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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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Jennifer C. Urquhart, Osama A. Alrehaili, Charles G. Fisher, Alyssa Fleming, Parham Rasoulinejad, Kevin Gurr, Stewart I. Bailey, Fawaz Siddiqi and Christopher S. Bailey

OBJECTIVE

A multicenter, prospective, randomized equivalence trial comparing a thoracolumbosacral orthosis (TLSO) to no orthosis (NO) in the treatment of acute AO Type A3 thoracolumbar burst fractures was recently conducted and demonstrated that the two treatments following an otherwise similar management protocol are equivalent at 3 months postinjury. The purpose of the present study was to determine whether there was a difference in long-term clinical and radiographic outcomes between the patients treated with and those treated without a TLSO. Here, the authors present the 5- to 10-year outcomes (mean follow-up 7.9 ± 1.1 years) of the patients at a single site from the original multicenter trial.

METHODS

Between July 2002 and January 2009, a total of 96 subjects were enrolled in the primary trial and randomized to two groups: TLSO or NO. Subjects were enrolled if they had an AO Type A3 burst fracture between T-10 and L-3 within the previous 72 hours, kyphotic deformity < 35°, no neurological deficit, and an age of 16–60 years old. The present study represents a subset of those patients: 16 in the TLSO group and 20 in the NO group. The primary outcome measure was the Roland Morris Disability Questionnaire (RMDQ) score at the last 5- to 10-year follow-up. Secondary outcome measures included kyphosis, satisfaction, the Numeric Rating Scale for back pain, and the 12-Item Short-Form Health Survey (SF-12) Mental and Physical Component Summary (MCS and PCS) scores. In the original study, outcome measures were administered at admission and 2 and 6 weeks, 3 and 6 months, and 1 and 2 years after injury; in the present extended follow-up study, the outcome measures were administered 5–10 years postinjury. Treatment comparison between patients in the TLSO group and those in the NO group was performed at the latest available follow-up, and the time-weighted average treatment effect was determined using a mixed-effects model of longitudinal regression for repeated measures averaged over all time periods. Missing data were assumed to be missing at random and were replaced with a set of plausible values derived using a multiple imputation procedure.

RESULTS

The RMDQ score at 5–10 years postinjury was 3.6 ± 0.9 (mean ± SE) for the TLSO group and 4.8 ± 1.5 for the NO group (p = 0.486, 95% CI −2.3 to 4.8). Average kyphosis was 18.3° ± 2.2° for the TLSO group and 18.6° ± 3.8° for the NO group (p = 0.934, 95% CI −7.8 to 8.5). No differences were found between the NO and TLSO groups with time-weighted average treatment effects for RMDQ 1.9 (95% CI −1.5 to 5.2), for PCS −2.5 (95% CI −7.9 to 3.0), for MCS −1.2 (95% CI −6.7 to 4.2) and for average pain 0.9 (95% CI −0.5 to 2.2).

CONCLUSIONS

Compared with patients treated with a TLSO, patients treated using early mobilization without orthosis maintain similar pain relief and improvement in function for 5–10 years.

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Khalid M. I. Salem, Aditya P. Eranki, Scott Paquette, Michael Boyd, John Street, Brian K. Kwon, Charles G. Fisher and Marcel F. Dvorak

OBJECTIVE

The study aimed to determine if the intraoperative segmental lordosis (as calculated on a cross-table lateral radiograph following a single-level transforaminal lumbar interbody fusion [TLIF] for degenerative spondylolisthesis/low-grade isthmic spondylolisthesis) is maintained at discharge and at 6 months postsurgery.

METHODS

The authors reviewed images and medical records of patients ≥ 16 years of age with a diagnosis of an isolated single-level, low-grade spondylolisthesis (degenerative or isthmic) with symptomatic spinal stenosis treated between January 2008 and April 2014. Age, sex, surgical level, surgical approach, and facetectomy (unilateral vs bilateral) were recorded. Upright standardized preoperative, early, and 6-month postoperative radiographs, as well as intraoperative lateral radiographs, were analyzed for the pelvic incidence, segmental lumbar lordosis (SLL) at the TILF level, and total LL (TLL). In addition, the anteroposterior position of the cage in the disc space was documented. Data are presented as the mean ± SD; a p value < 0.05 was considered significant.

RESULTS

Eighty-four patients were included in the study. The mean age of patients was 56.8 ± 13.7 years, and 46 patients (55%) were men. The mean pelvic incidence was 59.7° ± 11.9°, and a posterior midline approach was used in 47 cases (56%). All TLIF procedures were single level using a bullet-shaped cage. A bilateral facetectomy was performed in 17 patients (20.2%), and 89.3% of procedures were done at the L4–5 and L5–S1 segments. SLL significantly improved intraoperatively from 15.8° ± 7.5° to 20.9° ± 7.7°, but the correction was lost after ambulation. Compared with preoperative values, at 6 months the change in SLL was modest at 1.8° ± 6.7° (p = 0.025), whereas TLL increased by 4.3° ± 9.6° (p < 0.001). The anteroposterior position of the cage, approach, level of surgery, and use of a bilateral facetectomy did not significantly affect postoperative LL.

CONCLUSIONS

Following a single-level TLIF procedure using a bullet-shaped cage, the intraoperative improvement in SLL is largely lost after ambulation. The improvement in TLL over time is probably due to the decompression part of the procedure. The approach, level of surgery, bilateral facetectomy, and position of the cage do not seem to have a significant effect on LL achieved postoperatively.

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Ibrahim Hussain, Ori Barzilai, Anne S. Reiner, Lily McLaughlin, Natalie M. DiStefano, Shahiba Ogilvie, Anne L. Versteeg, Charles G. Fisher, Mark H. Bilsky and Ilya Laufer

OBJECTIVE

The Spinal Instability Neoplastic Score (SINS) correlates with preoperative disability and response to stabilization, with patients with higher scores experiencing greater relief after surgery. However, there is a paucity of data demonstrating the extent to which each component contributes to preoperative clinical status and response to stabilization surgery. The objectives of this study were 2-fold. First, to determine how SINS components correlate with pre- and postoperative patient-reported outcomes (PROs). Second, to determine whether patients with higher SINS (10–12) in the “indeterminate” group respond differently to surgery compared to patients with lower SINS (7–9).

METHODS

SINS and PROs were prospectively collected in 131 patients undergoing stabilization surgery for metastatic spinal disease. Association of SINS components and their individual scores with preoperative symptom burden and PRO symptom change after surgery was analyzed using the Spearman rank correlation coefficient (rho) and the Kruskal-Wallis test. SINS and association with preoperative PRO scores and mean differences in post- and preoperative PRO scores were compared for 2 SINS categories within the indeterminate group (7–9 vs 10–12) using the Wilcoxon 2-sample test and Wilcoxon signed-rank test.

RESULTS

The presence of mechanical pain, followed by metastatic location, correlated most strongly with preoperative functional disability measures and lower disability PRO scores following surgical stabilization. Blastic rather than lytic bone lesions demonstrated stronger association with pain reduction following stabilization. Following surgery, patients with SINS 10–12 demonstrated markedly greater improvement in pain and disability PRO scores nearly across the board compared to patients with SINS 7–9.

CONCLUSIONS

The presence of mechanical pain has the strongest correlation with preoperative disability and improvement in pain and disability PRO scores after surgery. Radiographic components of SINS also correlate with preoperative symptom severity and postoperative PRO, supporting their utilization in evaluation of spinal instability. Among patients with indeterminate SINS, patients with higher scores experience greater reduction in pain and disability PRO scores following surgical stabilization, suggesting that the indeterminate-SINS group includes distinct populations.