STUDY DESIGN:A retrospective cohort analysis. OBJECTIVE:This study aims to investigate whether waveform alterations in transcranial motor evoked potentials (TCMEPs) can reliably predict postoperative foot drop. SUMMARY OF BACKGROUND DATA:Nerve injury leading to foot drop is a potential complication of lumbosacral surgery. Very limited data exist on the use of intraoperative TCMEPs to identify iatrogenic foot drop. METHODS:We retrospectively reviewed neuromonitoring data from 130 consecutive spine surgeries with instrumentation involving L4-S1. TCMEP waveform analysis included amplitude (A), area under the curve (AUC), latency (L), and duration (D). Patient outcomes were correlated with neuromonitoring results. Intraoperative alert criteria were established on the basis of observed intraoperative changes. RESULTS:Three patients developed severe foot drop with a muscle weakness functional grade ranging from 0/5 to 3/5. Two patients developed a mild foot drop with functional grade 4/5. Twenty-three patients had preoperative weakness in an L5 distribution. One-hundred two patients who had neither preoperative nor postoperative neurological complications served as a control group. Amplitude significantly decreased in patients with a severe postoperative deficit (P = 0.005) as did AUC and duration (P < 0.05). Intraoperative alert criteria defined as a >65% decrease in AUC resulted in a sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 100%, 91.4%, 12%, and 100%, respectively. When defining an alert criteria as a >50% decrease in amplitude, sensitivity, specificity, PPV, and NPV were 100%, 87.9%, 8.8%, and 100%, respectively. CONCLUSION:Reduction of TCMEP waveform associated with postoperative severe foot drop can be detected during lumbar surgery. Other waveform parameters such as AUC may predict foot drop better than the amplitude. Additional examinations in larger samples of foot drops are needed to validate these alert threshold findings. LEVEL OF EVIDENCE:4.
BACKGROUND CONTEXT: Iatrogenic nerve injury has been described in many studies with the reported rates varying from 0.8% to 10% with the common deficit being a foot drop. Intraoperative neurophysiologic monitoring is commonly used during lumbar spine surgery to detect and prevent intraoperative iatrogenic neurological complications. Considering the limitations of SSEP and EMG monitoring alone some authors did suggest that TCMEPs could be considered for monitoring lumbosacral roots.
Objective: To evaluate the safety and effectiveness of two-level total disc replacement (TDR) using a Mobi-C(r) Cervical Artificial Disc at the 36 month follow-up. Methods: a Prospective, randomized, controlled, multicenter clinical trial of an artificial cervical disc (Mobi-C(r) Cervical Artificial Disc) was conducted under the Investigational Device Exemptions (IDE) and the U.S. Food & Drug Administration (FDA) regulations. A total of 339 patients with degenerative disc disease were enrolled to receive either two-level treatment with TDR, or a two-level anterior cervical discectomy and fusion (ACDF) as control. The 234 TDR patients and 105 ACDF patients were followed up at regular time points for three years after surgery. Results: At 36 months, both groups demonstrated an improvement in clinical outcome measures and a comparable safety profile. NDI scores, SF-12 PCS scores, patient satisfaction, and overall success indicated greater statistically significant improvement from baseline for the TDR group, in comparison to the ACDF group. The TDR patients experienced lower subsequent surgery rates and a lower rate of adjacent segment degeneration. On average, the TDR patients maintained segmental range of motion through 36 months with no device failure. Conclusion: Results at three-years support TDR as a safe, effective and statistically superior alternative to ACDF for the treatment of degenerative disc disease at two contiguous cervical levels.
STUDY DESIGN:This was a prospective, randomized, controlled multicenter trial.OBJECTIVE:The purpose of this study was to compare clinical outcomes at 4-year follow-up of patients receiving cervical total disk replacement (TDR) with those receiving anterior cervical discectomy and fusion (ACDF).SUMMARY OF BACKGROUND DATA:ACDF has been the traditional treatment for symptomatic disk degeneration. Several studies found single-level TDR to be as safe and effective as ACDF at ≥2 years follow-up.METHODS:Patients from 23 centers were randomized in a 2:1 ratio with 164 receiving the investigational device (Mobi-C Cervical Disc Prosthesis) and 81 receiving ACDF using an anterior plate and allograft. Patients were evaluated preoperatively and 6 weeks, 3, 6, 12, 18, 24, 36, and 48 months postoperatively. Outcome assessments included a composite success score, Neck Disability Index, visual analog scales assessing neck and arm pain, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent-segment degeneration.RESULTS:The composite success rate was similar in the 2 groups at 48-month follow-up. Mean Neck Disability Index, visual analog scale, and SF-12 scores were significantly improved in early follow-up in both groups with improvements maintained throughout 48 months. On some measures, TDR had significantly greater improvement during early follow-up. At no follow-up were TDR scores significantly worse than ACDF scores. Subsequent surgery rate was significantly higher for ACDF compared with TDR (9.9% vs. 3.0%, P<0.05). Range of motion was maintained with TDR having a mean baseline value of 8 degrees compared with 10 degrees at 48 months. The incidence of adjacent-segment degeneration was significantly higher with ACDF at inferior and superior segments compared with TDR (inferior: 50% vs. 30%, P<0.025; superior: 53% vs. 34%, P<0.025).CONCLUSIONS:Significant improvements were observed in pain and function. TDR patients maintained motion and had significantly lower rates of reoperation and adjacent-segment degeneration compared with ACDF. This study supports the safety and efficacy of TDR in appropriately selected patients.
Background Anterior cervical discectomy and fusion (ACDF) is the gold standard for treating symptomatic cervical disc degeneration. Cervical total disc replacements (TDRs) have emerged as an alternative for some patients. The purpose of this study was to evaluate the safety and effectiveness of a new TDR device compared with ACDF for treating single-level cervical disc degeneration. Methods This was a prospective, randomized, controlled, multicenter Food and Drug Administration (FDA) regulated Investigational Device Exemption (IDE) study. A total of 245 patients were treated (164 TDR: 81 ACDF). The primary outcome measure was overall success based on improvement in Neck Disability Index (NDI), no subsequent surgical interventions, and no adverse events (AEs) classified as major complications. Secondary outcome measures included SF-12, visual analog scale (VAS) assessing neck and arm pain, patient satisfaction, radiographic range of motion, and adjacent level degeneration. Patients were evaluated preoperatively and postoperatively at 6 weeks, 3, 6, 12, 18, and 24 months. The hypothesis was that the TDR success rate was non-inferior to ACDF at 24 months. Results Overall success rates were 73.6% for TDR and 65.3% for ACDF, confirming non-inferiority (p < 0.0025). TDR demonstrated earlier improvements with significant differences in NDI scores at 6 weeks and 3 months, and VAS neck pain and SF-12 PCS scores at 6 weeks (p<0.05). Operative level range of motion in the TDR group was maintained throughout follow-up. Radiographic evidence of inferior adjacent segment degeneration was significantly greater with ACDF at 12 and 24 months (p < 0.05). AE rates were similar. Conclusions Mobi-C TDR is a safe and effective treatment for single-level disc degeneration, producing outcomes similar to ACDF with less adjacent segment degeneration. Level of Evidence: Level I. Clinical relevance: This study adds to the literature supporting cervical TDR as a viable option to ACDF in appropriately selected patients with disc degeneration.
Anterior cervical discectomy and fusion (ACDF) is the standard for treatment of cervical degenerative disc disease (DDD). Recent studies have shown that secondary surgery rates are higher with ACDF compared to cervical disc arthroplasty (CDA) at one level. The published data on two-level CDA use is increasing, though it not yet determined what, if any, difference exists in the comparative rate of second surgeries between two-level ACDF and CDA.
Infections due to extraintestinal pathogenic E. coli (ExPEC) are very common in humans as well as in animals. In humans ExPEC infections include urinary tract infections (UTI), septicemia, and wound infections, which result in significant morbidity, mortality, and substantial healthcare costs. In view of the increasing number of ExPEC infections caused by more and more resistant strains, effective prevention would be desirable. Given the rising treatment costs, a vaccine may be cost-effective in selected patient groups, such as women with recurrent UTI, patients with neurologic disorders impairing bladder function and men with prostate hyperplasia. Previous vaccine studies used single target proteins or whole inactivated ExPEC cells. Here, we describe a vaccine system for oral application based on artificial multiple subunit vaccine proteins. Those multi-epitope proteins are composed of predicted epitopes derived from ExPEC virulence-associated proteins. As ExPEC are known to form intracellular biofilms in the urothelium and can also resist killing by non-activated macrophages, T-cell responses are supposed to be an important measure to counteract these stages of ExPEC during infection. Therefore, a live bacterial antigen delivery system based upon the Salmonella type-III secretion system (T3SS) was used in this study to directly deliver the vaccine proteins into the cytoplasm of the host cells. Epitope-rich domains of the proteins FyuA, IroN, ChuA, IreA, Iha, and Usp were expressed in an attenuated Salmonella enterica serovar Typhimurium strain and translocated into target cells for extended periods of time inducing a strong T-cell response. No significant antibody titre increase against the secreted vaccine proteins could be detected in vaginal wash or serum. Despite that, one of the vaccine proteins was able to significantly reduce bacterial load in the challenge model of intraperitoneal sepsis. This study shows that a vaccine encompassing distinct epitopes of virulence-associated ExPEC proteins (i) can be applied for a T3SS-dependent vaccination strategy, (ii) elicits T-cell responses and (iii) confers protection after a single application.
While the clinical outcome of anterior cervical fusion (ACF) is good, there is concern and data to support that it may accelerate degeneration of an adjacent segment due to the additional stresses created by the immobile fused segment during movement. There are multiple studies supporting that cervical total disc replacement (TDR) produces clinical outcomes that are as good as ACF. One potential advantage of TDR is that the mobility of the device may reduce the stresses on the adjacent segment, thereby reducing the occurrence of adjacent segment degeneration.
Anterior cervical discectomy and fusion (ACDF) is performed as the surgical procedure of choice to manage intractable radiculo-myelopathy resulting from degenerative disc disease (DDD) of the cervical spine. Published research has provided evidence that the procedure may increase the stress on the adjacent cervical segments and accelerate degeneration at these levels. Total disc arthroplasty (TDA) using artificial disc has been proposed as an alternative procedure to possibly reduce the stress on adjacent segments by motion preservation.
Anterior cervical fusion (ACF) has been long accepted as the standard of care for radiculopathy or myeloradiculopathy associated with degenerated cervical discs. Cervical total disc replacement (TDR) is designed to provide motion and relieve pain. The most viable way to evaluate the effectiveness of TDR in reducing symptoms is to compare it to ACF.
Tuberculosis has global presence and no part of human body is immune to it, most frequent site beings lungs. Nasopharyngeal tuberculosis is a rare type of extrapulmonary tuberculosis comprising only less than 1% of tuberculosis found in the upper respiratory tract. The authors are presenting here a case of primary tuberculousis affecting the nasopharynx (adenoids) which is one of the rare differential diagnosis of nasopharyngeal mass. Isolated nasopharyngeal tuberculosis is a rare condition even in the endemic areas. In literature there are varied clinical presentations of nasopharyngeal tuberculosis. Tuberculosis should be one of the differential diagnosis of nasopharyngeal lesion. Biopsy and histologic study should be performed in every patient to avoid misdiagnosis. When treated properly, nasopharyngeal tuberculosis carries a excellent prognosis, and complete resolution of disease is the rule.
BACKGROUND CONTEXT: Anterior cervical discectomy and fusion is considered to be the standard of care in treatment of patients suffering from axial neck pain, myelopathy and radiculopathy associated with degenerative cervical disc disease. Due to the restrictive nature of ACDF, load transfers on discs adjacent to the operative site tend to increase thereby potentially increasing the rate of degeneration at those levels. Cervical disc replacement seeks to decrease pain and resolve neurological deficits while maintaining normal cervical mobility. It is expected that by preserving natural cervical movement at the surgical site, surrounding levels will not exhibit increased degenerative symptoms.