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Background: Bilateral simultaneous total knee arthroplasty (BSTKA) has decreased in frequency due to concerns about higher rates of early mortality and complications than unilateral or staged surgeries. Purpose : We sought to evaluate whether technology assistance (encompassing robotics and computer assistance) decreases early mortality following BSTKA. Methods : We conducted a retrospective cohort study using a national all-payer claims database. Patients who underwent BSTKA from October 2015 to December 2020 were identified. Univariate and multivariable analyses were conducted to compare outcomes in patients who underwent BSTKA with technology assistance compared to conventional instrumentation. The primary outcome was 30-day postoperative mortality. Secondary outcomes were respiratory failure and fat embolism. A post-hoc analysis was performed to evaluate length of stay, readmission, and other medical complications. Results : A total of 14,870 patients who underwent BSTKA were included in this study. Of these, 860 patients underwent technology-assisted BSTKA, and 14,010 patients underwent BSTKA without technology assistance. After a multivariable analysis, patients who underwent technology-assisted BSTKA had equivalent odds of 30-day mortality compared to those who underwent BSTKA without technology assistance. Technology assistance was not protective against the development of acute respiratory failure or fat embolism. Conclusion : This retrospective cohort study found no differences in the rates of 30-day mortality, respiratory failure, or fat embolism after technology-assisted BSTKA compared to conventional BSTKA. On the post-hoc analysis, technology use was associated with a decreased length of stay, lower readmission risk, and decreased rates of deep vein thrombosis, pulmonary embolism, and blood transfusion., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Gregory Golladay, MD, reports relationships with Stryker, GLG, Cuerus, Arthroplasty Today, Journal of Arthroplasty, American Association of Hip and Knee Surgeons, and Virginia Orthopaedic Society. Savyasachi Thakkar, MD, reports relationships with KCI, OrthoAlign, Arthroplasty Today, Journal of Arthroplasty, and American Association of Hip and Knee Surgeons. The other authors declare no potential conflicts of interest., (© The Author(s) 2023.)

Background: While database studies have become more prevalent in the literature, there is concern over their value. In addition, the questions they are suitable to answer are limited. Questions/Purposes : We sought to determine the incidence of database studies in the orthopedic literature and in each subspecialty. In addition, we wanted to assess the impact of database studies on the literature by determining whether citations and Altmetric Attention Scores (AAS) varied by study type (studies using internal or external databases and those not using databases). Methods : We searched PubMed for articles published in impactful orthopedic surgery journals in the year 2018. All articles were discoverable on the Altmetric explorer portal database. Impact was determined by journal impact factor. Study design, subspecialty, number of citations, and AAS were obtained. Univariable analyses were conducted between study type, demographic variables, and the outcome of either citation count or AAS. Multivariable analyses were performed to identify independent predictors of the primary outcomes. Subgroup analyses were performed to differentiate the impact of external and internal database studies compared with non-database studies. Results : A total of 2684 total articles were eligible for inclusion. Of these, 366 studies (13.6%) were database studies. Hip and knee articles had the greatest incidence of database studies. Database studies had significantly more citations (5.9 vs 4.0) and significantly higher AAS (12.8 vs 11.3) compared with non-database studies. External database studies had significantly more citations (6.7 vs 4.8) and significantly higher AAS (14.0 vs 10.7) than internal database studies. Internal database studies had higher traditional citation counts but similar AAS to non-database studies. Conclusions : In 2018, database studies in well-reputed orthopedic journals had a greater number of citations but similar AAS compared with non-database studies. Further studies are warranted., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Peter K. Sculco, MD, reports relationships with Intelljoint Surgical; DePuy, A Johnson & Johnson Company; Zimmer; Lima Corporate; EOS Imaging; and Parvizi Surgical Innovation. Savyasachi C. Thakkar, MD, reports relationships with OrthoAlign and KCI. The other authors report no potential conflicts of interest., (© The Author(s) 2022.)

Background: Obesity is an independent risk factor for osteoarthritis and has been associated with increased rate of complications following lower-extremity total joint arthroplasty (TJA). Bariatric surgery (BS) is a surgical option for weight loss and for reducing obesity-related comorbidities in morbidly obese patients., Purpose/questions: The goal of this systematic review was to answer the following questions: (1) Does BS prior to TJA correlate with lower post-operative complication rates in morbidly obese patients undergoing TJA? (2) Does BS have an impact on revision rates following TJA?, Methods: Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and checklist, a systematic review of medical databases (PubMed/ MEDLINE, Cochrane Library, Web of Science, and Clinicaltrials.gov) was undertaken for articles published in English from January 1990 to September 2018. Inclusion criteria were studies that included at least ten patients who underwent BS prior to TJA, collected data on complications or other outcomes, and followed patients for at least 90 days after TJA. A descriptive and critical analysis of the results was performed., Results: From 799 studies, 13 met inclusion criteria. A total of 11,770 patients who had undergone bariatric surgery prior to TJA were analyzed. The quality of the evidence ranged between moderate and high. There was no consensus on the effect of previous BS on early- to short-term outcomes reported after TJA., Conclusion: The literature remains conflicted on the impact of BS prior to TJA on early, short-term, and long-term complications after TJA. Additional well-matched, observational studies may further our understanding of the impact of BS prior to TJA on outcomes. In particular the effect of various types of BS prior to TJA on outcomes has yet to be elucidated. Ideally, prospective studies with higher level of evidence will be more definitive on the effects of BS prior to TJA. Prospero Registration Number: CRD42016043025., Competing Interests: Conflict of InterestAlex Gu, Jordan S. Cohen, Michael-Alexander Malahias, MD, and Danny Lee declare that they have no conflicts of interest. Alexander S. McLawhorn, MD, MBA, reports personal fees from Intellijoint and Johnson & Johnson, and membership on the HSS Journal editorial board, outside the submitted work. Peter K. Sculco, MD, reports non-financial support from Intellijoint and personal fees from Lima Corporate, outside the submitted work.

GM3 synthase deficiency is due to biallelic pathogenic variants in ST3GAL5, which encodes a sialyltransferase that synthesizes ganglioside GM3. Key features of this rare autosomal recessive condition include profound intellectual disability, failure to thrive and infantile onset epilepsy. We expand the phenotypic spectrum with 3 siblings who were found by whole exome sequencing to have a homozygous pathogenic variant in ST3GAL5, and we compare these cases to those previously described in the literature. The siblings had normal birth history, subsequent developmental stagnation, profound intellectual disability, choreoathetosis, failure to thrive, and visual and hearing impairment. Ichthyosis and self-injurious behavior are newly described in our patients and may influence clinical management. We conclude that GM3 synthase deficiency is a neurodevelopmental disorder with consistent features of profound intellectual disability, choreoathetosis, and deafness. Other phenotypic features have variable expressivity, including failure to thrive, epilepsy, regression, vision impairment, and skin findings. Our analysis demonstrates a broader phenotypic range of this potentially under-recognized disorder.

Following the actions of the Food and Drug Administration (FDA) in April 2005, celecoxib became the only generally available cyclooxygenase-2 inhibiting antiinflammatory drug. The FDA instituted new precautions regarding the use of celecoxib and encouraged the use of "the lowest effective dose." This dose, as defined by the FDA and the package insert, is 200 mg/day for all patients; 200 mg/day of celecoxib is a strong dosage, equivalent to naproxen 500 mg twice daily. However, many patients receiving naproxen benefit from much lower, safer dosages. With celecoxib, studies have shown that a 50% lower dosage is effective and causes fewer adverse effects. Because nonsteroidal antiinflammatory drug-related events involving the gastrointestinal, renal, and cardiovascular systems are dose-related, it is essential to define the very lowest effective dosages of celecoxib and to make these dosages available for use. This article discusses the increasing trend of drug companies to market new drugs with one-size-fits-all or limited dosages, thereby making it difficult or impossible to individualize treatment based on patients' age, size, state of health, or use of concomitant medications. Imagine if naproxen had been marketed only at 500 mg twice daily or ibuprofen at 800 mg 4 times daily. Flexible, individualized dosing is required to provide optimal therapeutics. If celecoxib and valdecoxib had been marketed with a range of doses, many serious adverse effects might have been avoided. The marketing of strong, one-size-fits-all dosages places patients, physicians, and even manufacturers at unnecessary risk of unwanted events.

Background: Many popular oral over-the-counter (OTC) drugs were originally available only by prescription, but not at the low doses contained in their OTC counterparts. Yet, if OTC doses are effective for treating mild symptoms, why weren't these low, often safer doses made available at least by prescription when the drugs were first approved?, Objective: To examine issues surrounding the delayed approval of OTC doses by the Food and Drug Administration (FDA)., Methods: Information reviewed included package inserts, data obtained from manufacturers, and articles published in MEDLINE (1966 to December 2001). Medications examined included presently available and potentially approved OTC antiinflammatory, gastrointestinal, and antihistamine drugs., Results: Considerable data demonstrate the effectiveness of ibuprofen, naproxen, ranitidine, famotidine, nizatidine, diphenhydramine, and clemastine at OTC doses. Published studies also show the effectiveness of celecoxib, omeprazole, and fexofenadine at doses 33-50% lower than currently recommended for prescription use., Conclusions: OTC doses are effective for many patients with mild symptoms and for some with serious symptoms. However, OTC-like doses are usually not offered when drugs are approved for prescription use because new drugs are usually studied in patients with serious conditions requiring higher doses; manufacturers and the FDA seem to prefer a middle-dose approach; >75% of subjects in premarketing dose studies are male; and averaging the responses of study subjects may obscure a wide range of interindividual variation in drug response. Simplistic dosage guidelines make therapeutic decisions easier. Because dose-related adverse effects frequently diminish quality-of-life and reduce adherence, the early availability of OTC-like doses, at least by prescription, would allow healthcare professionals greater flexibility in matching medication doses to patients' widely differing needs.

Background: Previous studies with magnesium have shown beneficial effects in pain syndromes and in vascular disorders (hypertension, migraines, Raynaud's phenomenon). However, results have been variable, possibly because of the limited oral doses achievable due to frequent diarrhea., Objective: To describe the case of a 53-year-old white man (the author) with disabling erythromelalgia (EM) who achieved modest improvement limited by adverse effects with calcium antagonists and then obtained remission with the use of magnesium. Intolerant of several standard magnesium products, he attained high doses of magnesium by taking intravenous-grade magnesium sulfate diluted in water orally (up to 24 mL/d of MgSO4 50% = 1166 mg/d of magnesium)., Methods: After 12 months of continued improvement, patient 1, a board member of The Erythromelalgia Association, notified other members of the success of this therapy via an Internet communication channel. He encouraged those interested in high-dose magnesium therapy to consult their physicians and to report their results to the Association. Twelve patients responded to this request, describing several standard oral magnesium products., Results: Overall, 8 of 13 patients (61.5%) reported improvement (1, remission; 3, major improvement; 2, moderate improvement; 2, mild improvement). Four patients (30.8%) reported no response to magnesium therapy, and 1 patient's symptoms worsened. Two patients' magnesium dose was limited because of diarrhea., Conclusions: Despite recent progress in understanding and treating EM, this vascular disorder remains painful and life-altering for many patients. In this informal survey, the use of high oral doses of magnesium produced good and sometimes dramatic results in 8 of 13 patients who had been unresponsive to many other treatments. These results suggest a possible role for high-dose oral magnesium in the treatment of EM and, perhaps, other vascular disorders.

Objective: To survey cases of fluoroquinolone-associated adverse events that included peripheral nervous system (PNS) symptoms posted on Internet Web sites., Methods: Cases were obtained with the assistance of members of Web sites formed by people sustaining fluoroquinolone-related events. Information obtained met the standards of MedWatch, and each reported case was assessed using the Naranjo probability scale., Results: In contrast to previous reports suggesting that fluoroquinolone-associated PNS events are mild and short-term, 36 of the 45 cases reported severe events that typically involved multiple organ systems. Although many newer cases are still evolving, symptoms had lasted more than three months in 71% of cases and more than one year in 58%. Onset of adverse events was usually rapid, with 15 (33%) events beginning within 24 hours of initiating treatment, 26 (58%) within 72 hours, and 38 (84%) within one week. Sixty courses of fluoroquinolones were prescribed: levofloxacin (n = 33 cases), ciprofloxacin (n = 11), ofloxacin (n = 6), lomefloxacin (n = 1), trovafloxacin (n = 1); in eight cases the same antibiotic was prescribed twice., Conclusions: These cases suggest a possible association between fluoroquinolone antibiotics and severe, long-term adverse effects involving the PNS as well as other organ systems. The severity of these cases may reflect a different population than typically reported to drug companies or MedWatch, which often originate from healthcare providers. In contrast, Internet Web sites may provide a forum for patients experiencing adverse effects that have not resolved promptly. Further study is warranted. Meanwhile the occurrence of PNS symptoms during fluoroquinolone therapy should prompt immediate discontinuation of the agent used.

Background: Optimal therapeutics and the prevention of adverse drug effects begin with complete information. When new drugs are released, the manufacturer's product information is the main and often only readily available source of drug information and, therefore, greatly influences treatment strategies. Thus, it is vital that the information in the package insert is not only complete, but also as relevant as possible for the great diversity of patients that physicians encounter., Objective: To review the product information for sildenafil for comprehensiveness and accuracy, with respect to whether the information is sufficient to facilitate optimal therapeutics and to prevent avoidable adverse events in the wide diversity of patients with erectile dysfunction seen in clinical practice., Data Sources: Sildenafil package inserts, unpublished information provided by the manufacturer, Food and Drug Administration reports, and articles retrieved through MEDLINE through March 2000., Data Synthesis: Deficiencies or inaccuracies persist in the sildenafil product information regarding sildenafil's effects on blood pressure; potential drug interactions with cimetidine, protease inhibitors, some antihypertensive drugs, alcohol, and drugs that may competitively inhibit cytochrome P450 pathways; and recommended sildenafil doses for older patients., Conclusions: For physicians to practice optimal therapeutics, adequate, clinically relevant drug information is required. Several brief changes and additions in the sildenafil product information would assist physicians in making therapeutic decisions regarding the use of sildenafil in a very diverse patient population and in avoiding preventable adverse events.

Background: Sildenafil (Viagra) has been linked to 240 deaths (128 verified, 112 unverified) reported to the Food and Drug Administration (FDA) during 7.5 months of availability, and to 522 reported deaths after 13 months of availability. To date, no updated information about FDA-reported deaths has emerged, and no comparative analyses have been published., Objective: To compare the mortality rates between sildenafil and injectable alprostadil, both of which are used exclusively for treating erectile dysfunction., Methods: A comparison of the number of deaths per filled prescriptions reported to the FDA involving sildenafil and injectable alprostadil was undertaken to perhaps provide further insight into this issue. Materials included FDA statements on sildenafil adverse event reports to the FDA involving sildenafil and injectable alprostadil, and data on prescriptions filled for sildenafil and injectable alprostadil., Results: The number of deaths per prescriptions filled reported in association with sildenafil was significantly greater (5.15-6.28 times) than in association with injectable alprostadil., Discussion: Previous explanations for sildenafil-associated deaths have been based on the expected attrition within the population of men with erectile dysfunction and its commonly associated disorders, the physiologic stress of renewed sexual activity, and a pharmacologic effect of sildenafil. The results of this analysis may indicate that a pharmacologic effect of sidenafil is responsible for these deaths. However, other factors may also explain these findings: a greater frequency of reporting of sildenafil-associated events by physicians, a difference in the populations using these two drugs, or the number of prescriptions filled may not accurately reflect actual exposure., Conclusions: Further study should be undertaken to clarify the issues associated with sildenafil-related deaths. In the meantime, reasonable precautions might be considered in prescribing sildenafil, such as initiating treatment with a low test dose of sildenafil.