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INTRODUCTION: To evaluate the readability of surgical clinical trial consent forms and compare readability across surgical specialties. METHODS: We conducted a cross-sectional analysis of surgical clinical trial consent forms available on ClinicalTrials.gov to quantitatively evaluate readability, word count, and length variations among different specialties. The analysis was performed between November 2022 and January 2023. A total of 386 surgical clinical trial consent forms across 14 surgical specialties were included. RESULTS: The main outcomes were language complexity (measured using Flesch-Kincaid Grade Level), number of words (measured as word count), time to read (measured at reading speeds of 240 per min), and readability (measured by Flesch Reading Ease Score, Gunning Frog Index, Simple Measures of Gobbledygook Index, FORCAST, and Automated Readability Index). The surgical consent forms were a mean (standard deviation) of 2626 (1668) words long, with a mean of 12:53 min to read at 240 words per min. None of the surgical specialties had an average readability level of sixth grade or lower across all six indices, and only 16 out of 386 (4%) clinical trials met the recommended reading level. Furthermore, there was no significant difference in reading grade level between surgical specialties based on the Flesch-Kincaid Grade Level and Flesch Reading Ease indices. CONCLUSIONS: Our findings suggest that current surgical clinical trial consent documents are too long and complex, exceeding the recommended sixth-grade reading level. Ensuring readable clinical trial consent forms is not only ethically responsible but also crucial for protecting patients' rights and well-being by facilitating informed decision-making.
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Termos de Consentimento , Especialidades Cirúrgicas , Humanos , Compreensão , Estudos Transversais , Consentimento Livre e Esclarecido , InternetRESUMO
BACKGROUND AND OBJECTIVES: The optimal timing between preoperative embolization of hypervascular metastatic bone lesions and surgery has yet to be established. Our analysis sought to evaluate embolization timing impacts blood loss, transfusion risk, and operative time in patients with hypervascular primary tumors. METHODS: We identified patients with renal cell (RCC) or thyroid carcinoma undergoing surgery between 1992 and 2023. Patients were segregated into the following cohorts: (1) no embolization preoperatively, (2) surgery <24 h of embolization, and (3) surgery >24 h after embolization. Multivariate logistic regression analyses were performed to assess the effect of embolization timing while controlling for confounding variables. RESULTS: No differences were seen in all evaluated outcomes between immediate and delayed embolization cohorts. No differences in estimated blood loss were seen between the immediate (OR: 0.685, 95% CI: 0.159-2.949; p = 0.611) and delayed (OR: 0.568, 95% CI: 0.093-3.462; p = 0.539) surgery cohorts compared with patients without embolization. Surgery >24 h after embolization was not associated with a higher risk of prolonged operative time (OR: 13.499, 95% CI: 0.832-219.146; p = 0.067). CONCLUSIONS: These findings suggest that surgery may be safely delayed beyond 24 h from embolization without a higher risk of bleeding. In appropriately selected cohorts, embolization may not be needed preoperatively.
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Embolização Terapêutica , Neoplasias Renais , Neoplasias da Coluna Vertebral , Humanos , Neoplasias da Coluna Vertebral/cirurgia , Resultado do Tratamento , Estudos Retrospectivos , Neoplasias Renais/cirurgia , Perda Sanguínea Cirúrgica , Cuidados Pré-OperatóriosRESUMO
PURPOSE: To compare the efficacy of common intra-articular injections used in the treatment of knee osteoarthritis, including corticosteroid (CS), hyaluronic acid (HA), platelet-rich plasma (PRP), and bone marrow aspirate concentrate (BMAC), with a minimum follow-up of 6-months. METHODS: A literature search was conducted using the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines in August 2022 in the following databases: PubMed/MEDLINE, Scopus, Cochrane Database of Controlled Trials, and the Cochrane Database of Systematic Reviews. Level I to II randomized clinical trials with a minimum follow-up of 6 months that investigated the treatments of interest were included. Patient-reported outcome scores for pain and function at baseline and at latest follow-up were extracted, and the change in scores was converted to uniform 0 to 100 scales. Arm-based Bayesian network meta-analysis using a random-effects model was created to compare the treatment arms in pain and function. RESULTS: Forty-eight studies comprising a total of 9,338 knees were included. The most studied intra-articular injection was HA (40.9%), followed by placebo (26.2%), PRP (21.5%), CS (8.8%), and then BMAC (2.5%). HA and PRP both led to a significant improvement in pain compared with placebo. HA, PRP, and BMAC all led to a significant improvement in function scores when compared with placebo. Surface under the cumulative ranking curves (SUCRAs) of the interventions revealed that PRP, BMAC, and HA were the treatments with the highest likelihood of improvement in both pain and function, with overall SUCRA scores of 91.54, 76.46, and 53.12, respectively. The overall SUCRA scores for CS and placebo were 15.18 and 13.70, respectively. CONCLUSIONS: At a minimum 6-month follow-up, PRP demonstrated significantly improved pain and function for patients with knee osteoarthritis compared with placebo. Additionally, PRP exhibited the highest SUCRA values for these outcomes when compared with BMAC, HA, and CS. LEVEL OF EVIDENCE: Level II, meta-analysis of Level I to II studies.
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Corticosteroides , Ácido Hialurônico , Metanálise em Rede , Osteoartrite do Joelho , Plasma Rico em Plaquetas , Humanos , Osteoartrite do Joelho/tratamento farmacológico , Ácido Hialurônico/administração & dosagem , Ácido Hialurônico/uso terapêutico , Injeções Intra-Articulares , Corticosteroides/administração & dosagem , Corticosteroides/uso terapêutico , Medição da Dor , Viscossuplementos/administração & dosagem , Viscossuplementos/uso terapêutico , Transplante de Medula Óssea , Resultado do TratamentoRESUMO
BACKGROUND: A 2-stage revision continues to be the standard treatment for periprosthetic joint infection (PJI) in hip arthroplasty. The use of "functional" spacers may allow patients to return to daily living while optimizing their health for revision surgery. We aimed to evaluate the clinical outcomes of different spacer types regarding infection eradication, mechanical complications, and functional outcomes. METHODS: Patients who have complete Musculoskeletal Infection Society criteria for diagnosis of PJI that underwent one-stage or 2-stage revision were queried in an institutional surgical database between 2002 and 2022. Out of 286 patients, 210 met our inclusion criteria and were retrospectively reviewed for demographics, laboratory values, functional and patient-reported outcomes, and subsequent revisions. The study population had 54.3% women, a mean age of 61 years old, and a mean follow-up of 3.7 ± 3.2 years. There was no difference between age, body mass index, or Charlson Comorbidity Index scores between each cohort. Spacers were categorized as nonfunctional static, nonfunctional articulating, or functional articulating. Functional spacers were defined as those that allowed full weight bearing with no restrictions. Delphi criteria were used to define revision success, and failure was defined as a recurrent or persistent infection following definitive surgery. RESULTS: There was a significantly lower reoperation rate after a definitive implant in the functional articulating cohort (P = .003), with a trending higher infection eradication rate and a lower rate of spacer failure compared to the nonfunctional spacer cohort. At 5 years, functional articulating spacers had a 94.1% survivorship rate, nonfunctional articulating spacers had an 81.2% survival rate, and nonfunctional static spacers had a 71.4% survival rate. In the functional articulating spacer cohort, 14.6% had yet to get reimplanted, with an average follow-up time of 1.4 years. CONCLUSIONS: Within this large cohort of similar demographics, functional articulating spacers may result in better clinical outcomes and infection eradication during 2-stage revision arthroplasty for PJI.
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Artroplastia de Quadril , Prótese de Quadril , Infecções Relacionadas à Prótese , Reoperação , Humanos , Feminino , Pessoa de Meia-Idade , Reoperação/estatística & dados numéricos , Masculino , Artroplastia de Quadril/efeitos adversos , Artroplastia de Quadril/instrumentação , Infecções Relacionadas à Prótese/cirurgia , Infecções Relacionadas à Prótese/etiologia , Estudos Retrospectivos , Idoso , Prótese de Quadril/efeitos adversos , Resultado do Tratamento , Desenho de Prótese , Falha de PróteseRESUMO
BACKGROUND: Outpatient primary total knee arthroplasty (TKA) has been well-established as a safe and effective procedure; however, the safety of outpatient revision TKA remains unclear. Therefore, this study utilized a large database to compare outcomes between outpatient and inpatient revision TKA. METHODS: An all-payor database was queried to identify patients undergoing revision TKA from 2010 to 2022. Patients who had diagnosis codes related to periprosthetic joint infection (PJI) were excluded. Outpatient surgery was defined as a length of stay < 24 hours. Cohorts were matched by age, sex, Elixhauser Comorbidity Index, comorbidities (diabetes, obesity, tobacco use), components revised (1-versus 2-component), and revision etiology. Medical complications at 90 days and surgical complications at 1 and 2 years postoperatively were evaluated through multivariate logistic regression. A total of 4,342 aseptic revision TKAs were included. RESULTS: No differences in patient characteristics, procedure type, or revision etiologies were seen between groups. The outpatient cohort had a lower risk of PJI (odds ratio (OR): 0.547, 95% confidence interval (CI): 0.337 to 0.869; P = .012), wound dehiscence (OR: 0.393, 95% CI: 0.225 to 0.658; P < .001), transfusion (OR: 0.241, 95% CI: 0.055 to 0.750; P = .027), reoperation (OR: 0.508, 95% CI: 0.305 to 0.822; P = .007), and any complication (OR: 0.696, 95% CI: 0.584 to 0.829; P < .001) at 90 days postoperatively. At 1 year and 2 years postoperatively, outpatient revision TKA patients had a lower incidence of revision for PJI (OR: 0.332, 95% CI: 0.131 to 0.743; P = .011 and OR: 0.446, 95% CI; 0.217 to 0.859; P = .020, respectively) and all-cause revision (OR: 0.518, 95% CI: 0.377 to 0.706; P < .001 and OR: 0.548, 95% CI: 0.422 to 0.712; P < .001, respectively). CONCLUSIONS: Our findings suggest that revision TKA can be safely performed on an outpatient basis in appropriately selected patients who do not have an increased risk of adverse events relative to inpatient revision TKA. However, we could not ascertain case complexity in either cohort, and despite controlling for several potential confounders, other less tangible differences could exist between groups.
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BACKGROUND: Instability remains the leading cause of revision following total hip arthroplasty (THA). The objective of the present investigation was to determine whether an elevated body mass index (BMI) is associated with an increased risk of instability after primary THA. METHODS: An administrative claims database was queried for patients undergoing elective, primary THA for osteoarthritis between 2010 and 2022. Patients who underwent THA for a femoral neck fracture were excluded. Patients who had an elevated BMI were grouped into the following cohorts: 25 to 29.9 (n = 2,313), 30 to 34.9 (n = 2,230), 35 to 39.9 (n = 1,852), 40 to 44.9 (n = 1,450), 45 to 49.9 (n = 752), and 50 to 59.9 (n = 334). Patients were matched 1:1 based on age, sex, and Elixhauser Comorbidity Index, as well as a history of spinal fusion, neurodegenerative disorders, and alcohol abuse, to controls with a normal BMI (20 to 24.9). A multivariate logistic regression controlling for age, sex, Elixhauser Comorbidity Index, and additional risk factors for dislocation was used to evaluate dislocation rates at 30 days, 90 days, 6 months, 1 year, and 2 years. Rates of revision for instability were similarly compared at 1 year and 2 years postoperatively. RESULTS: No significant differences in dislocation rate were observed between control patients and each of the evaluated BMI classes at all evaluated postoperative intervals (all P values > .05). Similarly, the risk of revision for instability was comparable between the normal weight cohort and each evaluated BMI class at 1 year and 2 years postoperatively (all P values > .05). CONCLUSIONS: Controlling for comorbidities and known risk factors for instability, the present analysis demonstrated no difference in rates of dislocation or revision for instability between normal-weight patients and those in higher BMI classes.
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BACKGROUND: Because research experience is increasingly important in ranking orthopaedic residency and fellowship applicants, determining the accuracy of candidates reporting their scholarly activity is essential. However, disparate and inconsistent findings have made it difficult to draw meaningful conclusions from individual studies. QUESTIONS/PURPOSES: In this systematic review, we asked: (1) What percentage of research publications are misrepresented among orthopaedic residency and fellowship applicants? (2) What percentage of applications contain one or more example of academic misrepresentation? (3) Is research misrepresentation associated with any individual applicant characteristics? (4) What is the publication status of articles listed by applicants as having been submitted to journals? METHODS: A systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. PubMed, EBSCOhost, Medline, and Google Scholar electronic databases were searched on March 10, 2022, to identify all studies that evaluated research misrepresentation in orthopaedic residency and fellowship applications between January 1, 1995, and March 1, 2022. Articles were included if full-text articles in English were available and the study reported on research misrepresentation among orthopaedic residency or fellowship applicants. Studies investigating nonorthopaedic publications, systematic reviews, case studies, duplicate studies among databases, and gray literature were excluded. Two reviewers independently evaluated the quality of included studies using the Methodological Index for Nonrandomized Studies (MINORS) tool. This is a validated assessment tool that grades noncomparative studies from 0 to 16 and studies with control groups from 0 to 24, based on eight criteria related to study design, outcomes assessed, and follow-up. All included articles were noncomparative studies, so the maximum score here was 16, with higher scores indicating better study quality. The mean MINORS score was 13 ± 1 in the studies we included. The final analysis included 10 studies with 5119 applicants. Eight studies evaluated orthopaedic residency applicants and two evaluated fellowship applicants. The applicant classes ranged from 1996 to 2019. Research misrepresentation was defined among studies as nonauthorship of an existing article, claimed authorship of a nonexistent article, or incorrect listing of authorship order for an existing article. Each study's findings and definition of research misrepresentation were considered to allow for a discussion of overall trends. The percentage of misrepresentation was further broken down by the misrepresentation type. Applicant characteristics and destination of submitted articles were also evaluated. Given the potential overlap between applicants among the studies, no pooled analysis was conducted, and results are presented as a narrative summary. RESULTS: The percentage of overall publication misrepresentation was estimated to range between 1% (13 of 1100) and 21% (27 of 131), with more-recent studies reporting a lower proportion of overall articles misrepresented. Most studies we found claimed that authorship of a nonexistent article was the most common type of misrepresentation. Nonauthorship of an existing article and incorrect authorship order were less common. The percentage of applications with at least one misrepresentation was approximately 20% between 1998 and 2017. Most studies found no applicant characteristics, such as match outcomes, demographic markers, or academic records, that were consistently associated with a higher odds of the candidate misrepresenting his or her research credentials. Finally, approximately half of the articles listed as submitted to journals went on to publication, with one-third going to a different journal with a lower Impact Factor. CONCLUSIONS: Our systematic review found that the percentage of overall publication misrepresentations among orthopaedic residency and fellowship applicants has generally been low over the past 20 years. However, approximately one-fifth of applications had at least one research misrepresentation, with 2% having multiple misrepresentations on reported publications. There were no consistent applicant characteristics associated with higher odds of research misrepresentation. Additionally, most of the articles listed as submitted to journals for publication were ultimately published. CLINICAL RELEVANCE: Although the decrease in overall publication misrepresentation is encouraging, our finding that one-fifth of applicants have research misrepresentation is a cause for concern. In light of a continually evolving application process, orthopaedic residency and fellowship programs must ensure there is integrity related to information that is self-reported by applicants. These findings also serve to encourage faculty members involved in the application screening and decision process to limit biases related to applicant demographics perceived to be associated with a high odds of misrepresentation. Furthermore, governing agencies and program leadership should evaluate methods of verifying unpublished work and provide opportunities for applicants to give publication updates throughout the application cycle.
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Internato e Residência , Ortopedia , Má Conduta Científica , Humanos , Masculino , Feminino , Ortopedia/educação , Bolsas de Estudo , Candidatura a EmpregoRESUMO
BACKGROUND: To capture various social determinants of health, recent analyses have used comprehensive measures of socioeconomic disadvantage such as deprivation and vulnerability indices. Given that studies evaluating the effects of social deprivation on total joint arthroplasty (TJA) have yielded mixed results, a systematic review of this relationship might help answer questions about usage, complications, and results after surgery among patients in different socioeconomic groups and help guide targeted approaches to ensure health equity. QUESTIONS/PURPOSES: We asked: How is social deprivation associated with TJA (1) usage, (2) adverse events including discharge deposition and length of stay, and (3) patient-reported outcome measures (PROMs)? METHODS: A comprehensive review of the PubMed, EBSCO host, Medline, and Google Scholar electronic databases was conducted to identify all studies that evaluated social deprivation and TJA between January 1, 2000, and March 1, 2022. Studies were included if they evaluated comprehensive measures of socioeconomic deprivation rather than individual social determinants of health. Nineteen articles were included in our final analysis with a total of 757,522 patients. In addition to characteristics of included studies (such as patient population, procedure evaluated, and utilized social deprivation metric), we recorded TJA usage, adverse events, and PROM values as reported by each article. Two reviewers independently evaluated the quality of included studies using the Methodological Index for Nonrandomized Studies (MINORS) tool. The mean ± SD MINORS score was 13 ± 1 of 16, with higher scores representing better study quality. All the articles included are noncomparative studies. Given the heterogeneity of the included studies, a meta-analysis was not performed and results were instead presented descriptively. RESULTS: Although there were inconsistencies among the included articles, higher levels of social deprivation were associated with lower TJA usage even after controlling for various confounding variables. Similarly, there was agreement among studies regarding higher proportion of nonhome discharge for patients with more social deprivation. Although there was limited agreement across studies regarding whether patients with more social deprivation had differences in their baseline and postoperative PROMs scores, patients with more social deprivation had lower improvements from baseline for most of the included articles. CONCLUSION: These findings encourage continued efforts focusing on appropriate patient education regarding expectations related to functional improvement and the postoperative recovery process, as well as resources available for further information and social support. We suggest linking patient data to deprivation measures such as the Area Deprivation Index to help encourage shared decision-making strategies that focus on health literacy and common barriers related to access. Given the potential influence social deprivation may have on the outcome and utilization of TJA, hospitals should identify methods to determine patients who are more socially deprived and provide targeted interventions to help patients overcome any social deprivation they are facing. We encourage physicians to maintain close communication with patients whose circumstances include more severe levels of social deprivation to ensure they have access to the appropriate resources. Additionally, as multiple social deprivation metrics are being used in research, future studies should identify a consistent metric to ensure all patients that are socially deprived are reliably identified to receive appropriate treatment. LEVEL OF EVIDENCE: Level III, therapeutic study.
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Artroplastia de Quadril , Artroplastia do Joelho , Humanos , Artroplastia de Quadril/efeitos adversos , Alta do Paciente , Privação Social , Medidas de Resultados Relatados pelo PacienteRESUMO
BACKGROUND: Studies evaluating the effects of a psychiatric illness on orthopaedic surgical outcomes have yielded mixed results. Because awareness of patient comorbid mental health disorders has become increasingly important to tailor treatment plans, the aim of our systematic review was to present the findings of all studies reporting on the association between clinically diagnosed psychiatric illnesses and total joint arthroplasty (TJA) outcomes and evaluate the quality of evidence to provide a comprehensive summary. QUESTION/PURPOSE: Is there a consistently reported association between comorbid psychiatric illness and (1) complication risk, (2) readmission rates, (3) healthcare use and discharge disposition, and (4) patient-reported outcome measures (PROMs) after TJA? METHODS: The PubMed, EBSCO host, Medline, and Google Scholar electronic databases were searched on April 9, 2022, to identify all studies that evaluated outcomes after TJA in patients with a comorbid clinically diagnosed mental health disorder between January 1, 2000, and April 1, 2022. Studies were included if the full-text article was available in English, reported on primary TJA outcomes in patients with clinically diagnosed mental health disorders, included patients undergoing TJA without a psychiatric illness for comparison, and had a minimum follow-up time of 30 days for evaluating readmission rates, 90 days for other perioperative outcomes such as length of stay and complications, and 1-year minimum follow-up if assessing PROMs. Studies that used a mental health screening examination instead of clinical diagnoses were excluded to isolate for verified psychiatric illnesses. Additionally, systematic reviews, case reports, duplicate studies between the databases, and gray literature were excluded. Twenty-one studies were included in our final analysis comprising 31,023,713 patients with a mean age range of 57 to 69 years. Mental health diagnoses included depression, anxiety, bipolar disorder, schizophrenia, major personality disorder, and psychosis as well as concomitant mental disorders. Two reviewers independently evaluated the quality of included studies using the Methodological Index for Nonrandomized Studies (MINORS) tool. The mean MINORS score was 19.5 ± 0.91 of 24, with higher scores representing better study quality. All the articles included were retrospective, comparative studies. Given the heterogeneity of the included studies, a meta-analysis was not performed, and results are instead presented descriptively. RESULTS: Patients with schizophrenia were consistently reported to have higher odds of medical and surgical complications than patients without psychiatric illness, particularly anemia and respiratory complications. Among studies with the largest sample sizes, patients with depression alone or depression and anxiety had slightly higher odds of complications. Most studies identified higher odds of readmission among patients with depression, schizophrenia, and severe mental illness after TJA. However, for anxiety, there was no difference in readmission rates compared with patients without psychiatric illness. Slightly higher odds of emergency department visits were reported for patients with depression, anxiety, concomitant depression and anxiety, and severe mental illness across studies. When evaluating healthcare use, articles with the largest sample sizes reporting on depression and length of stay or discharge disposition found modestly longer length of stay and greater odds of nonhome discharge among patients with depression. Although several studies reported anxiety was associated with slightly increased total costs of hospitalization, the most robust studies reported no difference or slightly shorter average length of stay. However, the included studies only reported partial economic analyses of cost, leading to relatively superficial evidence. Patients with schizophrenia had a slightly longer length of stay and modestly lower odds of home discharge and cost. Likewise, patients with concomitant depression and anxiety had a slightly longer average length of stay, according to the two articles reporting on more than 1000 patients. Lastly, PROM scores were worse in patients with depression at a minimum follow-up of 1 year after TJA. For anxiety, there was no difference in improvement compared with patients without mental illness. CONCLUSION: Our systematic review found that individuals with psychiatric illness had an increased risk of postoperative complications, increased length of stay, higher costs, less frequent home discharge, and worse PROM scores after TJA. These findings encourage inclusion of comorbid psychiatric illness when risk-stratifying patients. Attention should focus on perioperative interventions to minimize the risk of thromboembolic events, anemia, bleeding, and respiratory complications as well as adequate pain management with drugs that do not exacerbate the likelihood of these adverse events to minimize emergency department visits and readmissions. Future studies are needed to compare patients with concomitant psychiatric illnesses such as depression and anxiety with patients with either diagnosis in isolation, instead of only comparing patients with concomitant diagnoses with patients without any psychiatric illnesses. Similarly, the results of targeted interventions such as cognitive behavioral therapy are needed to understand how orthopaedic surgeons might improve the quality of care for patients with a comorbid psychiatric illness.
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Transtornos Mentais , Humanos , Pessoa de Meia-Idade , Idoso , Estudos Retrospectivos , Transtornos Mentais/complicações , Transtornos Mentais/diagnóstico , Transtornos Mentais/epidemiologia , Artroplastia , Medidas de Resultados Relatados pelo Paciente , Atenção à SaúdeRESUMO
BACKGROUND: Serving as a principal investigator for a clinical trial can bring national visibility and recognition to physicians, and it can have a substantial impact on their promotion and tenure. In the field of orthopaedics, there is a well-known gender gap in terms of representation and leadership. Examining the representation of women in clinical trial leadership may help to inform and enable the design of targeted interventions and policies to foster a more inclusive and diverse environment in clinical trial leadership. QUESTIONS/PURPOSES: (1) What is the proportion of women principal investigators in orthopaedic clinical trials, and has this changed over time? (2) Are there trial characteristics (trial phase, status, funding source, and intervention) associated with women principal investigators? (3) What is the geographic distribution globally and regionally within the United States of clinical trials led by women principal investigators? METHODS: A cross-sectional survey of clinical trials using the ClinialTrials.gov registry and results database provided by the NIH was performed on August 22, 2022. Trial characteristics included principal investigator names and gender, trial phase, type, funding source, intervention, and location (defined by continent and US Census region). Our primary outcome was the overall proportion of women orthopaedic principal investigators over time. We assessed this by comparing the proportion of women principal investigators from 2007 to 2022. Our secondary outcomes were trial characteristics (trial phase, status, funding source, and intervention) and geographic distribution (globally and within the United States) associated with women principal investigators. Baseline characteristics of the clinical trials were calculated using frequencies and percentages for categorical variables. Fisher exact tests were conducted to evaluate differences in gender proportions based on the included clinical trial characteristics. Univariate linear regression was applied to analyze trends in the annual proportion of women principal investigators over time. RESULTS: The overall proportion of women principal investigators was 18% (592 of 3246), and this proportion increased over the study period. Specifically, the proportion of women leading clinical trials was 13% (16 of 121) in 2007 and 22% (53 of 242) in 2022 (r2 = 0.68; p < 0.001). This trend was also observed when evaluating only US women principal investigators (r2 = 0.47; p = 0.003) and non-US women principal investigators over the study period (r2 = 0.298; p = 0.03). There was no difference in the distribution of trial phases between men and women principal investigators. Most men and women were involved in "not applicable" or Phase IV trials. Similarly, there was no difference in trial status or funding source. However, women principal investigators had a higher proportion of studies involving behavioral interventions (11% [67 of 592]) compared with men principal investigators (3% [74 of 2654]; p = 0.03). The proportion of women principal investigators over the study period by world region revealed a higher proportion of women principal investigators in Asia (23% [88 of 391]), followed by South America (24% [12 of 49]), North America (18% [306 of 1746]), and Europe (16% [136 of 833]). Among all US trials over the study period, the proportion of women principal investigators across the US Census region was Northeast (19% [62 of 329]), South (18% [90 of 488]), West (20% [97 of 492]), and Midwest (13% [22 of 168]). CONCLUSION: Although there has been a notable increase in the proportion of women principal investigators over time, the overall representation remains relatively low. The disparities observed in trial characteristics and geographic distribution of women principal investigators further emphasize the need for targeted interventions and policies to foster a more inclusive and diverse environment in clinical trial leadership. CLINICAL RELEVANCE: These results underscore the importance of adopting practices and strategies that foster gender equity in the leadership of orthopaedic clinical trials. By establishing mentorship and sponsorship programs, early-career women surgeons can be connected with experienced leaders, cultivating a supportive network and offering valuable career guidance. Additionally, addressing geographic disparities in the representation of women principal investigators can involve the implementation of mentorship and sponsorship programs in regions with lower representation.
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BACKGROUND: Advanced practice professionals, including physician assistants (PAs) and nurse practitioners (NPs), play an important role in providing high-quality orthopaedic care. This role has been highlighted by projections of nationwide shortages in orthopaedic surgeons, with rural areas expected to be most affected. Given that approximately half of rural counties have no practicing orthopaedic surgeons and that advanced practice professionals have been shown to be more likely to practice in rural areas compared to physicians in other medical disciplines, orthopaedic advanced practice professionals may be poised to address orthopaedic care shortages in rural areas, but the degree to which this is true has not been well characterized. QUESTIONS/PURPOSES: (1) What percentage of rural counties have no orthopaedic caregivers, including surgeons and advanced practice professionals? (2) Is the density of advanced practice professionals greater than that of orthopaedic surgeons in rural counties? (3) Do orthopaedic advanced practice professionals only practice in counties that also have practicing orthopaedic surgeons? (4) Are NPs in states with full practice authority more likely to practice in rural counties compared with NPs in restricted practice authority states? METHODS: We identified orthopaedic surgeons and advanced practice professionals using the 2019 Medicare Provider Utilization and Payment Data, as this large dataset has been shown to be the most complete source of claims data nationwide. Each professional's ZIP Code was matched to counties per the US Postal Service ZIP Code Crosswalk Files. The total number and density of physician and advanced practice professionals per 100,000 residents were calculated per county nationwide. Counties were categorized as urban (large central metropolitan, large fringe metropolitan, medium metropolitan, and small metropolitan) or rural (micropolitan and noncore) using the National Center for Health Statistics Urban-Rural Classification Scheme. Comparisons between rural and urban county caregivers were conducted with the chi-square test and odds ratios. Population densities were compared with the Wilcoxon rank sum test. A bivariate density map was made to visualize the nationwide distribution of orthopaedic caregivers and determine the percentage of rural counties with no orthopaedic caregivers as well as whether orthopaedic advanced practice professionals practiced in counties not containing any surgeons. Additionally, to compare states with NP's full versus restricted practice authority, each NP was grouped based on their state to determine whether NPs in states with full practice authority were more likely to practice in rural counties. We identified a group of 31,091 orthopaedic caregivers, which was comprised of 23,728 physicians, 964 NPs, and 6399 PAs (7363 advanced practice professionals). A total of 88% (20,879 of 23,728) of physicians and 87% (6427 of 7363) of advanced practice professionals were in urban counties, which is comparable to nationwide population distributions. RESULTS: A total of 39% (1237 of 3139) of counties had no orthopaedic professionals (defined as orthopaedic surgeons or advanced practice professionals) in 2019. Among these counties, 82% (1015 of 1237) were rural and 18% (222 of 1237) were urban. The density of advanced practice professionals providing orthopaedic services compared with the density of orthopaedic surgeons was higher in rural counties (18 ± 70 versus 8 ± 40 per 100,000 residents; p = 0.001). Additionally, 3% (57 of 1974) of rural and 1% (13 of 1165) of urban counties had at least one orthopaedic advanced practice professional, but no orthopaedic surgeons concurrently practicing in the county. There was no difference between the percentage of rural counties with an NP in states with full versus restricted practice authority for NPs (19% [157 of 823] versus 26% [36 of 141], OR 1.45 [95% CI 0.99 to 2.2]; p = 0.08). CONCLUSION: As advanced practice professionals tended to only practice in counties which contain orthopaedic surgeons, our analysis suggests that plans to increase the number of advanced practice professionals alone in rural counties may not be sufficient to fully address the demand for orthopaedic care in rural areas that currently do not have orthopaedic surgeons in practice. Rather, interventions are needed to encourage more orthopaedic surgeons to practice in rural counties in collaborative partnerships with advanced practice professionals. In turn, rural orthopaedic advanced practice professionals may serve to further extend the accessibility of these surgeons, but it remains to be determined what the total number and ratio of advanced practice professionals and surgeons is needed to serve rural counties adequately. CLINICAL RELEVANCE: To increase rural orthopaedic outreach, state legislatures may consider providing financial incentives to hospitals who adopt traveling clinic models, incorporating advanced practice professionals in these models as physician-extenders to further increase the coverage of orthopaedic care. Furthermore, the creation of more widespread financial incentives and programs aimed at expanding the experience of trainees in serving rural populations are longer-term investments to foster interest and retention of orthopaedic caregivers in rural settings.
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Cirurgiões Ortopédicos , Cirurgiões , Idoso , Humanos , Estados Unidos , Medicare , População Rural , Qualidade da Assistência à SaúdeRESUMO
PURPOSE: Our systematic review and meta-analysis sought to assess how technology-assistance impacts (1) post-operative pain and (2) opioid use in patients undergoing primary total knee arthroplasty (TKA). METHODS: Four online databases were queried for studies published up to October 2021 that reported on pain and opioid usage between technology-assisted and manual TKA (mTKA) patients. Mantel-Haenszel (M-H) models were utilized to calculate pooled mean difference (MDs) and 95% confidence interval (CIs). Subgroup analyses were conducted to isolate robotic-arm assisted (RAA) and computed-assisted navigation (CAN) cohorts. Risk of bias was assessed for all included non-randomized studies with the Methodological Index for Non-Randomized Studies (MINORS) tool. For the randomized control trials included in our study, the Detsky scale was applied. RESULTS: Our analysis included 31 studies, reporting on a total of 761,300 TKAs (mTKA: n = 753,554; Computer-Assisted Navigation (CAN): n = 1,309; Robotic-Arm Assisted (RAA): n = 6437). No differences were demonstrated when evaluating WOMAC (MD: 0.00, 95% CI - 0.69 to 0.69; p = 1.00), KSS (MD: 0.01, 95% CI - 1.46 to 1.49; p = 0.99), KOOS (MD - 2.91, 95% CI - 6.17 to 0.34; p = 0.08), and VAS (MD - 0.54, 95% CI - 1.01 to - 0.007; p = 0.02) pain scores between cohorts. There was mixed evidence regarding how opioid consumption differed between TKA techniques. CONCLUSION: The present analysis demonstrated no difference in terms of pain across a variety of utilized patient-reported pain measurements. However, there were mixed results regarding how opioid consumption varied between manual and technology-assisted cohorts, particularly in the immediate post-operative period. LEVEL OF EVIDENCE: III.
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Artroplastia do Joelho , Transtornos Relacionados ao Uso de Opioides , Humanos , Analgésicos Opioides/uso terapêutico , Artroplastia do Joelho/efeitos adversos , Artroplastia do Joelho/métodos , Articulação do Joelho/cirurgia , Dor Pós-Operatória/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: As the demand for total joint arthroplasty continues to grow, patients increasingly turn to internet sources for accessible orthopaedic health information. We sought to evaluate the readability of online hip and knee arthroplasty patient education materials (PEMs). METHODS: Our systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-P guidelines (PROSPERO registration of the study protocol: CRD42022358872, September 19th, 2022). PubMed, EBSCOhost, Medline, and Google Scholar electronic databases were utilized to identify all studies evaluating online PEMs related to total joint arthroplasty between January 1, 2000, and August 1, 2022. The quality of studies was assessed with the Joanna Briggs Institute scale. RESULTS: Our initial search yielded 360 publications which were then screened for appropriate studies aligned with our review's purpose. A total of eleven cross-sectional studies were included. The total sample size across the studies consisted of 662 PEMs. Five studies evaluated professional or academic orthopaedic websites, six evaluated PEMs through web engines, and three evaluated apps or commercial websites. Most included studies found PEMs to be well above the recommended 6th-grade reading level. CONCLUSION: Arthroplasty PEMs produced by orthopaaedic websites, web searches, and apps have readability scores well above the recommended levels. Given the importance of health literacy on patient outcomes and satisfaction, work needs to be done to improve the readability of these materials.
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Compreensão , Letramento em Saúde , Humanos , Estudos Transversais , Educação de Pacientes como Assunto , Artroplastia , InternetRESUMO
BACKGROUND: Understanding mark-up ratios (MRs), the ratio between a healthcare institution's submitted charge and the Medicare payment received, for high-volume orthopaedic procedures is imperative to inform policy about price transparency and reducing surprise billing. This analysis examined the MRs for primary and revision total hip and knee arthroplasty (THA and TKA) services to Medicare beneficiaries between 2013 and 2019 across healthcare settings and geographic regions. METHODS: A large dataset was queried for all THA and TKA procedures performed by orthopaedic surgeons between 2013 and 2019, using Healthcare Common Procedure Coding System (HCPCS) codes for the most frequently used services. Yearly MRs, service counts, average submitted charges, average allowed payments, and average Medicare payments were analyzed. Trends in MRs were assessed. We evaluated 9 THA HCPCS codes, averaging 159,297 procedures a year provided by a mean of 5,330 surgeons. We evaluated 6 TKA HCPCS codes, averaging 290,244 procedures a year provided by a mean of 7,308 surgeons. RESULTS: For knee arthroplasty procedures, a decrease was noted for HCPCS code 27438 (patellar arthroplasty with prosthesis) over the study period (8.30 to 6.62; P = .016) and HCPCS code 27447 (TKA) had the highest median (interquartile range [IQR]) MR (4.73 [3.64 to 6.30]). For revision knee procedures, the highest median (IQR) MR was for HCPCS code 27488 (removal of knee prosthesis; 6.12 [3.83-8.22]). While no trends were noted for both primary and revision hip arthroplasty, median (IQR) MRs in 2019 for primary hip procedures ranged from 3.83 (hemiarthroplasty) to 5.06 (conversion of previous hip surgery to THA) and HCPCS code 27130 (total hip arthroplasty) had a median (IQR) MR of 4.66 (3.58-6.44). For revision hip procedures, MRs ranged from 3.79 (open treatment of femoral fracture or prosthetic arthroplasty) to 6.10 (revision of THA femoral component). Wisconsin had the highest median MR by state (>9) for primary knee, revision knee, and primary hip procedures. CONCLUSION: The MRs for primary and revision THA and TKA procedures were strikingly high, as compared to nonorthopaedic procedures. These findings represent high levels of excess charges billed, which may pose serious financial burdens to patients and must be taken into consideration in future policy discussions to avoid price inflation.
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Artroplastia de Quadril , Artroplastia do Joelho , Prótese do Joelho , Idoso , Humanos , Estados Unidos , Medicare , Articulação do Joelho , ReoperaçãoRESUMO
BACKGROUND: The purpose of this study was to assess the odds of developing medical and surgical adverse events following total hip arthroplasty (THA) in patients who have a history of radiation therapy (RT) for cancer. METHODS: A retrospective cohort study was conducted using a national database to identify patients who underwent primary THA (Current Procedural Terminology code 27130) from 2002 to 2022. Patients who had a prior RT were identified by International Classification of Diseases, Tenth Revision, Clinical Modification codes Z51.0 (encounter for antineoplastic RT), Z92.3 (personal history of irradiation), or Current Procedural Terminology code 101843 (radiation oncology treatment). One-to-one propensity score matching was conducted to generate 3 pairs of cohorts: 1) THA with/without a history of RT; 2) THA with/without a history of cancer; and 3) THA patients who have a history of cancer treated with/without RT. Surgical and medical complications were assessed at the 30-day, 90-day, and 1-year postoperative periods. RESULTS: Patients who have a history of RT had higher odds of developing anemia, deep vein thrombosis, pneumonia, pulmonary embolism, and prosthetic joint infection at all intervals. When controlling for a history of cancer, RT was associated with an increased risk of pulmonary embolism, heterotrophic ossification, prosthetic joint infection, and periprosthetic fracture at all postoperative time points. There was additionally an increased risk of aseptic loosening at 1 year (odds ratio: 2.0, 95% confidence interval: 1.2 to 3.1). CONCLUSION: These findings suggest that patients who have a history of antineoplastic RT are at an increased risk of developing various surgical and medical complications following THA.
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Antineoplásicos , Artroplastia de Quadril , Neoplasias , Embolia Pulmonar , Humanos , Artroplastia de Quadril/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos , Fatores de Risco , Embolia Pulmonar/etiologia , Neoplasias/complicações , Reoperação/efeitos adversosRESUMO
INTRODUCTION: As recent analyses have indicated that low-volume hospitals experience higher rates of complications following total knee arthroplasty (TKA), it remains important to evaluate how area deprivation index (ADI) of hospitals impacts the quantity of TKA performed. Our analysis sought to evaluate how the ADI of orthopedic surgeon's place of service influences TKA utilization. MATERIALS AND METHODS: The Medicare Provider Utilization and Payment Data Public Use File (MPUP-PUF) was queried to identify claims between 2013 and 2019 associated with Healthcare Common Procedure Coding System (HCPCS) code 27447 (TKA). The MPUP-PUF file was linked with publicly available ADI information as well as information regarding each provider's practice location. The Mann-Kendall trend test was used to analyze significant differences in TKA volume between ADI quintiles and differences in TKA volume overall between the years 2013 and 2019. An adjusted multivariable linear regression analysis was conducted to evaluate how ADI, and practice-specific characteristics, influenced TKA utilization volume. RESULTS: When isolating by ADI quintiles, no significant changes in TKA volume were demonstrated for Quintile 4 (Kendall's τ = 0.524; p = 0.13) and Quintile 5 (Kendall's τ = 0.524; p = 0.13) between 2013 and 2019. However, a significant increase in TKA volume over the study period was observed in Quintile 1 (Kendall's τ = 0.714 p = 0.034), Quintile 2 (Kendall's τ = 0.714 p = 0.034), and Quintile 3 (Kendall's τ = 0.905 p = 0.007). The adjusted multivariable linear regression model demonstrated that each increase in ADI quintile was associated with significantly lower TKA utilization (ß-estimate - 1.16; 95% CI - 2.04 to - 0.29; p = 0.009). CONCLUSIONS: Our findings suggest that resource deprivation contributes to disparities in TKA utilization. With the ongoing recognition of how social and neighborhood-level deprivation may influence access to end-stage osteoarthritis care and related perioperative outcomes, the present study serves to encourage continued efforts at ensuring equity in orthopedic care.
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Artroplastia do Joelho , Osteoartrite , Idoso , Humanos , Estados Unidos , Medicare , HospitaisRESUMO
INTRODUCTION: Although intra-articular injections (IAIs) serve as the first-line non-surgical management for severe osteoarthritis (OA), recent analyses have suggested they are associated with an increased infection risk following primary total hip arthroplasty (THA). Therefore, our systematic review and meta-analysis explored the relationship between IAIs and periprosthetic joint infection (PJI) following THA reported in the current literature. METHODS: Five online databases were queried for analyses published from January 1st, 2000-May 1st, 2021 reporting on PJI rates between patients undergoing primary THA who did and did not preoperatively receive an IAI. The overall pooled effect of injection status on PJI incidence was determined using Mantel-Haenszel (M-H) models. This was similarly conducted for segregated preoperative intervals: 0-3 months, > 3-6 months, > 6 + months. RESULTS: A total of 11 articles were included in our analysis reporting on 278,782 THAs (IAI: n = 41,138; no IAI: n = 237,644). Patients receiving pre-operative injections had a significantly higher risk of PJI (OR: 1.31, 95% CI 1.07-1.62; p = 0.009). However, this finding was not robust. IAI receipt within 3-months of THA was associated with significantly higher PJI rates (OR: 1.68, 95% CI 1.48-1.90; p < 0.001). However, no significant difference was demonstrated in the > 3-6 month (OR: 1.19, 95% CI 0.94-1.52; p = 0.16) and > 6 + month sub-analyses (OR: 1.20, 95% CI 0.96-1.50; p = 0.11). The results of all sub-analyses remained were robust. DISCUSSION: Our findings suggest that patients requiring THA should wait at least 3-months following IAI to reduce post-operative infection risk. This information can help inform patients considering OA management options, as well as adult reconstruction surgeons during preoperative optimization.
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Artrite Infecciosa , Artroplastia de Quadril , Osteoartrite , Infecções Relacionadas à Prótese , Adulto , Humanos , Artroplastia de Quadril/efeitos adversos , Infecções Relacionadas à Prótese/epidemiologia , Estudos Retrospectivos , Artrite Infecciosa/etiologia , Osteoartrite/complicações , Injeções Intra-Articulares , Fatores de RiscoRESUMO
INTRODUCTION: As patients increasingly utilize the Internet to obtain health-related information, the accuracy and usability of information prove critical, especially for patients and parents seeking care for relatively common orthopedic childhood disorders such as Legg-Calvé-Perthes (LCP) disease. Therefore, the purpose of this study is to evaluate available online health information regarding LCP disease. The study specifically seeks to (1) examine the accessibility, usability, reliability, and readability of online information, (2) compare the quality of sites from different sources, and (3) determine whether Health on the Net Foundation Code (HON-code) certification guarantees higher quality of information. MATERIALS AND METHODS: Websites from a query of both Google and Bing were compiled and scored using the Minervalidation tool (LIDA), an appraisal tool quantifying website quality, along with the Flesch-Kinkaid (FK) analysis, a metric assessing readability of content. All sites were organized based on source category [academic, private physician/physician group, governmental/non-profit organization (NPO), commercial, and unspecified] and HON-code certification. RESULTS: Physician-based and governmental/NPO sites had the highest accessibility, the unspecified site group were the most reliable and usable, and the physician-based group was found to require the least education to comprehend. Unspecified sites had a significantly higher rating of reliability than physician sites (p = 0.0164) and academic sites (p < 0.0001). HON-code-certified sites were found to have greater scores across quality domains along with being easier to read compared to sites without certification, with significantly higher reliability scoring (p < 0.0001). CONCLUSIONS: As a whole, information on the Internet regarding LCP disease is of poor quality. However, our findings also encourage patients to utilize HON-code-certified websites due to their significantly higher reliability. Future studies should analyze methods of improving this publicly available information. Additionally, future analyses should examine methods for patients to better identify reliable websites, as well as the best mediums for optimized patient access and comprehension.
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Doença de Legg-Calve-Perthes , Humanos , Criança , Doença de Legg-Calve-Perthes/terapia , Reprodutibilidade dos Testes , Compreensão , Pais , InternetRESUMO
INTRODUCTION: The purpose of this study was to systematically review the literature to understand the contemporary outcomes for patients with joint laxity managed with hip arthroscopy. MATERIALS AND METHODS: A search was performed utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Statement guidelines. All literature related to joint laxity in hip arthroscopy patients was identified. Inclusion criteria consisted of patient-reported outcomes and Beighton and Horan Joint Mobility Index scoring. Study quality was assessed using the Methodological Index of Non-Randomized Studies criteria. RESULTS: Seven articles were identified, including 412 patients (416 hips). Patients were predominantly female (range 83-100%). Mean patient age ranged from 13-69 years. Five studies consisting of 370 hips reported a range of 75 to 100% undergoing labral repair, 0 to 13% labral debridement, 0 to 7% labral reconstruction, 43 to 100% capsular closure, 94 to 99% femoroplasty, 3 to 80% rim resection, and 9 to 50% subspine decompression for surgical management. Post-operative follow-up range was 6-99 months. The mean range of improvement in Hip Outcomes Score Activities of Daily Living, Hip Outcomes Score-Sports Subscale, modified Harris Hip Score, Visual Analog Scale, and 12 item Short Form Health Survey were 17.6-31.3, 31.3-35.1, 22.5-53.8, - 2.79-8, and 12.4-16.9 respectively. CONCLUSION: Generalized ligamentous laxity patients managed with hip arthroscopy were predominantly young women. At short-term follow-up, mean patient-reported outcomes were positive, with improvement postoperatively in activities of daily living, sports, and quality of life.
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Impacto Femoroacetabular , Instabilidade Articular , Humanos , Feminino , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Masculino , Articulação do Quadril/cirurgia , Atividades Cotidianas , Instabilidade Articular/cirurgia , Instabilidade Articular/etiologia , Artroscopia/efeitos adversos , Qualidade de Vida , Resultado do Tratamento , Medidas de Resultados Relatados pelo Paciente , Impacto Femoroacetabular/cirurgia , Seguimentos , Estudos RetrospectivosRESUMO
INTRODUCTION: While presepsin has shown promise as a sepsis biomarker, it has only recently been considered in the field of orthopedic surgery. Therefore, the present review evaluates the role of presepsin in total joint arthroplasty (TJA) as well as its diagnostic and prognostic value in diagnosing PJI. METHODS: Utilizing 4 online databases, we thoroughly searched the literature for articles evaluating the role of presepsin in TJA as well as its prognostic and diagnostic value for PJI. RESULTS: Studies evaluating perioperative presepsin trends in primary TJA demonstrated that its natural course is similar to C-Reactive Protein (CRP). The area under (AUC) the receiver operating characteristic curves values for serum presepsin ranged from 0.86 to 0.926. These values were higher than the AUCs for CRP in each of their respective studies. However, synovial presepsin demonstrated a lower AUC (0.41). Prognostically, presepsin demonstrated potential in terms of infection monitoring following revision TJA for PJI. CONCLUSION: Although the data remains limited, presepsin may serve as a potential biomarker to evaluate the natural inflammatory response following TJA as well as to help diagnose PJI. The present review serves to set the foundation for future study into serum presepsin in larger patient cohorts. Further study is needed to evaluate how this biomarker compares to other laboratory values traditionally used for PJI diagnosis.