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Francis Lovecchio, Jeffrey G. Stepan, Ajay Premkumar, Michael E. Steinhaus, Maria Sava, Peter Derman, Han Jo Kim and Todd Albert

OBJECTIVE

Patients with lumbar spine pathology are at high risk for opioid misuse. Standardizing prescribing practices through an institutional intervention may reduce the overprescribing of opiates, leading to a decrease in the risk for opioid misuse and the number of pills available for diversion. Without quantitative data on the “minimum necessary quantity” of opioids appropriate for postdischarge prescriptions, the optimal method for changing existing prescribing practices is unknown. The purpose of this study was to determine whether mandatory provider education and prescribing guidelines could modify prescriber behavior and lead to a decreased amount of opioids prescribed at hospital discharge following lumbar spine surgery.

METHODS

Qualified staff were required to attend a mandatory educational conference, and a consensus method among the spine service was used to publish qualitative prescribing guidelines. Prescription data for 2479 patients who had undergone lumbar spine surgery were captured and compared based on the timing of surgery. The preintervention group consisted of 1177 patients who had undergone spine surgery in the period before prescriber education and guidelines (March 1, 2016–November 1, 2016). The postintervention group consisted of 1302 patients who had undergone spine surgery after the dissemination of the guidelines (February 1, 2017–October 1, 2017). Surgeries were classified as decompression or fusion procedures. Patients who had undergone surgeries for infection and patients on long-acting opioids were excluded.

RESULTS

For all lumbar spine surgeries (decompression and fusion), the mean amount of opioids prescribed at discharge was lower after the educational program and distribution of prescribing guidelines (629 ± 294 oral morphine equivalent [OME] preintervention vs 490 ± 245 OME postintervention, p < 0.001). The mean number of prescribed pills also decreased (81 ± 26 vs 66 ± 22, p < 0.001). Prescriptions for 81 or more tablets dropped from 65.5% to 25.5%. Tramadol was prescribed more frequently after prescriber education (9.9% vs 18.6%, p < 0.001). Refill rates within 6 weeks were higher after the institutional intervention (7.6% vs 12.4%, p < 0.07).

CONCLUSIONS

Qualitative guidelines and prescriber education are effective in reducing the amount of opioids prescribed at discharge and encouraging the use of weaker opioids. Coupling provider education with prescribing guidelines is likely synergistic in achieving larger reductions. The sustainability of these changes is yet to be determined.

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Kris Radcliff, Domagoj Coric and Todd Albert

OBJECTIVE

The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C) versus anterior cervical discectomy and fusion (ACDF). Although the long-term outcome of single-level disc replacement has been extensively described, there have not been previous reports of the 5-year outcome of 2-level cervical disc replacement.

METHODS

This study reports the 5-year results of a prospective, randomized US FDA investigational device exemption (IDE) study conducted at 24 centers in patients with 2-level, contiguous, cervical spondylosis. Clinical outcomes at up to 60 months were evaluated, including validated outcome measures, incidence of reoperation, and adverse events. The complete study data and methodology were critically reviewed by 3 independent surgeon authors without affiliation with the IDE study or financial or institutional bias toward the study sponsor.

RESULTS

A total of 225 patients received the Mobi-C cervical total disc replacement device and 105 patients received ACDF. The Mobi-C and ACDF follow-up rates were 90.7% and 86.7%, respectively (p = 0.39), at 60 months. There was significant improvement in all outcome scores relative to baseline at all time points. The Mobi-C patients had significantly more improvement than ACDF patients in terms of Neck Disability Index score, SF-12 Physical Component Summary, and overall satisfaction with treatment at 60 months. The reoperation rate was significantly lower with Mobi-C (4%) versus ACDF (16%). There were no significant differences in the adverse event rate between groups.

CONCLUSIONS

Both cervical total disc replacement and ACDF significantly improved general and disease-specific measures compared with baseline. However, there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the 2-level disc replacement patients versus ACDF control patients.

Clinical trial registration no. NCT00389597 (clinicaltrials.gov)

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Albert F. Pull ter Gunne, Cees J. H. M. van Laarhoven, Allard J. F. Hosman and Joost J. van Middendorp

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Jordan Gruskay, Jeremy Smith, Christopher K. Kepler, Kristen Radcliff, James Harrop, Todd Albert and Alexander Vaccaro

Object

Studies from many disciplines have found an association with the summer months, elevated temperature, humidity, and an increased rate of infection. The “July effect,” a hypothesis that the inexperience of new house staff at the beginning of an academic year leads to an increase in wound complications, has also been considered. Finally, an increase in trauma-related admissions in the summer months is likely to result in an increased incidence of postoperative infections. Two previous studies revealed mixed results concerning perioperative spinal wound infections in the summer months. The purpose of this study was to determine the months and/or seasons of the year that display significant fluctuation of postoperative infection rate in spine surgery. Based on the idea that infection rates are susceptible to seasonal factors, the authors hypothesized that spinal infections would increase during the summer months.

Methods

Inclusion criteria were all spine surgery cases at a single tertiary referral institution between January 2005 and December 2009; 8122 cases were included. Patients presenting with a contaminated wound or active infection were excluded. Infection rates were calculated on a monthly and seasonal basis and compared.

Results

A statistically significant increase in the infection rate was present on both a seasonal and monthly basis (p = 0.03 and p = 0.024) when looking at the seasonal change from spring to summer. A significant decrease in the infection rate was seen on a seasonal basis during the change from fall to winter (p = 0.04). The seasonal rate of infection was highest in the summer (4.1%) and decreased to the lowest point in the spring (2.8%) (p = 0.03).

Conclusions

At the authors' institution, spine surgeries performed during the summer and fall months were associated with a significantly higher incidence of wound infection compared with the winter and spring. These data support the existence of a seasonal effect on perioperative spinal infection rates, which may be explained by seasonal variation in weather patterns and house staff experience, among other factors.

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Steven M. Kurtz, Edmund Lau, Kevin L. Ong, Leah Carreon, Heather Watson, Todd Albert and Steven Glassman

Object

This retrospective analysis of Medicare administrative data was performed to evaluate the risk of infection following instrumented lumbar fusion over a 10-year follow-up period in the Medicare population. Although infection can be a devastating complication, due to its rarity it is difficult to characterize infection risk except in large patient populations.

Methods

Using ICD-9-CM and CPT4 procedure codes, the Medicare 5% analytical research files for inpatient, outpatient, and physician carrier claims were checked to identify patients who were treated between 1997 and 2009 with lumbar spine fusion in which cages or posterior instrumentation were used. Patients younger than 65 years old were excluded. Patients were followed continuously by using the matching denominator file until they withdrew from Medicare or died. The authors identified 15,069 patients with primary fusion procedures and 605 with revision of instrumented lumbar fusion. Infections were identified by the related ICD-9 codes (998.59 or 996.67) after fusion. Kaplan-Meier survival analysis and Cox regression were performed to determine adjusted infection risk for each type of spine procedure (primary vs revision) and surgical approach (anterior, posterior, combined anteroposterior), accounting for patient (for example, age, sex, comorbidities/Charlson Comorbidity Index [CCI], and state buy-in) and hospital (census region) characteristics.

Results

At 10 years, the overall infection incidence, including superficial and deep infections, was 8.5% in primary procedures and 12.2% in revisions. Among the factors considered, infection risk within 10 years was most influenced by comorbidities: for a CCI of 5 versus 0, the adjusted hazard ratio (AHR) was 2.48 (95% CI 1.93–3.19, p < 0.001); for ≥ 9 versus 2–3 fused vertebrae, the AHR was 2.39 (95% CI 1.20–4.76, p < 0.001); for revision versus primary fusion procedures, the AHR was 1.66 (95% CI 1.28–2.15, p < 0.001). Other significant predictors of 10-year infection risk included diagnosis of obesity (p < 0.001); state buy-in—a proxy for socioeconomic status (p = 0.02); age (p = 0.003); surgical approach (p = 0.03); census region (p = 0.02); and the year of the index procedure (p = 0.03).

Conclusions

Patient comorbidities were the greatest predictor of infection risk for the Medicare population. The high incidence of infection following instrumented fusion warrants increased focus on infection risk mitigation, especially for patients with comorbid conditions.

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John K. Ratliff, Bryan Lebude, Todd Albert, Tony Anene-Maidoh, Greg Anderson, Phillip Dagostino, Mitchel Maltenfort, Alan Hilibrand, Ashwini Sharan and Alexander R. Vaccaro

Object

Definitions of complications in spinal surgery are not clear. Therefore, the authors assessed a group of practicing spine surgeons and, through the surgeons' responses to an online and emailed survey, developed a simple definition of operative complications due to spinal surgery. To validate this assessment, the authors revised their survey to make it appropriate for a lay audience and repeated the assessment with a cohort of patients who underwent spine surgery.

Methods

The authors surveyed a cohort of practicing spine surgeons via email and a web-based survey. Surgeons were presented with various complication scenarios and were asked to grade the presence or absence of a complication as well as complication severity, with responses limited to “major complication” and “minor complication/adverse event.” The authors administered a similar assessment, modified for lay persons, to patients in a spinal surgery clinic.

Results

Complete responses were obtained from 229 surgeons; orthopedic surgeons comprised the majority of respondents (73%). The authors obtained completed surveys from 197 patients. Overall, there was consistent agreement between physicians and patients regarding the presence or absence of a complication in the majority of scenarios (8 [73%] of 11 scenarios with agreement that a complication was present). The overall kappa value, evaluating major versus minor complication, and presence or absence of a complication over the entire cohort, was fair (κ = 0.21). The authors found greater variation between the cohorts when evaluating complication severity. Patients were consistently more critical than physicians in the majority of scenarios in which a difference was evident. In 4 scenarios, patients were more likely than surgeons to deem the scenario a complication and to grade the complication as major versus minor (p < 0.01). In 3 additional scenarios, patients were more likely than physicians to grade a major complication as opposed to minor complication (p < 0.01). In only 1 scenario were patients less likely than physicians to report a complication (p < 0.001).

Conclusions

Comparing responses of spine surgeons and patients who underwent spinal surgery in assessing a group of common postoperative events, the authors found significant agreement on perception of presence of a complication in the majority of scenarios reviewed. However, patients were consistently more critical than surgeons when differences in reporting were found. The authors' data underscore the importance of reconciling differing opinions regarding complications through open discussions between physicians and patients to ensure accurate patient expectations of planned medical or surgical interventions.