The SPORT value compass: do the extra costs of undergoing spine surgery produce better health benefits?

BACKGROUND: The Spine Patient Outcomes Research Trial aimed to determine the comparative effectiveness of surgical care versus nonoperative care by measuring longitudinal values: outcomes, satisfaction, and costs. METHODS: This paper aims to summarize available evidence from the Spine Patient Outcomes Research Trial by addressing 2 important questions about outcomes and costs for 3 types of spine problem: (1) how do outcomes and costs of spine patients differ depending on whether they are treated surgically compared with nonoperative care? (2) What is the incremental cost per quality adjusted life year for surgical care over nonoperative care? RESULTS: After 4 years of follow-up, patients with 3 spine conditions that may be treated surgically or nonoperatively have systematic differences in value endpoints. The average surgical patient enjoys better health outcomes and higher treatment satisfaction but incurs higher costs. CONCLUSIONS: Spine care is preference sensitive and because outcomes, satisfaction, and costs vary over time and between patients, data on value can help patients make better-informed decisions and help payers know what their dollars are buying.

Developing a toolkit for comparing safety in spine surgery.

Safety information in spine surgery is important for informed patient choice and performance-based payment incentives, but measurement methods for surgical safety assessment are not standardized. Published reports of complication rates for common spinal procedures show wide variation. Factors influencing variation may include differences in safety ascertainment methods and procedure types. In a prospective cohort study, adverse events were observed in all patients undergoing spine surgery at two hospitals during a 2-year period. Multiple processes for adverse occurrence surveillance were implemented, and the associations between surveillance methods, surgery invasiveness, and observed frequencies of adverse events were examined. The study enrolled 1,723 patients. Adverse events were noted in 48.3% of the patients. Reviewers classified 25% as minor events and 23% as major events. Of the major events, the daily rounding team reported 38.4% of the events using a voluntary reporting system, surgeons reported 13.4%, and 9.1% were identified during clinical conferences. A review of medical records identified 86.7% of the major adverse events. The adverse events occurred during the inpatient hospitalization for 78.1% of the events, within 30 days for an additional 12.5%, and within the first year for the remaining 9.4%. A unit increase in the invasiveness index was associated with an 8.2% increased risk of a major adverse event. A Current Procedural Terminology-based algorithm for quantifying invasiveness correlated well with medical records-based assessment. Increased procedure invasiveness is associated with an increased risk of adverse events. The observed frequency of adverse events is influenced by the ascertainment modality. Voluntary reports by surgeons and other team members missed more than 50% of the events identified through a medical records review. Increased surgery invasiveness, measured from medical records or billing codes, is quantitatively associated with an increased risk of adverse events.

Accuracy of Stereovision-Updated Versus Preoperative CT-Based Image Guidance in Multilevel Lumbar Pedicle Screw Placement: A Cadaveric Swine Study.

Change in vertebral position between preoperative imaging and the surgical procedure reduces the accuracy of image-guided spinal surgery, requiring repeated imaging and surgical field registration, a process that takes time and exposes patients to additional radiation. We developed a handheld, camera-based, deformable registration system (intraoperative stereovision, iSV) to register the surgical field automatically and compensate for spinal motion during surgery without further radiation exposure. Methods: We measured motion-induced errors in image-guided lumbar pedicle screw placement in 6 whole-pig cadavers using state-of-the-art commercial spine navigation (StealthStation; Medtronic) and iSV registration that compensates for intraoperative vertebral motion. We induced spinal motion by using preoperative computed tomography (pCT) of the lumbar spine performed in the supine position with accentuated lordosis and performing surgery with the animal in the prone position. StealthStation registration of pCT occurred using metallic fiducial markers implanted in each vertebra, and iSV data were acquired to perform a deformable registration between pCT and the surgical field. Sixty-eight pedicle screws were placed in 6 whole-pig cadavers using iSV and StealthStation registrations in random order of vertebral level, relying only on image guidance without invoking the surgeon's judgment. The position of each pedicle screw was assessed with post-procedure CT and confirmed via anatomical dissection. Registration errors were assessed on the basis of implanted fiducials. Results: The frequency and severity of pedicle screw perforation were lower for iSV registration compared with StealthStation (97% versus 68% with Grade 0 medial perforation for iSV and StealthStation, respectively). Severe perforation occurred only with StealthStation (18% versus 0% for iSV). The overall time required for iSV registration (computational efficiency) was ∼10 to 15 minutes and was comparable with StealthStation registration (∼10 min). The mean target registration error was smaller for iSV relative to StealthStation (2.81 ± 0.91 versus 8.37 ± 1.76 mm). Conclusions: Pedicle screw placement was more accurate with iSV registration compared with state-of-the-art commercial navigation based on preoperative CT when alignment of the spine changed during surgery. Clinical Relevance: The iSV system compensated for intervertebral motion, which obviated the need for repeated vertebral registration while providing efficient, accurate, radiation-free navigation during open spinal surgery.

A level-wise spine registration framework to account for large pose changes.

PURPOSES: Accurate and efficient spine registration is crucial to success of spine image guidance. However, changes in spine pose cause intervertebral motion that can lead to significant registration errors. In this study, we develop a geometrical rectification technique via nonlinear principal component analysis (NLPCA) to achieve level-wise vertebral registration that is robust to large changes in spine pose. METHODS: We used explanted porcine spines and live pigs to develop and test our technique. Each sample was scanned with preoperative CT (pCT) in an initial pose and rescanned with intraoperative stereovision (iSV) in a different surgical posture. Patient registration rectified arbitrary spinal postures in pCT and iSV into a common, neutral pose through a parameterized moving-frame approach. Topologically encoded depth projection 2D images were then generated to establish invertible point-to-pixel correspondences. Level-wise point correspondences between pCT and iSV vertebral surfaces were generated via 2D image registration. Finally, closed-form vertebral level-wise rigid registration was obtained by directly mapping 3D surface point pairs. Implanted mini-screws were used as fiducial markers to measure registration accuracy. RESULTS: In seven explanted porcine spines and two live animal surgeries (maximum in-spine pose change of 87.5 mm and 32.7 degrees averaged from all spines), average target registration errors (TRE) of 1.70 ± 0.15 mm and 1.85 ± 0.16 mm were achieved, respectively. The automated spine rectification took 3-5 min, followed by an additional 30 secs for depth image projection and level-wise registration. CONCLUSIONS: Accuracy and efficiency of the proposed level-wise spine registration support its application in human open spine surgeries. The registration framework, itself, may also be applicable to other intraoperative imaging modalities such as ultrasound and MRI, which may expand utility of the approach in spine registration in general.

Identifying survivors with traumatic craniocervical dissociation: a retrospective study.

BACKGROUND: Traumatic craniocervical dissociation (CCD), which includes atlanto-occipital dissociation and vertical distraction between C1-C2, is often an immediately fatal injury that has increasingly been associated with survival to the hospital. Our aim was to identify survivors of CCD based on clinical presentation. METHODS: We retrospectively reviewed the Harborview Medical Center Trauma Registry and the King County Medical Examiners database from 2001 to 2006. Patients>or=12 y old were identified by ICD-9 code, radiographic diagnosis on lateral cervical spine films, and CT. We examined age, gender, mechanism of injury, presentation and prehospital and hospital interventions, and radiographic findings to distinguish survivors and non-survivors. RESULTS: Of 69 patients with CCD, 47 were diagnosed post mortem, 22 were diagnosed in hospital, and seven survived to discharge. When comparing survivors and non-survivors, age, gender, and injury severity score were not significant. Survivors had significantly higher GCS, and were more likely to be normotensive; none had cervical cord injury; 80% of non-survivors had a basion-dental interval (BDI) of >or=16mm. CONCLUSIONS: Trauma patients diagnosed with CCD in the ED, with cervical cord injury, requiring CPR, and with GCS of 3 will not survive their injury. Wider BDI is associated with mortality.

Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults.

CONTEXT: In recent decades, the fastest growth in lumbar surgery occurred in older patients with spinal stenosis. Trials indicate that for selected patients, decompressive surgery offers an advantage over nonoperative treatment, but surgeons often recommend more invasive fusion procedures. Comorbidity is common in older patients, so benefits and risks must be carefully weighed in the choice of surgical procedure. OBJECTIVE: To examine trends in use of different types of stenosis operations and the association of complications and resource use with surgical complexity. DESIGN, SETTING, AND PATIENTS: Retrospective cohort analysis of Medicare claims for 2002-2007, focusing on 2007 to assess complications and resource use in US hospitals. Operations for Medicare recipients undergoing surgery for lumbar stenosis (n = 32,152 in the first 11 months of 2007) were grouped into 3 gradations of invasiveness: decompression alone, simple fusion (1 or 2 disk levels, single surgical approach), or complex fusion (more than 2 disk levels or combined anterior and posterior approach). MAIN OUTCOME MEASURES: Rates of the 3 types of surgery, major complications, postoperative mortality, and resource use. RESULTS: Overall, surgical rates declined slightly from 2002-2007, but the rate of complex fusion procedures increased 15-fold, from 1.3 to 19.9 per 100,000 beneficiaries. Life-threatening complications increased with increasing surgical invasiveness, from 2.3% among patients having decompression alone to 5.6% among those having complex fusions. After adjustment for age, comorbidity, previous spine surgery, and other features, the odds ratio (OR) of life-threatening complications for complex fusion compared with decompression alone was 2.95 (95% confidence interval [CI], 2.50-3.49). A similar pattern was observed for rehospitalization within 30 days, which occurred for 7.8% of patients undergoing decompression and 13.0% having a complex fusion (adjusted OR, 1.94; 95% CI, 1.74-2.17). Adjusted mean hospital charges for complex fusion procedures were US $80,888 compared with US $23,724 for decompression alone. CONCLUSIONS: Among Medicare recipients, between 2002 and 2007, the frequency of complex fusion procedures for spinal stenosis increased while the frequency of decompression surgery and simple fusions decreased. In 2007, compared with decompression, simple fusion and complex fusion were associated with increased risk of major complications, 30-day mortality, and resource use.

Measuring protein biomarker concentrations using antibody tagged magnetic nanoparticles.

Under physiological conditions biomarker concentrations tend to rise and fall over time e.g. for inflammation. Ex vivo measurements provide a snapshot in time of biomarker concentrations, which is useful, but limited. Approaching real time monitoring of biomarker concentration(s) using a wearable, implantable or injectable in vivo sensor is therefore an appealing target. As an early step towards developing an in vivo biomarker sensor, antibody (AB) tagged magnetic nanoparticles (NPs) are used here to demonstrate the in vitro measurement of ~5 distinct biomarkers with high specificity and sensitivity. In previous work, aptamers were used to target a given biomarker in vitro and generate magnetic clusters that exhibit a characteristic rotational signature quite different from free NPs. Here the method is expanded to detect a much wider range of biomarkers using polyclonal ABs attached to the surface of the NPs. Commercial ABs exist for a wide range of targets allowing accurate and specific concentration measurements for most significant biomarkers. We show sufficient detection sensitivity, using an in-house spectrometer to measure the rotational signatures of the NPs, to assess physiological concentrations of hormones, cytokines and other signaling molecules. Detection limits for biomarkers drawn mainly from pain and inflammation targets were: 10 pM for mouse Granzyme B (mGZM-B), 40 pM for mouse interferon-gamma (mIFN-γ), 7 pM for mouse interleukin-6 (mIL-6), 40 pM for rat interleukin-6 (rIL-6), 40 pM for mouse vascular endothelial growth factor (mVEGF) and 250 pM for rat calcitonin gene related peptide (rCGRP). Much lower detection limits are certainly possible using improved spectrometers and nanoparticles.

Hand-Held Stereovision System for Image Updating in Open Spine Surgery.

BACKGROUND: Image guidance in open spinal surgery is compromised by changes in spinal alignment between preoperative images and surgical positioning. We evaluated registration of stereo-views of the surgical field to compensate for vertebral alignment changes. OBJECTIVE: To assess accuracy and efficiency of an optically tracked hand-held stereovision (HHS) system to acquire images of the exposed spine during surgery. METHODS: Standard midline posterior approach exposed L1 to L6 in 6 cadaver porcine spines. Fiducial markers were placed on each vertebra as "ground truth" locations. Spines were positioned supine with accentuated lordosis, and preoperative computed tomography (pCT) was acquired. Spines were re-positioned in a neutral prone posture, and locations of fiducials were acquired with a tracked stylus. Intraoperative stereovision (iSV) images were acquired and 3-dimensional (3D) surfaces of the exposed spine were reconstructed. HHS accuracy was assessed in terms of distances between reconstructed fiducial marker locations and their tracked counterparts. Level-wise registrations aligned pCT with iSV to account for changes in spine posture. Accuracy of updated computed tomography (uCT) was assessed using fiducial markers and other landmarks. RESULTS: Acquisition time for each image pair was <1 s. Mean reconstruction time was <1 s for each image pair using batch processing, and mean accuracy was 1.2 ± 0.6 mm across 6 cases. Mean errors of uCT were 3.1 ± 0.7 and 2.0 ± 0.5 mm on the dorsal and ventral sides, respectively. CONCLUSION: Results suggest that a portable HHS system offers potential to acquire accurate image data from the surgical field to facilitate surgical navigation during open spine surgery.

The case for restraint in spinal surgery: does quality management have a role to play?

Most quality improvement efforts in surgery have focused on the technical quality of care provided, rather than whether the care was indicated, or could have been provided with a safer procedure. Because risk is inherent in any procedure, reducing the number of unnecessary operations is an important issue in patient safety. In the case of lumbar spine surgery, several lines of evidence suggest that, in at least some locations, there may be excessively high surgery rates. This evidence comes from international comparisons of surgical rates; study of small area variations within countries; increasing surgical rates in the absence of new indications; comparisons of surgical outcomes between geographic areas with high or low surgical rates; expert opinion; the preferences of well-informed patients; and increasing rates of repeat surgery. From a population perspective, reducing unnecessary surgery may have a greater impact on complication rates than improving the technical quality of surgery that is performed. Evidence suggests this may be true for coronary bypass surgery in the US and hysterectomy rates in Canada. Though similar studies have not been done for spine surgery, wide geographic variations in surgical rates suggest that this could be the case for spine surgery as well. We suggest that monitoring geographic variations in surgery rates may become an important aspect of quality improvement, and that rates of repeat surgery may bear special attention. Patient registries can help in this regard, if they are very complete and rigorously maintained. They can provide data on surgical rates; offer post-marketing surveillance for new surgical devices and techniques; and help to identify patient subgroups that may benefit most from certain procedures.

Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015.

STUDY DESIGN: Analysis of National Inpatient Sample (NIS), 2004 to 2015. OBJECTIVE: Describe recent trends in US rates of lumbar fusion procedures and associated costs, by surgical indication. SUMMARY OF BACKGROUND DATA: Spinal fusion is appropriate for spinal deformity and instability, but evidence of effectiveness is limited for primary disc herniation and spinal stenosis without instability. It remains controversial for treatment of axial pain secondary to degenerative disc disease. There are potential non-instability, non-deformity indications for fusion surgery, including but not limited to severe foraminal stenosis and third-time disc herniation. METHODS: Elective lumber fusion trends were reported using Poisson regression, grouped by indication as degenerative scoliosis, degenerative spondylolisthesis, spinal stenosis, disc herniation, and disc degeneration. Generalize linear regression was used to estimate trends in hospital costs, adjusted for age, sex, indication, comorbidity, and inflation. RESULTS: Volume of elective lumbar fusion increased 62.3% (or 32.1% per 100,000 US adults), from 122,679 cases (60.4 per 100,000) in 2004 to 199,140 (79.8 per 100,000) in 2015. Increases were greatest among age 65 or older, increasing 138.7% by volume (73.2% by rate), from 98.3 per 100,000 (95% confidence interval [CI] 97.2, 99.3) in 2004 to 170.3 (95% CI 169.2, 171.5) in 2015. Although the largest increases were for spondylolisthesis (+47,390 operations, 111%) and scoliosis (+16,129 operations, 186.6%), disc degeneration, herniation, and stenosis combined to accounted for 42.3% of total elective lumbar fusions in 2015. Aggregate hospital costs increased 177% during these 12 years, exceeding $10 billion in 2015, and averaging more than $50,000 per admission. CONCLUSION: While the prevalence of spinal pathologies is not known, the rate of elective lumbar fusion surgery in the United States increased most for spondylolisthesis and scoliosis, indications with relatively good evidence of effectiveness. The proportion of fusions coded for indications with less evidence of effectiveness has slightly decreased in the most recent years. LEVEL OF EVIDENCE: 3.

Expenditures and health status among adults with back and neck problems.

CONTEXT: Back and neck problems are among the symptoms most commonly encountered in clinical practice. However, few studies have examined national trends in expenditures for back and neck problems or related these trends to health status measures. OBJECTIVES: To estimate inpatient, outpatient, emergency department, and pharmacy expenditures related to back and neck problems in the United States from 1997 through 2005 and to examine associated trends in health status. DESIGN AND SETTING: Age- and sex-adjusted analysis of the nationally representative Medical Expenditure Panel Survey (MEPS) from 1997 to 2005 using complex survey regression methods. The MEPS is a household survey of medical expenditures weighted to represent national estimates. Respondents were US adults (> 17 years) who self-reported back and neck problems (referred to as "spine problems" based on MEPS descriptions and International Classification of Diseases, Ninth Revision, Clinical Modification definitions). MAIN OUTCOME MEASURES: Spine-related expenditures for health services (inflation-adjusted); annual surveys of self-reported health status. RESULTS: National estimates were based on annual samples of survey respondents with and without self-reported spine problems from 1997 through 2005. A total of 23 045 respondents were sampled in 1997, including 3139 who reported spine problems. In 2005, the sample included 22 258 respondents, including 3187 who reported spine problems. In 1997, the mean age- and sex-adjusted medical costs for respondents with spine problems was $4695 (95% confidence interval [CI], $4181-$5209), compared with $2731 (95% CI, $2557-$2904) among those without spine problems (inflation-adjusted to 2005 dollars). In 2005, the mean age- and sex- adjusted medical expenditure among respondents with spine problems was $6096 (95% CI, $5670-$6522), compared with $3516 (95% CI, $3266-$3765) among those without spine problems. Total estimated expenditures among respondents with spine problems increased 65% (adjusted for inflation) from 1997 to 2005, more rapidly than overall health expenditures. The estimated proportion of persons with back or neck problems who self-reported physical functioning limitations increased from 20.7% (95% CI, 19.9%-21.4%) to 24.7% (95% CI, 23.7%-25.6%) from 1997 to 2005. Age- and sex-adjusted self-reported measures of mental health, physical functioning, work or school limitations, and social limitations among adults with spine problems were worse in 2005 than in 1997. CONCLUSIONS: In this survey population, self-reported back and neck problems accounted for a large proportion of health care expenditures. These spine-related expenditures have increased substantially from 1997 to 2005, without evidence of corresponding improvement in self-assessed health status.

Early Effects of Medicare's Bundled Payment for Care Improvement Program for Lumbar Fusion.

STUDY DESIGN: Retrospective analysis of Medicare claims linked to hospital participation in the Center for Medicare and Medicaid Innovation's episode-based Bundled Payment for Care Improvement (BPCI) program for lumbar fusion. OBJECTIVE: To describe the early effects of BPCI participation for lumbar fusion on 90-day reimbursement, procedure volume, reoperation, and readmission. SUMMARY OF BACKGROUND DATA: Initiated on January 1, 2013, BPCI's voluntary bundle payment program provides a predetermined payment for services related to a Diagnosis-Related Group-defined "triggering event" over a defined time period. As an alternative to fee-for-service, these reforms shift the financial risk of care on to hospitals. METHODS: We identified fee-for-service beneficiaries over age 65 undergoing a lumbar fusion in 2012 or 2013, corresponding to the years before and after BPCI initiation. Hospitals were grouped based on program participation status as nonparticipants, preparatory, or risk-bearing. Generalized estimating equation models adjusting for patient age, sex, race, comorbidity, and hospital size were used to compare changes in episode costs, procedure volume, and safety indicators based on hospital BPCI participation. RESULTS: We included 89,605 beneficiaries undergoing lumbar fusion, including 36% seen by a preparatory hospital and 7% from a risk-bearing hospital. The mean age of the cohort was 73.4 years, with 59% women, 92% White, and 22% with a Charlson Comorbidity Index of 2 or more. Participant hospitals had greater procedure volume, bed size, and total discharges. Relative to nonparticipants, risk-bearing hospitals had a slightly increased fusion procedure volume from 2012 to 2013 (3.4% increase vs. 1.6% decrease, P = 0.119), did not reduce 90-day episode of care costs (0.4% decrease vs. 2.9% decrease, P = 0.044), increased 90-day readmission rate (+2.7% vs. -10.7%, P = 0.043), and increased repeat surgery rates (+30.6% vs. +7.1% points, P = 0.043). CONCLUSION: These early, unintended trends suggest an imperative for continued monitoring of BPCI in lumbar fusion. LEVEL OF EVIDENCE: 3.

Understanding the value of minimally invasive procedures for the treatment of lumbar spinal stenosis: the case of interspinous spacer devices.

BACKGROUND CONTEXT: Minimally invasive lumbar spinal stenosis procedures have uncertain long-term value. PURPOSE: This study sought to characterize factors affecting the long-term cost-effectiveness of such procedures using interspinous spacer devices ("spacers") relative to decompression surgery as a case study. STUDY DESIGN: Model-based cost-effectiveness analysis. PATIENT SAMPLE: The Medicare Provider Analysis and Review database for the years 2005-2009 was used to model a group of 65-year-old patients with spinal stenosis who had no previous spine surgery and no contraindications to decompression surgery. OUTCOME MEASURES: Costs, quality-adjusted life years (QALYs), and cost per QALY gained were the outcome measures. METHODS: A Markov model tracked health utility and costs over 10 years for a 65-year-old cohort under three care strategies: conservative care, spacer surgery, and decompression surgery. Incremental cost-effectiveness ratios (ICER) reported as cost per QALY gained included direct medical costsfor surgery. Medicare claims data were used to estimate complication rates, reoperation, and related costs within 3 years. Utilities and long-term reoperation rates for decompression were derived frompublished studies. Spacer failure requiring reoperation beyond 3 years and post-spacer health utilities are uncertain and were evaluated through sensitivity analyses. In the base-case, the spacer failure rate was held constant for years 4-10 (cumulative failure: 47%). In a "worst-case" analysis, the 10-year cumulative reoperation rate was increased steeply (to 90%). Threshold analyses were performed to determine the impact of failure and post-spacer health utility on the cost-effectiveness of spacer surgery. RESULTS: The spacer strategy had an ICER of $89,500/QALY gained under base-case assumptions, and remained under $100,000 as long as the 10-year cumulative probability of reoperation did not exceed 54%. Under worst-case assumptions, the spacer ICER was $482,000/QALY and fell below $100,000 only if post-spacer utility was 0.01 greater than post-decompression utility or the cost of spacer surgery was $1,600 less than the cost of decompression surgery. CONCLUSIONS: Spacers may provide a reasonably cost-effective initial treatment option for patients with lumbar spinal stenosis. Their value is expected to improve if procedure costs are lower in outpatient settings where these procedures are increasingly being performed. Decision analysis is useful for characterizing the long-term cost-effectiveness potential for minimally invasive spinal stenosis treatments and highlights the importance of complication rates and prospective health utility assessment.

Use of Stereovision for Intraoperative Coregistration of a Spinal Surgical Field: A Human Feasibility Study.

BACKGROUND: The use of image guidance during spinal surgery has been limited by several anatomic factors such as intervertebral segment motion and ineffective spine immobilization. In its current form, the surgical field is coregistered with a preoperative computed tomography (CT), often obtained in a different spinal confirmation, or with intraoperative cross-sectional imaging. Stereovision offers an alternative method of registration. OBJECTIVE: To demonstrate the feasibility of stereovision-mediated coregistration of a human spinal surgical field using a proof-of-principle study, and to provide preliminary assessments of the technique's accuracy. METHODS: A total of 9 subjects undergoing image-guided pedicle screw placement also underwent stereovision-mediated coregistration with preoperative CT imaging. Stereoscopic images were acquired using a tracked, calibrated stereoscopic camera system mounted on an operating microscope. Images were processed, reconstructed, and segmented in a semi-automated manner. A multistart registration of the reconstructed spinal surface with preoperative CT was performed. Registration accuracy, measured as surface-to-surface distance error, was compared between stereovision registration and a standard registration. RESULTS: The mean surface reconstruction error of the stereovision-acquired surface was 2.20 ± 0.89 mm. Intraoperative coregistration with stereovision was performed with a mean error of 1.48 ± 0.35 mm compared to 2.03 ± 0.28 mm using a standard point-based registration method. The average computational time for registration with stereovision was 95 ± 46 s (range 33-184 s) vs 10to 20 min for standard point-based registration. CONCLUSION: Semi-automated registration of a spinal surgical field using stereovision is possible with accuracy that is at least comparable to current landmark-based techniques.

Validation of Using Claims Data to Measure Safety of Lumbar Fusion Surgery.

STUDY DESIGN: Retrospective analysis of patients undergoing elective lumbar fusion operations, comparing rates of repeat spine surgery based on method of ascertainment. OBJECTIVE: We report the accuracy of a claims-based approach for reporting repeat surgery compared with medical records abstraction as the "gold standard." SUMMARY OF BACKGROUND DATA: Previous studies have reported the validity of a claims-based algorithm for grouping patients by surgical indication and classifying operative features, but their accuracy in measuring surgical quality indicators has not been widely examined. METHODS: We identified a subset of patients undergoing elective lumbar fusion operations at a single institution from 1996 to 2011, excluding those with spinal fracture, spinal cord injury, or cancer. From the medical record we abstracted the incidence of repeat spine operation or rehospitalization at 1 year. We cross-classified each event record with its corresponding value derived from claims. The sensitivity and specificity of the claims-based approach were calculated for reoperation within 30, 90, and 365 days, and all-cause hospital readmission within 30 days. RESULTS: Medical records linked to claims data were obtained for 520 patients undergoing elective lumbar fusion. Reoperation rates based on chart review were 1.0%, 1.3%, 3.6%, compared with 0.8%, 1.7%, and 3.8% based on the final claims methods at 30, 90, and 365 days, respectively. The claims-based algorithm had sensitivities of 80.0%, 100%, and 94.1% and specificities of 100%, 99.6%, 99.2% for repeat surgery within 30, 90, and 365 days, respectively. The sensitivity for all-cause readmission was 50%. CONCLUSION: Health care quality improvement efforts often rely on administrative data to report surgical safety. We found that claims-based ascertainment of safety at a single institution was very accurate. However, accuracy depended on careful attention to the timing of outcomes, as well as the definitions and coding of repeat surgery, including how orthopedic device removal codes are classified. LEVEL OF EVIDENCE: 3.

Recombinant human BMP-2 and allograft compared with autogenous bone graft for reconstruction of diaphyseal tibial fractures with cortical defects. A randomized, controlled trial.

BACKGROUND: Currently, the treatment of diaphyseal tibial fractures associated with substantial bone loss often involves autogenous bone-grafting as part of a staged reconstruction. Although this technique results in high healing rates, the donor-site morbidity and potentially limited supply of suitable autogenous bone in some patients are commonly recognized drawbacks. The purpose of the present study was to investigate the benefit and safety of the osteoinductive protein recombinant human bone morphogenetic protein-2 (rhBMP-2) when implanted on an absorbable collagen sponge in combination with freeze-dried cancellous allograft. METHODS: Adult patients with a tibial diaphyseal fracture and a residual cortical defect were randomly assigned to receive either autogenous bone graft or allograft (cancellous bone chips) for staged reconstruction of the tibial defect. Patients in the allograft group also received an onlay application of rhBMP-2 on an absorbable collagen sponge. The clinical evaluation of fracture-healing included an assessment of pain with full weight-bearing and fracture-site tenderness. The Short Musculoskeletal Function Assessment (SMFA) was administered before and after treatment. Radiographs were used to document union, the presence of extracortical bridging callus, and incorporation of the bone-graft material. RESULTS: Fifteen patients were enrolled in each group. The mean length of the defect was 4 cm (range, 1 to 7 cm). Ten patients in the autograft group and thirteen patients in the rhBMP-2/allograft group had healing without further intervention. The mean estimated blood loss was significantly less in the rhBMP-2/allograft group. Improvement in the SMFA scores was comparable between the groups. No patient in the rhBMP-2/allograft group had development of antibodies to BMP-2; one patient had development of transient antibodies to bovine type-I collagen. CONCLUSIONS: The present study suggests that rhBMP-2/allograft is safe and as effective as traditional autogenous bone-grafting for the treatment of tibial fractures associated with extensive traumatic diaphyseal bone loss. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.

Risk factors for respiratory failure following operative stabilization of thoracic and lumbar spine fractures.

BACKGROUND: Respiratory failure is a serious complication that can adversely affect the hospital course and survival of multiply injured patients. Some studies have suggested that delayed surgical stabilization of spine fractures may increase the incidence of respiratory complications. However, the authors of these studies analyzed small sets of patients and did not assess the independent effects of multiple risk factors. METHODS: A retrospective cohort study was conducted at a regional level-I trauma center to identify risk factors for respiratory failure in patients with surgically treated thoracic and lumbar spine fractures. Demographic, diagnostic, and procedural variables were identified. The incidence of respiratory failure was determined in an adult respiratory distress syndrome registry maintained concurrently at the same institution. Univariate and multivariate analyses were used to determine independent risk factors for respiratory failure. An algorithm was formulated to predict respiratory failure. RESULTS: Respiratory failure developed in 140 of the 1032 patients in the study cohort. Patients with respiratory failure were older; had a higher mean Injury Severity Score (ISS) and Charlson Comorbidity Index Score; had greater incidences of pneumothorax, pulmonary contusion, and thoracic level injury; had a lower mean Glasgow Coma Score (GCS); were more likely to have had a posterior surgical approach; and had a longer mean time from admission to surgical stabilization than the patients without respiratory failure (p < 0.05). Multivariate analysis identified five independent risk factors for respiratory failure: an age of more than thirty-five years, an ISS of > 25 points, a GCS of < or = 12 points, blunt chest injury, and surgical stabilization performed more than two days after admission. An algorithm was created to determine, on the basis of the number of preoperative predictors present, the relative risk of respiratory failure when surgery was delayed for more than two days. CONCLUSIONS: Independent risk factors for respiratory failure were identified in an analysis of a large cohort of patients who had undergone operative stabilization of thoracic and lumbar spine fractures. Early operative stabilization of these fractures, the only risk factor that can be controlled by the physician, may decrease the risk of respiratory failure in multiply injured patients.

Towards standardized measurement of adverse events in spine surgery: conceptual model and pilot evaluation.

BACKGROUND: Independent of efficacy, information on safety of surgical procedures is essential for informed choices. We seek to develop standardized methodology for describing the safety of spinal operations and apply these methods to study lumbar surgery. We present a conceptual model for evaluating the safety of spine surgery and describe development of tools to measure principal components of this model: (1) specifying outcome by explicit criteria for adverse event definition, mode of ascertainment, cause, severity, or preventability, and (2) quantitatively measuring predictors such as patient factors, comorbidity, severity of degenerative spine disease, and invasiveness of spine surgery. METHODS: We created operational definitions for 176 adverse occurrences and established multiple mechanisms for reporting them. We developed new methods to quantify the severity of adverse occurrences, degeneration of lumbar spine, and invasiveness of spinal procedures. Using kappa statistics and intra-class correlation coefficients, we assessed agreement for the following: four reviewers independently coding etiology, preventability, and severity for 141 adverse occurrences, two observers coding lumbar spine degenerative changes in 10 selected cases, and two researchers coding invasiveness of surgery for 50 initial cases. RESULTS: During the first six months of prospective surveillance, rigorous daily medical record reviews identified 92.6% of the adverse occurrences we recorded, and voluntary reports by providers identified 38.5% (surgeons reported 18.3%, inpatient rounding team reported 23.1%, and conferences discussed 6.1%). Trained observers had fair agreement in classifying etiology of 141 adverse occurrences into 18 categories (kappa = 0.35), but agreement was substantial (kappa > or = 0.61) for 4 specific categories: technical error, failure in communication, systems failure, and no error. Preventability assessment had moderate agreement (mean weighted kappa = 0.44). Adverse occurrence severity rating had fair agreement (mean weighted kappa = 0.33) when using a scale based on the JCAHO Sentinel Event Policy, but agreement was substantial for severity ratings on a new 11-point numerical severity scale (ICC = 0.74). There was excellent inter-rater agreement for a lumbar degenerative disease severity score (ICC = 0.98) and an index of surgery invasiveness (ICC = 0.99). CONCLUSION: Composite measures of disease severity and surgery invasiveness may allow development of risk-adjusted predictive models for adverse events in spine surgery. Standard measures of adverse events and risk adjustment may also facilitate post-marketing surveillance of spinal devices, effectiveness research, and quality improvement.