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Marcel F. Dvorak, Michael G. Johnson, Michael Boyd, Garth Johnson, Brian K. Kwon and Charles G. Fisher

Object. The primary goal of this study was to describe the long-term health-related quality of life (HRQOL) outcomes in patients who have suffered Jefferson-type fractures. These outcomes were compared with matched normative HRQOL data and with the patient's perceptions of their HRQOL prior to the injury. Variables that potentially influence these HRQOL outcomes were analyzed.

No standardized outcome assessments have been published for patients who suffer these fractures; their outcomes have long thought to be excellent following treatment. Determining the optimal surrogate measure to represent preinjury HRQOL in trauma patients is difficult.

Methods. A retrospective review, radiographic analysis, and cross-sectional outcome assessment were performed. The Short Form (SF)—36 and the American Academy of Orthopaedic Surgeons/North American Spine Society (AAOS/NASS) outcome instruments were filled out by patients at final follow-up examination (follow-up period 75 months, range 19–198 months) to represent their current status as well as their perceptions of preinjury status.

In 34 patients, the SF-36 physical component score and the AAOS/NASS pain values were significantly lower than normative values. There was no significant difference between normative and preinjury values. Spence criteria greater than 7 mm and the presence of associated injuries predicted poorer outcome scores during the follow-up period.

Conclusions. Long-term follow-up examination of patients with Jefferson fractures indicated that patients' status does not return to the level of their perceived preinjury health status or that of normative population controls. Those with other injuries and significant osseous displacement (≥ 7 mm total) may experience poorer long-term outcomes. Limitations of the study included a relatively low (60%) response rate and the difficulties of identifying an appropriate baseline outcome in a trauma population with which the follow-up outcomes can be compared.

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Editorial

Measuring quality of life outcomes in spine clinical trials

Michael G. Fehlings and Anoushka Singh

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Andrea M. Simmonds, Y. Raja Rampersaud, Marcel F. Dvorak, Nicolas Dea, Angela D. Melnyk and Charles G. Fisher

OBJECT

A range of surgical options exists for the treatment of degenerative lumbar spondylolisthesis (DLS). The chosen technique inherently depends on the stability of the DLS. Despite a substantial body of literature dedicated to the outcome analysis of numerous DLS procedures, no consensus has been reached on defining or classifying the disorder with respect to stability or the role that instability should play in a treatment algorithm. The purpose of this study was to define grades of stability and to develop a guide for deciding on the optimal approach in surgically managing patients with DLS.

METHODS

The authors conducted a qualitative systematic review of clinical or biomechanical analyses evaluating the stability of and surgical outcomes for DLS for the period from 1990 to 2013. Research focused on nondegenerative forms of spondylolisthesis or spinal stenosis without associated DLS was excluded. The primary extracted results were clinical and radiographic parameters indicative of DLS instability.

RESULTS

The following preoperative parameters are predictors of stability in DLS: restabilization signs (disc height loss, osteophyte formation, vertebral endplate sclerosis, and ligament ossification), no disc angle change or less than 3 mm of translation on dynamic radiographs, and the absence of low-back pain. The validity and magnitude of each parameter’s contribution can only be determined through appropriately powered prospective evaluation in the future. Identifying these parameters has allowed for the creation of a preliminary DLS instability classification (DSIC) scheme based on the preoperative assessment of DLS stability.

CONCLUSIONS

Spinal stability is an important factor to consider in the evaluation and treatment of patients with DLS. Qualitative assessment of the best available evidence revealed clinical and radiographic parameters for the creation of the DSIC, a decision aid to help surgeons develop a method of preoperative evaluation to better stratify DLS treatment options.

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Rowan Schouten, Peter Lewkonia, Vanessa K. Noonan, Marcel F. Dvorak and Charles G. Fisher

OBJECT

The aim of this study was to define the expected functional and health-related quality of life outcomes following common thoracolumbar injuries on the basis of consensus expert opinion and the best available literature. Patient expectations are primarily determined by the information provided by health care professionals, and these expectations have been shown to influence outcome in various medical and surgical conditions. This paper presents Part 2 of a multiphase study designed to investigate the impact of patient expectations on outcomes following spinal injury. Part 1 demonstrated substantial variability in the information surgeons are communicating to patients. Defining the expected outcomes following thoracolumbar injury would allow further analysis of this relationship and enable surgeons to more accurately and consistently inform patients.

METHODS

Expert opinion was assembled by distributing questionnaires comprising 4 cases representative of common thoracolumbar injuries to members of the Spine Trauma Study Group (STSG). The 4 cases included a thoracolumbar junction burst fracture treated nonoperatively or with posterior transpedicular instrumentation, a low lumbar (L-4) burst fracture treated nonoperatively, and a thoracolumbar junction flexion-distraction injury managed with posterior fusion. For each case, 5 questions about expected outcomes were posed. The questions related to the proportion of patients who are pain free, the proportion who have regained full range of motion, and the patients' recreational activity restrictions and personal care and social life limitations, all at 1 year following injury, as well as the timing of return to work and length of hospital stay. Responses were analyzed and combined with the results of a systematic literature review on the same injuries to define the expected outcomes.

RESULTS

The literature review identified 38 appropriate studies that met the preset inclusion criteria. Published data were available for all injuries, but not all outcomes were available for each type of injury. The survey was completed by 31 (57%) of 53 surgeons representing 24 trauma centers across North America (15), Europe (5), India (1), Mexico (1), Japan (1) and Israel (1). Consensus expert opinion supplemented the available literature and was used exclusively when published data were lacking.

For example, 1 year following cast or brace treatment of a thoracolumbar burst fracture, the expected outcomes include a 40% chance of being pain free, a 70% chance of regaining pre-injury range of motion, and an expected ability to participate in high-impact exercise and contact sport with no or minimal limitation. Consensus expert opinion predicts reemployment within 4–6 months. The length of inpatient stay averages 4–5 days.

CONCLUSIONS

This synthesis of the best available literature and consensus opinion of surgeons with extensive clinical experience in spine trauma reflects the optimal methodology for determining functional prognosis after thoracolumbar trauma. By providing consistent, accurate information surgeons will help patients develop realistic expectations and potentially optimize outcomes.

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Y. Raja Rampersaud, Paul A. Anderson, John R. Dimar II, Charles G. Fisher and on behalf of the Spine Trauma Study Group and Degenerative Spine Study Group

OBJECTIVE

Reporting of adverse events (AEs) in spinal surgery uses inconsistent definitions and severity grading, making it difficult to compare results between studies. The Spinal Adverse Events Severity System, version 2 (SAVES-V2) aims to standardize the classification of spine surgery AEs; however, its inter- and intraobserver reliability are unknown. The objective of this study was to assess inter- and intraobserver reliability of the SAVES-V2 grading system for assessing AEs in spinal surgery.

METHODS

Two multinational, multicenter surgical study groups assessed surgical case vignettes (10 trauma and 12 degenerative cases) for AE occurrence by using SAVES-V2. Thirty-four members of the Spine Trauma Study Group (STSG) and 17 members of the Degenerative Spine Study Group (DSSG) participated in the first round of case vignettes. Six months later, the same case vignettes were randomly reorganized and presented in an otherwise identical manner. Inter- and intraobserver agreement on the presence, severity, number, and type of AE, as well as the impact of the AE on length of stay (LOS) were assessed using intraclass correlation (ICC), Cohen's kappa value, and the percentage of participants in agreement.

RESULTS

Agreement on the presence of AEs ranged from 97% to 100% in the 2 groups. Severity classification showed substantial interobserver (ICC = 0.75 for both groups) and intraobserver (ICC = 0.70 in DSSG, 0.71 in STSG) agreement. Judgments on the number of AEs showed high interobserver agreement and moderate intraobserver agreement in both groups. Both the STSG and DSSG had high intraobserver agreement on the type of AE; interobserver agreement for AE type was high in the STSG and fair in the DSSG. Agreement on impact of the AE on LOS was excellent in the DSSG and fair in the STSG.

CONCLUSIONS

There was good agreement on the presence, severity, and number of AEs in both trauma and degenerative cases in using the SAVES-V2. This grading system is a simple, reliable tool for identifying and capturing AEs in spinal surgery.

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Daniel M. Sciubba, Rory J. Petteys, Mark B. Dekutoski, Charles G. Fisher, Michael G. Fehlings, Stephen L. Ondra, Laurence D. Rhines and Ziya L. Gokaslan

With continued growth of the elderly population and improvements in cancer therapies, the number of patients with symptomatic spinal metastases is likely to increase, and this is a condition that commonly leads to debilitating neurological dysfunction and pain. Advancements in surgical techniques of resection and spinal reconstruction, improvements in clinical outcomes following various treatment modalities, generally increased overall survival in patients with metastatic spine disease, and a recent randomized trial by Patchell and colleagues demonstrating the superiority of a combined surgical/radiotherapeutic approach over a radiotherapy-only strategy have led many to suggest increasingly aggressive interventions for patients with such lesions. Optimal management of spinal metastases encompasses numerous medical specialties, including neurosurgery, orthopedic surgery, medical and radiation oncology, radiology, and rehabilitation medicine. In this review, the clinical presentation, diagnosis, and management of spinal metastatic disease are discussed. Ultimately, the goal of treatment in patients with spinal metastases remains palliative, and clinical judgment is required to select the appropriate patients for surgical intervention.

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John T. Street, R. Andrew Glennie, Nicolas Dea, Christian DiPaola, Zhi Wang, Michael Boyd, Scott J. Paquette, Brian K. Kwon, Marcel F. Dvorak and Charles G. Fisher

OBJECTIVE

The objective of this study was to determine if there is a significant difference in surgical site infection (SSI) when comparing the Wiltse and midline approaches for posterior instrumented interbody fusions of the lumbar spine and, secondarily, to evaluate if the reoperation rates and specific causes for reoperation were similar for both approaches.

METHODS

A total of 358 patients who underwent 1- or 2-level posterior instrumented interbody fusions for degenerative lumbar spinal pathology through either a midline or Wiltse approach were prospectively followed between March 2005 and January 2011 at a single tertiary care facility. A retrospective analysis was performed primarily to evaluate the incidence of SSI and the incidence and causes for reoperation. Secondary outcome measures included intraoperative complications, blood loss, and length of stay. A matched analysis was performed using the Fisher's exact test and a logistic regression model. The matched analysis controlled for age, sex, comorbidities, number of index levels addressed surgically, number of levels fused, and the use of bone grafting.

RESULTS

All patients returned for follow-up at 1 year, and adverse events were followed for 2 years. The rate of SSI was greater in the midline group (8 of 103 patients; 7.8%) versus the Wiltse group (1 of 103 patients; 1.0%) (p = 0.018). Fewer additional surgical procedures were performed in the Wiltse group (p = 0.025; OR 0.47; 95% CI 0.23–0.95). Proximal adjacent segment failure requiring reoperation occurred more frequently in the midline group (15 of 103 patients; 14.6%) versus the Wiltse group (6 of 103 patients; 5.8%) (p = 0.048). Blood loss was significantly lower in the Wiltse group (436 ml) versus the midline group (703 ml); however, there was no significant difference between the 2 groups in intraoperative complications or length of stay.

CONCLUSIONS

The patients who underwent the Wiltse approach had a decreased risk of wound breakdown and infection, less blood loss, and fewer reoperations than the midline patients. The risk of adjacent segment failure in short posterior constructs is lower with a Wiltse approach.

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C. Rory Goodwin, Eric W. Sankey, Ann Liu, Benjamin D. Elder, Thomas Kosztowski, Sheng-Fu L. Lo, Charles G. Fisher, Michelle J. Clarke, Ziya L. Gokaslan and Daniel M. Sciubba

OBJECT

Surgical procedures and/or adjuvant therapies are effective modalities for the treatment of symptomatic spinal metastases. However, clinical results specific to the skin cancer spinal metastasis cohort are generally lacking. The purpose of this study was to systematically review the literature for treatments, clinical outcomes, and survival following the diagnosis of a skin cancer spinal metastasis and evaluate prognostic factors in the context of spinal skin cancer metastases stratified by tumor subtype.

METHODS

The authors performed a literature review using PubMed, Embase, CINAHL, and Web of Science to identify articles since 1950 that reported survival, clinical outcomes, and/or prognostic factors for the skin cancer patient population with spinal metastases. The methodological quality of reviews was assessed using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) tool.

RESULTS

Sixty-five studies met the preset criteria and were included in the analysis. Of these studies, a total of 25, 40, 25, and 12 studies included patients who underwent some form of surgery, radiotherapy, chemotherapy, or observation alone, respectively. Sixty-three of the 65 included studies were retrospective in nature (Class of Evidence [CoE] IV), and the 2 prospective studies were CoE II. Based on the studies analyzed, the median overall survival for a patient with a spinal metastasis from a primary skin malignancy is 4.0 months; survival by tumor subtype is 12.5 months for patients with basal cell carcinoma (BCC), 4.0 months for those with melanoma, 4.0 months for those with squamous cell carcinoma, 3.0 months for those with pilomatrix carcinoma, and 1.5 months for those with Merkel cell carcinoma (p < 0.0001). The overall percentage of known continued disease progression after spine metastasis diagnosis was 40.1% (n = 244/608, range 25.0%–88.9%), the rate of known recurrence of the primary skin cancer lesion was 3.5% (n = 21/608, range 0.2%–100.0%), and the rate of known spine metastasis recurrence despite treatment for all skin malignancies was 2.8% (n = 17/608, range 0.0%–33.3%). Age greater than 65 years, sacral spinal involvement, presence of a neurological deficit, and nonambulatory status were associated with decreased survival in patients diagnosed with a primary skin cancer spinal metastasis. All other clinical or prognostic parameters were of low or insufficient strength.

CONCLUSIONS

Patients diagnosed with a primary skin cancer metastasis to the spine have poor overall survival with the exception of those with BCC. The median duration of survival for patients who received surgical intervention alone, medical management (chemotherapy and/or radiation) alone, or the combination of therapies was similar across interventions. Age, spinal region, and neurological status may be associated with poor survival following surgery.

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Tony Goldschlager, Nicolas Dea, Michael Boyd, Jeremy Reynolds, Shreyaskumar Patel, Laurence D. Rhines, Ehud Mendel, Marina Pacheco, Edwin Ramos, Tobias A. Mattei and Charles G. Fisher

OBJECT

Giant cell tumors (GCTs) of the spine are rare and complex to treat. They have a propensity for local recurrence and the potential to metastasize. Treatment is currently surgical and presents unique challenges due to the proximity of neural structures and the need for reconstruction. Denosumab has been shown in clinical trials to be an effective treatment for GCT, but has not yet been studied specifically in GCT of the spine or as a surgical adjunct. To the authors' knowledge this is the first such reported series.

METHODS

A multicenter, prospective series of 5 patients with GCT of the spine treated with denosumab were included. Patient demographic data, oncological history, neurological status, tumor staging, treatment details and adverse events, surgical procedure, complications, radiological and histological responses, and patient outcome were analyzed.

RESULTS

All patients were women, with a mean age of 38 years, and presented with pain; 2 patients had additional neurological signs and symptoms. The mean duration of symptoms was 62 weeks. No patient had a prior tumor or metastatic disease at presentation. All patients had Enneking Stage III tumors and were treated with monthly cycles of 120 mg of denosumab, with initial additional loading doses on Days 8 and 15. Patients were given daily supplements of calcium (500 mg) and vitamin D (400 IU). There were no denosumab-related adverse events. All patients had a radiological response to denosumab. One patient failed to have a histological response to denosumab, with > 90% of tumor cells found to be viable on histological investigation.

CONCLUSIONS

This study reports the early experience of using denosumab in the treatment of spinal GCT. The results demonstrate a clinically beneficial radiological response and an impressive histological response in most but not all patients. Further experience with denosumab and longer patient follow-up is required. Denosumab has the potential to change the treatment paradigm for spinal GCT.