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Joel A. Finkelstein and Carolyn E. Schwartz

The purpose of this article is to review the current state of outcome measurement in spine surgery, with an emphasis on patient-reported outcome measures (PROMs). The commonly used generic and disease-specific outcome measures used in spinal surgery and research will be discussed. The authors will introduce the concepts of response shift and appraisal processes, which may affect the face validity of PROMs, as well as their interpretation over time. It is not uncommon for there to be a discrepancy between the observed and expected outcome, which is not wholly explainable by objective measures. Current work on understanding how appraisal affects outcome measurement will be discussed, and future directions will be suggested to facilitate the continued evolution of PROMs.

There has been an evolution in the way clinicians measure outcomes following spinal surgery. In moving from purely physical, objective measures to a growing emphasis on the patient’s perspective, spine surgery outcomes are better able to integrate the impact at multiple levels of relevant change. Appraisal concepts and methods are gaining traction as ways to understand the cognitive processes underlying PROMs over time. Measurement of appraisal is a valuable adjunct to the current spine outcome tools.

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Zachary Tan, Stewart McLachlin, Cari Whyne, and Joel Finkelstein

OBJECTIVE

The cortical bone trajectory (CBT) technique for pedicle screw placement has gained popularity among spinal surgeons. It has been shown biomechanically to provide better fixation and improved pullout strength compared to a traditional pedicle screw trajectory. The CBT technique also allows for a less invasive approach for fusion and may have lower incidence of adjacent-level disease. A limitation of the current CBT technique is a lack of readily identifiable and reproducible visual landmarks to guide freehand CBT screw placement in comparison to the well-defined identifiable landmarks for traditional pedicle screw insertion. The goal of this study was to validate a safe and intuitive freehand technique for placement of CBT screws based on optimization of virtual CBT screw placement using anatomical landmarks in the lumbar spine. The authors hypothesized that virtual identification of anatomical landmarks on 3D models of the lumbar spine generated from CT scans would translate to a safe intraoperative freehand technique.

METHODS

Customized, open-source medical imaging and visualization software (3D Slicer) was used in this study to develop a workflow for virtual simulation of lumbar CBT screw insertion. First, in an ex vivo study, 20 anonymous CT image series of normal and degenerative lumbar spines and virtual screw insertion were conducted to place CBT screws bilaterally in the L1–5 vertebrae for each image volume. The optimal safe CBT trajectory was created by maximizing both the screw length and the cortical bone contact with the screw. Easily identifiable anatomical surface landmarks for the start point and trajectory that best allowed the reproducible idealized screw position were determined. An in vivo validation of the determined landmarks from the ex vivo study was then performed in 10 patients. Placement of virtual “test” cortical bone trajectory screws was simulated with the surgeon blinded to the real-time image-guided navigation, and the placement was evaluated. The surgeon then placed the definitive screw using image guidance.

RESULTS

From the ex vivo study, the optimized technique and landmarks were similar in the L1–4 vertebrae, whereas the L5 optimized technique was distinct. The in vivo validation yielded ideal, safe, and unsafe screws in 62%, 16%, and 22% of cases, respectively. A common reason for the nonidealized trajectories was the obscuration of patient anatomy secondary to severe degenerative changes.

CONCLUSIONS

CBT screws were placed ideally or safely 78% of the time in a virtual simulation model. A 22% rate of unsafe freehand trajectories suggests that the CBT technique requires use of image-guided navigation or x-ray guidance and that reliable freehand CBT screw insertion based on anatomical landmarks is not reliably feasible in the lumbar spine.

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Joel A. Finkelstein, Roland B. Stark, James Lee, and Carolyn E. Schwartz

OBJECTIVE

There is an increasing recognition of the importance of predictive analytics in spine surgery. This, along with the addition of personalized treatment, can optimize treatment outcomes. The goal of this study was to examine the value of clinical, demographic, expectation, and cognitive appraisal variables in predicting outcomes after surgery.

METHODS

This prospective longitudinal cohort study followed adult patients undergoing spinal decompression and/or fusion surgery for degenerative spinal conditions. The authors focused on predicting the numeric rating scale (NRS) for pain, based on past research finding it to be the most responsive of the spine patient-reported outcomes. Clinical data included type of surgery, adverse events, comorbidities, and use of pain medications. Demographics included age, sex, employment status, education, and smoking status. Data on expectations related to pain relief, ability to do household and exercise/recreational activities without pain, preventing future disability, and sleeping comfort. Appraisal items addressed 22 cognitive processes related to quality of life (QOL). LASSO (least absolute shrinkage and selection operator) and bootstrapping tested predictors hierarchically to determine effective predictive subsets at approximately 10 months postsurgery, based on data either at baseline (model 1) or at approximately 3 months (model 2).

RESULTS

The sample included 122 patients (mean age 61 years, with 53% being female). For model 1, analysis revealed better outcomes with patients expecting to be able to exercise or do recreational activities, focusing on recent events, and not focusing on how others see them (mean bootstrapped R2 [R2 boot] = 0.12). For model 2, better outcomes were predicted by expecting symptom relief, focusing on the positive and on one’s spinal condition (mean R2 boot = 0.38). Bootstrapped analyses documented the stability of parameter estimates despite the small sample.

CONCLUSIONS

Nearly 40% of the variance in spine outcomes was accounted for by cognitive factors, after adjusting for clinical and demographic factors. Different expectations and appraisal processes played a role in long- versus short-range predictions, suggesting that cognitive adaptation is important and relevant to pain relief outcomes after spine surgery. These results underscore the importance of addressing how people think about QOL and surgery outcomes to maximize the benefits of surgery.

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Miriam Kim, Paul Nolan, and Joel A. Finkelstein

Object. The 11th rib extrapleural—retroperitoneal approach offers an alternative means for access to the thoracolumbar junction. It provides excellent operative exposure without the need to transgress the diaphragm, resulting in less morbidity and reduced risk of pulmonary complications. This approach, however, has been dismissed by many surgeons offering the unsubstantiated criticism that it affords limited access. Thus far, only technical descriptions of the operative procedure are available in the literature, without documentation of the clinical outcomes of these patients.

In the current study the authors describe the 11th rib extrapleural—retroperitoneal approach to the thoracolumbar junction, and they evaluate the associated early and late morbidity in these patients.

Methods. From September 1996 to August 1999, the authors collected prospective data of consecutive patients who underwent surgery for a variety of pathological conditions of the thoracolumbar junction via this approach. In 26 consecutive patients requiring an anterior spinal procedure, lesions located between T-10 and T-11 were studied and followed for a mean period of 17 months (range 1–36 months). There were 13 men and 13 women whose mean age was 47 years (range 16–80 years), with the following pathological entities: trauma (13 cases), neoplasm (six cases), infection (two cases), and deformity (five cases). There were no cases of neurological deterioration. There were no significant pulmonary complications, and only one patient required insertion of a postoperative chest tube.

Conclusions. The 11th rib extrapleural—retroperitoneal approach was successfully used to treat patients with a variety of lesions in the thoracolumbar junction and was associated with little morbidity. The authors believe that previous criticism suggesting that this approach provides only limited access is unsubstantiated.

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Payam Mousavi, Sandra Roth, Joel Finkelstein, Gordon Cheung, and Cari Whyne

Object

The goal of this study was to quantify volumetrically cement fill and leakage in patients with osteoporotic and metastatic vertebral lesions undergoing percutaneous vertebroplasty and to establish whether these factors have any clinical significance at follow up.

Methods

Digital computerized tomography data were retrospectively collected from all cases at the authors' institution in which percutaneous vertebroplasty was performed for osteoporosis or metastatic disease. Patient selection was based on the consensus of a multidisciplinary team consisting of an orthopedic surgeon, an oncologist, and a neuroradiologist. A semiautomated thresholding technique was used to measure vertebral body volume, the volume of cement injected directly into the vertebra, and the volume of cement leakage. Pain-related scores were collected at four early stages of treatment, and all clinical complications were recorded.

Cement leakage was found in 87.9% of vertebrae treated with percutaneous vertebroplasty. In osteoporotic vertebrae it occurred mainly in the disc, whereas in metastatic lesions, it was found in multiple areas. Irrespective of leakage, both patients with osteoporotic and metastatic disease experienced significant immediate pain relief postoperatively.

Conclusions

Although there was no correlation between cement fill or cement leakage and pain relief, there exists a risk of serious complications due to cement leakage.

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Carolyn E. Schwartz, Roland B. Stark, Phumeena Balasuberamaniam, Mopina Shrikumar, Abeer Wasim, and Joel A. Finkelstein

OBJECTIVE

Over the past 2 decades, spine outcome research has become more standardized in response to recommendations from Deyo and others. By using the same generic and condition-specific patient-reported outcome (PRO) measures across studies, results are more easily compared. Given the challenges of maintaining high-quality data in clinical research studies, it would be important to evaluate the contribution of each PRO to confirm that it merits the respondent burden. This study aimed to examine the spine PROs’ association with clinically important change and relative responsiveness in explaining variance in patients’ global assessment of change (GAC).

METHODS

This prospective longitudinal cohort study included adults recruited from 4 active spine surgery practices at a Toronto-based hospital. Patients were diagnosed with a degenerative lumbar spinal condition and underwent spinal decompression and/or fusion surgery. Participants completed the RAND-36 (to generate the physical component score [PCS] and mental component score [MCS]), Oswestry Disability Index (ODI), the numeric rating scale (NRS) for pain, Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference, and a GAC item. Random-effects models were used to investigate the sensitivity of PROs to the GAC and their responsiveness over time (i.e., PRO main effects and PRO-by-time interactions, respectively).

RESULTS

The study sample included 168 patients (mean age 61 years, 50% female) with preoperative and up to 12 months of postoperative data. Random-effects models revealed significant main effects for all PROs. Significant time-by-PRO interactions were detected for the PCS, PROMIS, ODI, and NRS (p < 0.0005 in all cases), but not for the MCS. Further examination revealed different sensitivity of the PROs to the GAC at different times. The NRS, PROMIS, and PCS showed higher sensitivity early after surgery, and the PCS evinced a marked drop in sensitivity to the GAC at about 8 months postsurgery.

CONCLUSIONS

All PROs currently included in the spine outcome core measures are associated with patients’ subjective assessment of a clinically important change, and all but the MCS scores are responsive to such change. Based on these findings, the core spine PROs could be reduced to include fewer estimates of pain. The authors suggest replacing the less responsive measures with tools that help to characterize factors that are driving the patients’ subjective assessment of change and that meaningfully address some of the higher levels in the hierarchy of quality-of-life outcomes.

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Oliver G. S. Ayling, Raphaele Charest-Morin, Matthew E. Eagles, Tamir Ailon, John T. Street, Nicolas Dea, Greg McIntosh, Sean D. Christie, Edward Abraham, W. Bradley Jacobs, Christopher S. Bailey, Michael G. Johnson, Najmedden Attabib, Peter Jarzem, Michael Weber, Jerome Paquet, Joel Finkelstein, Alexandra Stratton, Hamilton Hall, Neil Manson, Y. Raja Rampersaud, Kenneth Thomas, and Charles G. Fisher

OBJECTIVE

Previous works investigating rates of adverse events (AEs) in spine surgery have been retrospective, with data collection from administrative databases, and often from single centers. To date, there have been no prospective reports capturing AEs in spine surgery on a national level, with comparison among centers.

METHODS

The Spine Adverse Events Severity system was used to define the incidence and severity of AEs after spine surgery by using data from the Canadian Spine Outcomes and Research Network (CSORN) prospective registry. Patient data were collected prospectively and during hospital admission for those undergoing elective spine surgery for degenerative conditions. The Spine Adverse Events Severity system defined minor and major AEs as grades 1–2 and 3–6, respectively.

RESULTS

There were 3533 patients enrolled in this cohort. There were 85 (2.4%) individual patients with at least one major AE and 680 (19.2%) individual patients with at least one minor AE. There were 25 individual patients with 28 major intraoperative AEs and 260 patients with 275 minor intraoperative AEs. Postoperatively there were 61 patients with a total of 80 major AEs. Of the 487 patients with minor AEs postoperatively there were 698 total AEs. The average enrollment was 321 patients (range 47–1237 patients) per site. The rate of major AEs was consistent among sites (mean 2.9% ± 2.4%, range 0%–9.1%). However, the rate of minor AEs varied widely among sites—from 7.9% to 42.5%, with a mean of 18.8% ± 9.7%. The rate of minor AEs varied depending on how they were reported, with surgeon reporting associated with the lowest rates (p < 0.01).

CONCLUSIONS

The rate of major AEs after lumbar spine surgery is consistent among different sites but the rate of minor AEs appears to vary substantially. The method by which AEs are reported impacts the rate of minor AEs. These data have implications for the detection and reporting of AEs and the design of strategies aimed at mitigating complications.

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Oliver G. S. Ayling, Y. Raja Rampersaud, Charlotte Dandurand, Po Hsiang (Shawn) Yuan, Tamir Ailon, Nicolas Dea, Greg McIntosh, Sean D. Christie, Edward Abraham, Christopher S. Bailey, Michael G. Johnson, Jacques Bouchard, Michael H. Weber, Jerome Paquet, Joel Finkelstein, Alexandra Stratton, Hamilton Hall, Neil Manson, Kenneth Thomas, and Charles G. Fisher

OBJECTIVE

Treatment of degenerative lumbar diseases has been shown to be clinically effective with open transforaminal lumbar interbody fusion (O-TLIF) or minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF). Despite this, a substantial proportion of patients do not meet minimal clinically important differences (MCIDs) in patient-reported outcomes (PROs). The objectives of this study were to compare the proportions of patients who did not meet MCIDs after O-TLIF and MIS-TLIF and to determine potential clinical factors associated with failure to achieve MCID.

METHODS

The authors performed a retrospective analysis of consecutive patients who underwent O-TLIF or MIS-TLIF for lumbar degenerative disorders and had been prospectively enrolled in the Canadian Spine Outcomes and Research Network. The authors analyzed the Oswestry Disability Index (ODI) scores, physical and mental component summary scores of SF-12, numeric rating scale (NRS) scores for leg and back pain, and EQ-5D scores of the patients in each group who did not meet the MCID of ODI at 2 years postoperatively.

RESULTS

In this study, 38.8% (137 of 353) of patients in the O-TLIF cohort and 41.8% (51 of 122) of patients in the MIS-TLIF cohort did not meet the MCID of ODI at 2 years postoperatively (p = 0.59). Demographic variables and baseline PROs were similar between groups. There were improvements across the PROs of both groups through 2 years, and there were no differences in any PROs between the O-TLIF and MIS-TLIF cohorts. Multivariable logistic regression analysis demonstrated that higher baseline leg pain score (p = 0.017) and a diagnosis of spondylolisthesis (p = 0.0053) or degenerative disc disease (p = 0.022) were associated with achieving the MCID at 2 years after O-TLIF, whereas higher baseline leg pain score was associated with reaching the MCID after MIS-TLIF (p = 0.038).

CONCLUSIONS

Similar proportions of patients failed to reach the MCID of ODI at 2 years after O-TLIF or MIS-TLIF. Higher baseline leg pain score was predictive of achieving the MCID in both cohorts, whereas a diagnosis of spondylolisthesis or degenerative disc disease was predictive of reaching the MCID after O-TLIF. These data provide novel insights for patient counseling and suggest that either MIS-TLIF or O-TLIF does not overcome specific patient factors to mitigate clinical success or failure in terms of the intermediate-term PROs associated with 1- to 2-level lumbar fusion surgical procedures for degenerative pathologies.