99 results on '"Heller JG"'
Search Results
2. Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial.
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Heller JG, Sasso RC, Papadopoulos SM, Anderson PA, Fessler RG, Hacker RJ, Coric D, Cauthen JC, Riew DK, Heller, John G, Sasso, Rick C, Papadopoulos, Stephen M, Anderson, Paul A, Fessler, Richard G, Hacker, Robert J, Coric, Domagoj, Cauthen, Joseph C, and Riew, Daniel K
- Abstract
Study Design: A prospective, randomized, multicenter study of surgical treatment of cervical disc disease.Objective: To assess the safety and efficacy of cervical disc arthroplasty using a new arthroplasty device at 24-months follow-up.Summary Of Background Data: Cervical disc arthroplasty preserves motion in the cervical spine. It is an alternative to fusion after neurologic decompression, whereas anterior decompression and fusion provides a rigorous comparative benchmark of success.Methods: We conducted a randomized controlled multicenter clinical trial enrolling patients with cervical disc disease. Ultimately 242 received the investigational device (Bryan Cervical Disc), and 221 patients underwent a single-level anterior cervical discectomy and decompression and fusion as a control group. Patients completed clinical and radiographic follow-up examinations at regular intervals for 2 years after surgery.Results: Analysis of 12- and 24-month postoperative data showed improvement in all clinical outcome measures for both groups; however, 24 months after surgery, the investigational group patients treated with the artificial disc had a statistically greater improvement in the primary outcome variables: Neck disability index score (P = 0.025) and overall success (P = 0.010). With regard to implant- or implant/surgical-procedure-associated serious adverse events, the investigational group had a rate of 1.7% and the control group, 3.2%. There was no statistical difference between the 2 groups with regard to the rate of secondary surgical procedures performed subsequent to the index procedure. Patients who received the artificial cervical disc returned to work nearly 2 weeks earlier than the fusion patients (P = 0.015).Conclusion: Two-year follow-up results indicate that cervical disc arthroplasty is a viable alternative to anterior cervical discectomy and fusion in patients with persistently symptomatic, single-level cervical disc disease. [ABSTRACT FROM AUTHOR]- Published
- 2009
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3. Artificial disc versus fusion: a prospective, randomized study with 2-year follow-up on 99 patients.
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Sasso RC, Smucker JD, Hacker RJ, and Heller JG
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- 2007
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4. Magnetic resonance imaging clarity of the Bryan, Prodisc-C, Prestige LP, and PCM cervical arthroplasty devices.
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Sekhon LH, Duggal N, Lynch JJ, Haid RW, Heller JG, Riew KD, Seex K, and Anderson PA
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- 2007
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5. Outcomes review of laminoplasty for the treatment of multilevel cervical spondylotic myelopathy.
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Park AE and Heller JG
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- 2006
6. Dysphagia after anterior cervical decompression and fusion: prevalence and risk factors from a longitudinal cohort study.
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Riley LH III, Skolasky RL, Albert TJ, Vaccaro AR, Heller JG, Riley, Lee H 3rd, Skolasky, Richard L, Albert, Todd J, Vaccaro, Alexander R, and Heller, John G
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- 2005
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7. An AOA critical issue. Disc replacements: this time will we really cure low-back and neck pain?
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Boden SD, Balderston RA, Heller JG, Hanley EN Jr., Zigler JE, Boden, Scott D, Balderston, Richard A, Heller, John G, Hanley, Edward N Jr, and Zigler, Jack E
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- 2004
8. Accurate identification of adverse outcomes after cervical spine surgery.
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Edwards CC II, Karpitskaya Y, Cha C, Heller JG, Lauryssen C, Yoon ST, Riew KD, Edwards, Charles C 2nd, Karpitskaya, Yekaterina, Cha, Chuck, Heller, John G, Lauryssen, Carl, Yoon, S Timothy, and Riew, K Daniel
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Background: Retrospective clinical studies frequently utilize surgeon records as a source of outcomes data. The accuracy of data derived from surgeon records, however, is unknown. The purpose of the present study was to evaluate the accuracy of surgeon records in documenting the prevalence of subjective adverse outcomes.Methods: Consecutive patients who had undergone anterior cervical arthrodesis by four spine surgeons during a ten-month period were included. Surgeon records from the routine six-week, three-month, and six-month postoperative visits were examined for documentation of persistent dysphagia and dysphonia. Patients completed surveys inquiring about the presence and magnitude of symptoms at these three time-points. Agreement between the surgeon records and the patient surveys was analyzed with use of the kappa coefficient.Results: One hundred and sixty-six patients had 342 postoperative visits. Dysphagia was documented twenty-six times in the surgeon records, compared with 107 times on the patient surveys. Dysphagia was thus underreported in 80% of cases. Similarly, dysphonia was documented ten times in the surgeon records, compared with seventy-two times on the patient surveys. Poor correlation between the surgeon records and the patient surveys was observed regardless of symptom severity, previous anterior cervical surgery, anterior arthrodesis of three motion segments or more, arthrodesis cephalad to the fifth cervical level, and anterior cervical plate use. Poor correlation between the surgeon records and the patient surveys also was observed for each surgeon, regardless of subspecialty or institution.Conclusions: Correlation between the surgeon records and the patient surveys was consistently poor, regardless of the specific patient and surgeon factor analyzed. While we chose to study dysphonia and dysphagia, it is conceivable that the results may be generalizable to many situations in which office notes are utilized to ascertain the prevalence of subjective adverse outcomes. These results suggest that the prevalence of such outcomes may be seriously underreported in studies that rely on the retrospective analysis of surgeon records. [ABSTRACT FROM AUTHOR]- Published
- 2004
9. Laminoplasty versus laminectomy and fusion for multilevel cervical myelopathy: an independent matched cohort analysis.
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Heller JG, Edwards CC II, Murakami H, Rodts GE, Heller, J G, Edwards, C C 2nd, Murakami, H, and Rodts, G E
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- 2001
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10. Patients May Return to Work Sooner After Laminoplasty: Occupational Outcomes of the Cervical Spondylotic Myelopathy Surgical Trial.
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Miranda SP, Whitmore RG, Kanter A, Mummaneni PV, Bisson EF, Barker FG 2nd, Harrop J, Magge SN, Heary RF, Fehlings MG, Albert TJ, Arnold PM, Riew KD, Steinmetz MP, Wang MC, Heller JG, Benzel EC, and Ghogawala Z
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- Humans, Male, Female, Middle Aged, Treatment Outcome, Adult, Prospective Studies, Aged, Spinal Fusion methods, Spinal Fusion statistics & numerical data, Spinal Cord Diseases surgery, Return to Work statistics & numerical data, Laminoplasty methods, Spondylosis surgery, Cervical Vertebrae surgery, Decompression, Surgical methods
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Background and Objectives: Return-to-work (RTW) is an important outcome for employed patients considering surgery for cervical spondylotic myelopathy (CSM). We conducted a post hoc analysis of patients as-treated in the Cervical Spondylotic Myelopathy Surgical Trial, a prospective, randomized trial comparing surgical approaches for CSM to evaluate factors associated with RTW., Methods: In the trial, patients were randomized (2:3) to either anterior surgery (anterior cervical decompression/fusion [ACDF]) or posterior surgery (laminoplasty [LP], or posterior cervical decompression/fusion [PCDF], at surgeon's discretion). Work status was recorded at 1, 3, 6, and 12 months postoperatively. For patients working full-time or part-time on enrollment, time to RTW was compared across as-treated surgical groups using discrete-time survival analysis. Multivariate logistic regression was used to assess predictors of RTW. Clinical outcomes were compared using a linear mixed-effects model., Results: A total of 68 (42%) of 163 patients were working preoperatively and were analyzed. In total, 27 patients underwent ACDF, 29 underwent PCDF, and 12 underwent LP. 45 (66%) of 68 patients returned to work by 12 months. Median time to RTW differed by surgical approach (LP = 1 month, ACDF = 3 months, PCDF = 6 months; P = .02). Patients with longer length-of-stay were less likely to be working at 1 month (odds ratio 0.51; 95% CI, 0.29-0.91; P = .022) and 3 months (odds ratio 0.39; 95% CI, 0.16-0.96; P = .04). At 3 months, PCDF was associated with lower Short-Form 36 physical component summary scores than ACDF (estimated mean difference [EMD]: 6.42; 95% CI, 1.4-11.4; P = .007) and LP (EMD: 7.98; 95% CI, 2.7-13.3; P = .003), and higher Neck Disability Index scores than ACDF (EMD: 12.48; 95% CI, 2.3-22.7; P = .01) and LP (EMD: 15.22; 95% CI, 2.3-28.1; P = .014), indicating worse perceived physical functioning and greater disability, respectively., Conclusion: Most employed patients returned to work within 1 year. LP patients resumed employment earliest, while PCDF patients returned to work latest, with greater disability at follow-up, suggesting that choice of surgical intervention may influence occupational outcomes., (Copyright © Congress of Neurological Surgeons 2024. All rights reserved.)
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- 2025
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11. Trends in Cervical Laminoplasty Incidence in the United States: A Comparison of Commercial Insurance, Medicare, and Device Manufacturer Databases.
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Rajan PV, Heo K, Heller JG, and Yoon ST
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Study Design: Retrospective database study., Objective: To leverage a commercial insurance claims database to explore trends in laminoplasty utilization and reimbursement in the United States. Secondarily, volume estimates were compared with data from the industry and from the Centers for Medicare and Medicaid (CMS)., Summary of Background Data: With purported benefits of motion preservation and lower complication rates than fusion, cervical laminoplasty is an important surgical technique. However, current commercial database studies suggest that laminoplasty adoption in the United States has been slow., Methods: The primary outcome was the total volume of laminoplasty procedures performed in the United States per year. Truven, a large commercial insurance claims database, was used to estimate laminoplasty volume from 2009 to 2019. Volume estimates for posterior cervical fusions were also generated as a comparator. Reimbursement data for laminoplasty adjusted for inflation were also generated. Trends in national procedural volumes and reimbursement over time were assessed with the Pearson correlation test. CMS Part B national summary statistics from 2000 to 2022 and market data from laminoplasty device manufacturers from 2017 to 2024 were qualitatively compared with volume estimates from Truven., Results: Truven volume of laminoplasty remained stable throughout the study period with an estimated annual volume of 944-1590 cases. Posterior cervical fusion volume was much higher, ranging from 7930 to 11,874 cases with increased trend. When compared qualitatively, Truven volume estimates were similar to those from CMS data, although industry volume estimates were comparatively higher (estimated total volume of 8352-11,428 cases). There was no statistically significant trend in Truven reimbursement values for laminoplasty from 2009 to 2019., Conclusions: Industry market data suggest more laminoplasty procedures are being performed nationally than what is estimated by commercial/CMS databases. This suggests possible growth in laminoplasty usage, given purported advantages to fusion in the properly indicated patient, and possibly calls into question the epidemiological accuracy of commercial claims databases., Level of Evidence: IV-Retrospective study., Competing Interests: J.G.H. reports intellectual property royalties, paid consultancy, paid presenter or speaker, and stock or stock options with Medtronic. S.T.Y. reports royalties from Meditech and Alphatec, paid consultancy with Alphatec, stock or stock options with Medyssey, research support from Empiric Spine and AOSpine, and board member/committee appointments for ISSLS and AOSpine Degen KF. The remaining authors declare no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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12. Association of Poor Bone Quality with Pseudarthrosis and Poor Clinical Outcomes in Single-Level Instrumented Lumbar Arthrodesis Using Local Autologous Bone Graft.
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Boden LM, Heller JG, and Fischgrund JS
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- Adult, Aged, Female, Humans, Male, Middle Aged, Bone Density, Osteoporosis complications, Tomography, X-Ray Computed, Transplantation, Autologous, Treatment Outcome, Bone Transplantation methods, Lumbar Vertebrae surgery, Lumbar Vertebrae diagnostic imaging, Pseudarthrosis surgery, Pseudarthrosis diagnostic imaging, Spinal Fusion methods
- Abstract
Introduction: Although osteoporosis and low bone mineral density is thought to lead to poor fusion outcomes, few studies have adequately addressed the correlation, and they were limited by small sample size at a single institution., Methods: We completed a secondary analysis of 182 patients enrolled at 26 spine centers across the United States in the EXO-SPINE FDA-approved clinical trial with 12-month CT-based fusion status determined by two independent, blinded radiologists. Using previously described CT-based techniques, we measured local and global Hounsfield units (HU) and examined the relationship with radiographic and clinical outcomes., Results: CT scans were available for review from 95 patients, with a mean age of 56.2 years and mean global density of 153.0 HU. No relationship was observed between HU and radiographic fusion status or clinical outcomes. Although 12% of patients had lumbar vertebral body HU measurements consistent with osteoporosis, this classification had no relation with fusion or clinical outcomes. Patients with pseudarthrosis had higher Oswestry Disability Index (22.2 vs. 16.6, P = 0.037) and back pain visual analog scale (7.0 vs. 4.9, P = 0.014) scores than patients with at least unilateral fusion at the 12-month follow-up., Discussion: In this large, multicenter study, lower vertebral body HU was not associated with worse fusion status after single-level instrumented posterolateral lumbar fusion using only local autologous bone graft. However, there was an association between radiographic fusion status and clinical outcomes, validating the importance of determining predictors of successful fusion. Assessment of fusion status with CT scans yielded a much lower fusion success rate with local bone graft than previously reported and may warrant additional investigation., (Copyright © 2024 by the American Academy of Orthopaedic Surgeons.)
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- 2024
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13. Assessing the Influence of Climate Change and Environmental Factors on the Top Tick-Borne Diseases in the United States: A Systematic Review.
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Deshpande G, Beetch JE, Heller JG, Naqvi OH, and Kuhn KG
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In the United States (US), tick-borne diseases (TBDs) have more than doubled in the past fifteen years and are a major contributor to the overall burden of vector-borne diseases. The most common TBDs in the US-Lyme disease, rickettsioses (including Rocky Mountain spotted fever), and anaplasmosis-have gradually shifted in recent years, resulting in increased morbidity and mortality. In this systematic review, we examined climate change and other environmental factors that have influenced the epidemiology of these TBDs in the US while highlighting the opportunities for a One Health approach to mitigating their impact. We searched Medline Plus, PUBMED, and Google Scholar for studies focused on these three TBDs in the US from January 2018 to August 2023. Data selection and extraction were completed using Covidence, and the risk of bias was assessed with the ROBINS-I tool. The review included 84 papers covering multiple states across the US. We found that climate, seasonality and temporality, and land use are important environmental factors that impact the epidemiology and patterns of TBDs. The emerging trends, influenced by environmental factors, emphasize the need for region-specific research to aid in the prediction and prevention of TBDs.
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- 2023
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14. Influence of participant and reviewer characteristics in application scores for a hematology research training program.
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Vesely SK, King A, Vettese E, Heller JG, Cuker A, Calhoun C, Stock W, Homer M, Fritz J, and Sung L
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- Humans, Male, Female, Minority Groups education, School Admission Criteria, Internship and Residency
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The American Society of Hematology Clinical Research Training Institute (CRTI) is a clinical research training program with a competitive application process. The objectives were to compare application scores based on applicant and reviewer sex and underrepresented minority (URM) status. We included applications to CRTI from 2003 to 2019. The application scores were transformed into a scale from 0 to 100 (100 was the strongest). The factors considered were applicant and reviewer sex and URM status. We evaluated whether there was an interaction between the characteristics and time related to application scores. In total, 713 applicants and 2106 reviews were included. There was no significant difference in scores according to applicant sex. URM applicants had significantly worse scores than non-URM applicants (mean [standard error] 67.9 [1.56] vs 71.4 [0.63]; P = .0355). There were significant interactions between reviewer sex and time (P = .0030) and reviewer URM status and time (P = .0424); thus, results were stratified by time. For the 2 earlier time periods, male reviewers gave significantly worse scores than did female reviewers; this difference did not persist for the most recent time period. The URM reviewers did not give significantly different scores across time periods. URM applicants received significantly lower scores than non-URM applicants. The impact of reviewer sex and URM status changed over time. Although male reviewers gave lower scores in the early periods, this effect did not persist in the late period. Efforts are required to mitigate the impact of applicant URM status on application scores., (© 2023 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.)
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- 2023
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15. Using Electrical Stimulation of the Ulnar Nerve Trunk to Predict Postoperative Improvement in Hand Clumsiness in Patients With Cervical Spondylotic Myelopathy.
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Murata S, Takami M, Endo T, Hashizume H, Iwasaki H, Tsutsui S, Nagata K, Murakami K, Taiji R, Kozaki T, Heller JG, and Yamada H
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- Humans, Prospective Studies, Ulnar Nerve, Cervical Vertebrae surgery, Postoperative Period, Electric Stimulation, Treatment Outcome, Spinal Cord Diseases surgery, Laminoplasty, Spinal Osteophytosis surgery, Spondylosis surgery
- Abstract
Study Design: A prospective cohort study., Objective: To investigate whether the immediate and short-term effects of preoperative electrical peripheral nerve stimulation (ePNS) on performance of the 10-second test could predict the early postoperative outcomes of patients with cervical spondylotic myelopathy (CSM)., Summary of Background Data: Previous studies have shown that early clinical improvement in CSM patients may be because of reversal of spinal cord ischemia after spinal cord compression., Materials and Methods: We conducted a 10-second test before surgery, after ePNS, and at discharge (one week after surgery) in 44 patients with CSM who underwent C3-C7 laminoplasty and evaluated their correlations. The effects of the procedures (ePNS or operation) and sides (stimulated or nonstimulated side) for the 10-second test were analyzed using repeated measures analysis of variance. The Pearson correlation coefficient was used to measure the relationship between the 10-second test values according to the method (after ePNS vs. surgery). In addition, the Bland-Altman method was used to evaluate the degree of agreement between the 10-second test obtained after ePNS versus shortly after surgery., Results: The preoperative 10-second test showed the most improvement immediately after the administration of ePNS, with a gradual decrease for the first 30 minutes after completion. After the initial 30 minutes, performance decreased rapidly, and by 60 minutes performance essentially returned to baseline. The 10-second post-ePNS had a strong positive correlation with the 10-second test in the early postoperative period (at discharge=one week after surgery). These phenomena were observed with the left hand, the side stimulated with ePNS, as well as the right hand, the side not stimulated., Conclusions: Early postoperative outcomes after CSM surgery may be predicted by the results of preoperative ePNS., Level of Evidence: Level 3., Competing Interests: The authors report no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2023
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16. Association of masking policies with mask adherence and distancing during the SARS-COV-2 pandemic.
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Puttock EJ, Marquez J, Young DR, Shirley AM, Han B, McKenzie TL, Smith NJ, Manuel K, Hoelscher D, Spear S, Ruiz M, Smith C, Krytus K, Martinez I, So H, Levy M, Nolan V, Bagley E, Mehmood A, Thomas JG, Apedaile L, Ison S, Barr-Anderson DJ, Heller JG, and Cohen DA
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- Adolescent, Female, Humans, Masks, Public Policy, SARS-CoV-2, COVID-19 prevention & control, Pandemics prevention & control
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Background: Quantification of the impact of local masking policies may help guide future policy interventions to reduce SARS-COV-2 disease transmission. This study's objective was to identify factors associated with adherence to masking and social distancing guidelines., Methods: Faculty from 16 U.S. colleges and universities trained 231 students in systematic direct observation. They assessed correct mask use and distancing in public settings in 126 US cities from September 2020 through August 2021., Results: Of 109,999 individuals observed in 126 US cities, 48% wore masks correctly with highest adherence among females, teens and seniors and lowest among non-Hispanic whites, those in vigorous physical activity, and in larger groups (P < .0001). Having a local mask mandate increased the odds of wearing a mask by nearly 3-fold (OR = 2.99, P = .0003) compared to no recommendation. People observed in non-commercial areas were least likely to wear masks. Correct mask use was greatest in December 2020 and remained high until June 2021 (P < .0001). Masking policy requirements were not associated with distancing., Discussion: The strong association between mask mandates and correct mask use suggests that public policy has a powerful influence on individual behavior., Conclusions: Mask mandates should be considered in future pandemics to increase adherence., (Copyright © 2022 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.)
- Published
- 2022
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17. Prospective comparison of dysphagia following anterior cervical discectomy and fusion (ACDF) with and without rhBMP-2.
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Bellamy JT, Dilbone E, Schell A, Premkumar A, Geddes B, Leckie S, Moatz B, Stephens B, Shenvi NV, and Heller JG
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- Bone Morphogenetic Protein 2, Cervical Vertebrae surgery, Diskectomy adverse effects, Humans, Postoperative Complications epidemiology, Postoperative Complications etiology, Postoperative Complications surgery, Prospective Studies, Quality of Life, Recombinant Proteins, Retrospective Studies, Transforming Growth Factor beta, Treatment Outcome, Deglutition Disorders epidemiology, Deglutition Disorders etiology, Deglutition Disorders surgery, Spinal Fusion adverse effects
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Background Context: Previous studies have called into question the safety of using rhBMP-2 in anterior cervical fusion due to the possibility of airway compromise and dysphagia. A retrospective chart review identified a significant increase in the severity of dysphagia after II-level ACDF with rhBMP-2 compared to patients who did not receive rhBMP-2. To date, this topic has not been studied prospectively., Purpose: Compare the incidence of dysphagia following anterior cervical discectomy and fusion (ACDF) when recombinant human bone morphogenetic protein-2 (rhBMP-2) is used with allograft compared to allograft alone., Study Design: Prospective cohort study., Patient Sample: A total of 114 patients completed a baseline SWAL-QOL survey and met the inclusion criteria. Thirty-nine patients underwent I- or II-level ACDF with allograft plus 0.5mg rhBMP-2/level. 44 patients underwent ACDF with allograft alone. Thirty-one patients undergoing a lumbar decompression were enrolled in a third cohort to control for dysphagia secondary to intubation., Outcome Measures: The primary outcome measure was the 14-point SWAL-QOL dysphagia questionnaire. Other patient factors obtained from anesthesia and operative records were examined to evaluate their potential relationship to postoperative dysphagia., Methods: The 14-point SWAL-QOL questionnaire was administered at multiple time points (pre-op, post-op 7 days, 6 weeks, 6 months, and at least 1 year). Multivariable repeated-measures analysis was applied to data., Results: Baseline adjusted SWAL-QOL means 7 days after surgery were significantly different between the three study groups. These differences resolved by 6 weeks postoperative, beyond which point there were no differences. At final follow-up, baseline adjusted SWAL-QOL means at 1 year were similar for the three study groups., Conclusions: This single-center study of anterior cervical surgery demonstrated that the addition of rhBMP-2 to an ACDF increased postoperative dysphagia at 7 days after surgery, but these patients recover to levels comparable to those who underwent ACDF without rhBMP-2 or lumbar surgery within 6 weeks., (Copyright © 2021 Elsevier Inc. All rights reserved.)
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- 2022
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18. Smokeless Tobacco Point of Sale Advertising, Placement and Promotion: Associations With Store and Neighborhood Characteristics.
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James SA, Heller JG, Hartman CJ, Schaff AC, Mushtaq N, and Beebe LA
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- Adolescent, Adult, Advertising, Commerce, Humans, Oklahoma, Tobacco Products, Tobacco, Smokeless
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Introduction: Objectives of this study were to determine retail and neighborhood characteristics associated with smokeless tobacco (ST) product promotion, price promotion, and storefront advertising among retailers in Oklahoma. Methods: In this statewide point-of-sale study, we collected data from 1,354 ST retailers. Using store characteristics and census tract information, we estimated summary statistics and adjusted prevalence ratios during 2019-2020. Results: Of ST retailers audited, 11.0% demonstrated ST youth promotion, 43.0% ST price promotions, and 19.6% ST storefront advertising. The adjusted prevalence ratio (aPR) for convenience stores was higher for all three ST strategies: youth promotion (aPR = 3.4, 95% CI 1.9, 6.2), price promotion (aPR = 3.8, 95% CI 2.9, 5.0), and storefront advertising (aPR=16.4, 95% CI 6.7, 40.3) compared to other store types. Metropolitan tobacco retailers had higher aPRs for youth promotion (aPR = 1.7, 95% CI 1.12 2.6) and storefront advertising (aPR = 1.5, 95% CI 1.2, 1.9). Conclusions: Findings of this study suggest there are currently ample opportunities for youth and adults at risk for tobacco initiation to be exposed to ST products in the retail environment. Convenience stores, more likely to be found and utilized in rural areas compared to metropolitan areas, are disproportionately more likely to engage in marketing strategies that could lure youth into trying smokeless tobacco., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 James, Heller, Hartman, Schaff, Mushtaq and Beebe.)
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- 2021
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19. Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial.
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Ghogawala Z, Terrin N, Dunbar MR, Breeze JL, Freund KM, Kanter AS, Mummaneni PV, Bisson EF, Barker FG 2nd, Schwartz JS, Harrop JS, Magge SN, Heary RF, Fehlings MG, Albert TJ, Arnold PM, Riew KD, Steinmetz MP, Wang MC, Whitmore RG, Heller JG, and Benzel EC
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- Aged, Aged, 80 and over, Cervical Vertebrae diagnostic imaging, Follow-Up Studies, Humans, Magnetic Resonance Imaging, Middle Aged, Postoperative Complications, Radiography, Spinal Cord diagnostic imaging, Treatment Outcome, Cervical Vertebrae surgery, Laminectomy methods, Patient Reported Outcome Measures, Spinal Cord Diseases surgery, Spinal Fusion methods, Spondylosis surgery
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Importance: Cervical spondylotic myelopathy is the most common cause of spinal cord dysfunction worldwide. It remains unknown whether a ventral or dorsal surgical approach provides the best results., Objective: To determine whether a ventral surgical approach compared with a dorsal surgical approach for treatment of cervical spondylotic myelopathy improves patient-reported physical functioning at 1 year., Design, Setting, and Participants: Randomized clinical trial of patients aged 45 to 80 years with multilevel cervical spondylotic myelopathy enrolled at 15 large North American hospitals from April 1, 2014, to March 30, 2018; final follow-up was April 15, 2020., Interventions: Patients were randomized to undergo ventral surgery (n = 63) or dorsal surgery (n = 100). Ventral surgery involved anterior cervical disk removal and instrumented fusion. Dorsal surgery involved laminectomy with instrumented fusion or open-door laminoplasty. Type of dorsal surgery (fusion or laminoplasty) was at surgeon's discretion., Main Outcomes and Measures: The primary outcome was 1-year change in the Short Form 36 physical component summary (SF-36 PCS) score (range, 0 [worst] to 100 [best]; minimum clinically important difference = 5). Secondary outcomes included 1-year change in modified Japanese Orthopaedic Association scale score, complications, work status, sagittal vertical axis, health resource utilization, and 1- and 2-year changes in the Neck Disability Index and the EuroQol 5 Dimensions score., Results: Among 163 patients who were randomized (mean age, 62 years; 80 [49%] women), 155 (95%) completed the trial at 1 year (80% at 2 years). All patients had surgery, but 5 patients did not receive their allocated surgery (ventral: n = 1; dorsal: n = 4). One-year SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, -2.6 to 3.1; P = .86). Of 7 prespecified secondary outcomes, 6 showed no significant difference. Rates of complications in the ventral and dorsal surgery groups, respectively, were 48% vs 24% (difference, 24%; 95% CI, 8.7%-38.5%; P = .002) and included dysphagia (41% vs 0%), new neurological deficit (2% vs 9%), reoperations (6% vs 4%), and readmissions within 30 days (0% vs 7%)., Conclusions and Relevance: Among patients with cervical spondylotic myelopathy undergoing cervical spinal surgery, a ventral surgical approach did not significantly improve patient-reported physical functioning at 1 year compared with outcomes after a dorsal surgical approach., Trial Registration: ClinicalTrials.gov Identifier: NCT02076113.
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- 2021
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20. Historical Perspective: Thomas E. Whitesides, Jr.
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Lockey SD, Kalantar SB, and Heller JG
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- History, 20th Century, Humans, Male, Spinal Diseases surgery, Orthopedic Surgeons history, Spinal Diseases history
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: Dr. Thomas Whitesides was a pioneer in general orthopedics and spine surgery. He brought the anterior approach to the United States in the management of thoracolumbar trauma, a revolutionary step at the time. At Emory, he taught 100s of residents and fellows using the Socratic method. Dr. Whitesides remains a valuable consultant for complex spine cases to this day.
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- 2020
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21. The impact of prophylactic intraoperative vancomycin powder on microbial profile, antibiotic regimen, length of stay, and reoperation rate in elective spine surgery.
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Grabel ZJ, Boden A, Segal DN, Boden S, Milby AH, and Heller JG
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- Adult, Elective Surgical Procedures adverse effects, Female, Humans, Length of Stay statistics & numerical data, Male, Middle Aged, Reoperation statistics & numerical data, Surgical Wound Infection epidemiology, Anti-Bacterial Agents therapeutic use, Antibiotic Prophylaxis methods, Elective Surgical Procedures methods, Spinal Diseases surgery, Surgical Wound Infection prevention & control, Vancomycin therapeutic use
- Abstract
Background Context: There is growing concern that the microbial profile of surgical site infection (SSI) in the setting of prophylactic vancomycin powder may favor more resistant and uncommon organisms., Purpose: To demonstrate the impact of prophylactic intraoperative vancomycin powder on microbial profile, antibiotic regimen, length of stay (LOS), and reoperation rate in spine surgical site infection., Study Design And/or Setting: Retrospective cohort study., Patient Sample: the study included 115 postoperative spine patients who were required to return to the operating room for SSI., Outcome Measures: The outcome measures were microbial profile, reoperation rate, antibiotic regimen, and LOS for patients with postoperative spine infection who either did (treated) or did not (untreated) receive prophylactic vancomycin powder during their index procedure., Methods: A retrospective review of patients who underwent posterior thoracic and/or lumbar spine surgery between 2010 and 2017 was conducted. Those undergoing surgical treatment of SSI were identified, and patients were divided into two groups - those who were treated with intraoperative vancomycin (treated) and those who were not (untreated). The organism profile for each group was compared. The average LOS, reoperation rate, and number of patients requiring more than 1 antibiotic were calculated for each patient in both groups., Results: There were 5,909 procedures performed. One hundred and fifteen SSIs were identified, resulting in a 1.9% infection rate. Prophylactic vancomycin powder was used in the index procedure for 42 of those cases. 23.8% of cultures in the vancomycin group were polymicrobial and 16.7% were gram-negative compared with 9.6% (p=0.039) and 4.1% (p=0.021) in the untreated group, respectively. In the vancomycin-treated group, 26.1% of patients underwent repeat irrigation and debridement compared with 38.4% in the untreated group (p=0.184). The percentage of patients in the treatment and untreated group who required more than 1 antibiotic was 26.0% and 26.1%, respectively (p=0.984). Mean LOS in the treatment group was 8.0 versus 7.9 for the untreated group (p=0.945) CONCLUSIONS: In this series, vancomycin powder was associated with a higher prevalence of gram-negative and polymicrobial organisms in patients that ultimately developed postoperative SSI. However, this did not adversely affect the need for multiple reoperations, antibiotic regimen, or LOS for these patients., (Copyright © 2018 Elsevier Inc. All rights reserved.)
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- 2019
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22. Epidemiology and treatment of central cord syndrome in the United States.
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Segal DN, Grabel ZJ, Heller JG, Rhee JM, Michael KW, Yoon ST, and Jain A
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Background: The objective of this study is to demonstrate the epidemiology and trends in management of patients with central cord syndrome (CCS) who present to the emergency department. Recent literature has reported that surgical treatment for CCS have increased over the previous decades., Methods: The National Emergency Department Sample (NEDS) was queried from 2009 through 2012 to generate national estimates of patients who presented to the emergency department in the United States and were diagnosed with CCS., Results: From 2009 through 2012, there were 11,975 emergency room visits for CCS (mean age 60 years). The two most common injury mechanisms were: fall (55%) and motor vehicle accident (15%). Concomitant cervical fractures were found in 10% patients. Ninety-three percent of patients were admitted to the hospital directly or after transfer to another facility, and 7% were discharged home. Fifty-five percent of patients were treated non-operatively, 39% were treated with cervical fusion surgery and 6% were treated with laminoplasty. Of patients who underwent cervical fusion, 62% received anterior decompression and fusion, 32% received posterior decompression and fusion, and 6% received combined anterior-posterior decompression and fusion. The incidence of in-hospital mortality was 2.6%. Mortality was associated with older patient age (OR 1.06, P<0.001) and greater comorbidities (OR 1.72, P<0.001)., Conclusions: Majority of patients who presented to the emergency room for CCS in the United States were treated non-operatively. Advanced age and greater comorbidities were the factors that were most associated with increased risk of in-hospital mortality in patients with CCS., Competing Interests: Conflicts of Interest: The authors have no conflicts of interest to declare.
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- 2018
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23. Motion-preserving, 2-stage transoral and posterior treatment of an unstable Jefferson fracture in a professional football player.
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Rodts GE, Baum GR, Stewart FG, and Heller JG
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- Athletic Injuries diagnostic imaging, Cervical Atlas diagnostic imaging, Humans, Male, Reoperation, Spinal Fractures diagnostic imaging, Young Adult, Athletic Injuries surgery, Cervical Atlas injuries, Cervical Atlas surgery, Football injuries, Fracture Fixation, Internal methods, Spinal Fractures surgery
- Abstract
The authors report the case of a patient who suffered a Jefferson fracture during a professional football game. The C-1 (atlas) fracture was widely displaced anteriorly, but the transverse ligament was intact. In an effort to enable a return to play and avoid intersegmental (C1-2) fusion, the patient underwent a transoral approach for open reduction and internal fixation of the fracture. The associated posterior ring fracture displacement widened after this procedure, and a subsequent posterior arthrodesis and fixation of the fracture site was performed 6 months later when the fracture failed to heal with rigid collar immobilization. The approach maintained the normal range of motion at the atlantoaxial and atlantooccipital joints, which would have been sacrificed by an atlantoaxial or occipitocervical fusion, as is traditionally performed. Ultimately, the patient decided not to return to the football field, but this approach could avoid the more significant loss of motion associated with atlantoaxial or occipitocervical fusion for unstable Jefferson fractures.
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- 2018
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24. Progressive Bone Formation After Cervical Disc Replacement: Minimum of 5-Year Follow-up.
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Zhou F, Ju KL, Zhao Y, Zhang F, Pan S, Heller JG, and Sun Y
- Subjects
- Adult, Cervical Vertebrae, Disability Evaluation, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neck Pain etiology, Ossification, Heterotopic etiology, Osteogenesis, Patient Reported Outcome Measures, Postoperative Complications etiology, Prevalence, Radiculopathy surgery, Retrospective Studies, Treatment Outcome, Young Adult, Ossification, Heterotopic epidemiology, Spondylosis surgery, Total Disc Replacement adverse effects
- Abstract
Study Design: Retrospective review., Objective: Our objective was to examine the prevalence, clinical significance, ramifications, and possible etiology of postoperative bone formation at the index level after cervical disc replacement (CDR) with a minimum of 5 years of follow-up., Summary of Background Data: CDR can be complicated by postoperative ossification and unwanted ankylosis at the index level, which some authors have termed "heterotopic ossification." This terminology may be inaccurate as it assumes the postoperative bone formation is unnatural and a consequence of the CDR surgery. We advocate that this phenomenon has more to do with individual patient factors rather than the surgery., Methods: Patients who underwent Bryan CDR for cervical myelopathy or radiculopathy between 12/2003 and 8/2008 with a minimum of 5-years follow-up were analyzed. They were divided into two groups, those with and without postoperative bone formation. Patient-reported outcomes (Japanese Orthopaedic Association score, Neck Disability Index, Visual Analogue Scale for neck and arm pain) and radiographic parameters were collected pre- and postoperatively and compared between groups., Results: Sixty-one patients (76 levels) were identified (mean follow-up 94.2 mo). The overall incidence of postoperative ossification was 50%. Both groups had sustained significant improvements across all patient-reported outcome measures at final follow-up. Notably, patients with more severe preoperative cervical spondylosis had higher rates of postoperative ossification (P = 0.036) and adjacent segment degeneration (P = 0.010)., Conclusion: Although the long-term incidence of postoperative bone formation after CDR was relatively high, this did not adversely affect patient outcomes. Patients with more severe preoperative spondylosis had higher rates of postoperative ossification, suggesting that postoperative ossification at the CDR segment is likely one of progressive bone formation in individuals already predisposed to forming bone rather than one of alleged heterotopic ossification as a consequence of the surgery., Level of Evidence: 3.
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- 2018
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25. Posterolateral Fusion Versus Interbody Fusion for Degenerative Spondylolisthesis: A Systematic Review and Meta-Analysis.
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McAnany SJ, Baird EO, Qureshi SA, Hecht AC, Heller JG, and Anderson PA
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- Female, Humans, Joint Instability complications, Male, Treatment Outcome, Joint Instability surgery, Lumbar Vertebrae surgery, Lumbosacral Region surgery, Spinal Fusion methods, Spondylolisthesis surgery
- Abstract
Study Design: Systematic literature review and meta-analysis., Objective: This study is a meta-analysis assessing the clinical outcomes of degenerative lumbar spondylolisthesis treated with either a posterolateral fusion (PLF) or interbody fusion (IBF) SUMMARY OF BACKGROUND DATA.: Degenerative spondylolisthesis remains one of the most common reasons for which lumbar fusion is performed in the United States. Both PLF and IBF have been advanced as adequate surgical techniques that result in successful fusion and improved clinical outcomes., Methods: A systematic review of PubMed, Cochrane, and Embase was performed. The pooled results were performed by calculating the effect size based on the Hedges g standardized difference in means or odds ratio. Studies were weighted by the inverse of the variance. Heterogeneity was assessed using the Q statistic and I. Sensitivity analysis was performed through single elimination of studies. Publication bias was assessed by funnel plot assessment and the Egger-Harbord test., Results: The systematic review resulted in 865 articles. After two-reviewer assessment, five articles were found to match all of the inclusion criteria and were included in the meta-analysis. The combined effect size was found to be in favor of PLF for length of stay (P = 0.002); however, there were no differences in fusion rate, operative time, Estimated blood loss, Oswestry Disability Index, Short Form 36, Visual Analog Scale, or complication rate between PLF and IBF. All of the variables demonstrated relative homogeneity, with I < 25. The sensitivity analysis validated the results of the model and there was no publication bias detected., Conclusion: Patients with degenerative spondylolisthesis can be effectively managed with either a PLF or IBF with no significant differences in clinical outcomes or fusion rate between the two groups. Length of stay was the only variable that was found to be in favor of either group, with the PLF group demonstrating a shortened hospitalization., Level of Evidence: 3.
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- 2016
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26. Cervical spondylotic myelopathy surgical trial: randomized, controlled trial design and rationale.
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Ghogawala Z, Benzel EC, Heary RF, Riew KD, Albert TJ, Butler WE, Barker FG 2nd, Heller JG, McCormick PC, Whitmore RG, Freund KM, and Schwartz JS
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- Aged, Humans, Male, Middle Aged, Patient Outcome Assessment, Quality of Life, Research Design, Spondylosis complications, Surveys and Questionnaires, Treatment Outcome, United States, Decompression, Surgical methods, Neurosurgical Procedures methods, Spinal Cord Diseases surgery, Spondylosis surgery
- Abstract
Background: Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There are significant practice variation and uncertainty as to the optimal surgical approach for treating CSM., Objective: To determine whether ventral surgery is associated with superior Short Form-36 Physical Component Summary outcome at the 1-year follow-up compared with dorsal (laminectomy/fusion or laminoplasty) surgery for the treatment of CSM, to investigate whether postoperative sagittal balance is an independent predictor of overall outcome, and to compare health resource use for ventral and dorsal procedures., Methods: The study is a randomized, controlled trial with a nonrandomized arm for patients who are eligible but decline randomization. Two hundred fifty patients (159 randomized) with CSM from 11 sites will be recruited over 18 months. The primary outcome is the Short Form-36 Physical Component Summary score. Secondary outcomes include disease-specific outcomes, overall health-related quality of life (EuroQOL 5-dimension questionnaire), and health resource use., Expected Outcomes: This will be the first randomized, controlled trial to compare directly the health-related quality-of-life outcomes for ventral vs dorsal surgery for treating CSM., Discussion: A National Institutes of Health-funded (1R13AR065834-01) investigator meeting was held before the initiation of the trial to bring multiple stakeholders together to finalize the study protocol. Study investigators, coordinators, and major stakeholders were able to attend and discuss strengths of, limitations of, and concerns about the study. The final protocol was approved for funding by the Patient-Centered Outcomes Research Institute (CE-1304-6173). The trial began enrollment on April 1, 2014.
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- 2014
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27. Comparative effectiveness of different types of cervical laminoplasty.
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Heller JG, Raich AL, Dettori JR, and Riew KD
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Study Design Systematic review. Study Rationale Numerous cervical laminoplasty techniques have been described but there are few studies that have compared these to determine the superiority of one over another. Clinical Questions The clinical questions include key question (KQ)1: In adults with cervical myelopathy from ossification of the posterior longitudinal ligament (OPLL) or spondylosis, what is the comparative effectiveness of open door cervical laminoplasty versus French door cervical laminoplasty? KQ2: In adults with cervical myelopathy from OPLL or spondylosis, are postoperative complications, including pain and infection, different for the use of miniplates versus the use of no plates following laminoplasty? KQ3: Do these results vary based on early active postoperative cervical motion? Materials and Methods A systematic review of the English-language literature was undertaken for articles published between 1970 and March 11, 2013. Electronic databases and reference lists of key articles were searched to identify studies evaluating (1) open door cervical laminoplasty and French door cervical laminoplasty and (2) the use of miniplates or no plates in cervical laminoplasty for the treatment of cervical spondylotic myelopathy or OPLL in adults. Studies involving traumatic onset, cervical fracture, infection, deformity, or neoplasms were excluded, as were noncomparative studies. Two independent reviewers (A.L.R., J.R.D.) assessed the level of evidence quality using the Grades of Recommendations Assessment, Development and Evaluation system, and disagreements were resolved by consensus. Results We identified three studies (one of class of evidence [CoE] II and two of CoE III) meeting our inclusion criteria comparing open door cervical laminoplasty with French door laminoplasty and two studies (one CoE II and one CoE III) comparing the use of miniplates with no plates. Data from one randomized controlled trial (RCT) and two retrospective cohort studies suggest no difference between treatment groups regarding improvement in myelopathy. One RCT reported significant improvement in axial pain and significantly higher short-form 36 scores in the French door laminoplasty treatment group. Overall, complications appear to be higher in the open door group than the French door group, although complete reporting of complications was poor in all studies. Overall, data from one RCT and one retrospective cohort study suggest that the incidence of complications (including reoperation, radiculopathy, and infection) is higher in the no plate treatment group compared with the miniplate group. One RCT reported greater pain as measured by the visual analog scale score in the no plate treatment group. There was no evidence available to assess the effect of early cervical motion for open door cervical laminoplasty compared with French door laminoplasty. Both studies comparing the use of miniplates and no plates reported early postoperative motion. Evidence from one RCT suggests that earlier postoperative cervical motion might reduce pain. Conclusion Data from three comparative studies are not sufficient to support the superiority of open door cervical laminoplasty or French door cervical laminoplasty. Data from two comparative studies are not sufficient to support the superiority of the use of miniplates or no plates following cervical laminoplasty. The overall strength of evidence to support any conclusions is low or insufficient. Thus, the debate continues while opportunity exists for the spine surgery community to resolve these issues with appropriately designed clinical studies.
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- 2013
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28. Neck Pain Following Cervical Laminoplasty: Does Preservation of the C2 Muscle Attachments and/or C7 Matter?
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Riew KD, Raich AL, Dettori JR, and Heller JG
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Study Design Systematic review. Objective In patients aged 18 years or older, with cervical spondylotic myelopathy or ossification of the posterior longitudinal ligament (OPLL), does sparing the C2 muscle attachments and/or C7-preserving cervical laminoplasty lead to reduced postoperative axial pain compared with conventional C3 to C7 laminoplasty? Do these results vary based on early active postoperative cervical motion? Methods A systematic review of the English-language literature was undertaken for articles published between 1970 and August 17, 2012. Electronic databases and reference lists of key articles were searched to identify studies evaluating C2/C3- or C7-preserving cervical laminoplasty for the treatment of cervical spondylotic myelopathy (CSM) or OPLL in adults. Studies involving traumatic onset, cervical fracture, infection, deformity, or neoplasms were excluded, as were noncomparative studies. Two independent reviewers assessed the level of evidence quality using the grading of recommendations assessment, development and evaluation (GRADE) system, and disagreements were resolved by consensus. Results We identified 11 articles meeting our inclusion criteria. Only the randomized controlled trial (RCT) showed no significant difference in late axial pain (at 12 months) when C7 spinous muscle preservation was compared with no preservation. However, seven other retrospective cohort studies showed significant pain relief in the preserved group compared with the nonpreserved group. The preservation group included those with preservation of the C7 spinous process and/or attached muscles, the deep extensor muscles, or C2 muscle attachment and/or C3 laminectomy (as opposed to laminoplasty). One study that included preservation of either the C2 or C7 posterior paraspinal muscles found that only preservation of the muscles attached to C2 resulted in reduced postoperative pain. Another study that included preservation of either the C7 spinous process or the deep extensor muscles found that only preservation of C7 resulted in reduced postoperative pain. Conclusion Although there is conflicting data regarding the importance of preserving C7 and/or the semispinalis cervicis muscle attachments to C2, there is enough evidence to suggest that surgeons should make every attempt to preserve these structures whenever possible since there appears to be little downside to doing so, unless it compromises the neurologic decompression.
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- 2013
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29. Results of cervical arthroplasty compared with anterior discectomy and fusion: four-year clinical outcomes in a prospective, randomized controlled trial.
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Sasso RC, Anderson PA, Riew KD, and Heller JG
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- Cervical Vertebrae physiopathology, Disability Evaluation, Diskectomy adverse effects, Humans, Intervertebral Disc Degeneration physiopathology, Pain, Postoperative Complications, Prospective Studies, Prostheses and Implants, Spinal Fusion adverse effects, Total Disc Replacement adverse effects, Total Disc Replacement instrumentation, Treatment Outcome, Cervical Vertebrae surgery, Diskectomy methods, Intervertebral Disc Degeneration surgery, Spinal Fusion methods, Total Disc Replacement methods
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- 2011
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30. Fusarium falciforme vertebral abscess and osteomyelitis: case report and molecular classification.
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Edupuganti S, Rouphael N, Mehta A, Eaton M, Heller JG, Bressler A, Brandt M, and O'Donnell K
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- DNA, Fungal chemistry, DNA, Fungal genetics, Epidural Abscess complications, Female, Fusarium classification, Fusarium genetics, Glucocorticoids adverse effects, Humans, Middle Aged, Molecular Sequence Data, Multilocus Sequence Typing, Mycological Typing Techniques, Mycoses microbiology, Mycoses pathology, Osteomyelitis complications, Osteomyelitis microbiology, Osteomyelitis pathology, Sequence Analysis, DNA, Spondylitis complications, Epidural Abscess microbiology, Epidural Abscess pathology, Fusarium isolation & purification, Mycoses diagnosis, Spondylitis microbiology, Spondylitis pathology
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Fusarium is a ubiquitous mold that can cause superficial infections such as keratitis and onychomycosis in immunocompetent humans; however, infections in immunocompromised hosts can be fatal. We report an unusual case of epidural abscess and vertebral osteomyelitis in a patient with an autoimmune disorder who was on long-term glucocorticoids. Multilocus DNA sequence-based typing revealed that the infection was caused by a novel three-locus haplotype of Fusarium falciforme designated FSSC 3+4qqq.
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- 2011
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31. Anterior exposure of the lumbar spine with and without an "access surgeon": morbidity analysis of 265 consecutive cases.
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Jarrett CD, Heller JG, and Tsai L
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- Abdominal Cavity anatomy & histology, Abdominal Cavity surgery, Adolescent, Adult, Aged, Aged, 80 and over, Aorta, Abdominal anatomy & histology, Aorta, Abdominal injuries, Blood Loss, Surgical, Blood Vessels anatomy & histology, Diskectomy adverse effects, Diskectomy methods, Diskectomy mortality, Erectile Dysfunction etiology, Erectile Dysfunction mortality, Erectile Dysfunction prevention & control, Female, Humans, Iliac Artery anatomy & histology, Iliac Artery injuries, Incidence, Intraoperative Complications etiology, Intraoperative Complications prevention & control, Lumbar Vertebrae anatomy & histology, Male, Middle Aged, Neurosurgical Procedures methods, Postoperative Hemorrhage etiology, Postoperative Hemorrhage mortality, Postoperative Hemorrhage prevention & control, Retroperitoneal Space anatomy & histology, Retroperitoneal Space surgery, Retrospective Studies, Spinal Fusion adverse effects, Spinal Fusion methods, Spinal Fusion mortality, Sympathetic Fibers, Postganglionic anatomy & histology, Sympathetic Fibers, Postganglionic injuries, Young Adult, Blood Vessels injuries, Intraoperative Complications mortality, Lumbar Vertebrae surgery, Neurosurgical Procedures adverse effects, Neurosurgical Procedures mortality, Patient Care Team statistics & numerical data
- Abstract
Study Design: Retrospective review, Objective: To compare the incidence and type of exposure-related complications for anterior lumbar surgery performed with and without an "access" surgeon., Summary of Background Data: No data exist comparing the incidence and type of exposure-related complications for anterior lumbar surgery performed with and without a vascular surgeon's assistance., Methods: A retrospective review was performed for 265 consecutive patients who underwent anterior lumbar spine surgery at our institution from 2003 to 2005. Each patient's records were reviewed for diagnosis, procedure, whether the surgical exposure was conducted by the spine surgeon (Spine) or with a vascular surgeon's assistance (Team), levels exposed, complications, and any lasting sequelae., Results: The percentage of patients with at least 1 intraoperative complication was 8% and 12% for the Spine and Team cases, respectively. Two percent of the Spine patients experienced an intraoperative vascular complication compared with 7% of the Team cases. No intraoperative vascular complication occurred in the single-level Spine exposures. Four percent of the patients with single-level exposures with Team approaches sustained an intraoperative vascular complication. Eight percent of the multilevel Spine cases sustained an intraoperative vascular complication compared with 9% of the multilevel Team exposures. There were 14 vascular injuries appreciated intraoperatively in a total of 13 patients. These injuries were directly repaired in 10 patients without any residual sequelae. The rate of vascular complications was statistically higher for multiple-level exposures (9%) versus single-level exposure (3%; P = 0.0357). The rate of retrograde ejaculation was 6% in the Spine cases whereas it was 7% in the Team approach., Conclusions: Our results do not support the notion that the presence of an "access" surgeon will change the type and rate of complications. With adequate training and judgment, spine surgeons may safely perform such exposures, provided vascular surgical assistance is readily available.
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- 2009
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32. New views on the hypothesis of respiratory cancer risk from soluble nickel exposure; and reconsideration of this risk's historical sources in nickel refineries.
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Heller JG, Thornhill PG, and Conard BR
- Abstract
Introduction: While epidemiological methods have grown in sophistication during the 20th century, their application in historical occupational (and environmental) health research has also led to a corresponding growth in uncertainty in the validity and reliability of the attribution of risk in the resulting studies, particularly where study periods extend back in time to the immediate postwar era (1945-70) when exposure measurements were sporadic, unsystematically collected and primitive in technique; and, more so, to the pre-WWII era (when exposure data were essentially non-existent). These uncertainties propagate with animal studies that are designed to confirm the carcinogenicity by inhalation exposure of a chemical putatively responsible for historical workplace cancers since exact exposure conditions were never well characterized. In this report, we present a weight of scientific evidence examination of the human and toxicological evidence to show that soluble nickel is not carcinogenic; and, furthermore, that the carcinogenic potencies previously assigned by regulators to sulphidic and oxidic nickel compounds for the purposes of developing occupational exposure limits have likely been overestimated., Methods: Published, file and archival evidence covering the pertinent epidemiology, biostatistics, confounding factors, toxicology, industrial hygiene and exposure factors, and other risky exposures were examined to evaluate the soluble nickel carcinogenicity hypothesis; and the likely contribution of a competing workplace carcinogen (arsenic) on sulphidic and oxidic nickel risk estimates., Findings: Sharp contrasts in available land area and topography, and consequent intensity of production and refinery process layouts, likely account for differences in nickel species exposures in the Kristiansand (KNR) and Port Colborne (PCNR) refineries. These differences indicate mixed sulphidic and oxidic nickel and arsenic exposures in KNR's historical electrolysis department that were previously overlooked in favour of only soluble nickel exposure; and the absence of comparable insoluble nickel exposures in PCNR's tankhouse, a finding that is consistent with the absence of respiratory cancer risk there. The most recent KNR evidence linking soluble nickel with lung cancer risk arose in a reconfiguration of KNR's historical exposures. But the resulting job exposure matrix lacks an objective, protocol-driven rationale that could provide a valid and reliable basis for analyzing the relationship of KNR lung cancer risk with any nickel species. Evidence of significant arsenic exposure during the processing step in the Clydach refinery's hydrometallurgy department in the 1902-1934 time period likely accounts for most of the elevated respiratory cancer risk observed at that time. An understanding of the mechanism for nickel carcinogenicity remains an elusive goal of toxicological research; as does its capacity to confirm the human health evidence on this subject with animal studies., Concluding Remarks: Epidemiological methods have failed to accurately identify the source(s) of observed lung cancer risk in at least one nickel refinery (KNR). This failure, together with the negative long-term animal inhalation studies on soluble nickel and other toxicological evidence, strongly suggest that the designation of soluble nickel as carcinogenic should be reconsidered, and that the true causes of historical lung cancer risk at certain nickel refineries lie in other exposures, including insoluble nickel compounds, arsenic, sulphuric acid mists and smoking.
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- 2009
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33. Kummel disease: a not-so-rare complication of osteoporotic vertebral compression fractures.
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Freedman BA and Heller JG
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- Aged, Fractures, Compression diagnostic imaging, Fractures, Compression physiopathology, Fractures, Compression surgery, Humans, Male, Osteoporosis diagnostic imaging, Osteoporosis physiopathology, Osteoporosis surgery, Radiography, Risk Factors, Spinal Fractures physiopathology, Spinal Fractures surgery, Fractures, Compression etiology, Osteoporosis complications, Spinal Fractures etiology
- Abstract
Kummel disease is the eponym for avascular necrosis of the vertebral body after a vertebral compression fracture. As our population ages, the prevalence of osteoporosis, its most common fragility fracture (vertebral compression fracture), and Kummel disease will increase. The purpose of this article is to report a prototypical case with complete radiographic and histologic workup and to provide facts regarding Kummel disease that are salient to the primary care provider.
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- 2009
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34. Clinical outcomes of BRYAN cervical disc arthroplasty: a prospective, randomized, controlled, multicenter trial with 24-month follow-up.
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Sasso RC, Smucker JD, Hacker RJ, and Heller JG
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- Adult, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Prosthesis Design, Spinal Diseases complications, Time Factors, Treatment Outcome, Arthroplasty, Replacement, Cervical Vertebrae, Intervertebral Disc, Joint Prosthesis, Spinal Diseases surgery
- Abstract
Study Design/setting: Prospective, randomized, 3-center, clinical trial., Objective: To prospectively compare the outcomes of cervical arthroplasty with the BRYAN Cervical Disc Prosthesis (Medtronic Sofamor Danek, Inc, Memphis, TN) to anterior cervical discectomy and fusion (ACDF)., Summary of Background Data: Surgical treatment of cervical disc pathology commonly involves techniques that employ discectomy and fusion (ACDF). This "gold-standard" technique has demonstrated good clinical and radiographic outcomes. Common adverse effects of this procedure are associated with the adjacent level degeneration and bone-graft harvest. Several investigators have independently reported successful short-term outcomes with the BRYAN Cervical Disc Prosthesis. In addition, a significant body of knowledge has been collected regarding the wear patterns and adjacent level effects of this device in human and animal models., Methods: As part of an FDA IDE trial, 3 centers collected prospective outcomes data on 115 patients randomized in a 1:1 ratio to ACDF (Control group) or arthroplasty with the BRYAN Cervical Disc Prosthesis (Investigational group)., Results: Demographic and surgical data were generally similar in the 2 populations. Outcomes data collected at routine postoperative intervals for 24 months demonstrated that the Investigational group had statistically significant (P<0.05) improvements as assessed by the Neck Disability Index, the Neck Pain Score, and SF-36 Physical component scores. The improvement in the Mental Component Subscore values for the BRYAN and control groups was equivalent at 24 months (P=0.055). Arm pain relief was similar in both groups (P=0.152). During the course of the 2-year follow-up, 4 patients in the Control group required surgical intervention and 3 patients in the Investigational group required ACDF for adjacent level disease., Conclusions: At 24 months, cervical arthroplasty with the BRYAN Cervical Disc Prosthesis compares favorably with ACDF as defined by standard outcomes scores.
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- 2007
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35. rhBMP-2 enhancement of posterolateral spinal fusion in a rabbit model in the presence of concurrently administered doxorubicin.
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Singh K, Smucker JD, Ugbo JL, Tortolani PJ, Tsai L, Fei Q, Kuh S, Rumi M, Heller JG, Boden SD, and Yoon ST
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- Animals, Bone Morphogenetic Protein 2, Bone Transplantation methods, Humans, Osteogenesis physiology, Rabbits, Recombinant Proteins therapeutic use, Spine drug effects, Antibiotics, Antineoplastic adverse effects, Bone Morphogenetic Proteins therapeutic use, Doxorubicin adverse effects, Osteogenesis drug effects, Spinal Fusion methods, Transforming Growth Factor beta therapeutic use
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Background Context: Spinal fusions can be necessary in patients undergoing chemotherapy with doxorubicin. In a previous study, doxorubicin was shown to decrease spinal fusion rates in a rabbit model of lumbar intertransverse process spinal fusion with autograft iliac crest bone. In the current study, we determine whether spinal fusion with recombinant human bone morphogenetic protein-2 (rhBMP-2) can overcome the inhibitory effect of doxorubicin in spinal fusion., Purpose: To determine if rhBMP-2 can overcome the inhibitory effects of doxorubicin (adriamycin) in an animal model of posterolateral spinal fusion., Study Design/setting: Prospective, controlled, rabbit model of posterolateral lumbar fusion., Outcome Measures: Spine fusion was assessed by manual palpation (by observers blinded to the treatment group) at the level of arthrodesis. Fusion was graded according to a five-tiered classification (0-4). Posteroanterior radiographs of the excised spines were also graded in a blinded fashion using a six-point scoring system (0-5) devised to describe the amount of bone observed between the L5-L6 transverse processes., Methods: Thirty-two New Zealand White rabbits underwent posterolateral fusion at L5-L6 with either autograft (iliac crest autograft bone) or rhBMP-2 (rhBMP-2/absorbable collagen sponge (0.86 mg/level). All animals received a dose of doxorubicin (2.5 mg/kg) known to inhibit spine fusion via the central vein of the ear immediately postoperatively. Five weeks postoperatively the rabbits were euthanized. Spine fusion was assessed by manual palpation, and graft quality was assessed with posteroanterior radiographs., Results: Four of the 16 spines (25%) in the autograft group and 16 of the 16 spines (100%) in the rhBMP-2 group fused in the presence of doxorubicin administration (p<.05). There was significantly increased bone formation in the rhBMP-2 group (p<.05). One unilateral, subclinical wound infection was observed in each group at the time of euthanization (autograft [n=1, 6%] and rhBMP-2 [n=1, 6%])., Conclusions: We confirm that when autograft is used, doxorubicin decreases spinal fusion rate (25%) compared with historical controls (60-75%). More importantly, using rhBMP-2 overcomes the inhibitory effect of doxorubicin, resulting in 100% fusion in our animal model. This study suggests that rhBMP-2 has the potential to improve fusion rates in human patients undergoing chemotherapy with doxorubicin.
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- 2007
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36. Increased swelling complications associated with off-label usage of rhBMP-2 in the anterior cervical spine.
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Smucker JD, Rhee JM, Singh K, Yoon ST, and Heller JG
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- Adolescent, Adult, Aged, Aged, 80 and over, Bone Morphogenetic Protein 2, Bone Morphogenetic Proteins therapeutic use, Child, Deglutition Disorders epidemiology, Deglutition Disorders etiology, Edema epidemiology, Female, Humans, Incidence, Male, Middle Aged, Neck, Postoperative Complications epidemiology, Recombinant Proteins administration & dosage, Recombinant Proteins therapeutic use, Transforming Growth Factor beta therapeutic use, Bone Morphogenetic Proteins adverse effects, Cervical Vertebrae surgery, Edema chemically induced, Postoperative Complications chemically induced, Spinal Fusion, Transforming Growth Factor beta adverse effects
- Abstract
Study Design/setting: Independent, retrospective clinical record review with a concurrent control., Objective: To identify whether rhBMP-2 is associated with an increased incidence of clinically relevant postoperative prevertebral swelling problems in patients undergoing anterior cervical fusions., Summary of Background Data: Bone Morphogenetic Protein-2 (rhBMP-2) is FDA approved as a bone graft substitute in anterior lumbar interbody fusions. rhBMP-2 has also been used "off-label" in anterior cervical fusions. We suspected that rhBMP-2 might increase the incidence of adverse swelling events., Methods: A total of 234 consecutive patients (ages 12-82 years) undergoing anterior cervical fusion with and without rhBMP-2 over a 2-year period at one institution comprised the study population. The incidence of clinically relevant prevertebral swelling was calculated. The populations were compared and statistical significance was determined., Results: A total of 234 patients met the study criteria, 69 of whom underwent anterior cervical spine fusions using rhBMP-2; 27.5% of those patients in the rhBMP-2 group had a clinically significant swelling event versus only 3.6% of patients in the non-rhBMP-2 group. This difference was statistically significant (P < 0.0001) and remained so after controlling for other significant predictors of swelling., Conclusions: Off-label use of rhBMP-2 in the anterior cervical spine is associated with an increased rate of clinically relevant swelling events.
- Published
- 2006
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37. Surgical treatment of destructive calcific lesions of the cervical spine in scleroderma: case series and review of the literature.
- Author
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Smucker JD, Heller JG, Bohlman HH, and Whitesides TE Jr
- Subjects
- Aged, Biopsy, Needle, Calcinosis diagnosis, Calcinosis diagnostic imaging, Female, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Neurologic Examination, Pain etiology, Postoperative Care, Preoperative Care, Retrospective Studies, Spinal Diseases diagnosis, Spinal Diseases diagnostic imaging, Tomography, X-Ray Computed, Calcinosis etiology, Calcinosis surgery, Cervical Vertebrae, Orthopedic Procedures adverse effects, Scleroderma, Localized complications, Spinal Diseases etiology, Spinal Diseases surgery
- Abstract
Study Design: An independent retrospective chart review combined with a review of current literature., Objectives: To describe a series of destructive, calcific masses of the cervical spine causing pain, neurologic dysfunction, and instability in patients with scleroderma and detail the surgical interventions required. To review benign, calcific cervical spine lesions associated with scleroderma and collagen vascular disorders., Summary of Background Data: Little is know about the diagnosis and management of the destructive, calcific lesions of scleroderma in the cervical spine., Methods: The medical and radiographic records of 3 patients with scleroderma lesions in the cervical spine were reviewed. A computer-based literature search of Ovid and PubMed databases was used to compile a comprehensive review of the topic., Results: The perioperative and surgical management of 3 cases of scleroderma of the cervical spine are discussed in the context of a complete literature review on the topic. These complex lesions were found to require significant resources with regard to diagnosis and management., Conclusions: Destructive, calcific masses in the cervical spine associated with scleroderma and an indication for surgical treatment are rare. Treatment is complex and not without significant risk to the patient.
- Published
- 2006
- Full Text
- View/download PDF
38. Current concepts in the management of metastatic spinal disease. The role of minimally-invasive approaches.
- Author
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Singh K, Samartzis D, Vaccaro AR, Andersson GB, An HS, and Heller JG
- Subjects
- Aged, Endoscopy methods, Female, Humans, Male, Middle Aged, Minimally Invasive Surgical Procedures methods, Orthopedic Procedures methods, Radiography, Radiosurgery methods, Spinal Neoplasms radiotherapy, Spinal Neoplasms surgery, Spine diagnostic imaging, Spine surgery, Spinal Neoplasms secondary
- Published
- 2006
- Full Text
- View/download PDF
39. The management of complex soft-tissue defects after spinal instrumentation.
- Author
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Singh K, Samartzis D, Heller JG, An HS, and Vaccaro AR
- Subjects
- Female, Humans, Male, Middle Aged, Risk Factors, Spinal Cord surgery, Surgical Flaps, Surgical Wound Dehiscence etiology, Surgical Wound Infection etiology, Neurosurgical Procedures, Plastic Surgery Procedures methods, Spine surgery, Surgical Wound Dehiscence surgery, Surgical Wound Infection surgery
- Published
- 2006
- Full Text
- View/download PDF
40. Open vertebral cement augmentation combined with lumbar decompression for the operative management of thoracolumbar stenosis secondary to osteoporotic burst fractures.
- Author
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Singh K, Heller JG, Samartzis D, Price JS, An HS, Yoon ST, Rhee J, Ledlie JT, and Phillips FM
- Subjects
- Aged, Aged, 80 and over, Female, Fractures, Compression etiology, Fractures, Compression therapy, Humans, Male, Middle Aged, Osteoporosis complications, Retrospective Studies, Spinal Fractures etiology, Spinal Fractures therapy, Spinal Stenosis etiology, Treatment Outcome, Bone Cements, Decompression, Surgical, Lumbar Vertebrae injuries, Polymethyl Methacrylate, Spinal Stenosis therapy, Thoracic Vertebrae injuries
- Abstract
Osteoporotic burst fractures with neurologic symptoms are typically treated with neural decompression and multilevel instrumented fusion. These large surgical interventions are challenging because of patients' advanced ages, medical co-morbidities, and poor fixation secondary to osteoporosis. The purpose of this retrospective clinical study was to describe a novel technique for the treatment of osteoporotic burst fractures and symptomatic spinal stenosis via a limited thoracolumbar decompression with open cement augmentation [vertebroplasty (VP) or kyphoplasty (KP)]. Indications for decompression and cement augmentation were intractable pain at the level of a known osteoporotic burst fracture with symptoms of spinal stenosis. As such, 25 patients (mean age, 76.1 years) with low-energy, osteoporotic, thoracolumbar burst fractures (7 males, 18 females; 39 fractures) were included. In all cases, laminectomy of the stenotic level(s) was followed by vertebral cement augmentation (9 VP; 16 KP). When a spondylolisthesis at the decompressed level was present, instrumentation was applied across the listhetic level (n = 9). Clinical outcome (1 = poor to 4 = excellent) was assessed on last clinical follow-up (mean, 44.8 wks). In addition, a modified MacNab's grading criteria was used to objectively assess patient outcomes postoperatively. Radiographic analysis of sagittal contour was assessed preoperatively, immediately postoperatively, and at final follow-up. The average time from onset of symptoms to intervention was 19 weeks (range, 0.3-94 wks). A mean of 1.6 fractures/patient was augmented (range, 1-3 fractures) and 2.8 levels were decompressed (range, 1-6 levels). No statistical difference in anatomic distribution or number of fractures between the VP and KP groups or in the instrumented versus noninstrumented patients was noted (P > 0.05). An overall subjective outcome score of 3.4 was noted. Twenty of 25 patients were graded as excellent/good according to the modified MacNab's criteria. The choice of augmentation procedure or use of instrumentation did not predict outcome (P = 0.08). Overall, 1.7 degrees of sagittal correction was obtained at final follow-up. One patient was noted to have progressive kyphosis after KP. The use of a limited-posterior decompression and open cement augmentation via VP or KP is a safe treatment option for patients who have osteoporotic burst fractures and who are incapacitated from fracture pain and concomitant stenosis. After thoracolumbar decompression, open VP/KP provides direct visualization of the posterior vertebral body wall, allowing for safe cement augmentation of burst fractures, stabilizing the spine, and obviating the need for extensive spinal reconstruction. Although clinically successful, this technique warrants careful patient selection.
- Published
- 2005
- Full Text
- View/download PDF
41. Kyphoplasty for salvage of a failed vertebroplasty in osteoporotic vertebral compression fractures: case report and surgical technique.
- Author
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Yoon ST, Qureshi AA, Heller JG, and Nordt JC 3rd
- Subjects
- Aged, Aged, 80 and over, Female, Humans, Kyphosis etiology, Kyphosis pathology, Lumbar Vertebrae diagnostic imaging, Lumbar Vertebrae pathology, Magnetic Resonance Imaging, Male, Methacrylates therapeutic use, Orthopedic Procedures adverse effects, Orthopedic Procedures standards, Postoperative Complications diagnostic imaging, Postoperative Complications pathology, Postoperative Complications surgery, Plastic Surgery Procedures adverse effects, Plastic Surgery Procedures standards, Reoperation methods, Reoperation standards, Spinal Fractures etiology, Spinal Fractures pathology, Tomography, X-Ray Computed, Treatment Failure, Treatment Outcome, Kyphosis surgery, Lumbar Vertebrae surgery, Orthopedic Procedures methods, Osteoporosis complications, Plastic Surgery Procedures methods, Spinal Fractures surgery
- Abstract
Osteoporotic vertebral compression fractures are a significant source of morbidity. Recently described techniques of vertebroplasty and kyphoplasty have provided consistent successful outcomes in the short term. However, techniques to address the failure of vertebroplasty have not been addressed. We present two cases of failed vertebroplasty that were revised with a kyphoplasty technique. Both patients had near complete resolution of preoperative symptoms and had a significant vertebral height restoration more than 10 months after revision with kyphoplasty. In conclusion, kyphoplasty technique can be utilized to salvage failed vertebroplasty.
- Published
- 2005
- Full Text
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42. The effects of doxorubicin (adriamycin) on spinal fusion: an experimental model of posterolateral lumbar spinal arthrodesis.
- Author
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Tortolani PJ, Park AE, Louis-Ugbo J, Attallah-Wasef ES, Kraiwattanapong C, Heller JG, Boden SD, and Yoon ST
- Subjects
- Animals, Disease Models, Animal, Female, Lumbar Vertebrae surgery, Rabbits, Time Factors, Wound Healing drug effects, Antibiotics, Antineoplastic adverse effects, Doxorubicin adverse effects, Fracture Healing drug effects, Spinal Fusion
- Abstract
Background Context: Malignant spinal lesions may require surgical excision and segmental stabilization. The decision to perform a concomitant fusion procedure is influenced in part by the need for adjunctive chemotherapy as well as the patient's anticipated survival. Although some evidence exists that suggests that chemotherapy may inhibit bony healing, no information exists regarding the effect of chemotherapy on spinal fusion healing., Purpose: To determine the effect of a frequently used chemotherapeutic agent, doxorubicin, on posterolateral spinal fusion rates., Study Design/setting: Prospective animal model of posterolateral lumbar fusion., Outcome Measures: Determination of spinal fusion by manual palpation of excised spines. Plain radiographic evaluation of denuded spines to evaluate intertransverse bone formation., Methods: Thirty-two New Zealand White rabbits underwent posterior intertransverse process fusion at L5-L6 with the use of iliac autograft bone. Rabbits randomly received either intravenous doxorubicin (2.5 mg/kg) by means of the central vein of the ear at the time of surgery (16 animals) or no treatment (16 animals; the control group). The animals were euthanized at 5 weeks, and the lumbar spines were excised. Spine fusion was assessed by manually palpating (by observers blinded to the treatment group) at the level of arthrodesis, and at the adjacent levels proximal and distal. This provided similar information to surgical fusion assessment by palpation in humans. Fusion was defined as the absence of palpable motion. Posteroanterior radiographs of the excised spines were graded in a blinded fashion using a five-point scoring system (0 to 4) devised to describe the amount of bone observed between the L5-L6 transverse processes. Power analysis conducted before initiation of the study indicated that an allocation of 16 animals to each group would permit detection of at least a 20% difference in fusion rates with statistical significance at p=.05., Results: Eleven of the 16 spines (69%) in the control group and 6 of the 16 spines (38%) in the doxorubicin group fused. This difference was statistically significant (=.038). There was no significant correlation (p>.05) between the radiographic grade of bone formation (0 to 4) and fusion as determined by palpation. There were four wound infections in the control group and four in the doxorubicin group. However, solid fusions were palpated in three of these four spines in both the control and treatment groups., Conclusions: No significant differences in wound complications were noted with doxorubicin administration. A single dose of doxorubicin administered intravenously at the time of surgery appears to play a significant inhibitory role in the process of spinal fusion. If similar effects occur in humans, these data suggest that doxorubicin may be harmful to bone healing in a spine fusion if given during the perioperative period. Further investigation will be necessary to determine the effect of time to aid at determining whether doxorubicin administered several weeks pre- or postoperatively results in improved fusion rate, and whether bone morphogenetic proteins can overcome these inhibitory effects.
- Published
- 2004
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43. Cervical laminoplasty: use of a novel titanium plate to maintain canal expansion--surgical technique.
- Author
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Park AE and Heller JG
- Subjects
- Decompression, Surgical instrumentation, Decompression, Surgical methods, Humans, Spinal Canal surgery, Bone Plates, Cervical Vertebrae surgery, Laminectomy instrumentation, Laminectomy methods, Titanium
- Abstract
Cervical laminoplasty is a technique used to achieve spinal cord decompression in cases of myelopathy or myeloradiculopathy. The most common reason for failure of this technique is restenosis due to hinge closure. Various techniques have been employed to hold the laminar "door" open while the body heals the lamina hinge in the new expanded position. Ideally, a method of achieving laminar fixation should be technically straightforward, provide secure laminar fixation, and be rapid to minimize the risk of iatrogenic injuries, blood loss, and operative time. The authors describe the use of a novel plate designed to accomplish these goals. The technical issues relevant to performing the laminoplasty and securing the laminae are discussed. The plate has been proven biomechanically to be equal or superior to the currently used techniques. The use of this plate will allow the patient to engage in an early active rehabilitation protocol-while minimizing the risk of restenosis of the canal. This may ultimately lead to better preservation of motion and decreased axial neck pain following laminoplasty.
- Published
- 2004
- Full Text
- View/download PDF
44. Safety and tolerability of ezetimibe.
- Author
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Heller JG
- Subjects
- Ezetimibe, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors adverse effects, Hypercholesterolemia drug therapy, Hypercholesterolemia enzymology, Azetidines adverse effects, Drug Tolerance physiology
- Published
- 2004
45. The accuracy of computed tomography in assessing cervical pedicle screw placement.
- Author
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Kim HS, Heller JG, Hudgins PA, and Fountain JA
- Subjects
- Humans, Observer Variation, Pilot Projects, Reproducibility of Results, Bone Screws, Cervical Vertebrae diagnostic imaging, Cervical Vertebrae surgery, Tomography, X-Ray Computed
- Abstract
Study Design: A blinded, prospective comparison of computed tomography scan accuracy for determining the location of cervical pedicle screw position in human cadavers., Objectives: To establish recommended computed tomography technique guidelines for assessing location of cervical pedicle screws., Summary of Background Data: A small number of studies have described the accuracy of roentgenography regarding the assessment of pedicle screw position. However, a few studies have investigated the accuracy of computed tomography in this respect. Ebraheim et al evaluated the relation of lateral mass screws to the nerve roots within the intervertebral foramen on oblique radiographs. No study has been undertaken, to our knowledge, to specifically define the reliability and validity of computed tomography scans in the case of cervical pedicle screw placement., Methods: As a pilot study, 10 cadaveric cervical spines from another study with bilateral 3.5 mm titanium pedicle screws were scanned with 1.0 mm axial slices. After the scans were interpreted by three blinded readers, each panel member was "trained" with regard to individual accuracy. Ten more cadaveric cervical spines were instrumented with 3.5 mm titanium screws in each pedicle (C2-C7). The specimens were then scanned with a variety of computed tomography techniques, including spiral acquisitions at 1.0 mm, 1.0 mm + reconstruction, 2.5 mm, 5.0 mm slices, and the three-dimensional Stealth Station recipes. The specimens were dissected, and malpositioned screws were recorded and photographed by independent raters. The same three readers from the pilot study then read each new scan in random order., Results: Reader accuracies in the pretraining pilot study were 74%, 68%, and 52%, with kappa coefficients of 0.49, 0.37, and 0.07, respectively, and significant intrarater variances (P = 0.014). After training, the accuracy rate improved significantly to 89%, 88%, and 85% in posttraining study, and the kappa coefficients were 0.81, 0.78, and 0.73, respectively. Kappa statistical analysis showed negligible interreader variance on the entire pivotal study except by the three-dimensional Stealth Station format. The overall mean kappa coefficients were 0.77, 0.75, and 0.73. Assessment of pedicle screw position was statistically inferior with 5.0 mm axial slices, in contrast to slices <3.0 mm., Conclusions: We demonstrated that reliance on computed tomography scan data in determining the misplacement of a pedicle screw is usually accurate given proper scan acquisition, presentation windows, and adequate reader training, but a clinically significant error rate remains. A conventional computed tomography scan should not be treated as a gold standard, particularly without regard to the readers' training.
- Published
- 2003
- Full Text
- View/download PDF
46. Use of recombinant human bone morphogenetic protein-2 to achieve posterolateral lumbar spine fusion in humans: a prospective, randomized clinical pilot trial: 2002 Volvo Award in clinical studies.
- Author
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Boden SD, Kang J, Sandhu H, and Heller JG
- Subjects
- Awards and Prizes, Bone Morphogenetic Protein 2, Calcium Phosphates administration & dosage, Drug Implants adverse effects, Female, Follow-Up Studies, Humans, Ilium transplantation, Internal Fixators, Low Back Pain etiology, Lumbosacral Region, Male, Middle Aged, Pilot Projects, Prospective Studies, Reoperation, Spinal Fusion adverse effects, Treatment Outcome, Bone Morphogenetic Proteins therapeutic use, Bone Substitutes administration & dosage, Bone Transplantation adverse effects, Intervertebral Disc Displacement surgery, Recombinant Proteins therapeutic use, Spinal Fusion methods, Transforming Growth Factor beta
- Abstract
Study Design: A prospective randomized clinical study was conducted., Objective: To determine whether the dose and carrier that were successful in rhesus monkeys could induce consistent radiographic spine fusion in humans., Summary of Background Data: Preclinical studies have demonstrated that recombinant human bone morphogenetic protein-2 (rhBMP-2), an osteoinductive bone morphogenetic protein, is successful at generating spine fusion in rabbits and rhesus monkeys., Methods: For this study, 25 patients undergoing lumbar arthrodesis were randomized (1:2:2 ratio) based on the arthrodesis technique: autograft/Texas Scottish Rite Hospital (TSRH) pedicle screw instrumentation (n = 5), rhBMP-2/TSRH (n = 11), and rhBMP-2 only without internal fixation (n = 9). On each side, 20 mg of rhBMP-2 were delivered on a carrier consisting of 60% hydroxyapatite and 40% tricalcium phosphate granules (10 cm /side). The patients had single-level disc degeneration, Grade 1 or less spondylolisthesis, mechanical low back pain with or without leg pain, and at least 6 months failure of nonoperative treatment., Results: All 25 patients were available for follow-up evaluation (mean, 17 months; range 12-27 months). The radiographic fusion rate was 40% (2/5) in the autograft/TSRH group and 100% (20/20) with rhBMP-2 group with or without TSRH internal fixation ( = 0.004). A statistically significant improvement in Oswestry score was seen at 6 weeks in the rhBMP-2 only group (-17.6; = 0.009), and at 3 months in the rhBMP-2/TSRH group (-17.0; = 0.003), but not until 6 months in the autograft/TSRH group (-17.3; = 0.041). At the final follow-up assessment, Oswestry improvement was greatest in the rhBMP-2 only group (-28.7, < 0.001). The SF-36 Pain Index and PCS subscales showed similar changes., Discussion: This pilot study is the first with at least 1 year of follow-up evaluation to demonstrate successful posterolateral spine fusion using a BMP-based bone graft substitute, with radiographs and CT scans as the determinant. Consistently, rhBMP-2 was able to induce bone in the posterolateral lumbar spine when delivered at a dose of 20 mg per side with or without the use of internal fixation. Patients with spondylolisthesis classified higher than Meyerding Grade 1 or with more than 5 mm of translational motion may still require internal fixation. Some patients did smoke during the postoperative period, and all in the rhBMP-2 groups still obtained solid fusions., Conclusions: Consistently, rhBMP-2 with the biphasic calcium phosphate granules induced radiographic posterolateral lumbar spine fusion with or without internal fixation in patients whose spondylolisthesis did not exceed Grade 1. Statistically greater and quicker improvement in patient-derived clinical outcome was measured in the rhBMP-2 groups.
- Published
- 2002
- Full Text
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47. Interpretation of analysis.
- Author
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Heller JG
- Subjects
- Antipsychotic Agents economics, Clozapine economics, Cost-Benefit Analysis, Data Interpretation, Statistical, Humans, Meta-Analysis as Topic, Quality of Life, Schizophrenia economics, Antipsychotic Agents therapeutic use, Clozapine therapeutic use, Schizophrenia drug therapy
- Published
- 2002
48. Corpectomy versus laminoplasty for multilevel cervical myelopathy: an independent matched-cohort analysis.
- Author
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Edwards CC 2nd, Heller JG, and Murakami H
- Subjects
- Adult, Aged, Cervical Vertebrae diagnostic imaging, Cervical Vertebrae surgery, Cohort Studies, Decompression, Surgical adverse effects, Disease Progression, Female, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Neck diagnostic imaging, Pain etiology, Pain Management, Radiography, Range of Motion, Articular, Retrospective Studies, Spinal Cord Compression diagnosis, Spinal Cord Compression surgery, Spinal Cord Diseases complications, Spinal Cord Diseases diagnosis, Spinal Stenosis diagnosis, Treatment Outcome, Decompression, Surgical methods, Laminectomy adverse effects, Laminectomy methods, Spinal Cord Diseases surgery, Spinal Stenosis surgery
- Abstract
Study Design: Matched patient cohorts using retrospective chart and radiographic review with independent clinical and radiographic follow-up were reviewed., Objective: To compare the clinical and radiographic outcomes of multilevel corpectomy and laminoplasty using an independent matched-cohort analysis., Summary of Background Data: The treatment of choice for multilevel cervical myelopathy remains a matter of investigation. For the decompression of three or more motion segments, multilevel corpectomy and laminoplasty have proven effective while avoiding the pitfalls of laminectomy. Direct clinical comparisons of these two procedures are few in number and are limited by the heterogeneity in their patient groups., Methods: Medical records of all patients treated for multilevel cervical myelopathy with either multilevel corpectomy or laminoplasty between 1994 and 1999 at the Emory Spine Center were reviewed. From a pool of 38 patients meeting stringent inclusion and exclusion criteria, 13 patients who underwent multilevel corpectomy were blindly matched with 13 patients who underwent laminoplasty based on known prognostic criteria. A single physician independently evaluated each patient and their radiographs at their latest follow-up appointment., Results: The cohorts were well matched by age, duration of symptoms, severity of myelopathy (Nurick grade), and preoperative sagittal alignment (C2-C7). Mean operative time, blood loss, and hospital stay were nearly identical. The mean follow-up for multilevel corpectomy and laminoplasty were 49 and 40 months, respectively. Improvement in function averaged 1.6 Nurick grades after laminoplasty and 0.9 grades after multilevel corpectomy (P > 0.05). Subjective improvements in strength, dexterity, sensation, pain, and gait were similar for the two operations. The prevalence of axial discomfort at the latest follow-up was the same for each cohort, but the analgesic requirements tended to be greater for patients who underwent multilevel corpectomy. Sagittal motion from C2 to C7 decreased by 57% after multilevel corpectomy and by 38% after laminoplasty. One complication (C6-C7 herniated nucleus pulposus [HNP] requiring anterior discetomy with fusion) occurred in the laminoplasty group. Multilevel corpectomy complications included progression of myelopathy, nonunion, persistent dysphagia, persistent dysphonia, and subjacent motion segment ankylosis., Conclusions: Both multilevel corpectomy and laminoplasty reliably arrest myelopathic progression in multilevel cervical myelopathy and can lead to significant neurologic recovery and pain reduction in a majority of patients. Surprisingly, the laminoplasty cohort tended to require less pain medication at final follow-up than did the multilevel corpectomy cohort. Given this and the higher prevalence of complications among multilevel corpectomy patients, it is believed that laminoplasty may be the preferred method of treatment for multilevel cervical myelopathy in the absence of preoperative kyphosis.
- Published
- 2002
- Full Text
- View/download PDF
49. Bone grafting alternatives in spinal surgery.
- Author
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Vaccaro AR, Chiba K, Heller JG, Patel TCh, Thalgott JS, Truumees E, Fischgrund JS, Craig MR, Berta SC, and Wang JC
- Subjects
- Animals, Bone Matrix transplantation, Genetic Therapy, Humans, Male, Middle Aged, Prostheses and Implants, Spinal Fusion trends, Transplantation, Homologous methods, Bone Morphogenetic Proteins therapeutic use, Bone Transplantation, Spinal Fusion methods, Spine surgery
- Abstract
Background Context: Bone grafting is used to augment bone healing and provide stability after spinal surgery. Autologous bone graft is limited in quantity and unfortunately associated with increased surgical time and donor-site morbidity. Alternatives to bone grafting in spinal surgery include the use of allografts, osteoinductive growth factors such as bone morphogenetic proteins and various synthetic osteoconductive carriers., Purpose: Recent research has provided insight into methods that may modulate the bone healing process at the cellular level in addition to reversing the effects of symptomatic disc degeneration, which is a potentially disabling condition, managed frequently with various fusion procedures. With many adjuncts and alternatives available for use in spinal surgery, a concise review of the current bone grafting alternatives in spinal surgery is necessary., Study Design/setting: A systematic review of the contemporary English literature on bone grafting in spinal surgery, including abstract information presented at national meetings., Methods: Bone grafting alternatives were reviewed as to their efficacy in extending or replacing autologous bone graft sources in spinal applications., Results: Alternatives to autologous bone graft include allograft bone, demineralized bone matrix, recombinant growth factors and synthetic implants. Each of these alternatives could possibly be combined with autologous bone marrow or various growth factors. Although none of the presently available substitutes provides all three of the fundamental properties of autograft bone (osteogenicity, osteoconductivity and osteoinductivity), there are a number of situations in which they have proven clinically useful., Conclusions: Alternatives to autogenous bone grafting find their greatest appeal when autograft bone is limited in supply or when acceptable rates of fusion may be achieved with these substitutes (or extenders) despite the absence of one or more of the properties of autologous bone graft. In these clinical situations, the morbidity of autograft harvest is reasonably avoided. Future research may discover that combinations of materials may cumulatively result in the expression of osteogenesis, osteoinductivity and osteoconductivity found in autogenous sources.
- Published
- 2002
- Full Text
- View/download PDF
50. Will public health survive QALYs?
- Author
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Heller JG
- Subjects
- Canada, Cost-Benefit Analysis, Drug Costs, Humans, Immunologic Factors economics, Immunologic Factors therapeutic use, Interferon-beta economics, Interferon-beta therapeutic use, Models, Theoretical, Multiple Sclerosis drug therapy, Public Health, Quality-Adjusted Life Years
- Published
- 2002
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