 and 4, in all planes of motion (p > 0.05). At the operated level, C4–5, the zero-profile construct showed greater decreases in axial rotation (–45% vs –36%) and lateral bending (–55% vs –38%), whereas the 2-level ACDF showed greater decreases in flexion-extension (–40% vs –34%). These differences were marginal and not statistically significant. Adjacent-level motion was nearly equivalent, with minor differences in flexion-extension.

Conclusions

When treating degeneration adjacent to a single-level ACDF, a zero-profile implant showed stabilizing potential at the operated level statistically similar to that of the standard revision with a 2-level plate. Revision for adjacent-level disease is common, and using a ZPD in this setting should be investigated clinically because it may be a faster, safer alternative.