Browsing by Author "Polly, David W"
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Item Open Access A novel classification system for spinal instability in neoplastic disease: an evidence-based approach and expert consensus from the Spine Oncology Study Group.(Spine, 2010-10) Fisher, Charles G; DiPaola, Christian P; Ryken, Timothy C; Bilsky, Mark H; Shaffrey, Christopher I; Berven, Sigurd H; Harrop, James S; Fehlings, Michael G; Boriani, Stefano; Chou, Dean; Schmidt, Meic H; Polly, David W; Biagini, Roberto; Burch, Shane; Dekutoski, Mark B; Ganju, Aruna; Gerszten, Peter C; Gokaslan, Ziya L; Groff, Michael W; Liebsch, Norbert J; Mendel, Ehud; Okuno, Scott H; Patel, Shreyaskumar; Rhines, Laurence D; Rose, Peter S; Sciubba, Daniel M; Sundaresan, Narayan; Tomita, Katsuro; Varga, Peter P; Vialle, Luiz R; Vrionis, Frank D; Yamada, Yoshiya; Fourney, Daryl RStudy design
Systematic review and modified Delphi technique.Objective
To use an evidence-based medicine process using the best available literature and expert opinion consensus to develop a comprehensive classification system to diagnose neoplastic spinal instability.Summary of background data
Spinal instability is poorly defined in the literature and presently there is a lack of guidelines available to aid in defining the degree of spinal instability in the setting of neoplastic spinal disease. The concept of spinal instability remains important in the clinical decision-making process for patients with spine tumors.Methods
We have integrated the evidence provided by systematic reviews through a modified Delphi technique to generate a consensus of best evidence and expert opinion to develop a classification system to define neoplastic spinal instability.Results
A comprehensive classification system based on patient symptoms and radiographic criteria of the spine was developed to aid in predicting spine stability of neoplastic lesions. The classification system includes global spinal location of the tumor, type and presence of pain, bone lesion quality, spinal alignment, extent of vertebral body collapse, and posterolateral spinal element involvement. Qualitative scores were assigned based on relative importance of particular factors gleaned from the literature and refined by expert consensus.Conclusion
The Spine Instability Neoplastic Score is a comprehensive classification system with content validity that can guide clinicians in identifying when patients with neoplastic disease of the spine may benefit from surgical consultation. It can also aid surgeons in assessing the key components of spinal instability due to neoplasia and may become a prognostic tool for surgical decision-making when put in context with other key elements such as neurologic symptoms, extent of disease, prognosis, patient health factors, oncologic subtype, and radiosensitivity of the tumor.Item Open Access An international consensus on the appropriate evaluation and treatment for adults with spinal deformity.(European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2018-03) Berven, Sigurd H; Kamper, Steven J; Germscheid, Niccole M; Dahl, Benny; Shaffrey, Christopher I; Lenke, Lawrence G; Lewis, Stephen J; Cheung, Kenneth M; Alanay, Ahmet; Ito, Manabu; Polly, David W; Qiu, Yong; de Kleuver, Marinus; AOSpine Knowledge Forum DeformityPurpose
Evaluation and surgical management for adult spinal deformity (ASD) patients varies between health care providers. The purpose of this study is to identify appropriateness of specific approaches and management strategies for the treatment of ASD.Methods
From January to July 2015, the AOSpine Knowledge Deformity Forum performed a modified Delphi survey where 53 experienced deformity surgeons from 24 countries, rated the appropriateness of management strategies for multiple ASD clinical scenarios. Four rounds were performed: three surveys and a face-to-face meeting. Consensus was achieved with ≥70% agreement.Results
Appropriate surgical goals are improvement of function, pain, and neural symptoms. Appropriate preoperative patient evaluation includes recording information on history and comorbidities, and radiographic workup, including long standing films and MRI for all patients. Preoperative pulmonary and cardiac testing and DEXA scan is appropriate for at-risk patients. Intraoperatively, appropriate surgical strategies include long fusions with deformity correction for patients with large deformity and sagittal imbalance, and pelvic fixation for multilevel fusions with large curves, sagittal imbalance, and osteoporosis. Decompression alone is inappropriate in patients with large curves, sagittal imbalance, and progressive deformity. It is inappropriate to fuse to L5 in patients with symptomatic disk degeneration at L5-S1.Conclusions
These results provide guidance for informed decision-making in the evaluation and management of ASD. Appropriate care for ASD, a very diverse spectrum of disease, must be responsive to patient preference and values, and considerations of the care provider, and the healthcare system. A monolithic approach to care should be avoided.Item Open Access Cell Saver for Adult Spinal Deformity Surgery Reduces Cost.(Spine deformity, 2017-07) Gum, Jeffrey L; Carreon, Leah Yacat; Kelly, Michael P; Hostin, Richard; Robinson, Chessie; Burton, Douglas C; Polly, David W; Shaffrey, Christopher I; LaFage, Virginie; Schwab, Frank J; Ames, Christopher P; Kim, Han Jo; Smith, Justin S; Bess, R Shay; International Spine Study GroupStudy design
Retrospective cohort.Objectives
To determine if the use of cell saver reduces overall blood costs in adult spinal deformity (ASD) surgery.Summary of background data
Recent studies have questioned the clinical value of cell saver during spine procedures.Methods
ASD patients enrolled in a prospective, multicenter surgical database who had complete preoperative and surgical data were identified. Patients were stratified into (1) cell saver available during surgery, but no intraoperative autologous infusion (No Infusion group), or (2) cell saver available and received autologous infusion (Infusion group).Results
There were 427 patients in the Infusion group and 153 in the No infusion group. Patients in both groups had similar demographics. Mean autologous infusion volume was 698 mL. The Infusion group had a higher percentage of EBL relative to the estimated blood volume (42.2%) than the No Infusion group (19.6%, p < .000). Allogeneic transfusion was more common in the Infusion group (255/427, 60%) than the No Infusion group (67/153, 44%, p = .001). The number of allogeneic blood units transfused was also higher in the Infusion group (2.4) than the No Infusion group (1.7, p = .009). Total blood costs ranged from $396 to $2,146 in the No Infusion group and from $1,262 to $5,088 in the Infusion group. If the cost of cell saver blood was transformed into costs of allogeneic blood, total blood costs for the Infusion group would range from $840 to $5,418. Thus, cell saver use yielded a mean cost savings ranging from $330 to $422 (allogeneic blood averted). Linear regression showed that after an EBL of 614 mL, cell saver becomes cost-efficient.Conclusion
Compared to transfusing allogeneic blood, cell saver autologous infusion did not reduce the proportion or the volume of allogeneic transfusion for patients undergoing surgery for adult spinal deformity. The use of cell saver becomes cost-efficient above an EBL of 614 mL, producing a cost savings of $330 to $422.Level of evidence
Level III.Item Open Access Commentary: Appropriate Use Criteria for Lumbar Degenerative Scoliosis: Developing Evidence-based Guidance for Complex Treatment Decisions.(Neurosurgery, 2017-03) Glassman, Steven D; Berven, Sigurd H; Shaffrey, Christopher I; Mummaneni, Praveen V; Polly, David WLumbar degenerative scoliosis is a relatively common problem, and is being treated more frequently due to the confluence of an aging population and an increased capacity and willingness to manage difficult problems in older patients. Lumbar degenerative scoliosis is a complex pathology as it often involves the intersection of degenerative spinal stenosis and spinal deformity. While previous studies provide an indication that these patients may benefit from surgical treatment, the substantial variability in treatment underscores the opportunity for improvement. Optimizing treatment for lumbar degenerative scoliosis is critical as surgical intervention, while potentially providing substantial clinical benefit also entails measurable risk and significant expense. In light of these issues, evidence-based guidance generated through Appropriate Use Criteria (AUC) development offers the potential to improve both the quality and cost effectiveness of care.The lumbar degenerative scoliosis AUC represents a significant step toward evidence-based treatment in spinal surgery. This is the first time that spine societies and industry partners have collaborated to support evidence development. The willingness of all involved to support a completely independent process underlines a commitment to trust the evidence. Subsequent studies may validate and/or refine the AUC recommendations, but the most important result is that the standard for evidence quality has been raised.Item Open Access Complication rates of three common spine procedures and rates of thromboembolism following spine surgery based on 108,419 procedures: a report from the Scoliosis Research Society Morbidity and Mortality Committee.(Spine, 2010-11) Smith, Justin S; Fu, Kai-Ming G; Polly, David W; Sansur, Charles A; Berven, Sigurd H; Broadstone, Paul A; Choma, Theodore J; Goytan, Michael J; Noordeen, Hilali H; Knapp, Dennis Raymond; Hart, Robert A; Donaldson, William F; Perra, Joseph H; Boachie-Adjei, Oheneba; Shaffrey, Christopher IStudy design
Retrospective review of a prospectively collected database.Objective
The Scoliosis Research Society (SRS) collects morbidity and mortality (M and M) data from its members. Our objectives were to assess complication rates for 3 common spine procedures, compare these results with prior literature as a means of validating the database, and to assess rates of pulmonary embolism (PE) and deep venous thrombosis (DVT) in all cases reported to the SRS over 4 years.Summary of background data
Few modern series document complication rates of spinal surgery as routinely practiced across academic and community settings. Those available are typically based on relatively low numbers of procedures or confined to single-surgeon experiences.Methods
The SRS M and M database was queried for lumbar microdiscectomy (LD), anterior cervical discectomy and fusion (ACDF), and lumbar stenosis decompression (LSD) cases from 2004 to 2007. Revisions were excluded. The database was also queried for occurrence of clinically evident PE and DVT in all cases from 2004 to 2007.Results
A total of 9692 LDs, 6735 ACDFs, and 10,329 LSDs were identified, with overall complication rates of 3.6%, 2.4%, and 7.0%, respectively. These rates are comparable to previously published smaller series. For assessment of PE and DVT, 108,419 cases were identified and rates were calculated per 1000 cases based on diagnosis, age group, and implant use. Overall rates of PE, death due to PE, and DVT were 1.38, 0.34, and 1.18, respectively. Among 82,082 adults, the rate of PE ranged from 0.47 for LD to 12.4 for metastatic tumor. Similar variations were noted for DVT and deaths due to PE.Conclusion
Overall major complication rates for LD, ACDF, and LSD based on the SRS M and M database are comparable to those in previously reported smaller series, supporting the validity of this database for study of other less common spinal disorders. In addition, our data provide general benchmarks of clinically evident PE and DVT rates as a basis for ongoing efforts to improve care.Item Open Access Complications associated with surgical treatment of traumatic spinal fractures: a review of the scoliosis research society morbidity and mortality database.(World neurosurgery, 2014-05) Williams, Brian J; Smith, Justin S; Saulle, Dwight; Ames, Christopher P; Lenke, Lawrence G; Broadstone, Paul A; Vaccaro, Alexander R; Polly, David W; Shaffrey, Christopher IObjective
Traumatic spinal fracture is a common indication for surgery, with an associated high incidence of perioperative complications. The literature provides a wide range in the incidence of complications. We seek to assess the perioperative morbidity and mortality of surgery for traumatic spinal fractures and to identify predictors of their occurrence.Methods
We performed a retrospective analysis of all traumatic spinal fracture cases submitted by members of the Scoliosis Research Society from 2004 to 2007.Results
A total of 108,478 cases were submitted from 2004 through 2007, with 6,706 (6.2%) performed for treatment of traumatic fracture. Twenty-two percent of patients had preoperative neurological deficits. Intraoperative neuromonitoring was used in 58% of cases. The overall incidence of complications was 6.9%. The perioperative mortality was 0.5%. There were 59 (0.9%) new postoperative neurological deficits. Multivariate analysis demonstrated preoperative neurological deficit (P = .001; odds ratio [OR] 1.449, 95% confidence interval [CI] [1.156 to 1.817]) and fusion (P =.001; OR 1.12, 95% CI [1.072 to 1.168]) as predictors of complications and use of intraoperative neuromonitoring (P = .016; OR 1.949, 95% CI [1.13 to 3.361]), and preoperative neurological deficit (P < .001; OR 2.964, 95% CI [1.667 to 5.271]) as predictors of new postoperative neurological deficits (P < .001).Conclusions
Overall, surgery for the treatment of spinal fractures was performed with relatively low incidences of perioperative complications (6.9%) and mortality (0.5%). These data may prove useful for patient counseling and ongoing efforts to improve the safety of operative care for patients with spinal fracture.Item Open Access Complications in the surgical treatment of 19,360 cases of pediatric scoliosis: a review of the Scoliosis Research Society Morbidity and Mortality database.(Spine, 2011-08) Reames, Davis L; Smith, Justin S; Fu, Kai-Ming G; Polly, David W; Ames, Christopher P; Berven, Sigurd H; Perra, Joseph H; Glassman, Steven D; McCarthy, Richard E; Knapp, Raymond D; Heary, Robert; Shaffrey, Christopher I; Scoliosis Research Society Morbidity and Mortality CommitteeStudy design
Retrospective review of a multicenter database.Objective
To determine the complication rates associated with surgical treatment of pediatric scoliosis and to assess variables associated with increased complication rates.Summary of background data
Wide variability is reported for complications associated with the operative treatment of pediatric scoliosis. Limited number of patients, surgeons, and diagnoses occur in most reports. The Scoliosis Research Society Morbidity and Mortality (M&M) database aggregates deidentified data, permitting determination of complication rates from large numbers of patients and surgeons.Methods
Cases of pediatric scoliosis (age ≤18 years), entered into the Scoliosis Research Society M&M database between 2004 and 2007, were analyzed. Age, scoliosis type, type of instrumentation used, and complications were assessed.Results
A total of 19,360 cases fulfilled inclusion criteria. Of these, complications occurred in 1971 (10.2%) cases. Overall complication rates differed significantly among idiopathic, congenital, and neuromuscular cases (P < 0.001). Neuromuscular scoliosis had the highest rate of complications (17.9%), followed by congenital scoliosis (10.6%) and idiopathic scoliosis (6.3%). Rates of neurologic deficit also differed significantly based on the etiology of scoliosis (P < 0.001), with the highest rate among congenital cases (2.0%), followed by neuromuscular types (1.1%) and idiopathic scoliosis (0.8%). Neur-omuscular scoliosis and congenital scoliosis had the highest rates of mortality (0.3% each), followed by idiopathic scoliosis (0.02%). Higher rates of new neurologic deficits were associated with revision procedures (P < 0.001) and with the use of corrective osteotomies (P < 0.001). The rates of new neurologic deficit were significantly higher for procedures using anterior screw-only constructs (2.0%) or wire-only constructs (1.7%), compared with pedicle screw-only constructs (0.7%) (P < 0.001).Conclusion
In this review of a large multicenter database of surgically treated pediatric scoliosis, neuromuscular scoliosis had the highest morbidity, but relatively high complication rates occurred in all groups. These data may be useful for preoperative counseling and surgical decision-making in the treatment of pediatric scoliosis.Item Open Access Correlation of higher preoperative American Society of Anesthesiology grade and increased morbidity and mortality rates in patients undergoing spine surgery.(Journal of neurosurgery. Spine, 2011-04) Fu, Kai-Ming G; Smith, Justin S; Polly, David W; Ames, Christopher P; Berven, Sigurd H; Perra, Joseph H; McCarthy, Richard E; Knapp, D Raymond; Shaffrey, Christopher I; Scoliosis Research Society Morbidity and Mortality CommitteeObject
Patients with varied medical comorbidities often present with spinal pathology for which operative intervention is potentially indicated, but few studies have examined risk stratification in determining morbidity and mortality rates associated with the operative treatment of spinal disorders. This study provides an analysis of morbidity and mortality data associated with 22,857 cases reported in the multicenter, multisurgeon Scoliosis Research Society Morbidity and Mortality database stratified by American Society of Anesthesiologists (ASA) physical status classification, a commonly used system to describe preoperative physical status and to predict operative morbidity.Methods
The Scoliosis Research Society Morbidity and Mortality database was queried for the year 2007, the year in which ASA data were collected. Inclusion criterion was a reported ASA grade. Cases were categorized by operation type and disease process. Details on the surgical approach and type of instrumentation were recorded. Major perioperative complications and deaths were evaluated. Two large subgroups--patients with adult degenerative lumbar disease and patients with major deformity--were also analyzed separately. Statistical analyses were performed with the chi-square test.Results
The population studied comprised 22,857 patients. Spinal disease included degenerative disease (9409 cases), scoliosis (6782 cases), spondylolisthesis (2144 cases), trauma (1314 cases), kyphosis (831 cases), and other (2377 cases). The overall complication rate was 8.4%. Complication rates for ASA Grades 1 through 5 were 5.4%, 9.0%, 14.4%, 20.3%, and 50.0%, respectively (p = 0.001). In patients undergoing surgery for degenerative lumbar diseases and major adult deformity, similarly increasing rates of morbidity were found in higher-grade patients. The mortality rate was also higher in higher-grade patients. The incidence of major complications, including wound infections, hematomas, respiratory problems, and thromboembolic events, was also greater in patients with higher ASA grades.Conclusions
Patients with higher ASA grades undergoing spinal surgery had significantly higher rates of morbidity than those with lower ASA grades. Given the common application of the ASA system to surgical patients, this grade may prove helpful for surgical decision making and preoperative counseling with regard to risks of morbidity and mortality.Item Open Access Defining rates and causes of mortality associated with spine surgery: comparison of 2 data collection approaches through the Scoliosis Research Society.(Spine, 2014-04) Shaffrey, Ellen; Smith, Justin S; Lenke, Lawrence G; Polly, David W; Chen, Ching-Jen; Coe, Jeffrey D; Broadstone, Paul A; Glassman, Steven D; Vaccaro, Alexander R; Ames, Christopher P; Shaffrey, Christopher IStudy design
Retrospective review of prospectively collected databases.Objective
To compare 2 approaches for assessment of mortality associated with spine surgery.Summary of background data
The Scoliosis Research Society collects morbidity and mortality data from its members. Previously, this included details for all spine cases and all complications. To reduce time burden and improve compliance, collection was changed to focus on a few major complications (death, neurological deficit, and blindness) for specific deformity diagnoses (scoliosis, spondylolisthesis, and kyphosis) and only for cases with complications.Methods
Data were extracted from the Scoliosis Research Society from 2004-2007 (detailed system) and 2009-2011 (simplified system). As an anchor for comparison, mortality rates were compared between the systems.Results
Between 2009 and 2011, the number of deformity cases reported were 87,162, with 131 deaths (1.50/1000 cases). The mean age of these 131 patients was 50, mean American Society of Anesthesiologists grade was 2.8, 10% were smokers, and 18% had diabetes. Rates of death (per 1000 cases) were: idiopathic scoliosis (0.4), congenital scoliosis (1.3), neuromuscular scoliosis (3.6), other scoliosis (3.1), spondylolisthesis (0.6), and kyphosis (4.7). Common causes of mortality included respiratory (48), cardiac (32), sepsis (12), organ failure (9), and blood loss (7). Compared with the detailed system, the simplified system had greater surgeon compliance (79% vs. 62%, P < 0.001), greater number of deformity cases per reporting surgeon per year (139 vs. 90, P < 0.001), and modest but significantly lower mortality rates (1.50 vs. 1.80/1000 cases; P < 0.001). Causes of death were comparable between the 2 systems.Conclusion
On the basis of the simplified collection system, the rate of mortality for spinal deformity surgery was 1.50 per 1000 cases. Compared with the detailed system, the simplified system had significantly improved compliance and similar mortality rates. Although the simplified system is limited by less data collected, it achieves better compliance and may prove effective, especially if supplemented with focused data collection modules.Item Open Access Does bone morphogenetic protein increase the incidence of perioperative complications in spinal fusion? A comparison of 55,862 cases of spinal fusion with and without bone morphogenetic protein.(Spine, 2011-09) Williams, Brian J; Smith, Justin S; Fu, Kai-Ming G; Hamilton, D Kojo; Polly, David W; Ames, Christopher P; Berven, Sigurd H; Perra, Joseph H; Knapp, Dennis R; McCarthy, Richard E; Shaffrey, Christopher I; Scoliosis Research Society Morbidity and Mortality CommitteeStudy design
Retrospective review of a multi-institutional, multisurgeon database.Objective
Assess for associations between bone morphogenetic protein (BMP) use and rate of complications in spinal fusion.Summary of background data
BMP is commonly used in spinal surgery to augment fusion; however, there is limited evidence demonstrating its associated complications.Methods
We performed a retrospective analysis of all fusion cases submitted by members of the Scoliosis Research Society from 2004 to 2007. We stratified on the basis of the use of BMP and evaluated for complications and associated characteristics.Results
A total of 55,862 cases of spinal fusion were identified with BMP used in 21% (11,933) of the cases. Excluding anterior cervical fusions, there were no significant differences between fusions with and without BMP with regard to overall complications (8.4% vs. 8.5%; P = 0.5), wound infections (2.4% vs. 2.4%; P = 0.8), or epidural hematomas/seromas (0.2% vs. 0.2%; P = 0.3). Anterior cervical fusions with BMP were associated with more overall complications (5.8% vs. 2.4%; P < 0.001) and more wound infections (2.1% vs. 0.4%; P < 0.001) than fusions without BMP. On multivariate analysis for thoracolumbar and posterior cervical fusions, BMP use was not a significant predictor of complications (P = 0.334; odds ratio = 1.039; 95% confidence interval = 0.961-1.124; covariates were BMP use, patient age, revision vs. primary surgery). Multivariate analysis for anterior cervical spinal fusion demonstrated that BMP use remained a significant predictor of complications (P < 0.001, odds ratio = 1.6; 95% confidence interval = 1.516-1.721), after adjusting for the effects of patient age and whether the surgery was a revision procedure.Conclusion
BMP use with anterior cervical fusion was associated with an increased incidence of complications. Use of BMP was not associated with more complications in thoracolumbar and posterior cervical fusions.Item Open Access Impact of cost valuation on cost-effectiveness in adult spine deformity surgery.(The spine journal : official journal of the North American Spine Society, 2017-01) Gum, Jeffrey L; Hostin, Richard; Robinson, Chessie; Kelly, Michael P; Carreon, Leah Yacat; Polly, David W; Bess, R Shay; Burton, Douglas C; Shaffrey, Christopher I; Smith, Justin S; LaFage, Virginie; Schwab, Frank J; Ames, Christopher P; Glassman, Steven D; International Spine Study GroupBackground context
Over the past decade, the number of adult spinal deformity (ASD) surgeries has more than doubled in the United States. The complex surgeries needed to manage ASD are associated with significant resource utilization and high cost, making them a primary target for increased scrutiny. Accordingly, it is important to not only demonstrate value in ASD surgery as clinical effectiveness but also to translate outcome assessment to cost-effectiveness.Purpose
To compare the difference between Medicare allowable rates and the actual, direct hospital costs for ASD surgeries.Study design
Longitudinal cohort.Patient sample
Consecutive patients enrolled in an ASD database from a single institution.Outcome measures
Short Form (SF)-6D.Methods
Consecutive patients enrolled in an ASD database from a single institution from 2008 to 2013 were identified. Direct hospital costs were collected from hospital administrative records for the entire inpatient episode of surgical care. Medicare allowable rates were calculated for the same inpatient stays using the year-appropriate Center for Medicare-Medicaid Services Inpatient Pricer Payment System Tool. The SF-6D, a utility index derived from the SF-36v1, was used to determine quality-adjusted life years (QALY). Costs and QALYs were discounted at 3.5% annually.Results
Of 580 surgical ASD patients eligible for 2-year follow up, 346 (60%) had complete baseline and 2-year data, and 60 were Medicare beneficiaries comprising the cohort for the present study. Mean SF-6D gained is 0.10 during year 1 after surgery and 0.02 at year 2, resulting in a cumulative SF-6D gain of 0.12 over 2 years. Mean Medicare allowable rate over the 2 years is $82,050 (range $42,383 to $220,749) and mean direct cost is $99,114 (range $28,447 to $217,717). Mean cost per QALY over 2 years is $683,750 using Medicare allowable rates and $825,950 using direct costs. This difference of $17,181 between the 2 cost calculation represents a 17% difference, which was statistically significant (p<.001).Conclusions
There is a significant difference in direct hospital costs versus Medicare allowable rates in ASD surgery and in turn, there is a similar difference in the cost per QALY calculation. Utilizing Medicare allowable rates not only underestimates (17%) the cost of ASD surgery, but it also creates inaccurate and unrealistic expectations for researchers and policymakers.Item Open Access Incidence of unintended durotomy in spine surgery based on 108,478 cases.(Neurosurgery, 2011-01) Williams, Brian J; Sansur, Charles A; Smith, Justin S; Berven, Sigurd H; Broadstone, Paul A; Choma, Theodore J; Goytan, Michael J; Noordeen, Hilali H; Knapp, D Raymond; Hart, Robert A; Zeller, Reinhard D; Donaldson, William F; Polly, David W; Perra, Joseph H; Boachie-Adjei, Oheneba; Shaffrey, Christopher IBackground
Unintended durotomy is a common complication of spinal surgery. However, the incidences reported in the literature vary widely and are based primarily on relatively small case numbers from a single surgeon or institution.Objective
To provide spine surgeons with a reliable incidence of unintended durotomy in spinal surgery and to assess various factors that may influence the risk of durotomy.Methods
We assessed 108,478 surgical cases prospectively submitted by members of the Scoliosis Research Society to a deidentified database from 2004 to 2007.Results
Unintended durotomy occurred in 1.6% (1745 of 108 478) of all cases. The incidence of unintended durotomy ranged from 1.1% to 1.9% on the basis of preoperative diagnosis, with the highest incidence among patients treated for kyphosis (1.9%) or spondylolisthesis (1.9%) and the lowest incidence among patients treated for scoliosis (1.1%). The most common indication for spine surgery was degenerative spinal disorder, and among these patients, there was a lower incidence of durotomy for cervical (1.0%) vs thoracic (2.2%; P = .01) or lumbar (2.1%, P < .001) cases. Scoliosis procedures were further characterized by etiology, with the highest incidence of durotomy in the degenerative subgroup (2.2% vs 1.1%; P < .001). Durotomy was more common in revision compared with primary surgery (2.2% vs 1.5%; P < .001) and was significantly more common among elderly (> 80 years of age) patients (2.2% vs 1.6%; P = .006). There was a significant association between unintended durotomy and development of a new neurological deficit (P < .001).Conclusion
Unintended durotomy occurred in at least 1.6% of spinal surgeries, even among experienced surgeons. Our data provide general benchmarks of durotomy rates and serve as a basis for ongoing efforts to improve safety of care.Item Open Access Independent Prognostic Factors Associated With Improved Patient-Reported Outcomes in the Prospective Evaluation of Elderly Deformity Surgery (PEEDS) Study.(Global spine journal, 2023-05) Hassan, Fthimnir M; Lenke, Lawrence G; Berven, Sigurd H; Kelly, Michael P; Smith, Justin S; Shaffrey, Christopher I; Dahl, Benny T; de Kleuver, Marinus; Spruit, Maarten; Pellise, Ferran; Cheung, Kenneth MC; Alanay, Ahmet; Polly, David W; Sembrano, Jonathan; Matsuyama, Yukihiro; Qiu, Yong; Lewis, Stephen J; AO Spine Knowledge Forum DeformityStudy design
Prospective, multicenter, international, observational study.Objective
Identify independent prognostic factors associated with achieving the minimal clinically important difference (MCID) in patient reported outcome measures (PROMs) among adult spinal deformity (ASD) patients ≥60 years of age undergoing primary reconstructive surgery.Methods
Patients ≥60 years undergoing primary spinal deformity surgery having ≥5 levels fused were recruited for this study. Three approaches were used to assess MCID: (1) absolute change:0.5 point increase in the SRS-22r sub-total score/0.18 point increase in the EQ-5D index; (2) relative change: 15% increase in the SRS-22r sub-total/EQ-5D index; (3) relative change with a cut-off in the outcome at baseline: similar to the relative change with an imposed baseline score of ≤3.2/0.7 for the SRS-22r/EQ-5D, respectively.Results
171 patients completed the SRS-22r and 170 patients completed the EQ-5D at baseline and at 2 years postoperative. Patients who reached MCID in the SRS-22r self-reported more pain and worse health at baseline in both approaches (1) and (2). Lower baseline PROMs ((1) - OR: .01 [.00-.12]; (2)- OR: .00 [.00-.07]) and number of severe adverse events (AEs) ((1) - OR: .48 [.28-.82]; (2)- OR: .39 [.23-.69]) were the only identified risk factors. Patients who reached MCID in the EQ-5D demonstrated similar characteristics regarding pain and health at baseline as the SRS-22r using approaches (1) and (2). Higher baseline ODI ((1) - OR: 1.05 [1.02-1.07]) and number of severe AEs (OR: .58 [.38-.89]) were identified as predictive variables. Patients who reached MCID in the SRS22r experienced worse health at baseline using approach (3). The number of AEs (OR: .44 [.25-.77]) and baseline PROMs (OR: .01 [.00-.22] were the only identified predictive factors. Patients who reached MCID in the EQ-5D experienced less AEs and a lower number of actions taken due to the occurrence of AEs using approach (3). The number of actions taken due to AEs (OR: .50 [.35-.73]) was found to be the only predictive variable factor. No surgical, clinical, or radiographic variables were identified as risk factors using either of the aforementioned approaches.Conclusion
In this large multicenter prospective cohort of elderly patients undergoing primary reconstructive surgery for ASD, baseline health status, AEs, and severity of AEs were predictive of reaching MCID. No clinical, radiological, or surgical parameters were identified as factors that can be prognostic for reaching MCID.Item Open Access Minimum Detectable Measurement Difference for Health-Related Quality of Life Measures Varies With Age and Disability in Adult Spinal Deformity(SPINE, 2018-07) Kelly, Michael P; Kim, Han Jo; Ames, Christopher P; Burton, Douglas C; Carreon, Leah Yacat; Polly, David W; Hostin, Richard; Jain, Amit; Gum, Jeffrey L; Lafage, Virginie; Schwab, Frank J; Shaffrey, Christopher I; Smith, Justin S; Bess, Shay; International Spine Study GroupCopyright © 2018 Wolters Kluwer Health, Inc. All rights reserved. Study Design. Retrospective cohort. Objective. To investigate the minimum detectable measurement difference (MDMD) in the Scoliosis Research Society-22r (SRS-22r) outcomes instrument in adult spinal deformity (ASD) and to evaluate the effect of baseline data on measurable difference. Summary of Background Data. The minimum clinically important difference (MCID) is the smallest, clinically relevant change observed and has been proposed for the SRS-22r instrument in ASD as 0.4. The MCID must be greater than the MDMD to be useful. The MDMD for the SRS-22r has not been calculated, nor have the effect of patient baseline values on MDMD. Methods. A prospective observation cohort was queried for patients treated both operatively and nonoperatively for ASD. Patients with baseline and 1-year, 2-year follow-up SRS-22r data were included in the analysis. The MDMD was calculated using classical test theory and item-response theory methods. Effect size and standardized response means were calculated. The effect of baseline data values was evaluated for MDMD. Results. A total 839 Patients were eligible for cohort inclusion with 428 (51%) eligible for analysis with complete data. MDMD for Pain (0.6) and Self-Image (0.5) were greater than 0.4. MDMD varied with age (highest for the youngest patients) and with disability (highest for SF-36 Physical Component Summary <28.6). MDMD was less than 0.4 for Activity (0.3), Mental Health (0.3), and Total Score (0.2). Gender and mental health did not affect MDMD for the SRS-22r instrument. Conclusion. An MCID of 0.4 for the SRS-22r total score and domain scores may not be an appropriate value as the calculated MDMD is greater than 0.4 for both the Pain and Self-Image subscores. The MDMD for the SRS-22r instrument varied with age and baseline disability, making the assessment of clinically significant change more difficult using this tool. The MCID must be considered in the setting of the MDMD for instruments used to assess outcomes in ASD.Item Open Access Morbidity and mortality associated with spinal surgery in children: a review of the Scoliosis Research Society morbidity and mortality database.(Journal of neurosurgery. Pediatrics, 2011-01) Fu, Kai-Ming G; Smith, Justin S; Polly, David W; Ames, Christopher P; Berven, Sigurd H; Perra, Joseph H; Glassman, Steven D; McCarthy, Richard E; Knapp, D Raymond; Shaffrey, Christopher I; Scoliosis Research Society Morbidity and Mortality CommitteeObject
Currently, few studies regarding morbidity and mortality associated with operative treatment of spinal disorders in children are available to guide the surgeon. This study provides more detailed morbidity and mortality data with an analysis of 23,918 pediatric cases reported in the multicenter, multisurgeon Scoliosis Research Society morbidity and mortality database.Methods
The Scoliosis Research Society morbidity and mortality database was queried for the years from 2004 to 2007. The inclusion criterion was age 18 years or younger. Cases were categorized by operation type and diagnosis. Details on the surgical approach, use of neurophysiological monitoring, and type of instrumentation were recorded. Major perioperative complications and deaths were evaluated. Statistical analysis was performed with chi-square testing, with a p value < 0.05 considered significant.Results
A total of 23,918 patients were included. The mean age was 13 ± 3.6 years (± SD). Spinal pathology included the following: scoliosis (in 19,642 patients), kyphosis (in 1455), spondylolisthesis (in 748), trauma (in 478), and other (in 1595 patients). The overall complication rate was 8.5%. Major complications included wound infections (2.7%), new neurological deficits (1.4%), implant-related complications (1.6%), and hematomas (0.4%). The most common medical complications were respiratory related (0.9%). Morbidity rates differed based on pathology, with patients undergoing treatment for kyphosis and spondylolisthesis having higher overall rates of morbidity (14.7% and 9.6%, respectively). Patients undergoing revision procedures (2034) or corrective osteotomies (2787) were more likely to suffer a complication or new neurological deficit. The majority of these deficits improved at least partially. Thirty-one deaths were reported for an overall rate of 1.3 per 1000. Respiratory complications were the most common cause of mortality (13 cases). Twenty-six of the deaths occurred in children undergoing scoliosis correction.Conclusions
Spinal surgery in children is associated with a range of complications depending on the type of operation. Mortality rates for all indications and operations were low. Patients undergoing more aggressive corrective procedures for deformity are more likely to suffer complications and new neurological deficits.Item Open Access Morbidity and mortality in the surgical treatment of 10,242 adults with spondylolisthesis.(Journal of neurosurgery. Spine, 2010-11) Sansur, Charles A; Reames, Davis L; Smith, Justin S; Hamilton, D Kojo; Berven, Sigurd H; Broadstone, Paul A; Choma, Theodore J; Goytan, Michael James; Noordeen, Hilali H; Knapp, Dennis Raymond; Hart, Robert A; Zeller, Reinhard D; Donaldson, William F; Polly, David W; Perra, Joseph H; Boachie-Adjei, Oheneba; Shaffrey, Christopher IObject
This is a retrospective review of 10,242 adults with degenerative spondylolisthesis (DS) and isthmic spondylolisthesis (IS) from the morbidity and mortality (M&M) index of the Scoliosis Research Society (SRS). This database was reviewed to assess complication incidence, and to identify factors that were associated with increased complication rates.Methods
The SRS M&M database was queried to identify cases of DS and IS treated between 2004 and 2007. Complications were identified and analyzed based on age, surgical approach, spondylolisthesis type/grade, and history of previous surgery. Age was stratified into 2 categories: > 65 years and ≤ 65 years. Surgical approach was stratified into the following categories: decompression without fusion, anterior, anterior/posterior, posterior without instrumentation, posterior with instrumentation, and interbody fusion. Spondylolisthesis grades were divided into low-grade (Meyerding I and II) versus high-grade (Meyerding III, IV, and V) groups. Both univariate and multivariate analyses were performed.Results
In the 10,242 cases of DS and IS reported, there were 945 complications (9.2%) in 813 patients (7.9%). The most common complications were dural tears, wound infections, implant complications, and neurological complications (range 0.7%-2.1%). The mortality rate was 0.1%. Diagnosis of DS had a significantly higher complication rate (8.5%) when compared with IS (6.6%; p = 0.002). High-grade spondylolisthesis correlated strongly with a higher complication rate (22.9% vs 8.3%, p < 0.0001). Age > 65 years was associated with a significantly higher complication rate (p = 0.02). History of previous surgery and surgical approach were not significantly associated with higher complication rates. On multivariate analysis, only the grade of spondylolisthesis (low vs high) was in the final best-fit model of factors associated with the occurrence of complications (p < 0.0001).Conclusions
The rate of total complications for treatment of DS and IS in this series was 9.2%. The total percentage of patients with complications was 7.9%. On univariate analysis, the complication rate was significantly higher in patients with high-grade spondylolisthesis, a diagnosis of DS, and in older patients. Surgical approach and history of previous surgery were not significantly correlated with increased complication rates. On multivariate analysis, only the grade of spondylolisthesis was significantly associated with the occurrence of complications.Item Open Access Morbidity and mortality in the surgical treatment of 10,329 adults with degenerative lumbar stenosis.(Journal of neurosurgery. Spine, 2010-05) Fu, Kai-Ming G; Smith, Justin S; Polly, David W; Perra, Joseph H; Sansur, Charles A; Berven, Sigurd H; Broadstone, Paul A; Choma, Theodore J; Goytan, Michael J; Noordeen, Hilali H; Knapp, D Raymond; Hart, Robert A; Zeller, Reinhard D; Donaldson, William F; Boachie-Adjei, Oheneba; Shaffrey, Christopher IObject
The purpose of this study was to evaluate the prospectively collected Scoliosis Research Society (SRS) database to assess the incidences of morbidity and mortality (M&M) in the operative treatment of degenerative lumbar stenosis, one of the most common procedures performed by spine surgeons.Methods
All patients who underwent surgical treatment for degenerative lumbar stenosis between 2004 and 2007 were identified from the SRS M&M database. Inclusion criteria for analysis included an age >or= 21 years and no history of lumbar surgery. Patients were treated with either decompression alone or decompression with concomitant fusion. Statistical comparisons were performed using a 2-sided Fisher exact test.Results
Of the 10,329 patients who met the inclusion criteria, 6609 (64%) were treated with decompression alone, and 3720 (36%) were treated with decompression and fusion. Among those who underwent fusion, instrumentation was placed in 3377 (91%). The overall mean patient age was 63 +/- 13 years (range 21-96 years). Seven hundred nineteen complications (7.0%), including 13 deaths (0.1%), were identified. New neurological deficits were reported in 0.6% of patients. Deaths were related to cardiac (4 cases), respiratory (5 cases), pulmonary embolus (2 cases), and sepsis (1 case) etiologies, and a perforated gastric ulcer (1 case). Complication rates did not differ based on patient age or whether fusion was performed. Minimally invasive procedures were associated with fewer complications and fewer new neurological deficits (p = 0.01 and 0.03, respectively).Conclusions
The results from this analysis of the SRS M&M database provide surgeons with useful information for preoperative counseling of patients contemplating surgical intervention for symptomatic degenerative lumbar stenosis.Item Open Access Morbidity and mortality in the surgical treatment of six hundred five pediatric patients with isthmic or dysplastic spondylolisthesis.(Spine, 2011-02) Fu, Kai-Ming G; Smith, Justin S; Polly, David W; Perra, Joseph H; Sansur, Charles A; Berven, Sigurd H; Broadstone, Paul A; Choma, Theodore J; Goytan, Michael J; Noordeen, Hilali H; Knapp, D Raymond; Hart, Robert A; Donaldson, William F; Boachie-Adjei, Oheneba; Shaffrey, Christopher IStudy design
Retrospective analysis of prospectively collected database.Objective
To analyze the rate of complications, including neurologic deficits, associated with operative treatment of pediatric isthmic and dysplastic spondylolisthesis.Summary of background data
Pediatric isthmic and dysplastic spondylolisthesis are relatively uncommon dis-orders. Several prior studies have suggested a high rate of complication associated with operative intervention. How-ever, most of these studies were performed with sufficiently small sample sizes such that the presence of one complication could significantly affect the overall rate. The Scoliosis Research Society (SRS) prospectively collects morbidity and mortality (M&M) data from its members. This multicentered, multisurgeon database permits analysis of the surgical treatment of this relatively rare condition on an aggregate scale and provides surgeons with useful information for preoperative counseling.Methods
Patients who underwent surgical treatment for isthmic or dysplastic spondylolisthesis from 2004 to 2007 were identified from the SRS M&M database. Inclusion criteria for analysis included age ≤ 21 and a primary diagnosis of isthmic or dysplastic spondylolisthesis.Results
Of 25,432 pediatric cases reported, there were a total of 605 (2.4%) cases of pediatric dysplastic (n ∇ 62, 10%) and isthmic (n ∇ 543, 90%) spondylolisthesis, with a mean age of 15 years (range, 4-21). Approximately 50% presented with neural element compression, and less than 1% of cases were revisions. Surgical procedures included fusions in 92%, osteotomies in 39%, and reductions in 38%. The overall complication rate was 10.4%. The most common complications included postoperative neurologic deficit (n ∇ 31, 5%), dural tear (n ∇ 8, 1.3%), and wound infection (n ∇ 12, 2%). Perioperative deep venous thrombosis and pulmonary embolus were reported in 2 (0.3%) and 1 (0.2%) patients, respectively. There were no deaths in this series.Conclusion
Pediatric isthmic and dysplastic spondylolisthesis are relatively uncommon disorders, representing only 2.4% of pediatric spine procedures in the present study. Even among experienced spine surgeons, surgical treatment of these spinal conditions is associated with a relatively high morbidity.Item Open Access Opioid Use Prior to Adult Spine Deformity Correction Surgery is Associated With Worse Pre- and Postoperative Back Pain and Prolonged Opioid Demands.(Global spine journal, 2024-06) Sardi, Juan P; Smith, Justin S; Gum, Jeffrey L; Rocos, Brett; Charalampidis, Anastasios; Lenke, Lawrence G; Shaffrey, Christopher I; Cheung, Kenneth MC; Qiu, Yong; Matsuyama, Yukihiro; Pellisé, Ferran; Polly, David W; Sembrano, Jonathan N; Dahl, Benny T; Kelly, Michael P; de Kleuver, Marinus; Spruit, Maarten; Alanay, Ahmet; Berven, Sigurd H; Lewis, Stephen J; AO Spine Knowledge Forum DeformityProspective multicenter database post-hoc analysis. Opioids are frequently prescribed for painful spinal conditions to provide pain relief and to allow for functional improvement, both before and after spine surgery. Amidst a current opioid epidemic, it is important for providers to understand the impact of opioid use and its relationship with patient-reported outcomes. The purpose of this study was to evaluate pre-/postoperative opioid consumption surrounding ASD and assess patient-reported pain outcomes in older patients undergoing surgery for spinal deformity. Patients ≥60 years of age from 12 international centers undergoing spinal fusion of at least 5 levels and a minimum 2-year follow-up were included. Patient-reported outcome scores were collected using the Numeric Rating Scale for back and leg pain (NRS-B; NRS-L) at baseline and at 2 years following surgery. Opioid use, defined based on a specific question on case report forms and question 11 from the SRS-22r questionnaire, was assessed at baseline and at 2-year follow-up. Of the 219 patients who met inclusion criteria, 179 (81.7%) had 2-year data on opioid use. The percentages of patients reporting opioid use at baseline (n = 75, 34.2%) and 2 years after surgery (n = 55, 30.7%) were similar (P = .23). However, at last follow-up 39% of baseline opioid users (Opi) were no longer taking opioids, while 14% of initial non-users (No-Opi) reported opioid use. Regional pre- and postoperative opioid use was 5.8% and 7.7% in the Asian population, 58.3% and 53.1% in the European, and 50.5% and 40.2% in North American patients, respectively. Baseline opioid users reported more preoperative back pain than the No-Opi group (7.0 vs 5.7, P = .001), while NRS-Leg pain scores were comparable (4.8 vs 4, P = .159). Similarly, at last follow-up, patients in the Opi group had greater NRS-B scores than Non-Opi patients (3.2 vs 2.3, P = .012), but no differences in NRS-Leg pain scores (2.2 vs 2.4, P = .632) were observed. In this study, almost one-third of surgical ASD patients were consuming opioids both pre- and postoperatively world-wide. There were marked international variations, with patients from Asia having a much lower usage rate, suggesting a cultural influence. Despite both opioid users and nonusers benefitting from surgery, preoperative opioid use was strongly associated with significantly more back pain at baseline that persisted at 2-year follow up, as well as persistent postoperative opioid needs.Item Open Access Optimal surgical care for adolescent idiopathic scoliosis: an international consensus.(European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2014-12) de Kleuver, Marinus; Lewis, Stephen J; Germscheid, Niccole M; Kamper, Steven J; Alanay, Ahmet; Berven, Sigurd H; Cheung, Kenneth M; Ito, Manabu; Lenke, Lawrence G; Polly, David W; Qiu, Yong; van Tulder, Maurits; Shaffrey, ChristopherPurpose
The surgical management of adolescent idiopathic scoliosis (AIS) has seen many developments in the last two decades. Little high-level evidence is available to support these changes and guide treatment. This study aimed to identify optimal operative care for adolescents with AIS curves between 40° and 90° Cobb angle.Methods
From July 2012 to April 2013, the AOSpine Knowledge Forum Deformity performed a modified Delphi survey where current expert opinion from 48 experienced deformity surgeons, representing 29 diverse countries, was gathered. Four rounds were performed: three web-based surveys and a final face-to-face meeting. Consensus was achieved with ≥ 70% agreement. Data were analyzed qualitatively and quantitatively.Results
Consensus of what constitutes optimal care was reached on greater than 60 aspects including: preoperative radiographs; posterior as opposed to anterior (endoscopic) surgical approaches; use of intraoperative spinal cord monitoring; use of local autologous bone (not iliac crest) for grafts; use of thoracic and lumbar pedicle screws; use of titanium anchor points; implant density of <80% for 40°-70° curves; and aspects of postoperative care. Variability in practice patterns was found where there was no consensus. In addition, there was consensus on what does not constitute optimal care, including: routine pre- and intraoperative traction; routine anterior release; use of bone morphogenetic proteins; and routine postoperative CT scanning.Conclusions
International consensus was found on many aspects of what does and does not constitute optimal operative care for adolescents with AIS. In the absence of current high-level evidence, at present, these expert opinion findings will aid health care providers worldwide define appropriate care in their regions. Areas with no consensus provide excellent insight and priorities for future research.