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STUDY DESIGN: A large case series of anterior revision surgery in patients who had complications following lumbar total disc replacement with the CHARITE artificial disc. OBJECTIVES: To analyze and discuss the etiology of implant-related complications and to present a strategy that can be applied to lumbar intervertebral disc prostheses in cases where anterior revision surgery is necessary. SUMMARY OF BACKGROUND DATA: This report represents the largest single-site, consecutive case series reported in the literature of anterior revision surgery following lumbar disc arthroplasty. METHODS: A total of 18 patients are included in this study. All patients required an anterior revision procedure for repositioning or removal of the prosthesis. The mean time to revision was 6 months (range, 9 days to 4 years). RESULTS: In 17 of 20 cases, implant removal was required and the patient was converted to a fusion. In 3 cases, primary revision of the CHARITE artificial disc was performed. Six revision cases were performed within the early postoperative period, defined as 7 to 14 days. All early cases were approached via reexploration of the original anterior midline retroperitoneal incision. Late revision was required in 14 cases, ranging from 3 weeks to 4 years following initial arthroplasty. A variety of surgical approaches were used in late revisions, including the lateral transpsoas approach at L3-L4 or L4-L5 (n = 5), expanded ipsilateral left retroperitoneal approach at L4-L5 (n = 2), contralateral right retroperitoneal approach at L5-S1 (n = 6), and transperitoneal approach (n = 1). Following 20 consecutive, anterior revision procedures, implant revision was successfully achieved in all cases. CONCLUSIONS: Total disc replacement implant revisions occur largely as a result of technical errors in positioning and sizing of the implant. In addition, adherence to strict patient selection criteria will eliminate many cases of implant failure. When necessary, anterior revision surgery can be performed safely when a strategic approach is used. [ABSTRACT FROM AUTHOR]

STUDY DESIGN: A prospective, randomized, multicenter, Food and Drug Administration regulated Investigational Device Exemption (IDE) clinical trial. OBJECTIVES: To discern whether there is a correlation between surgical volume and clinical outcomes, as well as the complication rate and perioperative data points, for lumbar total disc replacement. To examine the early experience for lumbar total disc replacement as part of an IDE study. SUMMARY OF BACKGROUND DATA: To our knowledge, an analysis of the effect of surgical volume has not been performed for any spine surgical procedure. Prior reports of the early experience with lumbar total disc replacement consist of retrospective reviews with nonspecific indications. METHODS: An analysis was performed of the Food and Drug Administration IDE Study of the Charité Artificial Disc (DePuy Spine, Inc., Raynham, MA). Patients enrolled in the control group were omitted from the analysis. Up to 5 nonrandomized cases (representing the early experience) were performed at each site before beginning the randomized arm of the study. There were 3 comparisons performed: nonrandomized cases (71) versus randomized cases (205); randomized cases performed by high-enrolling surgeons versus low-enrolling surgeons; and randomized cases at high-volume institutions versus low-volume institutions. RESULTS: The high-enrolling groups had a significantly lower mean hospital stay and operating time compared to the low-enrolling groups (P < 0.05). High-enrolling surgeons and institutions showed significantly shorter operating times, length of hospital stay, and complication rates. High-enrolling surgeons had significantly fewer device failures and cases of neurologic deterioration. Mean operating time and hospital stay were significantly lower in the randomized group (P < 0.05) compared to the nonrandomized group. Blood loss and approach-related complications were similar between the 2 groups. Device failure requiring removal was 4.2% in the nonrandomized group and 1.5% in the randomized group. CONCLUSIONS: Surgeons and institutions with a high volume of lumbar total disc replacement cases have a reduction in key perioperative and postoperative parameters that provide a clinical and/or economic benefit. Surgeons may expect longer hospital stays, higher blood loss, and a higher rate of certain complications in their early experience with total disc replacement procedures, but there was no effect on clinical outcomes. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study is to describe and compare older individuals (over the age of 55) presently incarcerated in the Tennessee State Prison System who have diagnosed with mental illnesses with those older prisoners without diagnoses of mental illnesses. Method (Design, Setting, Participants): This study examined 671 Tennessee State Prison inmates 55 years of age and older. These prisoners were divided into two groups: those having a diagnosis of mental illness and those without such a diagnosis. Factors such as incidence of reincarceration, length of sentencing, mental illnesses and offenses committed were compared. Results (Interventions, Measurements): This study showed many characteristics of the mentally ill geriatric offender. Significance was found between gender and psychiatric illness, as well as between gender and the illnesses of depression and dementia. Women with a depressive disorder were more likely to have committed murder, and men with dementia were more like to have committed a sex crime. Conclusions: These findings indicate that there are a number of older individuals currently incarcerated in Tennessee prisons. Sixteen percent of these individuals had a diagnosis of a mental illness. This study's findings raise critical issues relative to the older incarcerated mentally ill population, which require additional research. [ABSTRACT FROM AUTHOR]

US-bound immigrants and refugees undergo a mandatory overseas medical examination that includes tuberculosis screening; this exam is not routinely required for temporary visitors applying for non-immigrant visas (NIV) to visit, work, or study in the United States. US health departments and foreign ministries of health report tuberculosis cases in travelers to Centers for Disease Control and Prevention Quarantine Stations. We reviewed cases reported to this passive surveillance system from January 2011 to June 2016. Of 1252 cases of tuberculosis in travelers reported to CDC, 114 occurred in travelers with a long-term NIV. Of these, 83 (73%) were infectious; 18 (16%) with multidrug-resistant tuberculosis (MDR TB) and one with extensively drug-resistant tuberculosis (XDR TB). We found evidence that NIV holders are diagnosed with tuberculosis disease in the United States. Given that long-term NIV holders were over-represented in this data set, despite the small proportion (4%) of overall non-immigrant admissions they represent, expanding the US overseas migration health screening program to this population might be an efficient intervention to further reduce tuberculosis in the United States., (© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

COVID-19 vaccines protect against severe COVID-19-associated outcomes, including hospitalization and death. As SARS-CoV-2 has evolved, and waning vaccine effectiveness has been noted, vaccine formulations and policies have been updated to provide continued protection against severe illness and death from COVID-19. Since September 2022, bivalent mRNA COVID-19 vaccines have been recommended in the United States, but the variants these vaccines protect against are no longer circulating widely. On September 11, 2023, the Food and Drug Administration (FDA) approved the updated (2023-2024 Formula) COVID-19 mRNA vaccines by Moderna and Pfizer-BioNTech for persons aged ≥12 years and authorized these vaccines for persons aged 6 months-11 years under Emergency Use Authorization (EUA). On October 3, 2023, FDA authorized the updated COVID-19 vaccine by Novavax for use in persons aged ≥12 years under EUA. The updated COVID-19 vaccines include a monovalent XBB.1.5 component, which is meant to broaden vaccine-induced immunity and provide protection against currently circulating SARS-CoV-2 XBB-sublineage variants including against severe COVID-19-associated illness and death. On September 12, 2023, the Advisory Committee on Immunization Practices recommended vaccination with updated COVID-19 vaccines for all persons aged ≥6 months. These recommendations will be reviewed as new evidence becomes available or new vaccines are approved and might be updated., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.

An estimated 30 million passengers are transported on 272 cruise ships worldwide each year* (1). Cruise ships bring diverse populations into proximity for many days, facilitating transmission of respiratory illness (2). SARS-CoV-2, the virus that causes coronavirus disease (COVID-19) was first identified in Wuhan, China, in December 2019 and has since spread worldwide to at least 187 countries and territories. Widespread COVID-19 transmission on cruise ships has been reported as well (3). Passengers on certain cruise ship voyages might be aged ≥65 years, which places them at greater risk for severe consequences of SARS-CoV-2 infection (4). During February-March 2020, COVID-19 outbreaks associated with three cruise ship voyages have caused more than 800 laboratory-confirmed cases among passengers and crew, including 10 deaths. Transmission occurred across multiple voyages of several ships. This report describes public health responses to COVID-19 outbreaks on these ships. COVID-19 on cruise ships poses a risk for rapid spread of disease, causing outbreaks in a vulnerable population, and aggressive efforts are required to contain spread. All persons should defer all cruise travel worldwide during the COVID-19 pandemic., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.

Background: Ships destined for, or departing from, U.S. ports of entry must report certain signs and symptoms of potentially communicable diseases of public health interest among travelers to the Division of Global Migration and Quarantine (DGMQ) at the Centers for Disease Control and Prevention., Methods: We reviewed ships' varicella case and outbreak reports from January 2010 through December 2015., Results: DGMQ received 967 reports of varicella and 13 reports of herpes zoster. Most varicella case-patients were 20-49 years of age (84.7%, 472/557) and were cruise ship crew members (78.4%, 758/967). Most often, cruise ship crew member case-patients were born in or held passports from Indonesia (21.7%, 80/369), Philippines (17.6%, 65/369), or India (17.3%, 64/369). Ninety-nine varicella outbreaks were reported, including 439 varicella cases and one herpes zoster case; 97 (98.0%) outbreaks occurred on cruise ships, and 90.2% of associated cases were among crew members (397/440). Most varicella cases were in crew members, who are adults often from tropical regions where varicella immunity is acquired later in childhood or young adulthood or without varicella vaccination programs., Conclusion: Varicella vaccination as appropriate for susceptible travelers, particularly crew members, before maritime travel may decrease risk of varicella infection and prevent outbreaks on ships., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

In 2014, the Centers for Disease Control and Prevention conducted conveyance contact investigations for 2 Middle East respiratory syndrome cases imported into the United States, comprising all passengers and crew on 4 international and domestic flights and 1 bus. Of 655 contacts, 78% were interviewed; 33% had serologic testing. No secondary cases were identified.

Background: Deaths and certain illnesses onboard ships arriving at US ports are required to be reported to the US Centers for Disease Control and Prevention (CDC), and notifications of certain illnesses are requested., Methods: We performed a descriptive analysis of required maritime illness and death reports of presumptive diagnoses and requested notifications to CDC's Division of Global Migration and Quarantine, which manages CDC's Quarantine Stations, from January 2010 to December 2014., Results: CDC Quarantine Stations received 2891 individual maritime case reports: 76.8% (2221/2891) illness reports, and 23.2% (670/2891) death reports. The most frequent individual illness reported was varicella (35.9%, 797/2221) and the most frequently reported causes of death were cardiovascular- or pulmonary-related conditions (79.6%, 533/670). There were 7695 cases of influenza-like illness received within aggregate notifications. CDC coordinated 63 contact investigations with partners to identify 972 contacts; 88.0% (855/972) were notified. There was documentation of 6.5% (19/293) receiving post-exposure prophylaxis. Three pertussis contacts were identified as secondary cases; and one tuberculosis contact was diagnosed with active tuberculosis., Conclusion: These data provide a picture of US maritime illness and death reporting and response. Varicella reports are the most frequent individual disease reports received. Contact investigations identified few cases of disease transmission., (Copyright © 2017. Published by Elsevier Ltd.)

Objective: CDC routinely conducts contact investigations involving travelers on commercial conveyances, such as aircrafts, cargo vessels, and cruise ships., Methods: The agency used established systems of communication and partnerships with other federal agencies to quickly provide accurate traveler contact information to states and jurisdictions to alert contacts of potential exposure to two travelers with Middle East Respiratory Syndrome Coronavirus (MERS-CoV) who had entered the United States on commercial flights in April and May 2014., Results: Applying the same process used to trace and notify travelers during routine investigations, such as those for tuberculosis or measles, CDC was able to notify most travelers of their potential exposure to MERS-CoV during the first few days of each investigation., Conclusion: To prevent the introduction and spread of newly emerging infectious diseases, travelers need to be located and contacted quickly.

Rocky Mountain spotted fever (RMSF) is an emerging public health issue on some American Indian reservations in Arizona. RMSF causes an acute febrile illness that, if untreated, can cause severe illness, permanent sequelae requiring lifelong medical support, and death. We describe costs associated with medical care, loss of productivity, and death among cases of RMSF on two American Indian reservations (estimated population 20,000) between 2002 and 2011. Acute medical costs totaled more than $1.3 million. This study further estimated $181,100 in acute productivity lost due to illness, and $11.6 million in lifetime productivity lost from premature death. Aggregate costs of RMSF cases in Arizona 2002-2011 amounted to $13.2 million. We believe this to be a significant underestimate of the cost of the epidemic, but it underlines the severity of the disease and need for a more comprehensive study., (© The American Society of Tropical Medicine and Hygiene.)

Background: Rocky Mountain spotted fever (RMSF) is a disease that now causes significant morbidity and mortality on several American Indian reservations in Arizona. Although the disease is treatable, reported RMSF case fatality rates from this region are high (7%) compared to the rest of the nation (<1%), suggesting a need to identify clinical points for intervention., Methods: The first 205 cases from this region were reviewed and fatal RMSF cases were compared to nonfatal cases to determine clinical risk factors for fatal outcome., Results: Doxycycline was initiated significantly later in fatal cases (median, day 7) than nonfatal cases (median, day 3), although both groups of case patients presented for care early (median, day 2). Multiple factors increased the risk of doxycycline delay and fatal outcome, such as early symptoms of nausea and diarrhea, history of alcoholism or chronic lung disease, and abnormal laboratory results such as elevated liver aminotransferases. Rash, history of tick bite, thrombocytopenia, and hyponatremia were often absent at initial presentation., Conclusions: Earlier treatment with doxycycline can decrease morbidity and mortality from RMSF in this region. Recognition of risk factors associated with doxycycline delay and fatal outcome, such as early gastrointestinal symptoms and a history of alcoholism or chronic lung disease, may be useful in guiding early treatment decisions. Healthcare providers should have a low threshold for initiating doxycycline whenever treating febrile or potentially septic patients from tribal lands in Arizona, even if an alternative diagnosis seems more likely and classic findings of RMSF are absent., (Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.)

Background: Rocky Mountain spotted fever (RMSF) has emerged as a significant cause of morbidity and mortality since 2002 on tribal lands in Arizona. The explosive nature of this outbreak and the recognition of an unexpected tick vector, Rhipicephalus sanguineus, prompted an investigation to characterize RMSF in this unique setting and compare RMSF cases to similar illnesses., Methods: We compared medical records of 205 patients with RMSF and 175 with non-RMSF illnesses that prompted RMSF testing during 2002-2011 from 2 Indian reservations in Arizona., Results: RMSF cases in Arizona occurred year-round and peaked later (July-September) than RMSF cases reported from other US regions. Cases were younger (median age, 11 years) and reported fever and rash less frequently, compared to cases from other US regions. Fever was present in 81% of cases but not significantly different from that in patients with non-RMSF illnesses. Classic laboratory abnormalities such as low sodium and platelet counts had small and subtle differences between cases and patients with non-RMSF illnesses. Imaging studies reflected the variability and complexity of the illness but proved unhelpful in clarifying the early diagnosis., Conclusions: RMSF epidemiology in this region appears different than RMSF elsewhere in the United States. No specific pattern of signs, symptoms, or laboratory findings occurred with enough frequency to consistently differentiate RMSF from other illnesses. Due to the nonspecific and variable nature of RMSF presentations, clinicians in this region should aggressively treat febrile illnesses and sepsis with doxycycline for suspected RMSF., (Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.)

Objective: To evaluate whether cosmetically relevant dental effects occurred among children who had received doxycycline for treatment of suspected Rocky Mountain spotted fever (RMSF)., Study Design: Children who lived on an American Indian reservation with high incidence of RMSF were classified as exposed or unexposed to doxycycline, based on medical and pharmacy record abstraction. Licensed, trained dentists examined each child's teeth and evaluated visible staining patterns and enamel hypoplasia. Objective tooth color was evaluated with a spectrophotometer., Results: Fifty-eight children who received an average of 1.8 courses of doxycycline before 8 years of age and who now had exposed permanent teeth erupted were compared with 213 children who had never received doxycycline. No tetracycline-like staining was observed in any of the exposed children's teeth (0/58, 95% CI 0%-5%), and no significant difference in tooth shade (P=.20) or hypoplasia (P=1.0) was found between the 2 groups., Conclusions: This study failed to demonstrate dental staining, enamel hypoplasia, or tooth color differences among children who received short-term courses of doxycycline at <8 years of age. Healthcare provider confidence in use of doxycycline for suspected RMSF in children may be improved by modifying the drug's label., (Published by Elsevier Inc.)

Before the current Ebola epidemic in West Africa, there were few documented cases of symptomatic Ebola patients traveling by commercial airline, and no evidence of transmission to passengers or crew members during airline travel. In July 2014 two persons with confirmed Ebola virus infection who were infected early in the Nigeria outbreak traveled by commercial airline while symptomatic, involving a total of four flights (two international flights and two Nigeria domestic flights). It is not clear what symptoms either of these two passengers experienced during flight; however, one collapsed in the airport shortly after landing, and the other was documented to have fever, vomiting, and diarrhea on the day the flight arrived. Neither infected passenger transmitted Ebola to other passengers or crew on these flights. In October 2014, another airline passenger, a U.S. health care worker who had traveled domestically on two commercial flights, was confirmed to have Ebola virus infection. Given that the time of onset of symptoms was uncertain, an Ebola airline contact investigation in the United States was conducted. In total, follow-up was conducted for 268 contacts in nine states, including all 247 passengers from both flights, 12 flight crew members, eight cleaning crew members, and one federal airport worker (81 of these contacts were documented in a report published previously). All contacts were accounted for by state and local jurisdictions and followed until completion of their 21-day incubation periods. No secondary cases of Ebola were identified in this investigation, confirming that transmission of Ebola during commercial air travel did not occur.

In March 2014, CDC identified a possible cluster of four laboratory-confirmed measles cases among passengers transiting a domestic terminal in a U.S. international airport. Through epidemiologic assessments conducted by multiple health departments and investigation of flight itineraries by CDC, all four patients were linked to the same terminal gate during a 4-hour period on January 17, 2014. Patient 1, an unvaccinated man aged 21 years with rash onset February 1, traveled on two domestic flights on January 17 and 18 that connected at the international airport. Patient 2, an unvaccinated man aged 49 years with rash onset February 1, traveled from the airport on January 17. Patient 3, an unvaccinated man aged 19 years with rash onset January 30, traveled domestically with at least a 4-hour layover at the airport on January 17. Patient 4, an unvaccinated man aged 63 years with rash onset February 5, traveled on a flight to the airport on January 17.

Rocky Mountain spotted fever, a tick-borne disease caused by Rickettsia rickettsii, is challenging to diagnose and rapidly fatal if not treated. We describe a decedent who was co-infected with group A β-hemolytic streptococcus and R. rickettsii. Fatal cases of Rocky Mountain spotted fever may be underreported because they present as difficult to diagnose co-infections., (© The American Society of Tropical Medicine and Hygiene.)

On September 30, 2014, the Texas Department of State Health Services reported a case of Ebola virus disease (Ebola) diagnosed in Dallas, Texas, and confirmed by CDC, the first case of Ebola diagnosed in the United States. The patient (patient 1) had traveled from Liberia, a country which, along with Sierra Leone and Guinea, is currently experiencing the largest recorded Ebola outbreak. A nurse (patient 2) who provided hospital bedside care to patient 1 in Texas visited an emergency department (ED) with fever and was diagnosed with laboratory-confirmed Ebola on October 11, and a second nurse (patient 3) who also provided hospital bedside care visited an ED with fever and rash on October 14 and was diagnosed with laboratory-confirmed Ebola on October 15. Patient 3 visited Ohio during October 10-13, traveling by commercial airline between Dallas, Texas, and Cleveland, Ohio. Based on the medical history and clinical and laboratory findings on October 14, the date of illness onset was uncertain; therefore, CDC, in collaboration with state and local partners, included the period October 10-13 as being part of the potentially infectious period, out of an abundance of caution to ensure all potential contacts were monitored. On October 15, the Ohio Department of Health requested CDC assistance to identify and monitor contacts of patient 3, assess the risk for disease transmission, provide infection control recommendations, and assess and guide regional health care system preparedness. The description of this contact investigation and hospital assessment is provided to help other states in planning for similar events.

Study Design: The current study of 251 consecutive 1-level anterior cervical reconstructions was undertaken to compare the incidence of dysphagia between cervical disk replacement and conventional anterior cervical fusion and instrumentation., Objectives: This is a report of 251 patients from 5 investigational centers in the Food and drug Administration's prospective, randomized porous-coated motion (PCM) trial using a validated dysphagia outcomes instrument. The dysphagia data for both PCM and anterior cervical diskectomy and fusion (ACDF) patients were reviewed from 5 centers to (1) compare the severity of dysphagia, (2) compare the postoperative incidence of dysphagia, and (3) to compare the resolution of perioperative dysphagia., Summary of Background Data: Dysphagia and dysphonia after anterior surgical approaches to the cervical spine have been previously reported. The current prospective, randomized investigation quantifies clinical dysphagia based on 3 criteria-severity, incidence, and resolution-in a time-course evaluation., Methods: Patients between 18 and 65 years with 1-level symptomatic cervical radiculopathy and/or myelopathy for progressive neurologic symptoms, were randomized to undergo anterior decompression and PCM arthroplasty (N=151) or ACDF (control) (N=100). Patients self-reported dysphagia severity using the Bazaz scale preoperatively and at follow-up. The Bazaz scale has 4 classes of severity based upon the problems with swallowing that the patient has with both liquids and solids., Results: The Bazaz results demonstrate that although both the PCM and ACDF groups exhibited an initial postoperative problem with swallowing, the PCM group continued to improve with increasing time after implantation, whereas the ACDF only improved minimally. The PCM treatments indicated significantly lower incidence of dysphagia at 3 and 12 months postoperatively compared with ACDF controls (P<0.05). An increase in dysphagia severity at either the 6-week or 3-month follow-up visit was reported in 35 (42%) PCM and 29 (64%) ACDF subjects. Long-term resolution of these symptoms was noted in 74% (26/35) of the PCM subjects as compared with 41.4% (12/29) of the ACDF subjects (P=0.015)., Conclusions: In a prospective randomized clinical study the incidence of postoperative dysphagia and the long-term resolution of the dysphagia was greatly improved in the PCM group compared with the instrumented ACDF control group.

Background Context: The CHARITE artificial disc, a lumbar spinal arthroplasty device, was approved by the United States Food and Drug Administration in 2004 based on two-year safety and effectiveness data from a multicenter, prospective, randomized investigational device exemption (IDE) study. No long-term, randomized, prospective study on the CHARITE disc or any other artificial disc has been published to date., Purpose: The purpose of this study was to compare the safety and effectiveness at the five-year follow-up time point of lumbar total disc replacement using the CHARITE artificial disc (DePuy Spine, Raynham, MA) with that of anterior lumbar interbody fusion (ALIF) with BAK cages and iliac crest autograft, for the treatment of single-level degenerative disc disease from L4 to S1, unresponsive to nonoperative treatment., Study Design/setting: Randomized controlled trial-five-year follow-up., Patient Sample: Ninety CHARITE patients and 43 BAK patients., Outcome Measures: Self-reported measures: visual analog scale (VAS); validated Oswestry disability index (ODI version 1.0); Short-Form 36 Questionnaire, and patient satisfaction. Physiologic measures: radiographic range of motion, disc height, and segmental translation. Functional measures: work status., Methods: Of the 375 subjects enrolled in the CHARITE IDE trial, 277 were eligible for the five-year study and 160 patients thereof completed the five-year follow-up. The completers included 133 randomized patients. Overall success was defined as improvement> or =15 pts in ODI vs. baseline, no device failure, absence of major complications, and maintenance or improvement of neurological status. Additional clinical outcomes included an ODI questionnaire as well as VAS, SF-36, and patient satisfaction surveys. Work status was tracked for all patients. Safety assessments included occurrence and severity of adverse events and device failures. Radiographic analyses such as index- and adjacent-level range of motion, segmental translation, disc height, and longitudinal ossification were also carried out., Results: Overall success was 57.8% in the CHARITE group vs. 51.2% in the BAK group (Blackwelder's test: p=0.0359, Delta=0.10). In addition, mean changes from baseline for ODI (CHARITE: -24.0 pts vs. BAK: -27.5 pts), VAS pain scores (CHARITE: -38.7 vs. BAK: -40.0), and SF-36 questionnaires (SF-36 Physical Component Scores [PCS]: CHARITE: 12.6 pts vs. BAK: 12.3 pts) were similar across groups. In patient satisfaction surveys, 78% of CHARITE patients were satisfied vs. 72% of BAK patients. A total of 65.6% patients in the CHARITE group vs. 46.5% patients in the BAK group were employed full-time. This difference was statistically significant (p=0.0403). Long-term disability was recorded for 8.0% of CHARITE patients and 20.9% of BAK patients, a difference that was also statistically significant (p=0.0441). Additional index-level surgery was performed in 7.7% of CHARITE patients and 16.3% of BAK patients. Radiographic findings included operative and adjacent-level range of motion (ROM), intervertebral disc height and segmental translation. At the five-year follow-up, the mean ROM at the index level was 6.0 degrees for CHARITE patients and 1.0 degrees for BAK patients. Changes in disc height were also similar for both CHARITE and BAK patients (0.7 mm for both groups, p=0.9827). Segmental translation was 0.4 and 0.8mm in patients implanted with CHARITE at L4-L5 vs. L5-S1, respectively, and 0.1mm in BAK patients., Conclusions: The results of this five-year, prospective, randomized multicenter study are consistent with the two-year reports of noninferiority of CHARITE artificial disc vs. ALIF with BAK and iliac crest autograft. No statistical differences were found in clinical outcomes between groups. In addition, CHARITE patients reached a statistically greater rate of part- and full-time employment and a statistically lower rate of long-term disability, compared with BAK patients. Radiographically, the ROMs at index- and adjacent levels were not statistically different from those observed at two-years postsurgery.

Object: A secondary lumbar surgery at a previously surgically treated level is believed to result in minimal clinical improvement. The clinical results of the CHARITE Investigational Device Exemption (IDE) study were analyzed to assess the effect of previous surgery on clinical outcomes following either total disc replacement with the CHARITE device or anterior lumbar interbody fusion with a BAK cage and iliac crest autograft., Methods: Patients with prior microdiscectomy, laminectomy, or minimal medial facetectomy were not excluded from enrollment in the CHARITE IDE study. Thus, the following 3 groups were analyzed: all patients treated with the CHARITE Artificial Disc, whether randomized or nonrandomized; only patients treated with CHARITE devices randomized against patients with BAK devices; and control patients with BAK devices. Each group was further subdivided based on the patients' medical history, whether they had undergone prior surgery (prior surgery group) or had not (no prior surgery group). For all groups, baseline demographics were collected and compared for any potential recruitment bias. Postoperative improvements based on Oswestry Disability Index (ODI), visual analog scale (VAS), and patient satisfaction scores were further collected and statistically analyzed., Results: For all 3 groups, there were no statistical differences in clinical improvement from 3 months to 2 years postoperatively as measured using ODI and VAS scores between the subgroups (those who had prior surgery and those who did not)., Conclusions: Patients indicated for 1-level lumbar arthroplasty with previous lumbar decompressive surgery can be expected to have similar clinical outcomes to patients undergoing arthroplasty without prior lumbar decompressive surgery. Similarly, candidates for anterior lumbar fusion with prior decompressive surgery may experience similar benefits from the surgical procedure as those without.

Object: Patient selection is perhaps the most important factor in successful lumbar surgery. In this study, the authors analyzed the clinical outcomes of patients enrolled in the CHARITE investigational device exemption (IDE) trial who underwent revision surgery after primary total disc replacement with CHARITE or an anterior lumbar interbody fusion (ALIF) with placement of a BAK cage and iliac crest autograft. This revision surgery was either a supplemental posterior lumbar fixation or a 360 degrees fusion. Statistical analysis was conducted to compare clinical success in patients who underwent revision surgery with those who did not., Methods: The patients enrolled in the CHARITE IDE study were divided into 6 groups according to treatment and repeated operation status, and their Oswestry Disability Index (ODI) and visual analog scale (VAS) scores at the 2-year follow-up and at baseline were compared. The patients had received the following treatments by group: A) ALIF without reoperation; B) ALIF with conversion to 360 degrees fusion; C) arthroplasty (randomized) without repeated operation; D) arthroplasty with supplemental posterior lumbar fixation; E) arthroplasty (nonrandomized) without repeated operation; and F) arthroplasty (nonrandomized) with supplemental posterior lumbar fixation. Outcome scores in the groups of patients who required revision surgeries (Groups B, D, and F; 23 patients) were compared with the groups that did not require revision surgery (Groups A, C, and E; 299 patients)., Results: Patients who required revision surgery had a significantly lower level of clinical improvement than those who did not. The mean change in ODI score was -53.0% in Groups A, C, and E, but just -12.7% in Groups B, D, and F (p < 0.0001). The mean change in VAS score was -59.1% in Groups A, C, and E, compared to -23.4% in Groups B, D, and F (p < 0.0001). No significant differences were identified in analyzing absolute change in scores and the percentage change. A comparison of outcomes in patients who had undergone arthroplasty without reoperation (Groups C and E) with all patients who had undergone revision surgery (Groups B, D, and F) demonstrated similar results (p < 0.0001)., Conclusions: The 7.1% of patients who underwent a secondary stabilization procedure had poor clinical improvement. This finding may indicate that if the alternative treatment had been the initial treatment, these patients would not have benefited, and further implies a 7.1% rate of imprecision in preoperative evaluation.

Object: One of the goals of lumbar arthroplasty is to restore and maintain range of motion (ROM) and to protect adjacent levels from abnormal motion, which may be a factor in transition syndrome following arthrodesis. In this study, in vitro ROM results were compared with in vivo, 2-year postoperative radiographic ROM evaluations., Methods: Radiographs of patients enrolled in the CHARITE investigational device exemption study were analyzed at baseline and at 2 years postoperatively. The ROM in flexion/extension at the implanted and adjacent levels was measured, normalized, and compared with ROM results obtained using cadaver (in vitro) evaluations., Results: Preoperative ROM distributions in patients enrolled for arthroplasty or fusion at the L4-5 level was as follows: 28% motion was observed at L3-4, 35% at L4-5 and 37% at L5-S1. Following a one-level arthroplasty at L4-5, the in vivo ROM distribution from L-3 to S-1 at the 2-year time point was 36% at L3-4, 30% at L4-5 and 35% at L5-S1. Following a one-level fusion with BAK and pedicle screws at L4-5, the in vivo ROM distribution from L-3 to S-1 at the 2-year time point was 45% at L3-4, 9% at L4-5 and 46% at L5-S1., Conclusions: The baseline as well as the 2-year in vivo data confirmed previously published in vitro data. One-level arthroplasty was shown herein to replicate the normal distribution of motion of the intact spine.

Background Context: Degenerative disc disease (DDD) is a cause of low back pain commonly requiring surgical intervention. The option of lumbar total disc replacement (TDR) represents an advance in the surgical treatment of DDD. However, new treatments, particularly those that include the use of new implants, may lead to increased costs to both hospitals and payers. Therefore, it is both necessary and appropriate to examine the potential costs associated with a new procedure such as total disc replacement compared with traditional treatments for a specific pathology., Purpose: To perform an economic analysis of lumbar TDR versus three different techniques for lumbar fusion., Study Design/setting: A cost-minimization model., Methods: An economic model examining hospital and payer cost perspectives was developed to compare costs of TDR with the CHARITE Artificial Disc to three spinal fusion procedures: anterior lumbar interbody fusion (ALIF) with iliac crest bone graft (ICBG); ALIF with INFUSE Bone Graft and LT-Cages, and instrumented posterior lumbar interbody fusion (IPLIF) with ICBG. The hospital perspective compares direct medical costs during the index hospitalization. The payer perspective considers direct medical costs of the index hospitalization and those incurred in the following two-year period. The model contains a Diagnostic Related Group (DRG) arm based strictly on DRG coding and payment, and a per-diem arm that includes a device carve-out cost and payment., Results: In the DRG and per-diem arms of the model, compared with TDR, hospital costs are 12.0% higher for ALIF with ICBG, 36.5% higher for ALIF with INFUSE, and 36.5% higher for IPLIF. For payers, in the per-diem arm compared with TDR, ALIF with ICBG has 4.4% lower cost, whereas ALIF with INFUSE and IPLIF have costs of 16.1% and 27.1% higher, respectively. In the DRG arm compared with TDR, payer cost is 87.1% higher for ALIF with ICBG, 82.8% higher for ALIF with INFUSE, and 99.0% higher for IPLIF., Conclusions: The model shows that the overall economic effect of one-level TDR procedures on hospitals and payers is likely to be less than or at worse equivalent to one-level lumbar fusion procedures.

Background: Introduction of a new surgical technology may result in higher rates of adverse events compared with rates reported in the study performed to gain regulatory approval. The purpose of our study was to describe the incidence of reported adverse events during the first 18 months following US Food and Drug Administration (FDA) approval of the first lumbar arthroplasty device available in the United States and to discern data trends., Methods: Reports of adverse events submitted to the FDA in patients receiving the Charité artificial disc were reviewed and pooled by similarity. We analyzed 135 medical device reports filed with the FDA regarding the Charité artificial disc between October 26, 2004, and April 26, 2006. Sixteen reports were excluded for lack of information regarding cause or because described events were vague or unrelated to the procedure., Results: Rate of adverse events reported to the FDA as a percentage of devices of which the device manufacturer was aware had been dispensed at 6, 12, and 18 months following approval was 0.58%, 2.34%, and 2.13%, respectively. The adverse event reported most frequently through 18 months was anterior migration with reoperation (0.65%); other reported adverse events were, in decreasing order, sizing and malposition errors resulting in reoperation (0.36%), posterior element fracture resulting in reoperation (0.30%), major vascular injury requiring a blood transfusion (0.23%), and subsidence requiring reoperation (0.20%). Three non-device-related patient deaths were reported following FDA approval. The reported rate of sizing/malposition errors leading to reoperation of 0.36% was the same rate as that seen in the investigational device exemption (IDE) study of the Charité artificial disc. All other reported rates were lower than rates of the same events reported in the study., Conclusions: Medical device reporting is an important yet highly anecdotal and incomplete event-tracking process. However, it is the principal means available in the United States for obtaining information on the clinical performance of a device after its approval for sale and does provide some data, albeit imperfect, in this regard. The cumulative medical device reports through the 18 months following FDA approval, measured against the number of devices dispensed, suggests a rate of adverse events that either tracks or is somewhat less than that reported in the IDE study. This suggests that a repeat of the "cage rage," a "lumbar arthroplasty rage," has not yet occurred.

Background: Previous reports of lumbar total disc replacement (TDR) have described significant complications. The US Food and Drug Administration (FDA) investigational device exemption (IDE) study of the Charité artificial disc represents the first level I data comparison of TDR to fusion., Methods: In the prospective, randomized, multicenter IDE study, patients were randomized in a 2:1 ratio, with 205 patients in the Charité group and 99 patients in the control group (anterior lumbar interbody fusion [ALIF] with BAK cages). Inclusion criteria included confirmed single-level degenerative disc disease at L4-5 or L5-S1 and failure of nonoperative treatment for at least 6 months. Complications were reported throughout the study., Results: The rate of approach-related complications was 9.8% in the investigational group and 10.1% in the control group. The rate of major neurological complications was similar between the 2 groups (investigational = 4.4%, control = 4.0%). There was a higher rate of superficial wound infection in the investigational group but no deep wound infections in either group. Pseudarthrosis occurred in 9.1% of control group patients. The rate of subsidence in the investigational group was 3.4%. The reoperation rate was 5.4% in the investigational group and 9.1% in the control group., Conclusions: The incidence of perioperative and postoperative complications for lumbar TDR was similar to that of ALIF. Vigilance is necessary with respect to patient indications, training, and correct surgical technique to maintain TDR complications at the levels experienced in the IDE study.

Background: Several lumbar disc prostheses are being developed with the goal of preserving mobility in patients with degenerative disc disease. The disadvantage of lumbar artificial disc replacement (ADR) compared with anterior interbody fusion (ALIF) is the increased potential for displacement or component failure. Revision or removal of the device is complicated by adherence of the aorta, iliac vessels, and the ureter to the operative site. Because of these risks of anterior lumbar procedures, vascular surgeons usually provide access to the spine. We report our experience with secondary exposure of the lumbar spine for revision or explantation of the Charité disc prosthesis., Methods: Between January 2001 and May 2006, 19 patients with prior implantation of Charité Artificial Discs required 21 operations for repositioning or removal of the device. Two patients had staged removal of prostheses at two levels. One patient had simultaneous explantation at two levels. The mean age was 49 years (range, 31 to 69 years; 56% men, 42% women). The initial ADR was performed at our institution in 14 patients (74%). The mean time from implantation to reoperation was 7 months (range, 9 days to 4 years). The levels of failure were L3-4 in one, L4-5 in nine, and L5-S1 in 12., Results: The ADR was successfully removed or revised in all patients that underwent reoperation. Three of the 12 procedures at L5-S1 were performed through the same retroperitoneal approach as the initial access. One of these three, performed after a 3-week interval, was converted to a transperitoneal approach because of adhesions. The rest of the L5-S1 prostheses were exposed from a contralateral retroperitoneal approach. Four of the L4-5 prostheses were accessed from the original approach and five from a lateral, transpsoas exposure (four left, one right). The only explantation at L3-4 was from a left lateral transpsoas approach. Nineteen of the 22 ADR were converted to ALIF. Two revisions at L5-S1 involved replacement of the entire prosthesis. One revision at L4-5 required only repositioning of an endplate. Access-related complications included, in one patient each, iliac vein injury, temporary retrograde ejaculation, small-bowel obstruction requiring lysis, and symptomatic, large retroperitoneal lymphocele. There were no permanent neurologic deficits, deep vein thromboses, or deaths., Conclusions: Owing to vascular and ureteral fixation, anterior exposure of the lumbar spine for revision or explantation of the Charité disc replacement should be performed through an alternative approach unless the procedure is performed < or = 2 weeks of the index procedure. The L5-S1 level can be accessed through the contralateral retroperitoneum. Reoperation at L3-4 and L4-5 usually requires explantation and fusion that is best accomplished by way of a lateral transpsoas exposure.

Study Design: A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial., Objectives: The purpose of this study was to compare the safety and effectiveness of lumbar total disc replacement, using the CHARITE artificial disc (DePuy Spine, Raynham, MA), with anterior lumbar interbody fusion, for the treatment of single-level degenerative disc disease from L4-S1 unresponsive to nonoperative treatment., Summary of Background Data: Reported results of lumbar total disc replacement have been favorable, but studies have been limited to retrospective case series and/or small sample sizes., Methods: Three hundred four (304) patients were enrolled in the study at 14 centers across the United States and randomized in a 2:1 ratio to treatment with the CHARITE artificial disc or the control group, instrumented anterior lumbar interbody fusion. Data were collected pre- and perioperatively at 6 weeks and at 3, 6, 12, and 24 months following surgery. The key clinical outcome measures were a Visual Analog Scale assessing back pain, the Oswestry Disability Index questionnaire, and the SF-36 Health Survey., Results: Patients in both groups improved significantly following surgery. Patients in the CHARITE artificial disc group recovered faster than patients in the control group. Patients in the CHARITE artificial disc group had lower levels of disability at every time interval from 6 weeks to 24 months, compared with the control group, with statistically lower pain and disability scores at all but the 24 month follow-up (P < 0.05). At the 24-month follow-up period, a significantly greater percentage of patients in the CHARITE artificial disc group expressed satisfaction with their treatment and would have the same treatment again, compared with the fusion group (P < 0.05). The hospital stay was significantly shorter in the CHARITE artificial disc group (P < 0.05). The complication rate was similar between both groups., Conclusions: This prospective, randomized, multicenter study demonstrated that quantitative clinical outcome measures following lumbar total disc replacement with the CHARITE artificial disc are at least equivalent to clinical outcomes with anterior lumbar interbody fusion. These results support earlier reports in the literature that total disc replacement with the CHARITE artificial disc is a safe and effective alternative to fusion for the surgical treatment of symptomatic disc degeneration in properly indicated patients. The CHARITE artificial disc group demonstrated statistically significant superiority in two major economic areas, a 1-day shorter hospitalization, and a lower rate of reoperations (5.4% compared with 9.1%). At 24 months, the investigational group had a significantly higher rate of satisfaction (73.7%) than the 53.1% rate of satisfaction in the control group (P = 0.0011). This prospective randomized multicenter study also demonstrated an increase in employment of 9.1% in the investigational group and 7.2% in the control group.

Study Design: A prospective, randomized, multicenter, Food and Drug Administration-regulated, investigational device exemption clinical trial., Objectives: To compare the safety and effectiveness of lumbar total disc replacement (TDR) with the CHARITE artificial disc (DePuy Spine, Raynham, MA) to anterior lumbar interbody fusion for the treatment of single-level degenerative disc disease from L4-S1 unresponsive to nonoperative treatment. In addition, to evaluate the radiographic outcomes of lumbar artificial disc replacement at either L4-L5 or L5-S1 with the CHARITE artificial disc as compared to anterior lumbar interbody fusion with cylindrical cages and iliac crest bone graft; and to determine if a correlation exists between clinical outcomes and surgical accuracy of TDR placement within the disc space., Summary of Background Data: Prior investigators have reported excellent radiographic results with the CHARITE artificial disc for the treatment of lumbar degenerative disc disease. These encouraging results are the product of retrospective reviews without a control. Very few studies have reported on the segmental motion of an intervertebral level implanted with an artificial disc, and no studies have reported a correlation of radiographic and clinical outcomes., Methods: A prospective, randomized, multicenter, US Food and Drug Administration, investigational device exemption study with 24-month follow-up was performed at 14 centers throughout the United States. A total of 304 subjects were randomized in a 2:1 ratio, with 205 in the investigational group (TDR with the CHARITE artificial disc) and 99 in the control group (anterior lumbar interbody fusion with BAK cages and iliac crest bone graft). A total of 71 TDR training cases were performed (up to 5 at each site) before randomization beginning at each site. Plain radiographs were analyzed for each subject in both groups regarding range of motion (ROM) in flexion/extension, restoration of disc space height, and subsidence. Prosthesis placement in the coronal and midsagittal planes was analyzed for the 276 patients with TDR. Correlations were performed between prosthesis placement and clinical outcomes., Results: Patients in the investigational group had a 13.6% mean increase, and those in the control group an 82.5% decrease in mean flexion/extension ROM at 24 months postoperatively compared to baseline. Patients in the investigational group had significantly better restoration of disc height than the control group (P < 0.05). There was significantly less subsidence in the investigational group compared to the control group (P < 0.05). The surgical technical accuracy of CHARITE artificial disc placement was divided into 3 groups: I, ideal (83%); II, suboptimal (11%); and III, poor (6%), and correlated with clinical outcomes. The flexion/extension ROM and prosthesis function improved with the surgical technical accuracy of radiographic placement (P = 0.003)., Conclusions: Preoperative ROM in flexion/extension was restored and maintained in patients receiving a TDR. TDR with the CHARITE artificial disc resulted in significantly better restoration of disc space height, and significantly less subsidence than anterior interbody fusion with BAK cages. Clinical outcomes and flexion/extension ROM correlated with surgical technical accuracy of CHARITE artificial disc placement. In the majority of cases, placement of the CHARITE artificial disc was ideal.

To preserve segmental lumbar motion and to prevent adjacent segment disease, there has been a growing enthusiasm for the use of intervertebral disc prosthesis as an alternative to segmental lumbar fusion. To date, more than 100-disc prostheses have been designed, but only 10 prostheses have been approved and implanted in humans. The Charité Artificial Disc has had the longest clinical follow-up with more than 5000 implantations in over 30 countries and reported > 10-year satisfactory results.

Spinal deformity has classically and historically been studied by those in the discipline of orthopedic surgery. This may be attributable to the orthopedic interventionalists' experience with osseous fixation for long-bone and other skeletal fractures. Neurosurgeons have maintained a long-standing interest in complex cervical spinal disorders, and their interest in the larger field of complex spinal deformity has been expanding. An understanding of spinal deformity disorders, biomechanics, bone biology, and metallurgy is necessary before clinical, teaching, and research activities can be undertaken within neurosurgery. The authors describe basic and advanced concepts of spinal deformity management with cases to illustrate teaching points.

Object: The authors evaluated cervical spine radiographs to determine sagittal alignment in patients who underwent one- or two-level arthroplasty with the Bryan cervical artificial disc prosthesis., Methods: The curvature of the surgically treated spinal segments and the overall curvature of the cervical spine were evaluated in 13 patients who underwent 16 cervical arthroplasty device placements. Preoperative and postoperative lateral radiographs were reviewed and compared using standardized techniques for measuring spinal curvature. Patients who underwent a single-level cervical arthroplasty had a 4.7 degrees mean reduction (p < 0.05) in lordosis after cervical artificial disc replacement. The three patients who underwent two-level cervical arthroplasty had no significant changes in the sagittal alignment., Conclusions: Patients who underwent arthroplasty with a Bryan cervical artificial disc had a focal loss of lordosis (that is, kyphosis) at the treated levels after single-level procedures. Nevertheless, there was no significant change in the overall sagittal curvature of the cervical spine after single-level artificial disc replacements. The patients who underwent two-level artificial disc placement had no significant changes in lordosis at the treated levels or in the overall curvature. The likely source of this outcome appears to be the endplate milling procedures that reorient the vertebral endplates.

Object: Arthrodesis is the gold standard for surgical treatment of lumbar degenerative disc disease (DDD). Solid fusion, however, can cause stress and increased motion in the segments adjacent to the fused level. This may initiate and/or accelerate the adjacent-segment disease process. Artificial discs are designed to restore and maintain normal motion of the lumbar intervertebral segment. Restoring and maintaining normal motion of the segment reduces stresses and loads on adjacent level segments. A US Food and Drug Administration Investigational Device Exemptions multicentered study of the Charité artificial disc was completed. The control group consisted of individuals who underwent anterior lumbar interbody fusion involving BAK cages and iliac crest bone graft. This is the first report of Class I data in which a lumbar artificial disc is compared with lumbar fusion., Methods: Of 304 individuals enrolled in the study, 205 were randomized to the Charité disc-treated group and 99 to the BAK fusion-treated (control) group. Neurological status was equivalent between the two groups at 6, 12, and 24 months postoperatively. The number of patients with major, minor, or other neurological complications was equivalent. There was a greater incidence of both major and minor complications in the BAK fusion group at 0 to 42 days postoperatively. Compared with data reported in the lumbar fusion literature, the Charité disc-treated patients had equivalent or better mean changes in visual analog scale and Oswestry Disability Index scores., Conclusions: The Charité artificial disc is safe and effective for the treatment of single-level lumbar DDD, resulting in no higher incidence of neurological complications compared with BAK-assisted fusion and leading to equivalent or better outcomes compared with those obtained in the control group and those reported in the lumbar fusion literature.

Study Design: A description of a novel surgical approach to the lumbar spine and a prospective evaluation of the early surgical outcomes., Objectives: Describe the early postoperative results and the operative technique of a new, minimally invasive transpsoas approach for anterior fusion of the lumbar spine that minimizes the risk to large vessels and other critical structures., Summary of Background Data: Standard anterior endoscopic approaches to the lumbar spine require mobilization of the great vessels and sympathetic plexus. Vascular injury and retrograde ejaculation are complications clearly associated with this approach. A retroperitoneal, transpsoas approach to the lumbar spine may reduce these risks., Methods: From 1996 to 2002, 21 patients (13 females, 8 males; mean age 50.0 years) underwent an endoscopic, retroperitoneal transpsoas approach for exposure of the lumbar spine. Surgical indications included discogenic pain in 14 patients, spinal instability at a level adjacent to a previous fusion in 3 patients, and progressive degenerative scoliosis in 4 patients. Data were reviewed to document the early postoperative results for this procedure. Illustrations were created to clearly describe this approach., Results: Average operative time for the single level cases was 149 minutes (range 120-170 minutes); blood loss was 150 cc (range 50-650); postoperative hospital stay was 4.1 days. At long-term follow-up, visual analogue scale scores had decreased an average of 5.9. Mean follow-up was 3.1 years (range 2 months-6.0 years). Six patients (30%) experienced paresthesias in the groin/thigh region. Five of these same patients also complained of groin/thigh pain (27%). Two patients had symptoms that lasted longer than 1 month. One patient was converted to a mini-open lateral approach. There were no vascular injuries., Conclusions: Early results show the endoscopic lateral transpsoas approach to the lumbar spine to be a safe, minimally invasive method for anterior fusion of the first through the fourth lumbar vertebrae. Although there is a risk of groin/thigh numbness or pain, and these symptoms are mostly transient. This approach allows for exposure of the lumbar spine without mobilization of the great vessels or sympathetic plexus.

Since the fifth century BC, physicians have sworn to uphold the Hippocratic Oath that includes the statement, "Whatever, in connection with my professional service, ... I see or hear, in the life of men, which ought not be spoken abroad, I will not divulge, as reckoning that all such should be kept secret." However, health care and provider responsibility have evolved so as to make this more difficult for physicians to uphold. We discuss growing issues surrounding health care providers' ability to maintain patient confidentiality and to perform their responsibilities, and their "duty to warn and/or protect" third parties. Particular Tennessee cases heard on appeal show a change in the health care enviromnent relative to provider liability to third parties.

The legal concept of vicarious liability and the Doctrine of Respondeat Superior occurs when the servant (employee) commits a tort or civil wrong within the scope of employment and the master (employer) is held liable although the master may have done nothing wrong. In this article, legal cases are presented to emphasize the importance of these issues, which frequently involve physician extenders and physicians as employers in our current health care climate. Physicians need to be aware of this doctrine in the supervision of their staff and their day-to-day medical practice.

Study Design: Prospectively collected data from regular clinical follow-up evaluations were tabulated, analyzed, reviewed using a patient self-reported questionnaire., Objective: To develop a classification system and present the long-term functional outcome of video-assisted thorascopic surgery for refractory thoracic disc disease., Summary of Background Data: Recent studies have found an 11.1% to 14.5% prevalence of thoracic disc herniations. Surgical approaches have included laminectomy, pediculectomy, costotransversectomy, lateral extracavitary, transverse arthropediculectomy, transthoracic-transpleural thoracotomy, and thoracoscopy. Recent reports have documented encouraging early results with video-assisted thorascopic surgery for thoracic disc herniations. Comparisons between thoracoscopy and open thoracotomy have demonstrated improvement in postoperative pain and morbidity with the use of endoscopic techniques., Methods: This study included 100 consecutive patients (45 women and 55 men) with an average follow-up evaluation of 4 years (range, 2-6 years). The average age of the patients was 42 years (range, 22-76 years). The average duration of symptoms was 26 months (range, 6-96 months), and 18 patients had undergone prior spine surgery. Patients were graded as follows according to the presenting symptoms (Table 1): Grade 1 (pure axial; n = 28), Grade 2 (pure radicular; n = 5), Grade 3A (axial and thoracic radicular; n = 38), Grade 3B (axial with lower leg pain; n = 19), Grade 4 (myelopathic; n = 8), or Grade 5 (paralytic = 2)., Results: A total of 117 discs were excised in 100 patients. Of the 40 patients who underwent fusion, 27 had autologous rib struts and 13 had threaded fusion. The mean operative time was 173 minutes, blood loss 259 mL, average ICU stay less than 1 day, and average hospital stay 4 days. Minor complications occurred in 21 patients, all of which resolved with no untoward effect. No patient's neurologic status worsened. Four patients underwent a secondary fusion, and a pseudarthrosis developed in one patient. Clinical success was defined objectively as an improvement in Oswestry score of 20% or more at 2 years and at final follow-up assessment, as compared with the preoperative Oswestry score. Overall, objective clinical success was observed at 2 years in 73% of the patients, and at final follow-up assessment in 70% of patients. The average percentage of improvement in Oswestry scores was most marked in Grade 4 patients (myelopathy; 60%), followed by Grade 3A patients (axial and thoracic radicular pain; 37%), Grade 3B patients (axial with leg pain; 28%), and Grade 1 patients (pure axial; 24%). The Oswestry disability score (Table 2) and back pain visual analog score (Table 3) also were significantly improved (P < 0.05) at 2 years and at final follow-up assessment in these patients. In the Grade 2 patients, those pure thoracic radicular pain, Oswestry scores initially improved significantly up to 1 year (P < 0.05). At 2 years, no significant improvement could be shown, and four of the five Grade 2 patients reported increased axial pain as their main symptom at the final follow-up assessment. Significant improvement also was seen in patients with no prior spine surgery and patients with preoperative Oswestry disability scores greater than 50. Of the 68 patients who responded to the final questionnaire, 12 rated the procedure as excellent, 37 as good, 11 as fair, and 8 as poor. Also, 57 (83.8%) of these 68 patients were satisfied and indicated they would recommend the surgery. Of the 36 patients at the final follow up assessment who had severe disability, 34 (94%) were satisfied, as compared with 23 of the 32 patients (72%) who had presented with milder disability., Conclusions: The clinical classification system helps in differentiating different presentations of thoracic disc disease and their final outcome. Video-assisted thorascopic surgery appears to be a safe and efficacious method for the treatment of refractory symptomatic thoracic disc herniations. The current data suggest that the procedure has an acceptable long-term outcome, with an 84% overall subjective patient satisfaction rate, and with objective long-term clinical success achieved in 70% of patients.

The thorascopic approach for the microsurgical removal of herniated thoracic discs is described, and perioperative management is also discussed. The microsurgical techniques used for decompression of the spinal canal in the thoracic spine are presented in detail. The diagnostic imaging, surgical positioning, approach, port placement, localization of the thoracic level, exposure of the surgical field, excision of the rib head, exposure with removal of the herniated disc, and postoperative management are outlined. Surgical and operative "pearls" in thoracoscopic spinal surgery for removing herniated thoracic discs when possible are described and illustrated.

The effectiveness of mediation as a primary tool to resolve pharmaceutical service denials by managed care is discussed. A three-month prospective randomized trial of 48 medical appeal cases involving prescription drugs was conducted by Tennessee's Department of Health. Patients whose prescription claims were denied by the state's Medicaid managed care program and whose appeals were deemed medically unnecessary by one of two independent reviewers were randomly assigned to either a standard procedure group or a mediation group. Appeals assigned to the standard procedure group were immediately referred for administrative hearing. In the mediation group, the independent reviewer assigned to the case contacted the patient's care provider, discussed the case, and recommended an alternative drug. The care provider either accepted the suggested compromise, concluding the appeals process, or declined the suggestion, allowing the appeal to go to hearing. Reviewers recorded the amount of time they spent on each appeal. The mediation did not substantially increase the time the reviewers spent on each case (mean +/- S.D. minutes, 15.83+/-7.89 mediation versus 12.26+/-6.96 standard procedure). The mean number of appealed drugs was also similar between groups (1.46+/-0.78 mediation versus 1.35+/-0.89 standard procedure). Only 21% of appealed cases went to hearings in the mediation group, while 80% did in the standard procedure group. The average cost to the state for employing mediation ($142.92+/-$186.77) was significantly lower than the average cost incurred by using standard procedures ($355.75+/-$175.43). Mediation is an effective and efficient tool for resolving patients' appeals of denied pharmaceutical services.

Study Design: Operative reports were reviewed for patients who underwent laparoscopic fusion at the L4-L5 level and information regarding the mobilization of the vessels was recorded., Objective: The purpose of this study was to describe variations in the approach used to address anatomical variations in the location of the great vessel bifurcation in the region of the L4-L5 intervertebral disc space when performing laparoscopic interbody fusion procedures., Summary of Background Data: Recent interest in laparoscopic spine surgery using threaded cages has resulted in questions regarding the ability to safely access the L4-L5 disc using this approach. The laparoscopic transperitoneal approach to L5-S1 is below the bifurcation of the great vessels, thus requiring minimal mobilization of the iliac vessels. However, the transperitoneal approach to L4-L5 may be complicated by the bifurcation of the great vessels anterior to this disc space. Difficulty in placing two cages may occur if the vessels cannot be adequately mobilized., Methods: Data were collected for the consecutive series of the first 58 patients (40 males, 18 females; mean age 42.5 years) undergoing laparoscopic anterior lumbar interbody fusion (ALIF) at the L4-L5 level using BAK cages. Operative notes were reviewed to determine variations in the operative approach. In particular, it was recorded if the L4-L5 disc was accessed above, or below the bifurcation of the aorta and the vena cava, or between these structures. The blood loss, operative time, and length of hospitalization were compared with respect to approach variation., Results: In 30 patients, the L4-L5 disc was accessed above the great vessel bifurcation, in 18 patients below the bifurcation, and in the remaining 10 patients, by passing between the vessels. There were no statistically significant differences in the operative time, blood loss, or length of hospitalization with respect to the approach used. Three patients were converted to open procedures as a result of bleeding from segmental veins. None required transfusions and there were no postoperative sequelae. In two patients, successful endoscopic repair of segmental vein avulsion from the vena cava was performed using endoscopic loop ligatures. One patient had a secondary procedure to remove a cage that was causingnerve irritation, and one patient reported retrograde ejaculation after a two level fusion. Another patient, in whom a posterior herniation was removed, later presented with a cerebrospinal fluid leak. Most of the operative complications occurred early in the series., Conclusions: Laparoscopic transperitoneal approach to L4-L5 for insertion of threaded fusion cages is feasible. The laparoscopic L4-L5 procedure can be accomplished with few complications, provided a dedicated team of collaborative surgeons with experience in laparoscopic spine techniques is employed. Variations in vascular anatomy did not prevent successful insertion of two threaded fusion cages.

Object: In this review the authors address the surgical strategies required to resect residual herniated thoracic discs., Methods: Data obtained in 15 patients who had undergone prior thoracic discectomy and who harbored residual or incompletely excised symptomatic thoracic discs were reviewed retrospectively. The surgical procedures that had failed to excise the herniated discs completely included 11 posterolateral approaches, one thoracotomy, and three thoracoscopy-guided surgical procedures. Of the lesions that were incompletely resected or residual, there were 13 central calcified, two soft. 12 extradural, and three intradural discs. Indications for reoperation were often multiple in each patient and included misidentification of the level of disc disease at the initial operation (five cases), abandoning the procedure because of intraoperative spinal cord injury (three cases), inadequate visualization of the pathological entity (eight cases), migration of a soft disc fragment within the spinal canal (one case), and intradural disc extension (three cases). The symptoms at the time of reoperation included myelopathy in 13 patients and radicular pain in two patients. The mean interval before reoperation was 150 days (range 1 day-4 years). The reoperation procedures included one thoracotomy and 14 video-assisted thoracoscopic procedures performed ipsilateral (11 cases) or contralateral (four cases) to the site of the initial surgery. The herniated disc material was excised completely in all 15 cases without causing new neurological deficits. Reoperation complications included atelectasis in three patients, intercostal neuralgia in two, a loosened screw that required removal in one, residual intradural disc herniation that required a second reoperation in one patient, and a cerebrospinal fluid leak in one patient. Of the 13 patients who experienced myelopathy prior to operation, 10 recovered neurological function and three stabilized. All patients with radicular pain improved., Conclusions: Calcified, large, broad-based, centrally located, or transdural thoracic disc herniations can be difficult to resect. These lesions require a ventral operative approach to visualize the dura adequately for a safe and complete resection.

Study Design: Two hundred-forty consecutive patients underwent laparoscopic instrumented interbody fusion using custom-designed instrumentation and BAK (Sulzer Spine Tech, Minneapolis, MN) fusion cages. The surgeries were performed at eight spine centers during U.S. Food and Drug Administration investigational device evaluation clinical trials. This cohort was compared with 591 consecutive patients undergoing open anterior fusion with the same device., Objectives: To investigate the feasibility and safety of the laparoscopic approach compared with that of open procedures., Summary of Background Data: In other areas of medicine, advances in laparoscopic surgical procedures have resulted in reduced morbidity, expense, and pain when compared with results of the open counterpart., Methods: The open anterior procedure was performed using a retroperitoneal approach. The laparoscopic procedure was performed transperitoneally with carbon dioxide insufflation to provide visualization using a 10-mm endoscope. Two hollow, titanium, threaded interbody implants packed with autologous bone were inserted into the diseased interspace., Results: The laparoscopy group had a shorter hospital stay and reduced blood loss but had increased operative time. Operative time improved in the laparoscopy group as surgeons' experience increased. Operative complications were comparable in both groups, with an occurrence of 4.2% in the open approach and 4.9% in the laparoscopic approach. Overall, the device-related reoperation rate was higher in the laparoscopy group (4.7% vs. 2.3%), primarily as a result of intraoperative disc herniation. Conversion to open procedure in the laparoscopy group was 10%, with most cases predictable and preventable., Conclusions: The laparoscopic procedure is associated with a learning curve, but once mastered, it is effective and safe when compared with open techniques of fusion.

Study Design: Eighteen patients with lumbar instability from fractures, postlaminectomy syndrome, or infection were treated prospectively with minimally invasive retroperitoneal lumbar fusions., Objectives: To determine if interbody Bagby and Kuslich fusion cages and femoral allograft bone dowels can be inserted in a transverse direction via a lateral endoscopic retroperitoneal approach to achieve spinal stability., Summary of Background Data: Endoscopic spinal approaches have been used to achieve lower lumbar fusion when instrumentation is placed through a laparoscopic, transperitoneal route. However, complications of using this approach include postoperative intra-abdominal adhesions, retrograde ejaculation, great vessel injury, and implant migration. This study is the first clinical series investigating the use of the lateral retroperitoneal minimally invasive approach for lumbar fusions from L1 to L5., Methods: Eighteen patients underwent anterior interbody decompression and/or stabilization via endoscopic retroperitoneal approaches. In most cases, three 12-mm portals were used. Two parallel transverse interbody cages restored the neuroforaminal height and the desired amount of lumbar lordosis was achieved by inserting a larger anterior cage, distraction plug, or bone dowel., Results: The overall morbidity of the procedure was lower than that associated with traditional "open" retroperitoneal or laparotomy techniques, with a mean length of hospital stay of 2.9 days (range, outpatient procedure to 5 days). The mean estimated intraoperative blood loss was 205 cc (range, 25-1000 cc). There were no cases of implant migration, significant subsidence, or pseudoarthrosis at mean follow-up examination of 24.3 months (range, 12-40 months) after surgery., Conclusions: This preliminary study of 18 patients illustrates that endoscopic techniques can be applied effectively through a retroperitoneal approach with the patient in the lateral position. Unlike the patients who had undergone transperitoneal procedures described in previous reports, in these preliminary 18 patients, there were no cases of retrograde ejaculation, injury to the great vessels, or implant migration.