Prospective, Randomized, Blinded Clinical Trial Comparing PEEK and Allograft Spacers in Patients Undergoing Anterior Cervical Discectomy and Fusion Surgeries.

STUDY DESIGN: Prospective, randomized, blinded clinical trial. OBJECTIVE: To examine clinical and radiological outcomes in patients undergoing anterior cervical discectomy and fusion (ACDF) surgeries randomized to receive either polyether-ether-ketone (PEEK) or structural bone allografts. SUMMARY OF BACKGROUND DATA: The biomechanical qualities as well as osteoconductive, osteogenic, and osteoinductive properties of various graft materials have been previously evaluated. There remain questions, however, as to whether there are any clinical and/or radiographic outcome differences in the selection of interbody graft types for ACDF. METHODS: Patients undergoing one- to three-level ACDF with single anterior plate fixation were randomized (1:1 ratio) to receive either cortical allograft or PEEK interbody spacers. Radiographic and clinical outcomes were assessed at 3, 6, 12, and 24 months with an additional postoperative radiographic assessment. RESULTS: A total of 120 patients were enrolled and randomized. Comparing clinical outcomes, no differences in arm or neck pain scores were noted; however, there was a statistically significant (≤0.041) improvement in SF-36 PCS scores for the allograft group at all follow-up time points and a tendency toward lower disability scores. Overall, evidence of radiographic fusion was achieved in 87 (91.6%) patients: five (10.2%) and three (6.5%) patients had pseudoarthrosis (P = 0.72) in the PEEK and allograft groups, respectively. At 24 months' follow-up time, any cervical or segmental alignment restoration achieved with surgery was lost and no statistically significant changes were detected when all levels of surgery were included. Likewise, there were no statistically significant differences between the groups for anterior or posterior body height measurements at the 24 months' follow-up. Approximately 20% of patients had anterior and posterior subsidence, all grade 0 regardless of the group assignment. CONCLUSION: Comparable radiographic outcomes were observed for patients undergoing one- to three-level PEEK versus allograft-assisted ACDF surgeries. Although MCID comparisons suggest that allograft and PEEK-treated patients have similar clinical outcomes, testing that incorporates the magnitude of the change suggests that there may be a statistically significant greater magnitude of improvement for the allograft group patients, but further studies with a larger sample size would be helpful to determine if a true effect exists.

Prospective, randomized, double-blinded clinical trial comparing PEEK and allograft spacers in patients undergoing transforaminal lumbar interbody fusion surgeries.

BACKGROUND CONTEXT: Allograft and polyether-ether-ketone (PEEK) radiographic, biomechanical, histological properties have been extensively studied and both spacers have their advantages and shortcomings. There are no comparative randomized or double-blinded spinal fusion clinical trials reported to date. PURPOSE: The study's primary objective was to prospectively investigate clinical and radiological outcomes in patients undergoing lumbar interbody fusions and randomized to receive either PEEK or structural bone allografts. STUDY DESIGN/ SETTING: A prospective, randomized, double-blinded clinical trial was initiated at a single center. PATIENT SAMPLE: A total of 138 patients were enrolled, randomized and 121 patients completed the study. OUTCOME MEASURES: The primary clinical outcome parameters were scored from standardized patient-reported questionnaires. The severity of lower back and leg pain was evaluated using the 11-point Visual Analog Scale (VAS). The Oswestry Disability Questionnaire was used to evaluate chronic disability and activities of daily living. Health-related quality of life and functional outcomes were assessed using Health-related Quality of Life Questionnaire (SF-36 v2). Two scores within the scoring algorithm were analyzed: Physical Component (PCS) and Mental Component Summary (MCS). The primary radiological outcomes included restoration and maintenance of vertebral body height, lumbar sagittal and segmental alignment, and fusion status. METHODS: All patients were followed for 2 years ± 2 months; radiographic and clinical outcomes were assessed at 3, 6, 12 and 24 months with an additional follow-up at 3 weeks for radiographic assessment. RESULTS: A total of 138 patients undergoing transforaminal lumbar interbody fusions (TLIF) were randomized (1:1) to receive either cortical allograft or PEEK interbody lordotic spacers. Although no differences were detected between the allograft and PEEK patient groups at any of the follow-up time points, there was a highly significant (p<.0001) improvement in all clinical outcome measures. Overall, evidence of radiographic fusion was achieved in 118 (97.5%) patients at the 24 months follow-up. Three patients, all in the allograft group, had pseudoarthrosis and underwent revision surgeries. Postoperative improvement of sagittal alignment, anterior (ABH) or posterior body height (PBH) was initially achieved, but it was mainly lost or reduced at the final follow-up and there were no statistically significant differences between the groups. At the end of the study, improvement and maintenance of lumbar lordosis were achieved in 43.3% and 49.2% patients and segmental alignment in 38.3% and 36.1% for the allograft and PEEK patient groups, respectively. Similarly, ABH was improved and maintained in 28.3% and 36.1% patients and PBH in 28.3% and 44.3% for the allograft and PEEK groups, respectively. CONCLUSIONS: Although allograft-assisted surgeries may have reduced fusion rates, the study findings demonstrated that TLIF surgery with two different types of cages and in conjunction with rhBMP-2 resulted in similar radiological or clinical outcomes and a highly statistically significant improvement in all clinical outcome measures at the end of the study regardless of the randomization group.

Local Retropharyngeal Space Anesthetic for Dysphagia Reduction after Anterior Cervical Discectomy and Fusion Surgery: A Single-Center, Prospective, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.

OBJECTIVE: The main objective of this study was to analyze the ability of local anesthetic instillation into the retropharyngeal space to reduce dysphagia symptoms and occurrence rates in patients undergoing anterior cervical discectomy and fusion (ACDF) procedures. METHODS: A single-center, prospective, randomized, double-blinded, and placebo-controlled clinical study was performed. We enrolled patients undergoing one- or two-level ACDF procedures for cervical degenerative disc disease with disc herniation, radiculopathy and/or myelopathy symptoms. The patients were randomly assigned (1:1 ratio) to receive either 0.5% bupivacaine hydrochloride or 0.9% NaCl solution. RESULTS: Forty-three (74%) and 41 (77%) of patients reported dysphagia symptoms at the time of discharge in the investigational and control groups, respectively. There were no statistically significant differences in duration of dysphagia symptoms, Swallowing-Quality of Life (SWAL-QOL) survey or pain scores between the investigational and control patient groups at any of the follow-up time points. Controlling for independent variables, only younger age significantly predicted dysphagia symptoms at discharge, 2-week, and 3-month follow-ups (P ≤ 0.03; R ≥ -0.038; OR 0.96, 95% CI 0.93-0.99. Female sex was associated with lower SWAL-QOL scores at discharge (P = 0.046; R = 0.87; OR 2.38, 95% CI 1.02-5.56). A total of 8 (13.8%) and 6 (11.3%) patients in the investigational and control groups, respectively, were referred to a specialist or underwent speech therapy for their dysphagia symptoms. There were no adverse reactions to the study drug observed. CONCLUSIONS: Local retropharyngeal space anesthetic instillation did not reduce dysphagia symptoms or occurrence rates in patients undergoing anterior discectomy and fusion surgeries.

Medical complications and mortality in octogenarians undergoing elective spinal fusion surgeries.

BACKGROUND: The consequences of suffering postoperative complications in elderly undergoing spinal surgeries may be different compared to younger patients. The primary objective of this study was to identify the types and frequency of medical complications and mortality rates in patients 80 years of age or older undergoing elective spinal fusion surgeries for degenerative spinal disease. METHODS: A prospective observational study with a retrospective chart review was performed, which included all consecutive patients ≥80 years old undergoing elective spinal fusion surgeries from May 2012 to August 2015. We identified a total of 95 patients, of which 39 cervical and 56 lumbar surgeries were performed. There were 41 female and 54 male patients with the mean age of 82.8 years (range, 80-91). The perioperative complications were allocated into the following categories: infection, pulmonary, cardiac, gastrointestinal, hematologic, urologic, neurovascular, thromboembolic, and other. Baseline and postoperative clinical outcome scores were compared to evaluate efficacy. RESULTS: The mean follow-up time was 14.8 months (range, 5 days to 37 months) with an overall mortality rate of 8.4%. The 30-day, 90-day, and 1-year mortality rates were 2.1, 2.1, and 4.2%, respectively. There were 53.9 and 71.4% patients with complications in the cervical and lumbar patient groups, respectively. The presence of general comorbidities and the number of intervertebral levels predicted the occurrence of perioperative complications. Also, longer OR times were associated with a higher number of complications per patient and the occurrence of a UTI. Dysphagia was a significant predictor in developing pneumonia and atelectasis. CONCLUSIONS: The incidence of perioperative medical complications and mortality rates in octogenarians undergoing elective spinal surgeries are quite high. The benefits of having surgery must be weighed against the risks of not only surgical but also adverse medical events. An informed decision-making process should include discussion of potential postoperative morbidity specific to this patient population in order to guide patient's acceptance of higher risks and expectations postoperatively. It is also important to identify potential complications and adapt preventive measures in order to help minimize them in this patient population.

Prediction based on preoperative opioid use of clinical outcomes after transforaminal lumbar interbody fusions.

OBJECTIVE Opioid analgesics have become some of the most prescribed drugs in the world, despite the lack of long-term studies evaluating the benefits of opioid medications versus their risks associated with chronic use. In addition, long-term opioid use may be associated with worse long-term clinical outcomes. The primary objective of this study was to evaluate whether preoperative opioid use predicted inferior clinical outcomes among patients undergoing transforaminal lumbar interbody fusion (TLIF) for symptomatic lumbar degenerative disc disease. METHODS The authors of this observational study prospectively enrolled 93 patients who underwent 1-level to 2-level TLIFs in 2011-2014; the patient cohort was divided into 2 groups according to preoperative opioid use or no such use. Visual analog scale (VAS) scores for low-back pain and leg pain, Oswestry Disability Index scores, and the scores of the mental component summary (MCS) and physical component summary (PCS) on the 36-Item Short Form Health Survey were used to assess pain, disability, and health-related quality of life outcomes, respectively. The clinical scores for the 2 groups were determined preoperatively and at a 12-month follow-up examination. RESULTS In total, 60 (64.5%) patients took prescribed opioid medications preoperatively. Compared with those not taking opioids preoperatively, these patients had significantly higher VAS scores for low-back pain (p = 0.016), greater disability (p = 0.013), and lower PCS scores (p = 0.03) at the 12-month follow-up. The postoperative MCS scores were also significantly lower (p = 0.035) in the opioid-use group, but these lower scores were due to significantly lower baseline MCS scores in this group. A linear regression analysis did not detect opioid dose-related effects on leg and back pain, disability, and MCS and PCS scores, suggesting that poorer outcomes are not significantly correlated with higher opioid doses taken by the patients. CONCLUSIONS The use of opioid medications to control pain before patients underwent lumbar fusion for degenerative lumbar conditions was associated with less favorable clinical outcomes postoperatively. This is the first study that has demonstrated this association in a homogeneous cohort of patients undergoing TLIF; this association should be studied further to evaluate the conclusions of the present study. Clinical trial registration no.: NCT01406405 ( clinicaltrials.gov ).

The Timing of Surgery and Symptom Resolution in Patients Undergoing Transforaminal Lumbar Interbody Fusion for Lumbar Degenerative Disk Disease and Radiculopathy.

OBJECTIVE: Success rates of surgical interventions for lumbar disorders vary significantly depending on multiple factors and, among them, the duration of symptoms. It is not clear whether there is a "cutoff" time when decompression and fusion surgery becomes less effective in the conditions with chronic nerve root compression symptomatology. The main objective of this study was to analyze whether duration of symptoms has any effect on clinical outcomes and primarily resolution of radicular pain symptoms due to degenerative disk disease and stenosis with spondylolisthesis in patients undergoing transforaminal lumbar interbody fusion (TLIF). METHODS: The prospective observational study was performed. Eighty-four patients with radicular symptoms due to degenerative disk disease and stenosis with spondylolisthesis with no previous fusion surgeries and undergoing 1- to 3-level TLIF surgery were enrolled. Fifteen patients (18%) were lost to follow-up and were excluded from this analysis leaving a total of 69 patients. Standardized questionnaires were used to analyze clinical outcomes and were administered preoperatively within 3 months of scheduled surgery, and postoperatively at 3, 6, 12, and 24 months. To emphasize the change in clinical outcome scores, the relevant scores were calculated as the ratio of minimal clinically important difference values and change scores. The change scores were calculated by subtracting the postoperative scores from the baseline scores. Multiple regression analyses were conducted to examine the relationship of the duration of symptoms and relevant minimal clinically important difference ratio values while controlling for independent variables. Further, a comparison between 2 groups of patients was performed to analyze the changes of clinical outcomes for the patients who underwent fusion within <24 months versus ≥24 months. RESULTS: It was determined that the duration of symptoms was a significant predictor of better leg pain resolution (P=0.018), but not back pain resolution (P=0.27), or improvement in ODI (P=0.10) and SF-36 PCS scores (P=0.19). The patients with shorter duration of symptoms had significantly better radicular symptom resolution (P=0.032) compared with patients who waited at least 24 months or longer to undergo fusion. CONCLUSIONS: A shorter duration of symptoms was found to be a statistically significant predictor for better resolution of radicular symptoms in patients undergoing TLIF for painful degenerative disk disease and stenosis with spondylolisthesis.

Post-Treatment Gliosarcoma Extension into the Pterygomaxillary Fossa: Literature Review and Case Report.

Only four primary gliosarcoma case reports are described in the literature with transcranial (intradural to extradural) penetration into the region of the infratemporal fossa. This is the first report of a primary glioblastoma (GBM) that evolved into secondary or post-treatment gliosarcoma without evidence of a second de novo tumor and with extension into the left pterygomaxillary fossa.

RhBMP-2-induced radiculitis in patients undergoing transforaminal lumbar interbody fusion: relationship to dose.

BACKGROUND CONTEXT: Recombinant human bone morphogenetic protein-2 (rhBMP-2) remains the primary synthetic osteoinductive material used in spinal fusion surgery today. The early inflammation reaction to rhBMP-2 manifesting with radicular symptoms has been previously reported in patients undergoing transforaminal lumbar interbody fusion (TLIF). There is a disagreement with regard to the factors affecting its occurrence and whether such symptoms are dose dependent. PURPOSE: The purpose of this analysis was to determine the incidence of rhBMP-2-induced radiculitis and its relationship to dose. STUDY DESIGN/SETTING: A retrospective cohort analysis was performed of the prospectively collected data. PATIENT SAMPLE: All consecutive patients (n=204) who underwent one- or two-level TLIF and instrumented posterolateral fusion with an off-label rhBMP-2 use were included in this analysis. OUTCOME MEASURES: The patients who developed new radicular symptoms after initial improvement postoperatively and had sterile fluid collections indicative of inflammatory process, or in the absence of any structural abnormalities that would explain these symptoms on imaging studies, were deemed to have rhBMP-2-induced radiculitis. METHODS: Magnetic resonance imaging (MRI) scans were obtained for all patients who developed postoperative radicular symptoms. Correlations between the total rhBMP-2 dose, dose per spinal level, and incidence of radiculitis were evaluated while controlling for age, sex, number of TLIF levels, and surgeon. RESULTS: The incidence of postoperative radiculitis was 11.3% (23 out of 204). The average total rhBMP-2 dose was 4.9 mg (range=2.1-12) and the average dose per spinal level was 3.8 mg (range=1.05-12). Logistic regression analysis did not identify any significant correlations between the rhBMP-2 doses and the incidence of radiculitis (p=.6). CONCLUSION: The incidence of rhBMP-2-induced radiculitis in patients undergoing TLIF is quite high, but there were no dose-related correlations found. The study, however, cannot rule out a possibility that a larger variation in bone morphogenetic protein (BMP) doses could still be a factor in the development of rhBMP-2-associated radiculitis.

Case Series of Anterior Intervertebral Graft Extrusions in Transforaminal Lumbar Interbody Fusion Surgeries.

BACKGROUND: According to the published reports, revision surgery is sometimes recommended even in patients with asymptomatic anterior lumbar intervertebral graft migrations. The main purpose of this chart review study was to report on the clinical course and outcomes of patients who had anterior intervertebral graft extrusions after transforaminal lumbar interbody fusion (TLIF). METHODS: From July 2002 to July 2014, 1259 consecutive TLIF surgeries were performed. These were reviewed, and patients who had anterior intervertebral graft extrusions were identified. RESULTS: The incidence of graft extrusion was 0.6% (7 of 1259 patients). There were 6 female patients and 1 male patient with an average age of 65.7 years (range, 44-80 years). All patients underwent TLIF with bilateral pedicle screw fixation, and 6 received recombinant human bone morphogenetic protein-2. Graft migrations were diagnosed between 5 days and 8 months postoperatively except for 2 cases in which migration occurred intraoperatively. The patients were closely followed for an average of 27.4 months (range, 12-43 months). All patients remained asymptomatic during the follow-up period and had solid fusion despite extrusions with an average time to fusion of 13 months (range, 10-18 months). No other adverse events occurred during the follow-up period. CONCLUSIONS: The risks of additional and highly invasive revision surgery should be weighed against the potential short-term and long-term complications associated with graft extrusions or migrations. It was demonstrated that fusion may take longer but can be achieved, and close observation may be adequate for asymptomatic patients.

Guideline summary review: An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spondylolisthesis.

BACKGROUND CONTEXT: The North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Degenerative Lumbar Spondylolisthesis features evidence-based recommendations for diagnosing and treating degenerative lumbar spondylolisthesis. The guideline updates the 2008 guideline on this topic and is intended to reflect contemporary treatment concepts for symptomatic degenerative lumbar spondylolisthesis as reflected in the highest quality clinical literature available on this subject as of May 2013. The NASS guideline on this topic is the only guideline on degenerative lumbar spondylolisthesis included in the Agency for Healthcare Research and Quality's National Guideline Clearinghouse (NGC). PURPOSE: The purpose of this guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for patients with degenerative lumbar spondylolisthesis. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition. STUDY DESIGN: A systematic review of clinical studies relevant to degenerative spondylolisthesis was carried out. METHODS: This NASS spondyolisthesis guideline is the product of the Degenerative Lumbar Spondylolisthesis Work Group of NASS' Evidence-Based Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questions to address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members used the NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guidelines were submitted to an internal peer review process and ultimately approved by the NASS Board of Directors. Upon publication, the Degenerative Lumbar Spondylolisthesis guideline was accepted into the NGC and will be updated approximately every 5 years. RESULTS: Twenty-seven clinical questions were addressed in this guideline update, including 15 clinical questions from the original guideline and 12 new clinical questions. The respective recommendations were graded by strength of the supporting literature, which was stratified by levels of evidence. Twenty-one new or updated recommendations or consensus statements were issued and 13 recommendations or consensus statements were maintained from the original guideline. CONCLUSIONS: The clinical guideline was created using the techniques of evidence-based medicine and best available evidence to aid practitioners in the care of patients with degenerative lumbar spondylolisthesis. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flow chart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/Pages/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx and will remain updated on a timely schedule.

A Preliminary Report on the CO2 Laser for Lumbar Fusion: Safety, Efficacy and Technical Considerations.

The purpose of this study was to evaluate potential technical advantages of the CO2 laser technology in mini-open transforaminal lumbar interbody fusion (TLIF) surgeries and report our preliminary clinical data on the safety and clinical outcomes. There is currently no literature discussing the recently redeveloped CO2 laser technology application for lumbar fusion. Safety and clinical outcomes were compared between two groups: 24 patients that underwent CO2 laser-assisted one-level TLIF surgeries and 30 patients that underwent standard one-level TLIF surgeries without the laser. There were no neural thermal injuries or other intraoperative laser-related complications encountered in this cohort of patients. At a mean follow-up of 17.4 months, significantly reduced lower back pain scores (P=0.013) were reported in the laser-assisted patient group compared to a standard fusion patient group. Lower extremity radicular pain intensity scores were similar in both groups. Laser-assisted TLIF surgeries showed a tendency (P = 0.07) of shorter operative times that was not statistically significant. Based on this preliminary clinical report, the safety of the CO2 laser device for lumbar fusion surgeries was assessed. There were no neural thermal injuries or other intraoperative laser-related complications encountered in this cohort of patients. Further investigation of CO2 laser-assisted lumbar fusion procedures is warranted in order to evaluate its effect on clinical outcomes.

The duration of symptoms and clinical outcomes in patients undergoing anterior cervical discectomy and fusion for degenerative disc disease and radiculopathy.

BACKGROUND CONTEXT: There have been controversial reports published in the literature on the duration of symptoms (DOS) and clinical outcome correlation in patients undergoing anterior cervical discectomy and fusion (ACDF) for painful degenerative disc disease and radiculopathy. PURPOSE: The primary purpose of this study was to analyze if the DOS has any effect on clinical outcomes. STUDY DESIGN/SETTING: A post hoc analysis was performed on an original prospective clinical study analyzing clinical outcomes and cervical sagittal alignment correlations. PATIENTS SAMPLE: Fifty-eight patients undergoing one- or two-level ACDF surgeries for cervical degenerative radiculopathy were analyzed. OUTCOME MEASURES: Standardized questionnaires were used to evaluate clinical outcomes. Neck and arm pain was evaluated using (Visual Analog Scale [VAS]). Two scales of Health-Related Quality-of-Life Questionnaire (Short-Form 36 Health Survey [SF-36]) were used for this study: the physical component summary (PCS) and mental component summary (MCS). Neck disability index (NDI) was used to evaluate chronic disability in activities of daily living. The patients completed a self-reported Patient Satisfaction with Results Survey. METHODS: Patients who had previous or redo surgeries, were diagnosed with myelopathy or had more than two-level ACDF surgeries were excluded, leaving a total of 58 patients. The mean follow-up was 37.2 months (range 12-54). Patients were divided into two groups for clinical outcome analyses according to the DOS: patients who had surgery within 6 months (n=29) or more than 6 months (n=29) after becoming symptomatic. RESULTS: There were no statistically significant differences in any demographic or clinical parameters among the patient groups. Controlling for preoperative scores, the patients who had surgery within 6 months reported significantly higher reduction (p=.04) in arm pain scores compared with the patients who waited more than 6 months. No significant differences were detected in postoperative neck pain VAS (p=.3), NDI (p=.06), SF-36 PCS (p=.08), and MCS (p=.8) scores. CONCLUSIONS: Neck and upper extremity pain can be successfully treated conservatively. In those cases, when surgical intervention is pursued, patients with shorter DOS have better improvement in radiculopathy symptoms that is statistically significant.

Unilateral and bilateral pedicle screw fixation in transforaminal lumbar interbody fusion: radiographic and clinical analysis.

BACKGROUND: Transforaminal lumbar interbody fusion with bilateral segmental pedicle screw (PS) fixation is a widely used and well-recognized technique that provides fixation and load-bearing capacity, while restoring morphometric spine parameters and relieving symptoms in patients with degenerative disc disease. A supplemental interspinous process fixation plate (ISFP) as an adjunct to unilateral PS fixation allows for reduced invasiveness of this technique compared with bilateral PS placement. The biomechanical comparison results have been previously reported, but the significance of these findings has not been studied in clinical settings. METHODS: A prospective cohort study with a supplemental retrospective chart review and radiographic analysis was performed. Patients were divided into 2 groups: bilateral PS fixation (n = 75) or unilateral PS fixation + ISFP (n = 96). Lateral lumbar standing radiographs were obtained for preoperative and postoperative foraminal height (FH), disc height, segmental sagittal alignment, and lumbar sagittal alignment measurements. Standardized questionnaires were used to compare postoperative clinical outcomes. RESULTS: The estimated blood loss, duration of procedure, and length of hospital stay were significantly lower for 1-level and 2-level procedures in the unilateral PS + ISFP group. A statistically significant mean disc height increase was observed in both groups. Regardless of the disc height increase, a statistically significant FH loss was detected in the bilateral PS group (from 17.1 mm to 16.3 mm; 4.7% loss; P = 0.04) compared with FH height loss in the unilateral PS + ISFP group that was not statistically significant (from 19.0 mm to 18.4 mm; 3.2% loss; P = 0.1). The analysis of segmental sagittal alignment, lumbar sagittal alignment, clinical outcomes, and fusion rates did not demonstrate any statistically significant differences. CONCLUSIONS: Significantly reduced surgical invasiveness was associated with unilateral PS + ISFP fixation, which represents the major advantage of this technique. Unilateral fixation was also associated with a slightly lower reduction in FH and was equally effective as bilateral PS fixation in regard to fusion rates, clinical outcomes, and other radiographic outcomes studied.

The accuracy of pedicle screw placement using intraoperative image guidance systems.

OBJECT: Several retrospective studies have demonstrated higher accuracy rates and increased safety for navigated pedicle screw placement than for free-hand techniques; however, the accuracy differences between navigation systems has not been extensively studied. In some instances, 3D fluoroscopic navigation methods have been reported to not be more accurate than 2D navigation methods for pedicle screw placement. The authors of this study endeavored to identify if 3D fluoroscopic navigation methods resulted in a higher placement accuracy of pedicle screws. METHODS: A systematic analysis was conducted to examine pedicle screw insertion accuracy based on the use of 2D, 3D, and conventional fluoroscopic image guidance systems. A PubMed and MEDLINE database search was conducted to review the published literature that focused on the accuracy of pedicle screw placement using intraoperative, real-time fluoroscopic image guidance in spine fusion surgeries. The pedicle screw accuracy rates were segregated according to spinal level because each spinal region has individual anatomical and morphological variations. Descriptive statistics were used to compare the pedicle screw insertion accuracy rate differences among the navigation methods. RESULTS: A total of 30 studies were included in the analysis. The data were abstracted and analyzed for the following groups: 12 data sets that used conventional fluoroscopy, 8 data sets that used 2D fluoroscopic navigation, and 20 data sets that used 3D fluoroscopic navigation. These studies included 1973 patients in whom 9310 pedicle screws were inserted. With conventional fluoroscopy, 2532 of 3719 screws were inserted accurately (68.1% accuracy); with 2D fluoroscopic navigation, 1031 of 1223 screws were inserted accurately (84.3% accuracy); and with 3D fluoroscopic navigation, 4170 of 4368 screws were inserted accurately (95.5% accuracy). The accuracy rates when 3D was compared with 2D fluoroscopic navigation were also consistently higher throughout all individual spinal levels. CONCLUSIONS: Three-dimensional fluoroscopic image guidance systems demonstrated a significantly higher pedicle screw placement accuracy than conventional fluoroscopy or 2D fluoroscopic image guidance methods.

A novel case of resolved postherpetic neuralgia with subsequent development of trigeminal neuralgia: a case report and review of the literature.

A 72-year-old female patient is presented, who was diagnosed with herpes zoster along the left ophthalmic branch of the trigeminal nerve with associated cutaneous vesicles. The patient subsequently developed postherpetic neuralgia in the same dermatome, which, after remission, transformed into paroxysmal trigeminal pain. The two different symptom sets, with the former consistent with PHN and the later consistent with trigeminal neuralgia, were unique to our practice and the literature.

Preliminary results on feasibility of outpatient instrumented transforaminal lumbar interbody fusion.

STUDY DESIGN: A retrospective chart review study was performed. OBJECTIVE: The primary objective of this study was to analyze our preliminary results to examine whether it is safe and effective to perform instrumented lumbar interbody fusions on an outpatient basis by comparing 2 groups of patients who were discharged the same day versus those who stayed overnight. The secondary objective was to identify the need for prolonged observation for complications that may occur in the immediate postoperative period. SUMMARY OF BACKGROUND DATA: There is currently no information in the literature on the safety and complication rates of instrumented transforaminal lumbar interbody fusions performed in an ambulatory surgery setting. METHODS: Surgeries were performed at an ambulatory surgery center (n=27) or hospital outpatient departments (n=25). The mean age of patients was 49.8 years (range, 19-72 y). The safety of outpatient lumbar fusions was assessed by analyzing complications that occurred from the moment of discharge up to the seventh postoperative day (0-7 POD), as well as all complications that occurred up to 6 months postoperatively (>7 POD). The efficacy of surgical intervention was also evaluated by assessing change in pain, patient satisfaction scores, and fusion rates. RESULTS: There were no cases of pneumonia, urinary tract infection, or thromboembolic complications. Four patients (14%) who had surgeries performed at an ambulatory surgery center had complications within 7 days postoperatively compared with 1 (4%) patient who had surgery performed at a hospital outpatient department. This difference was not statistically significant (P=0.36, Fisher exact test). Lower back and leg pain was significantly (P<0.0001) decreased postoperatively. The average postoperative back pain was 18.8 (range, 0-90) compared with 74.5 (range, 0-100) preoperatively as measured on a 0-100 visual analog scale. The average postoperative leg pain was 9.1 (range, 0-60) compared with 54.2 (range, 0-100) preoperatively. CONCLUSIONS: Although further confirmation is needed, this study discusses the possibility of performing instrumented lumbar interbody fusions with the transforaminal lumbar interbody fusion technique as an outpatient procedure. These results support a future prospective randomized study with a well-defined patient selection criteria.

Complications in patients undergoing combined transforaminal lumbar interbody fusion and posterior instrumentation with deformity correction for degenerative scoliosis and spinal stenosis.

BACKGROUND: Utilization of the transforaminal lumbar interbody fusion (TLIF) approach for scoliosis offers the patients deformity correction and interbody fusion without the additional morbidity associated with more invasive reconstructive techniques. Published reports on complications associated with these surgical procedures are limited. The purpose of this study was to quantify the intra- and postoperative complications associated with the TLIF surgical approach in patients undergoing surgery for spinal stenosis and degenerative scoliosis correction. METHODS: This study included patients undergoing TLIF for degenerative scoliosis with neurogenic claudication and painful lumbar degenerative disc disease. The TLIF technique was performed along with posterior pedicle screw instrumentation. The average follow-up time was 30 months (range, 15-47). RESULTS: A total of 29 patients with an average age of 65.9 years (range, 49-83) were evaluated. TLIFs were performed at 2.2 levels on average (range, 1-4) in addition to 6.0 (range, 4-9) levels of posterolateral instrumented fusion. The preoperative mean lumbar lordosis was 37.6° (range, 16°-55°) compared to 40.5° (range, 26°-59.2°) postoperatively. The preoperative mean coronal Cobb angle was 32.3° (range, 15°-55°) compared to 15.4° (range, 1°-49°) postoperatively. The mean operative time was 528 min (range, 276-906), estimated blood loss was 1091.7 mL (range, 150-2500), and hospitalization time was 8.0 days (range, 3-28). A baseline mean Visual Analog Scale (VAS) score of 7.6 (range, 4-10) decreased to 3.6 (range, 0-8) postoperatively. There were a total of 14 (49%) hardware and/or surgical technique related complications, and 8 (28%) patients required additional surgeries. Five (17%) patients developed pseudoarthrosis. The systemic complications (31%) included death (1), cardiopulmonary arrest with resuscitation (1), myocardial infarction (1), pneumonia (5), and pulmonary embolism (1). CONCLUSION: This study suggests that although the TLIF approach is a feasible and effective method to treat degenerative adult scoliosis, it is associated with a high rate of intra- and postoperative complications and a long recovery process.

Effect on clinical outcomes of patient pain expectancies and preoperative Mental Component Summary scores from the 36-Item Short Form Health Survey following anterior cervical discectomy and fusion.

OBJECT: The primary purpose of this study was to analyze what effect preoperative patient expectations and 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) scores have on clinical outcomes. To the authors' knowledge, there are no prospective studies that have examined the effects of both preoperative pain expectations and SF-36 MCS scores on clinical outcomes and satisfaction with results following anterior cervical discectomy and fusion (ACDF). METHODS: This study analyzed 79 patients (38 men, 41 women) undergoing 1- to 3-level ACDF surgery. Preoperatively, patients were divided into 2 groups for the expectation analyses: patients who expected complete resolution of pain postoperatively (44 total) and those who expected some residual pain (35 total) postoperatively. Preoperative SF-36 MCS scores were used to test the possible effects of mental health on clinical outcomes and satisfaction. Clinical outcomes were evaluated using visual analog scales (VASs) for neck/arm pain, Neck Disability Index (NDI), SF-36 Physical Component Summary (PCS)/MCS, and patient satisfaction with results scales. The mean follow-up duration was 38.8 months (range 7-59 months). RESULTS: All postoperative measures depicted significant improvement overall. Patients who expected no pain reported lower postoperative neck/arm pain scores (p < 0.02), higher SF-36 MCS scores (p = 0.04), and higher satisfaction with results scores (p = 0.01) compared with patients who expected some pain, after controlling for their respective preoperative scores. Higher preoperative SF-36 MCS scores predicted significantly lower postoperative neck pain (p = 0.003) and NDI (p = 0.004) scores, as well as higher postoperative SF-36 PCS (p = 0.002), SF-36 MCS (p = 0.001), and satisfaction (p = 0.03) scores, after controlling for their respective preoperative scores. CONCLUSIONS: Patients who expected no pain postoperatively reported better scores on the nonstandardized outcome measure scales (VAS arm/neck, satisfaction with results), and higher SF-36 MCS scores. Higher preoperative MCS scores were related to better overall (standardized and nonstandardized) clinical outcomes (VAS neck, NDI, SF-36 PCS/MCS, and satisfaction with results). The results suggest that optimism in patients' expectations as well as mental well-being are related to improved clinical outcomes and higher patient satisfaction.

Prospective, randomized, double-blind clinical study evaluating the correlation of clinical outcomes and cervical sagittal alignment.

BACKGROUND: Sagittal alignment of the cervical spine has received increased attention in the literature as an important determinant of clinical outcomes after anterior cervical diskectomy and fusion. Surgeons use parallel or lordotically fashioned grafts depending on preference or simple availability. OBJECTIVE: To quantitatively assess and compare cervical sagittal alignment and clinical outcome when lordotic or parallel allografts were used for fusion. METHODS: A prospective, randomized, double-blind clinical study that enrolled 122 patients was performed. The mean follow-up was 37.5 months (range, 12-54 months). RESULTS: The mean postoperative cervical sagittal alignment was 19° (range, -7°-36°) and 18° (range, -7°-37°) in the lordotic and parallel graft patient groups, respectively. The mean segmental sagittal alignment was 6° (range, -4°-19°) and 7° (range, -3°-19°) in the lordotic and parallel graft patient groups, respectively. There were no statistically significant differences in clinical outcome scores between the lordotic and parallel graft patient groups. However, patients who had maintained or improved segmental sagittal alignment, regardless of graft type, achieved a higher degree of improvement in Short Form-36 Physical Component Summary and Neck Disability Index scores. This was statistically significant (P < .038). CONCLUSION: The use of lordotically shaped allografts does not increase cervical/segmental sagittal alignment or improve clinical outcomes. Maintaining a consistent segmental sagittal alignment or increasing segmental lordosis was related to a higher degree of improvement in clinical outcomes.

Minimally invasive versus open transforaminal lumbar interbody fusion.

BACKGROUND: Available clinical data are insufficient for comparing minimally invasive (MI) and open approaches for transforaminal lumbar interbody fusion (TLIF). To date, a paucity of literature exists directly comparing minimally invasive (MI) and open approaches for transforaminal lumbar interbody fusion (TLIF). The purpose of this study was to directly compare safety and effectiveness for these two surgical approaches. MATERIALS AND METHODS: Open or minimally invasive TLIF was performed in 63 and 76 patients, respectively. All consecutive minimally invasive TLIF cases were matched with a comparable cohort of open TLIF cases using three variables: diagnosis, number of spinal levels, and history of previous lumbar surgery. Patients were treated for painful degenerative disc disease with or without disc herniation, spondylolisthesis, and/or stenosis at one or two spinal levels. Clinical outcome (self-report measures, e.g., visual analog scale (VAS), patient satisfaction, and MacNab's criteria), operative data (operative time, estimated blood loss), length of hospitalization, and complications were assessed. Average follow-up for patients was 37.5 months. RESULTS: The mean change in VAS scores postoperatively was greater (5.2 vs. 4.1) in theopen TLIF patient group (P = 0.3). MacNab's criteria score was excellent/good in 67% and 70% (P = 0.8) of patients in open and minimally invasive TLIF groups, respectively. The overall patient satisfaction was 72.1% and 64.5% (P = 0.4) in open and minimally invasive TLIF groups, respectively. The total mean operative time was 214.9 min for open and 222.5 min for minimally invasive TLIF procedures (P = 0.5). The mean estimated blood loss for minimally invasive TLIF (163.0 ml) was significantly lower (P < 0.0001) than the open approach (366.8 ml). The mean duration of hospitalization in the minimally invasive TLIF (3 days) was significantly shorter (P = 0.02) than the open group (4.2 days). The total rate of neurological deficit was 10.5% in the minimally invasive TLIF group compared to 1.6% in the open group (P = 0.02). CONCLUSIONS: Minimally invasive TLIF technique may provide equivalent long-term clinical outcomes compared to open TLIF approach in select population of patients. The potential benefit of minimized tissue disruption, reduced blood loss, and length of hospitalization must be weighted against the increased rate of neural injury-related complications associated with a learning curve.