Explore the vast range of titles available.

Background National databases are increasingly being used for research in spine surgery; however, one limitation of such databases that has received sparse mention is the frequency of missing data. Studies using these databases often do not emphasize the percentage of missing data for each variable used and do not specify how patients with missing data are incorporated into analyses. This study uses the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database to examine whether different treatments of missing data can influence the results of spine studies. Questions/purposes (1) What is the frequency of missing data fields for demographics, medical comorbidities, preoperative laboratory values, operating room times, and length of stay recorded in ACS-NSQIP? (2) Using three common approaches to handling missing data, how frequently do those approaches agree in terms of finding particular variables to be associated with adverse events? (3) Do different approaches to handling missing data influence the outcomes and effect sizes of an analysis testing for an association with these variables with occurrence of adverse events? Methods Patients who underwent spine surgery between 2005 and 2013 were identified from the ACS-NSQIP database. A total of 88,471 patients undergoing spine surgery were identified. The most common procedures were anterior cervical discectomy and fusion, lumbar decompression, and lumbar fusion. Demographics, comorbidities, and perioperative laboratory values were tabulated for each patient, and the percent of missing data was noted for each variable. These variables were tested for an association with “any adverse event” using three separate multivariate regressions that used the most common treatments for missing data. In the first regression, patients with any missing data were excluded. In the second regression, missing data were treated as a negative or “reference” value; for continuous variables, the mean of each variable’s reference range was computed and imputed. In the third regression, any variables with > 10% rate of missing data were removed from the regression; among variables with ≤ 10% missing data, individual cases with missing values were excluded. The results of these regressions were compared to determine how the different treatments of missing data could affect the results of spine studies using the ACS-NSQIP database. Results Of the 88,471 patients, as many as 4441 (5%) had missing elements among demographic data, 69,184 (72%) among comorbidities, 70,892 (80%) among preoperative laboratory values, and 56,551 (64%) among operating room times. Considering the three different treatments of missing data, we found different risk factors for adverse events. Of 44 risk factors found to be associated with adverse events in any analysis, only 15 (34%) of these risk factors were common among the three regressions. The second treatment of missing data (assuming “normal” value) found the most risk factors (40) to be associated with any adverse event, whereas the first treatment (deleting patients with missing data) found the fewest associations at 20. Among the risk factors associated with any adverse event, the 10 with the greatest effect size (odds ratio) by each regression were ranked. Of the 15 variables in the top 10 for any regression, six of these were common among all three lists. Conclusions Differing treatments of missing data can influence the results of spine studies using the ACS-NSQIP. The current study highlights the importance of considering how such missing data are handled. Clinical Relevance Until there are better guidelines on the best approaches to handle missing data, investigators should report how missing data were handled to increase the quality and transparency of orthopaedic database research. Readers of large database studies should note whether handling of missing data was addressed and consider potential bias with high rates or unspecified or weak methods for handling missing data.

Background Industry payments made to physicians by drug and device manufacturers or group purchasing organizations are now reported to the Centers for Medicare and Medicaid Services (CMS) as a part of the Physician Payments Sunshine Act. Initial reports from the program show that orthopaedic surgeons lead all physician specialties in total and average industry payments. However, before further discussion of these payments and their implications can take place, it remains to be seen whether these figures are a true reflection of the field of orthopaedic surgery in general, rather than the result of a few outlier physicians in the field. In addition, the nature and sources of these funds should be determined to better inform the national dialogue surrounding these payments. Questions/Purposes We asked: (1) How do industry payments to orthopaedic surgeons compare with payments to physicians and surgeons in other fields, in terms of median payments and the Gini index of disparity? (2) How much do payments to the highest-receiving orthopaedic surgeons contribute to total payments? (3) What kind of industry payments are orthopaedic surgeons receiving? (4) How much do the highest-paying manufacturers contribute to total payments to orthopaedic surgeons? Materials and Methods We reviewed the most recent version of the CMS Sunshine Act Open Payments database released on December 19, 2014, containing data on payments made between August 1, 2013 and December 31, 2013. Data on total payments to individual physicians, physician specialty, the types of payments made, and the manufacturers making payments were reviewed. The Gini index of statistical dispersion was calculated for payments made to orthopaedic surgeons and compared with payments made to physicians and surgeons in all other medical specialties. A Gini index of 0 indicates complete equality of payments to everyone in the population, whereas an index of 1 indicates complete inequality, or all income going to one individual. Results A total of 15,376 orthopaedic surgeons receiving payments during the 5-month period were identified, accounting for USD 109,846,482. The median payment to orthopaedic surgeons receiving payments was USD 121 (interquartile range, USD 34–619). The top 10% of orthopaedic surgeons receiving payments (1538 surgeons) received at least USD 4160 and accounted for 95% of total payments. Royalties and patent licenses accounted for 69% of all industry payments to orthopaedic surgeons. Conclusions Even as a relatively small specialty, orthopaedic surgeons received substantial payments from industry (more than USD 110 million) during the 5-month study period. Whether there is a true return of value from these payments remains to be seen; however, future ethical and policy discussions regarding industry payments to orthopaedic surgeons should take into account the large disparities in payments that are present and also the nature of the payments being made. It is possible that patients and policymakers may view industry payments to orthopaedic surgeons more positively in light of these new findings. Level of Evidence Level III, Economic and Decision Analysis.

Background The FDA approves novel, high-risk medical devices through the premarket approval (PMA) process based on clinical evidence supporting device safety and effectiveness. Devices subsequently may undergo postmarket modifications that are approved via one of several PMA supplement review tracks, usually without additional supporting clinical data. While orthopaedic devices cleared via the less rigorous 510(k) pathway have been studied previously, devices cleared through the PMA pathway and those receiving postmarket PMA supplements warrant further investigation. Questions/purposes We asked: What are (1) the types of original orthopaedic devices receiving FDA PMA approval, (2) the number and rate of postmarket device changes approved per device, (3) the types of PMA supplement review tracks used, (4) the types of device changes approved via the various review tracks, and (5) the number of device recalls and market withdrawals that have occurred for these devices? Methods All original PMA-approved orthopaedic devices between January 1982 and December 2014 were identified in the publically available FDA PMA database. The number of postmarket device changes approved, the PMA supplement review track used, the types of postmarket changes, and any FDA recalls for each device were assessed. Results Seventy original orthopaedic devices were approved via the FDA PMA pathway between 1982 and 2014. These devices included 34 peripheral joint implants or prostheses, 18 spinal implants or prostheses, and 18 other devices or materials. These devices underwent a median 6.5 postmarket changes during their lifespan or 1.0 changes per device–year (interquartile range, 0.4–1.9). The rate of new postmarket device changes approved per active device, increased from less than 0.5 device changes per year in 1983 to just fewer than three device changes per year in 2014, or an increase of 0.05 device changes per device per year in linear regression analysis (95% CI, 0.04–0.07). Among the 765 total postmarket changes, 172 (22%) altered device design or components. The majority of the design changes were reviewed via either the real-time review track (n = 98; 57%), intended for minor design changes, or the 180-day review track (n = 71; 41%), intended for major design changes. Finally, a total of 12 devices had FDA recalls at some point during their lifespan, two being for hip prostheses with high revision rates. Conclusions Relatively few orthopaedic devices undergo the FDA PMA process before reaching the market. Orthopaedic surgeons should be aware that high-risk medical devices cleared via the FDA’s PMA pathway do undergo considerable postmarket device modification after reaching the market, with potential for design “drift,” ie, shifting away from the initially tested and approved device designs. Clinical Relevance As the ultimate end-users of these devices, orthopaedic surgeons should be aware that even among high-risk medical devices approved via the FDA’s PMA pathway, considerable postmarket device modification occurs. Continued postmarket device monitoring will be essential to limit patient safety risks.

Purpose Alpine skiing and snowboarding are both popular winter sports that can be associated with significant orthopaedic injuries. However, there is a lack of nationally representative injury data for the two sports. Methods The National Trauma Data Bank was queried for patients presenting to emergency departments due to injuries sustained from skiing and snowboarding during 2011 and 2012. Patient demographics, comorbidities, and injury patterns were tabulated and compared between skiing and snowboarding. Risk factors for increased injury severity score and lack of helmet use were identified using multivariate logistic regression. Results Of the 6055 patients identified, 55.2 % were skiers. Sixty-one percent had fractures. Lower extremity fractures were the most common injury and occurred more often in skiers ( p  < 0.001). Upper extremity fractures were more common in snowboarders, particularly distal radius fractures ( p  < 0.001). On multivariate analysis, increased injury severity was independently associated with age 18–29, 60–69, 70+, male sex, a positive blood test for alcohol, a positive blood test for an illegal substance, and wearing a helmet. Lack of helmet use was associated with age 18–29, 30–39, smoking, a positive drug test for an illegal substance, and snowboarding. Conclusions Young adults, the elderly, and those using substances were shown to be at greater risk of increased injury severity and lack of helmet use. The results of this study can be used clinically to guide the initial assessment of these individuals following injury, as well as for targeting preventive measures and education. Level of evidence Prognostic Level III.

In the humerus, pain is a poor guide for differentiating between benign enchondromas and malignant well-differentiated chondrosarcomas. Radionuclide bone scans often are used, and chondrosarcomas reliably show increased uptake. However, it remains to be seen whether enchondromas consistently have negative findings on bone scans, which would provide reliable differentiation from malignant lesions. Imaging and medical records were reviewed for patients who underwent radionuclide bone scans for enchondroma of the humerus at one academic medical center over a period of 7 years. Bivariate logistic regression was used to determine the association of bone scan results with the finding of endosteal scalloping on radiographs and magnetic resonance imaging (MRI) scans. During initial evaluation, 25 patients who had enchondroma of the humerus underwent radionuclide bone scans. No patients showed progression of lesions during an average follow-up of 69 weeks. On bone scan, 18 (72%) had significantly positive findings, 5 (20%) had mildly positive findings, and 2 (8%) had negative findings. Of the 22 patients who underwent MRI scans, 4 showed endosteal scalloping and none showed aggressive features. No statistically significant association was seen between significantly positive ( P =.299) or mildly positive findings on bone scans ( P =.810) and the finding of endosteal scalloping on radiographs or MRI scans. Enchondromas rarely showed negative findings on bone scans, and bone scan findings did not correlate with the findings on radiographs or MRI scans. The diagnosis of enchondroma can be made based on clinical and radiographic findings, and the added utility of bone scans does not justify their regular use. [ Orthopedics . 2020;43(6):e498–e502.]

Study Design: Retrospective cohort study. Objective: The objective of this study is to determine how often patients with degenerative cervical myelopathy (DCM) and initially treated with cervical steroid injections (CSI) and to determine whether these injections provide any benefit in delaying ultimate surgical treatment. Methods: All patients with a new diagnosis of DCM, without previous cervical spine surgery or steroid injections, were identified in PearlDiver, a large insurance database. Steroid injection and surgery timing was identified using Current Procedural Terminology (CPT) codes. Multivariate logistic regression identified associations with surgical treatment. Results: A total of 686 patients with DCM were identified. Pre-surgical cervical spine steroid injections were utilized in 244 patients (35.6%). All patients underwent eventual surgical treatment. Median time from initial DCM diagnosis to surgery was 75.5 days (mean 351.6 days; standard deviation 544.9 days). Cervical steroid injections were associated with higher odds of surgery within 1 year (compared to patients without injections, OR = 1.44, P < .001) and at each examined time point through 5 years (OR = 2.01, P < .001). In multivariate analysis comparing injection types, none of the 3 injection types were associated with decreased odds of surgery within 1 month of diagnosis. Conclusions: While cervical steroid injections continue to be commonly performed in patients with DCM, there is an overall increased odds of surgery after any type of cervical injection. Therefore injections should not be used to prevent surgical management of DCM.

Study Design: Retrospective cohort study. Objective: To (1) define utilization trends for navigated instrumented posterior lumbar fusion (PLF), (2) compare reasons and rates of revision at 30-day, 60-day, 90-day, and 1-year follow-up, and (3) compare 90-day perioperative complications between navigated versus conventional instrumented PLF. Methods: Patients who underwent navigated or conventional instrumented PLF were identified from the Humana insurance database using the PearlDiver Patient Records between 2007-2017. Usage of navigation was characterized. Patient demographics and operative characteristics (number of levels fused, interbody usage) were compared between the 2 treatment groups. Propensity score matching was done and comparisons were made for revision rates at different follow-up periods (categorized by reasons) and other 90-day perioperative complications. Results: This study included 1,648 navigated and 23 429 conventional instrumented PLF. Navigated cases increased over the years studied to approximately 10% in 2017. Statistical analysis after propensity score matching revealed significantly lower rates of hardware-related revision at 90-day follow-up in the navigated cohort (0.49% versus 1.15%, P = .033). At 1-year follow-up, the navigated cohort continued to have significantly lower rates of hardware-related revision (1.70% versus 2.73%, P = .044) as well as all cause revision (2.67% versus 4.00%, P = .032). There were no statistical differences between the 2 cohorts in any of the 90-day perioperative complications studied, such as cellulitis and blood transfusion (P > .05 for all). Conclusions: These findings suggest that navigation is associated with reductions in hardware-related revisions after instrumented PLF. However, these results should be interpreted cautiously in the setting of potential confounding by other unmeasured variables.

Background Medicare currently reimburses hospitals for inpatient admissions with “bundled” payments based on patient Diagnosis-related Groups (DRGs) regardless of true hospital costs. At present, DRG 536 (fractures of the hip and pelvis) includes a broad spectrum of patients with orthopaedic trauma, likely with varying inpatient resource utilization. With the growing incidence of fractures in the elderly, inadequate reimbursements from Medicare for certain patients with DRG 536 may lead to growing financial strain on healthcare institutions caring for these patients with higher costs. Questions/purposes The purposes of the study were to determine whether (1) inpatient length of stay; (2) intensive care unit stay; and (3) ventilator time differ among subpopulations with Medicare DRG 536. Methods A total of 56,683 patients, 65 years or older, with fractures of the hip or pelvis were identified in the 2011 and 2012 National Trauma Data Bank. This clinical registry contains data on trauma cases from more than 900 participating trauma centers, allowing analysis of resource utilization in centers across the United States. Patients were grouped in the following subgroups: hip fractures (n = 35,119), nonoperative pelvic fractures (n = 15,506), acetabulum fractures, operative and nonoperative, (n = 7670), and operative pelvic fractures (n = 682). Total inpatient length of stay, intensive care unit (ICU) stay, and ventilator time were compared across groups using multivariate analysis that controlled for hospital factors. Results After controlling for patient and hospital factors, difference in inpatient length of stay was −0.2 days for patients with nonoperative pelvis fractures compared with inpatient length of stay for patients with hip fractures (95% CI, −0.4 to −0.1 days; p = 0.001); 1.7 days for patient with acetabulum fractures (95% CI, 1.4–1.9 days; p < 0.001); and 7.7 days for patients with operative pelvic fractures (95% CI, 7.0–8.4 days; p < 0.001). The difference in ICU length of stay for patients with nonoperative pelvis fractures was 0.8 days compared with ICU length of stay for patients with hip fractures (95% CI, 0.7–0.9 days; p < 0.001); 1.9 days for patients with acetabulum fractures (95% CI, 1.8–2.1 days; p < 0.001); and 6.3 days for patients with operative pelvic fractures (95% CI, 5.9–6.7 days; p < 0.001). The difference in mechanical ventilation time for patients with nonoperative fractures was 0.5 days compared with ventilation time for patients with hip fractures (95% CI, 0.4–0.6 days; p < 0.001); 1.1 days for patients with acetabulum fractures (95% CI, 1.0–1.2 days; p < 0.001); and 3.9 days for patients with operative fractures (95% CI, 2.5–3.2 days; p < 0.001). Conclusions In our current multitiered trauma system, certain centers will see higher proportions of patients with acetabulum and operative pelvic fractures. Because hospitals are reimbursed equally for these subgroups of Medicare DRG 536, centers that care for a greater proportion of patients with more-complex pelvic trauma will experience lower financial margins per trauma patient, limiting their potential for growth and investment compared with competing institutions that may not routinely see patients with high-energy trauma. Because of this, we believe reevaluation of this Medicare Prospective Payment System DRG is warranted. Level of Evidence Level IV, economic and decision analysis.

Study Design: Systematic review. Objective: Indirect decompression via lateral lumbar interbody fusion (LLIF) can ameliorate central and foraminal lumbar stenosis. In severe central stenosis, additional posterior direct decompression is utilized. The aim of this review is to synthesize existing literature on these 2 techniques and identify significant differences in outcomes between isolated indirect decompression via LLIF and combined indirect decompression supplemented with direct posterior decompression. Methods: A database search algorithm was utilized to query MEDLINE, COCHRANE, and EMBASE to identify literature reporting adult decompression study groups that involved an oblique or lateral fusion approach through September 2020. Improvement in outcomes measures and complication rates were pooled and tested for significance. Results: A total of 110 publications were assessed with 15 studies meeting inclusion criteria, including 557 patients and 1008 levels. Mean age was 63.1 years with BMI of 27.5 kg/m2. For the combined indirect and direct decompression cohort, lumbar lordosis (LL) increased 133.9%, from 22.8o to 48.7o, while the indirect decompression cohort LL increased 8.9%, from 41.9o to 45.5o. Difference in LL improvement between cohorts was insignificant (P > .05). Oswestry Disability Index (ODI) decreased from 36.5 to 19.4 in the combined indirect and direct decompression cohort, and from 44.4 to 23.1 in the indirect decompression cohort. ODI reduction was insignificant (P = .053). Conclusions: Prior studies of both indirect decompression as well as combined indirect and direct decompression of lumbar spine stenosis are limited by small samples, heterogeneous populations, and lack of direct comparisons. Both procedures result in improved function and pain postoperatively with direct decompression restoring more lordosis in patients with worse preoperative alignment.