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BACKGROUND: The 2018 American Association of Hip and Knee Surgeons clinical practice guideline (CPG) 'Tranexamic Acid Use in Total Joint Arthroplasty' evaluated the efficacy and safety of tranexamic acid in primary total joint arthroplasty. The following review assessed the statistical fragility of the randomized controlled trial (RCT) outcomes on which the CPG recommendations were based using a fragility analysis. METHODS: All dichotomous outcomes from the randomized controlled trials used to guide the CPG from its associated network and direct meta-analyses were analyzed. Fragility and reverse fragility indices (FI and rFI) and quotients (FQ and rFQ) were calculated for each outcome. Mean indices and quotients were calculated for each guideline question, outcome category, and comparison of tranexamic dose, formulation, and administration timing. RESULTS: This review evaluated 403 dichotomous outcomes on transfusion and complication rates associated with tranexamic acid (TXA) administration. The mean FI of significant outcomes of the CPG was 5.23, and the mean rFI of nonsignificant outcomes was 5.80. Outcomes assessing complication rates had a mean rFI of 6.48. Most outcomes on transfusion in categories comparing TXA to placebo administration had higher mean FIs than rFIs, and all outcomes comparing transfusion risk associated with different TXA formulations and doses had higher mean rFIs than FI or no associated significant outcomes. CONCLUSION: The rFI and FIs calculated for this CPG are comparable to or higher than mean values reported across orthopaedic literature, indicating the relative statistical stability of its included outcomes. As we learn more about fragility analyses and their potential applications, this type of statistical analysis shows promise as a useful tool to incorporate into future guidelines to assess the quality of RCTs and evaluate the strength of recommendations.

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INTRODUCTION: Mechanical loosening is a leading cause of failure of total knee arthroplasties (TKAs) for which obesity may be a risk factor. With rising rates of obesity and increasing incidence of TKA, the identification of factors to mitigate this cause of failure is necessary. The purpose of this study is to determine if the use of a tibial stem extender (TSE) decreases the risk of mechanical loosening in patients with obesity undergoing TKA. MATERIALS: The American Joint Replacement Registry (AJRR) and linked Center of Medicare Services (CMS) claims database were utilized to identify a patient cohort with a body mass index of 30 kg/m2 or greater and age 65 years or older who underwent primary elective TKA between 2012 and 2021. METHODS: Patients were divided into cohorts based on obesity class and TSE utilization. The estimated association of TSE use, BMI categories, and covariates with the risk of revisions for mechanical loosening in both unadjusted and adjusted settings was determined. Hazard ratios (HRs) and their 95% confidence intervals (CIs) for the risk of mechanical loosening were calculated. RESULTS: 258,775 TKA cases were identified. 538 of 257,194 (0.21%) patients who did not receive a TSE and one patient out of 1,581 (0.06%) with a TSE were revised for mechanical loosening. In adjusted analysis, TSE use was not protective against mechanical loosening and BMI > 40 was not a significant risk factor. CONCLUSION: Use of a TSE was not found to be protective against mechanical loosening in patients with obesity; however, analysis was limited by the small number of outcome events in the cohort. Further analysis with a larger cohort of patients with TSE and a longer follow up time is necessary to corroborate this finding.

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Introduction: Fragility analysis is a method of further characterising the robustness of statistical outcomes. This study evaluates the statistical fragility of randomised controlled trials (RCTs) comparing patellar resurfacing versus non-patellar surfacing in total knee arthroplasty (TKA). Methods: PubMed, MEDLINE and EMBASE were searched for RCTs comparing outcomes in TKA based on patellar resurfacing. Fragility index (FI) and reverse FI (collectively, "FI") were calculated for dichotomous outcomes as the number of outcome reversals needed to change statistical significance. Fragility quotient (FQ) was calculated by dividing the FI by the sample size for that outcome. Median FI and FQ were calculated for each individual outcome and for the overall study. Subanalyses were performed to assess FI and FQ based on outcome type, statistical significance and loss to follow-up. Results: Twenty-one RCTs were included in the analysis, capturing 3910 subjects. The overall median FI was 5.0 (interquartile range, [IQR] 4.0-6.0), and the overall median FQ was 0.048 (IQR 0.022-0.065). The outcome of anterior knee pain has a median FI of 6.0 (IQR 4.0-6.0) and a median FQ of 0.057 (IQR 0.025-0.065). Only five (7%) outcomes were significant. The loss to follow-up was greater than the FI in 12 of 19 studies (63%) with available data. Conclusion: RCTs comparing patellar resurfacing in TKAs show significant statistical fragility; a few outcome reversals can alter findings. The majority of outcomes were nonsignificant, indicating that the choice to resurface the patella may not affect most clinical outcomes; however, clinical conclusions are limited by the statistical fragility of the analysed outcomes. Larger RCTs for this comparison are necessary, and we suggest adding FI and FQ to RCT reports with p values to improve the interpretability of results. Level of Evidence: Level II.

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BACKGROUND: There are myriad strategies to reduce opioid consumption after total knee arthroplasty (TKA). Recent studies have suggested that preoperative counseling may reduce opioid use after a variety of orthopedic procedures. The purpose of this study was to investigate whether preoperative video-based patient education regarding opioid use and abuse reduces opioid consumption after TKA. METHODS: In this prospective randomized controlled trial, patients were randomized before TKA to either receive preoperative video-based counseling or not. Counseling involved a pretaped 5-minute video that educated patients on statistics regarding the "opioid epidemic" and discussed safe use and alternatives to opioids after TKA. There were no significant differences in baseline patient demographics between groups. All patients received a similar multimodal perioperative pain management protocol and completed a daily diary for 2 weeks postoperatively. Diary records measured pain levels using a visual analog score, opioid consumption, side effects experienced, and patient opinion and satisfaction regarding their pain control. RESULTS: Patients in the counseling group consumed significantly less morphine milligram equivalents on postoperative days 0 to 3 (78.8 versus 106.1, P = .020) and in week one postoperatively (129.9 versus 180.7, P = .028), with a trend of less consumption over 2 weeks postoperatively (186.9 versus 239.1, P = .194). There were no significant differences in the number of patients requiring refills, side effects, or daily pain levels between the 2 groups. CONCLUSIONS: This study found significantly decreased opioid consumption within the first week after TKA in patients who received preoperative video counseling.

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BACKGROUND: Fragility analysis is a method of further characterizing outcomes in terms of the stability of statistical findings. This study assesses the statistical fragility of recent randomized controlled trials (RCTs) evaluating robotic-assisted versus conventional total knee arthroplasty (RA-TKA versus C-TKA). METHODS: We queried PubMed for RCTs comparing alignment, function, and outcomes between RA-TKA and C-TKA. Fragility index (FI) and reverse fragility index (RFI) (collectively, "FI") were calculated for dichotomous outcomes as the number of outcome reversals needed to change statistical significance. Fragility quotient (FQ) was calculated by dividing the FI by the sample size for that outcome event. Median FI and FQ were calculated for all outcomes collectively as well as for each individual outcome. Subanalyses were performed to assess FI and FQ based on outcome event type and statistical significance, as well as study loss to follow-up and year of publication. RESULTS: The overall median FI was 3.0 (interquartile range, [IQR] 1.0 to 6.3) and the median reverse fragility index was 3.0 (IQR 2.0 to 4.0). The overall median FQ was 0.027 (IQR 0.012 to 0.050). Loss to follow-up was greater than FI for 23 of the 38 outcomes assessed. CONCLUSIONS: A small number of alternative outcomes is often enough to reverse the statistical significance of findings in RCTs evaluating dichotomous outcomes in RA-TKA versus C-TKA. We recommend reporting FI and FQ alongside P values to improve the interpretability of RCT results.

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BACKGROUND: Connected consciousness, assessed by response to command, occurs in at least 5% of general anaesthetic procedures and perhaps more often in young people. Our primary objective was to establish the incidence of connected consciousness after tracheal intubation in young people aged 18-40 yr. The secondary objectives were to assess the nature of these responses, identify relevant risk factors, and determine their relationship to postoperative outcomes. METHODS: This was an international, multicentre prospective cohort study using the isolated forearm technique to assess connected consciousness shortly after tracheal intubation. RESULTS: Of 344 enrolled subjects, 338 completed the study (mean age, 30 [standard deviation, 6.3] yr; 232 [69%] female). Responses after intubation occurred in 37/338 subjects (11%). Females (13%, 31/232) responded more often than males (6%, 6/106). In logistic regression, the risk of responsiveness was increased with female sex (odds ratio [ORadjusted]=2.7; 95% confidence interval [CI], 1.1-7.6; P=0.022) and was decreased with continuous anaesthesia before laryngoscopy (ORadjusted=0.43; 95% CI, 0.20-0.96; P=0.041). Responses were more likely to occur after a command to respond (and not to nonsense, 13 subjects) than after a nonsense statement (and not to command, four subjects, P=0.049). CONCLUSIONS: Connected consciousness occured after intubation in 11% of young adults, with females at increased risk. Continuous exposure to anaesthesia between induction of anaesthesia and tracheal intubation should be considered to reduce the incidence of connected consciousness. Further research is required to understand sex-related differences in the risk of connected consciousness.

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An 83-year-old male with a history of both melanoma and non-melanoma skin cancers presented with a light pink non-ulcerated slightly raised 0.6 × 0.5-cm papule on his left lower extremity. Biopsy specimen revealed a proliferation of intraepidermal round blue cells. On immunohistochemical staining, CD56, chromogranin, and pancytokeratin were faintly positive within the lesional population, while synaptophysin was strongly positive. CD45, CK5/6, CK7, CK20, Melan-A, SOX10, and TTF-1 stains were negative. There was no dermal component identified. A Merkel cell polyomavirus stain was negative. Distant metastases and other in situ pathologies were excluded and a diagnosis of Merkel cell carcinoma in situ (MMCIS) was made. The majority of MCCIS lesions reported in the literature have been discovered amongst other non-melanoma neoplasms. Our findings of an MCCIS with purely intraepidermal involvements without the association with another squamous cell neoplasm is rare finding.

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BACKGROUND: To encourage implementation of the American College of Surgeons (ACS) NSQIP Risk Calculator for total gastrectomy for gastric cancer, its predictive performance for this specific procedure should be validated. We assessed its discriminatory accuracy and goodness of fit for predicting 12 adverse outcomes. STUDY DESIGN: Data were collected on all patients with gastric cancer who underwent total gastrectomy with curative intent at Memorial Sloan Kettering Cancer Center between 2002 and 2017. Preoperative risk factors from the electronic medical record were manually inserted into the ACS-NSQIP Risk Calculator. Predictions for adverse outcomes were compared with observed outcomes by Brier scores, c-statistics, and Hosmer-Lemeshow p value. RESULTS: In a total of 452 patients, the predicted rate of all complications (29%) was lower than the observed rate (45%). Brier scores varied between 0.017 for death and 0.272 for any complication. C-statistics were moderate (0.7-0.8) for death and renal failure, good (0.8-0.9) for cardiac complication, and excellent (≥0.9) for discharge to nursing or rehabilitation facility. Hosmer-Lemeshow p value found poor goodness of fit for pneumonia only. CONCLUSIONS: For adverse outcomes after total gastrectomy with curative intent in gastric cancer patients, performance of the ACS-NSQIP Risk Calculator is variable. Its predictive performance is best for cardiac complications, renal failure, death, and discharge to nursing or rehabilitation facility.

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