The Statistical Fragility of Trials Comparing Cervical Disc Arthroplasty and Anterior Cervical Discectomy and Fusion: A Meta Analysis.

STUDY DESIGN: Meta-analysis. OBJECTIVE: Assess the robustness of randomized controlled trials (RCTs) that compared cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic degenerative cervical pathology by using fragility indices. SUMMARY OF BACKGROUND DATA: RCTs comparing these surgical approaches have shown that CDA may be equivalent or even superior to ACDF due to better preservation of normal spinal kinematics. METHODS: RCTs reporting clinical outcomes after CDA versus ACDF for degenerative cervical disc disease were evaluated. Data for outcome measures were classified as continuous or dichotomous. Continuous outcomes included: Neck Disability Index (NDI), overall pain, neck pain, radicular arm pain, and modified Japanese Orthopaedic Association (mJOA) scores. Dichotomous outcomes included: any adjacent segment disease (ASD), superior-level ASD, and inferior-level ASD. The fragility index (FI) and continuous FI (CFI) were determined for dichotomous and continuous outcomes, respectively. The corresponding fragility quotient (FQ) and continuous FQ (CFQ) were calculated by dividing FI/CFI by sample size. RESULTS: Twenty-five studies (78 outcome events) were included. Thirteen dichotomous events had a median FI of 7 (IQR: 3-10) and the median FQ was 0.043 (IQR: 0.035-0.066). Sixty-five continuous events had a median CFI of 14 (IQR: 9-22) and median CFQ of 0.145 (IQR: 0.074-0.188). This indicates that, on average, altering the outcome of 4.3 patients out of 100 for the dichotomous outcomes, and 14.5 out of 100 for continuous outcomes, would reverse trial significance. Of the 13 dichotomous events that included lost to follow-up data, 8 (61.5%) represented ≥7 patients lost. Of the 65 continuous events reporting lost to follow-up data, 22 (33.8%) represented ≥14 patients lost. CONCLUSION: RCTs comparing ACDF and CDA have fair to moderate statistical robustness and do not suffer from statistical fragility.

Anemia and Its Severity Is Associated With Worse Postoperative Outcomes Following Open Reduction Internal Fixation of Ankle Fractures.

BACKGROUND: Ankle fractures are often treated in a nonemergent fashion and therefore offer the chance for treatment of preoperative anemia. Although preoperative anemia has been associated with postoperative morbidity following certain types of orthopaedic procedures, its effect on postoperative outcomes following open reduction internal fixation (ORIF) of ankle fractures has not been evaluated. The purpose of this study was to determine the influence of preoperative anemia on 30-day postoperative outcomes following ankle fracture ORIF. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (ASC-NSQIP) registry was queried from 2005 to 2019 for patients undergoing ankle fracture ORIF. Patients were stratified into nonanemic, mildly anemic, and moderately to severely anemic. Univariate analyses were used to assess differences in patient characteristics between cohorts. Multivariate logistic regressions adjusting for these differences were performed to assess the effect of preoperative anemia on 30-day postoperative outcomes. RESULTS: We obtained data for 21 211 patients, of whom 14 931 (70.39%) were not anemic, 3982 (18.77%) were mildly anemic, and 2298 (10.83%) were moderately to severely anemic. After adjustment, mild preoperative anemia was associated with higher odds of any adverse event (P < .001), deep surgical site infections (SSIs; P = .013), sepsis (P = .001), 30-day readmission (P < .001), and extended length of stay (LOS) (P < .001). Similarly, moderate to severe anemia in these patients was also associated with increased odds of any adverse event (P < .001), deep SSIs (P = .003), sepsis (P = .001), readmission (P < .001), and extended LOS (P < .001). Both mild (P = .004) and moderate to severe (P < .001) anemia groups had higher odds of requiring a blood transfusion. CONCLUSION: Preoperative anemia is associated with an increased risk of adverse postoperative outcomes in patients undergoing ORIF for ankle fractures. Future studies should evaluate whether optimization of hematocrit in these patients results in improved outcomes. LEVEL OF EVIDENCE: Level III, comparative study.

Orthopaedic Surgeon Distribution in the United States.

BACKGROUND: There is limited research on the supply and distribution of orthopaedic surgeons in the United States. The goal of this study was to analyze the association of orthopaedic surgeon distribution in the United States with geographic and sociodemographic factors. METHODS: County-level data from the US Department of Health and Human Services Area Health Resources Files were used to determine the density of orthopaedic surgeons across the United States on a county level. Data were examined from 2000 to 2019 to analyze trends over time. Bivariate and multivariable negative binomial regression models were constructed to identify county-level sociodemographic factors associated with orthopaedic surgeon density. RESULTS: In 2019, 51% of the counties in the United States did not have an orthopaedic surgeon. Metropolitan counties had a mean of 22 orthopaedic surgeons per 100,000 persons while nonmetropolitan and rural counties had a mean of 2 and 0.1 orthopaedic surgeons per 100,000 persons, respectively. Over the past 2 decades, there was a significant increase in the percentage of orthopaedic surgeons in metropolitan counties (77% in 2000 vs 93% in 2019, P < 0.001) and in the proportion of orthopaedic surgeons 55 years and older (32% in 2000 vs 39% in 2019, P < 0.001). Orthopaedic surgeon density increased with increasing median home value (P < 0.001) and median household income (P < 0.001). Counties with a higher percentage of persons in poverty (P < 0.001) and higher unemployment rate (P < 0.001) and nonmetropolitan (P < 0.001) and rural (P < 0.001) counties had a lower density of orthopaedic surgeons. On multivariable analysis, a model consisting of median home value (P < 0.001), rural counties (P < 0.001), percentage of noninsured persons (P < 0.001), and percentage of foreign-born persons (P < 0.001) predicted orthopaedic surgeon density. CONCLUSION: Access to orthopaedic surgeons in the United States in rural areas is decreasing over time. County-level socioeconomic factors such as wealth and urbanization were found to be closely related with surgeon density.

Early Postoperative Complications in Total Hip and Knee Arthroplasties Before and During the COVID-19 Pandemic: A Retrospective Analysis of 38,234 Patients.

Background: The outcomes of total joint arthroplasty during the coronavirus disease 2019 (COVID-19) pandemic are unknown. We sought to compare early postoperative complications in total hip arthroplasty (THA) and total knee arthroplasty (TKA) prior to and during the COVID-19 pandemic. Methods: Patients in the American College of Surgeons National Surgical Quality Improvement Program database who had THA or TKA in the latter halves (July to December) of 2019 and 2020 were identified. Patients were divided into pre-COVID-19 (2019) and during-COVID-19 (2020) cohorts. Propensity score matching and logistic regression were used to detect correlations between operative period and outcomes. Statistical significance was set at α = 0.05. Results: A total of 38,234 THA and 61,956 TKA patients were included. There was a significantly higher rate of outpatient procedures in 2020 than that in 2019 for both THA (41.68% vs 6.59%, P < .001) and TKA (41.68% vs 7.56%, P < .001). On matched analysis, surgery in 2020 had lower odds of hospital stay for >1 day (THA: odds ratio [OR] 0.889; P < .001) (TKA: OR 0.644; P < .001) and nonhome discharge (THA: 0.655; P < .001) (TKA: 0.497; P < .001). There was also increased odds of superficial surgical site infection in THA (OR 1.272; P = .040) and myocardial infarction in TKA patients (OR 1.488; P = .042) in 2020 compared to those in 2019. There was no difference in the 15 other outcomes assessed. Conclusions: Total joint arthroplasty surgery remains safe despite the COVID-19 pandemic. A statistically significant increase was detected in superficial surgical site infection and myocardial infarction risk during 2020 compared to 2019; however, the clinical significance of this is questionable. A shift away from inpatient stay was also present, possibly reflecting efforts to minimize nosocomial exposure to COVID-19.

Patient Out-of-Pocket Cost Burden With Elective Orthopaedic Surgery.

INTRODUCTION: Out-of-pocket (OOP) costs for medical and surgical care can result in substantial financial burden for patients and families. Relatively little is known regarding OOP costs for commercially insured patients receiving orthopaedic surgery. The aim of this study is to analyze the trends in OOP costs for common, elective orthopaedic surgeries performed in the hospital inpatient setting. METHODS: This study used an employer-sponsored insurance claims database to analyze billing data of commercially insured patients who underwent elective orthopaedic surgery between 2014 and 2019. Patients who received single-level anterior cervical diskectomy and fusion (ACDF), single-level posterior lumbar fusion (PLF), total knee arthroplasty (TKA), and total hip arthroplasty (THA) were identified. OOP costs associated with the surgical episode were calculated as the sum of deductible payments, copayments, and coinsurance. Monetary data were adjusted to 2019 dollars. General linear regression, Wilcoxon-Mann-Whitney, and Kruskal-Wallis tests were used for analysis, as appropriate. RESULTS: In total, 10,225 ACDF, 28,841 PLF, 70,815 THA, and 108,940 TKA patients were analyzed. Most patients in our study sample had preferred provider organization insurance plans (ACDF 70.3%, PLF 66.9%, THA 66.2%, and TKA 67.0%). The mean OOP costs for patients, by procedure, were as follows: ACDF $3,180 (SD = 2,495), PLF $3,166 (SD = 2,529), THA $2,884 (SD = 2,100), and TKA $2,733 (SD = 1,994). Total OOP costs increased significantly from 2014 to 2019 for all procedures (P < 0.0001). Among the insurance plans examined, patients with high-deductible health plans had the highest episodic OOP costs. The ratio of patient contribution (OOP costs) to total insurer contribution (payments from insurers to providers) was 0.07 for ACDF, 0.04 for PLF, 0.07 for THA, and 0.07 for TKA. CONCLUSION: Among commercially insured patients who underwent elective spinal fusion and major lower extremity joint arthroplasty surgery, OOP costs increased from 2014 to 2019. The OOP costs for elective orthopaedic surgery represent a substantial and increasing financial burden for patients.

Prescription Patterns, Associated Factors, and Outcomes of Opioids for Operative Foot and Ankle Fractures: A Systematic Review.

BACKGROUND: Pain management after foot and ankle surgery must surmount unique challenges that are not present in orthopaedic surgery performed on other parts of the body. However, disparate and inconsistent evidence makes it difficult to draw meaningful conclusions from individual studies. QUESTIONS/PURPOSES: In this systematic review, we asked: what are (1) the patterns of opioid use or prescription (quantity, duration, incidence of persistent use), (2) factors associated with increased or decreased risk of persistent opioid use, and (3) the clinical outcomes (principally pain relief and adverse events) associated with opioid use in patients undergoing foot or ankle fracture surgery? METHODS: We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for our review. We searched PubMed, Embase, Scopus, Cochrane, and Web of Science on October 15, 2021. We included studies published from 2010 to 2021 that assessed patterns of opioid use, factors associated with increased or decreased opioid use, and other outcomes associated with opioid use after foot or ankle fracture surgery (principally pain relief and adverse events). We excluded studies on pediatric populations and studies focused on acute postoperative pain where short-term opioid use (< 1 week) was a secondary outcome only. A total of 1713 articles were assessed and 18 were included. The quality of the 16 included retrospective observational studies and two randomized trials was evaluated using the Methodological Index for Non-Randomized Studies criteria and the Jadad scale, respectively; study quality was determined to be low to moderate for observational studies and good for randomized trials. Mean patient age ranged from 42 to 53 years. Fractures studied included unimalleolar, bimalleolar, trimalleolar, and pilon fractures. RESULTS: Proportions of postoperative persistent opioid use (defined as use beyond 3 or 6 months postoperatively) ranged from 2.6% (546 of 20,992) to 18.5% (32 of 173) and reached 39% (28 of 72) when including patients with prior opioid use. Among the numerous associations reported by observational studies, two or more preoperative opioid prescriptions had the strongest overall association with increased opioid use, but this was assessed by only one study (OR 11.92 [95% confidence interval (CI) 9.16 to 13.30]; p < 0.001). Meanwhile, spinal and regional anesthesia (-13.5 to -41.1 oral morphine equivalents (OME) difference; all p < 0.01) and postoperative ketorolac use (40 OME difference; p = 0.037) were associated with decreased opioid consumption in two observational studies and a randomized trial, respectively. Three observational studies found that opioid use preoperatively was associated with a higher proportion of emergency department visits and readmission (OR 1.41 to 17.4; all p < 0.001), and opioid use at 2 weeks postoperatively was associated with slightly higher pain scores compared with nonopioid regimens (ß = 0.042; p < 0.001 and Likert scale 2.5 versus 1.6; p < 0.05) in one study. CONCLUSION: Even after noting possible inflation of the harms of opioids in this review, our findings nonetheless highlight the need for opioid prescription guidelines specific for foot and ankle surgery. In this context, surgeons should utilize short (< 1 week) opioid prescriptions, regional anesthesia, and multimodal pain management techniques, especially in patients at increased risk of prolonged opioid use. LEVEL OF EVIDENCE: Level III, therapeutic study.