Assessing the Readability of Clinical Trial Consent Forms for Surgical Specialties.

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.

Epidemiological Trends and Outcomes of Unicompartmental Knee Arthroplasty Among 104 Million Patients in the United States.

BACKGROUND: Unicompartmental knee arthroplasty (UKA) is an alternative to total knee arthroplasty for localized osteoarthritis. Recent advancements in UKA implant design and expanding patient criteria may have increased its utilization. However, few studies have examined the use of UKA in the United States. Thus, this study assessed the current and projected future trends of UKA and robotic UKA in the United States through 2035, along with postoperative outcomes. METHODS: A collaborative healthcare research network was queried to identify patients who had undergone UKA. Primary outcomes measured included prevalence (P), incidence proportion (IP), and incidence rate (IR) from 2012 to 2022. Chi-square analyses were done to compare outcomes across categorical data. Regression modeling was performed to project UKA to the year 2035. Statistical significance was held at P < 0.05 for all analyses. RESULTS: In 2022, 1,662 UKAs were performed within the network, a 590% increase from 2012 (241 performed). The incidence proportion increased on an average annual basis by 41.8%, the incidence rate by 50%, and the prevalence by 51.3%. A year following UKA, conversion to total knee arthroplasty was the most common orthopaedic complication (39.9%). As of 2022, there were 68 robotic UKAs performed, a 518% increase from the 11 performed in 2012. Regression analysis for UKA through 2035 showed that IP will be 0.04%, IR will be 1.75 x 10-6 cases/person-day, and prevalence will be 0.3%. CONCLUSION: These findings are consistent with prior studies indicating a higher utilization of UKA over the past decade. Reported complications were not uncommon, as nearly 40% of patients required a conversion to a total knee arthroplasty. Further research is needed to optimally identify criteria for appropriate patients and determine the benefits robotic UKA may provide, specifically reducing the risk of conversion to a TKA.

Impact of external beam radiation on total shoulder arthroplasty outcomes: a propensity-matched cohort study.

BACKGROUND: External beam radiation therapy has a number of deleterious effects on the body, and a number of post-operative complications have been reported for several surgeries including total knee arthroplasty. However, few studies have investigated the impact of external beam radiation therapy for total shoulder arthroplasty (TSA). Our study aimed to assess the systemic and joint complications associated with TSA in patients with prior radiation exposures, as well as evaluate the surgical outcomes of radiation patients compared to non-radiation TSA patients. MATERIALS AND METHODS: A retrospective cohort analysis was conducted using the TriNetX Analytics Network. A 1:1 propensity score matching function was utilized to create two cohorts with matched baseline characteristics within the TriNetX network. Comparisons of the primary and secondary outcomes between the two cohorts were made using odds ratios. A p value of < 0.05 was determined to be significant. RESULTS: A total of 75,510 patients that received TSA were identified with 1505 having a history of radiation therapy (RT) and 73,605 with no radiation therapy (non-RT). After propensity matching, both groups contained 1484 patients. RT patients were at higher risk for developing prosthetic joint infection, acute renal failure, altered mental state, cerebrovascular event, DVT, PE, pneumonia, respiratory failure, and UTI compared to non-RT patients at different time points (p < 0.5). CONCLUSION: Patients with prior history of external beam radiation undergoing TSA had a higher risk of systemic complications and prosthetic joint infection compared to patients without a prior history. These complications suggest a more complicated post-operative management course for these patients.

Are periprosthetic hip fractures more severe than native hip fractures? A systematic review of outcomes and resource utilization.

BACKGROUND: There is a paucity of data comparing periprosthetic hip fracture (PPHFx) outcomes and resource utilization to native fractures. Many surgeons consider periprosthetic hip fractures to be more severe injuries than native fractures. The aim of this systematic review is to characterize the outcomes of PPHFx and assess their severity relative to native hip fractures (NHFx). METHODS: A Preferred Reporting Items for Systematic Reviews and Meta-Analysis systematic review was conducted using Medline, Biosis, and Cinahl. Primary outcomes were time to surgery, length of stay (LOS), cost of management, disposition, complication rates, readmission rates, and mortality. RESULTS: 14 articles (13,489 patients) from 2010 to 2018 were included in the study. Study quality was generally low. Patient follow-up ranged from 1 month to 3.2 years. LOS ranged from 5.2 to 38 days. US cost of management was best estimated at $53,669 ± 19,817. Discharge to skilled nursing facilities ranged from 64.5 to 74.5%. Time to surgery ranged from 1.9 to 5.7 days. Readmission rates ranged from 12 to 32%. Per Clavien-Dindo classification, 33.9% suffered minor complications; 14.3% suffered major complications. 1 month and 1 year mortality ranged from 2.9% to 10% and 9.7% to 45%, respectively. CONCLUSION: Time to surgery and LOS were longer for PPHFx relative to NHFx. Complications' rates were higher for PPHFx compared to NHFx. There is no evidence for differences in LOS, cost, discharge, readmission rates, or mortality between PPHFx and NHFx. These results may serve as a baseline in future evaluation of PPHFx management.

Immediate plate fixation of open tibial plafond fractures does not elevate risk of infection.

OBJECTIVE: To determine if immediate plate fixation of open tibial plafond fractures has a negative effect on soft tissue complications and increases the risk of deep infection. DESIGN: This was a single-institution retrospective cohort study performed at level-1 trauma center. All patients with open OTA/AO 43C plafond fractures treated over 20-year period with follow-up until fracture union or development of deep infection. Ninety-nine of 333 identified patents met the inclusion criteria. The intervention was operative treatment of open tibial plafond fractures. The main outcome measurements were return to operating room for deep infection, nonunion, and below knee amputation. RESULTS: The overall rate of complications was 52%. Gender, body mass index, tobacco use, diabetes, ASA classification, time to OR from injury, wound location, and associated fibula fracture were not associated with deep infection. There was a significant difference in Gustilo-Anderson fracture grade among infected versus non-infected (P = 0.04). There was no significant difference in postoperative infection rates between patients treated with external fixation, external fixation and limited plate fixation, and plate fixation alone during initial surgery (P = 0.64). CONCLUSION: It is well established that open pilon fractures have a high incidence for postoperative infection and development of complications such as nonunion. As these injuries have poor clinical outcomes, any additional measures to prevent infection and soft tissue complications should be utilized. In appropriately selected cases, both immediate plate fixation and immediate limited plate fixation with external fixation at the time of I&D do not appear to elevate risk of deep infection. LEVEL OF EVIDENCE: Therapeutic Level III.

Comparing outcomes in revision total hip arthroplasty in inpatient versus outpatient setting: a matched cohort analysis.

BACKGROUND: As the population ages, revision total hip arthroplasty (rTHA) is becoming more common. However, there is a paucity of literature regarding perioperative outcomes following inpatient versus outpatient rTHA. Our study aims to compare perioperative complications and readmission rates associated with rTHA in a large national cohort. METHODS: A retrospective, propensity-matched cohort study was conducted using the National Surgical Quality Improvement Program database from 2006 to 2020. Patients undergoing rTHA in the inpatient setting were propensity matched to patients receiving rTHA in the outpatient setting. Following 1:1 matching, multivariate analyses were performed to compare perioperative complications and readmission. RESULTS: A total of 207,102 patients were identified, including 181,164 outpatient primary THA, 25,466 inpatient rTHA, and 492 outpatient rTHA patients. Following propensity matching, outpatient primary THA versus outpatient rTHA had 210 patients and inpatient rTHA versus outpatient rTHA had 214 patients. Patients in the outpatient rTHA had a significantly higher operative time (132.4 ± 73.2 versus 90.9 ± 32.7, p < 0.001) and length of stay (1.6 ± 1.6 vs. 0.9 ± 1.0, p < 0.001) compared to outpatient primary THA. When comparing inpatient versus outpatient rTHA, the outpatient cohort had lower operative time (131.1 ± 70.9 vs. 145.4 ± 71.5, p = 0.038), total length of stay (1.7 ± 1.8 vs. 3.6 ± 4.1, p < 0.001), and bleeding complications (6% vs. 18%, p < 0.001). CONCLUSION: There were no difference in the odds of complications between outpatient primary and revision THA. Additionally, rTHA performed in an outpatient setting did not show any increase in immediate compared to inpatient settings. These findings suggest that rTHA can be safely performed on certain patients.

Are orthopedic clinical trials representative? An analysis of race and ethnicity reported in clinical trials between 2007 and 2022 : Running title: representation of clinical trials in orthopedic surgery.

INTRODUCTION: Prior studies investigating the racial and ethnic representation of orthopedic trial participants have found low rates of reporting, but these studies are dated due to the passing of the National Institutes of Health Final Rule in 2017 requiring the reporting of racial and ethnic data among clinical trials. Therefore, we evaluated the representativeness of orthopedic clinical trials before and after the Final Rule. METHODS: A cross-sectional survey of orthopaedic clinical trials registered at ClinicalTrials.gov between October 1, 2007 and May 20, 2023 was conducted. After identifying and screening 23,752 clinical trials, 1564 trials were included in the analysis. Trials started before the implementation of the Final Rule on January 18, 2017 were grouped and compared to trials that began after. Odds ratios (OR) were utilized to identify trial characteristics associated with reporting race/ethnicity data. One-proportion z tests compared the representation of each racial and ethnic category to the 2020 United States Census. RESULTS: In total, 34% (544 of 1564) of orthopedic clinical trials evaluated reported the race of participants, while 28% (438 of 1564) reported ethnicity. Trials registered after the Final Rule were more likely to report racial (OR: 5.15, 95%CI: 3.72-7.13, p < 0.001) and ethnic (OR: 3.23, 95%CI: 2.41-4.33, p < 0.001) representation of participants. Compared with the distribution of race and ethnicity reported by the United States 2020 Census, orthopedic trials had 16.6% more White participants (95% CI 16.4%, 16.8%; p < 0.001), 3.2% fewer Black participants (95%CI 3.1%, 3.3%; p < 0.001), and 5.7% fewer Hispanic/Latino participants (95%CI 5.2%, 6.2%; p < 0.001). Trials with enrollment sizes over 100 participants were also more likely to report race and ethnicity, with odds increasing with increased sample size. CONCLUSIONS: The Final Rule marginally improved the reporting of race and ethnicity in orthopedic clinical trials, and underrepresentation of Black or African American, Multiracial, and Hispanic populations persists. LEVEL OF EVIDENCE: III.

Photodynamic bone stabilization for traumatic and pathologic fractures: a systematic review of utilization, complications, and patient-reported outcomes.

INTRODUCTION: The photodynamic bone stabilization system (PBSS) was was developed in 2010, and in 2018 gained FDA approval in the United States. Given its relative novelty, our analysis sought to analyze the available literature exploring the indications, outcomes, and complications of the PBSS. METHODS: We performed a systematic review (PROSPERO registration of study protocol: CRD42022363065, October 8th, 2022). PubMed, EBSCOHost, and Google Scholar electronic databases were queried to identify articles evaluating PBSS in the treatment of pathologic or traumatic fractures between January 1 2010 and 15 October 2022. The quality of the included studies was assessed using the Methodological Index for Nonrandomized Studies tool. RESULTS: Our initial search yielded 326 publications, which were then screened for appropriate studies that aligned with the purpose of our review. A total of thirteen studies, comprising seven case series, four case reports, and two cohort studies. The total sample size of the included studies consisted of 345 patients, with 242 females (70%) and 103 males (30%). The implants were most commonly utilized in the humerus (41%), radius (12%), and metacarpal (12%). The most common complications were related to broken implants (5%) and dislocation (1%). Most studies reported complete fracture healing and return of full strength and range of motion. CONCLUSION: Despite being a relatively novel technology, PBSS appears to be a viable option for fracture stabilization. Most studies included in our analysis reported complete fracture healing and return of function with minimal complications.

Is Social Deprivation Associated With Usage, Adverse Events, and Patient-reported Outcome Measures in Total Joint Arthroplasty? A Systematic Review.

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.

What is the Association Between Clinically Diagnosed Psychiatric Illness and Total Joint Arthroplasty? A Systematic Review Evaluating Outcomes, Healthcare Use, and Patient-reported Outcome Measures.

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.

What Are the Trends in Research Publication Misrepresentation Among Orthopaedic Residency and Fellowship Applicants From 1996 to 2019? A Systematic Review.

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.

What Is the Geographic Distribution and Density of Orthopaedic Advanced Practice Professionals in Rural Counties? A Large-database Study.

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.

What Are the Trends in Women's Representation Among Lead Investigators of Orthopaedic Clinical Trials?

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.

Readability of Online Patient Educational Materials in Pediatric Orthopaedics: A Systematic Review.

BACKGROUND: As most patients and their families utilize online education materials, ensuring that their readability is at or below the recommended reading level of sixth grade is imperative to enhance informed consent, patient involvement, and shared decision-making. We evaluated and compared the readability of online patient education materials (PEMs) about pediatric orthopaedics for academic-sponsored websites and search-engine result websites. METHODS: Following the PRISMA-P guidelines, we performed a systematic review to answer our study question (PROSPERO registration of the study protocol: CRD42022352323, August 8, 2022). PubMed, EBSCOhost, Medline, and Google Scholar electronic databases were utilized to identify all studies evaluating the readability of pediatric orthopaedic online PEMs between January 1, 2000 and September 9, 2022. We included studies with full-text manuscripts in English addressing the readability of pediatric orthopaedic online patient education materials. We excluded general reviews, papers, case reports, duplicate studies between databases, grey literature, and publications in languages other than English. The quality of included studies was assessed using the Joanna Briggs Institute (JBI) tool for cross-sectional studies. RESULTS: Our initial search yielded 196 candidate publications. Of these, 11 studies met inclusion criteria. These included a total of 893 PEMs assessed for readability between January 2001 to December 2021. The mean JBI score was 7.3±1.1. Each of the seven studies assessing PEMs from academic-sponsored sources reported mean readability scores of at least an eighth-grade level. Among the 5 studies assessing the readability of PEMs accessed through search engines, 3 studies reported ninth-grade reading level whereas the other 2 reported 10th-grade. Academic and search-engine website readability scores remained constant between 2001 and 2021. CONCLUSIONS: Our analysis showed poor readability scores for both academic-sponsored website PEMs and those accessed through search engines. In addition, the readability scores remained constant between 2001 and 2021, indicating that revisions to orthopaedic online PEMs are needed. Supplementation with visuals should be included to educate patients with lower health literacy. LEVEL OF EVIDENCE: III.

Implant Selection Strategies for Total Joint Arthroplasty: The Effects on Cost Containment and Physician Autonomy.

BACKGROUND: With continued declines in reimbursement for total joint arthroplasty, health systems have explored implant cost containment measures to generate sustainable margins. This review evaluated how implementation of (1) implant price control programs, (2) vendor purchasing agreements, and (3) bundled payment models affected implant costs and physician autonomy in implant selection. METHODS: PubMed, EBSCOhost, and Google Scholar were searched to identify studies that evaluated the efficacy of total hip or total knee arthroplasty implant selection strategies. The review included publications between January 1, 2002, and October 17, 2022. The mean Methodological Index for Nonrandomized Studies score was 18.3 ± 1.8. RESULTS: A total of 13 studies (32,197 patients) were included. All studies implementing implant price capitation programs found decreased implant costs, ranging 2.2 to 26.1% and increased utilization of premium implants. Most studies found bundled payments models reduced total joint arthroplasty implant costs with greatest reduction being 28.9%. Additionally, while absolute single vendor agreements had higher implant costs, preferred single vendor agreements had reduced implant costs. When given price constraints, surgeons tended to select more premium implants. CONCLUSION: Alternative payment models that incorporated implant selection strategies saw reduced costs and surgeon utilization of premium implants. The study findings encourage further research on implant selection strategies, which must balance the goals of cost containment with physician autonomy and optimized patient care. LEVEL OF EVIDENCE: Level III.

Complications in Osteonecrosis Patients Following Total Knee Arthroplasty: A Propensity-Matched Cohort Study.

BACKGROUND: Several studies have demonstrated high complication rates in osteonecrosis (ON) patients undergoing total hip arthroplasty. However, there is a paucity of literature regarding outcomes of total knee arthroplasty (TKA) in ON patients. Our study aimed to assess preoperative risk factors associated with the development of ON and determine the incidence of postoperative complications up to one year following TKA. METHODS: A retrospective cohort study was conducted using a large national database. Patients who had a primary TKA and ON were isolated using Current Procedural Terminology code 27447 and ICD-10-CM code M87, respectively. A total of 185,045 patients were identified, including 181,151 patients who had a TKA and 3,894 patients who had a TKA and ON. After propensity matching, both groups each contained 3,758 patients. Intercohort comparisons of primary and secondary outcomes after propensity score matching were made using the odds ratio. A P value of < .01 was determined to be significant. RESULTS: The ON patients were found to have an increased risk for prosthetic joint infection, urinary tract infection, deep vein thrombosis, pulmonary embolism, wound dehiscence pneumonia, and the development of heterotopic ossification at different time points. Osteonecrosis patients had an increased risk of revision at the 1-year time point (odds ratio = 2.068, P < .0001). CONCLUSION: The ON patients had a higher risk of systemic and joint complications than non-ON patients. These complications suggest a more complicated management course for patients who have ON prior to and after TKA.

Is Penicillin Allergy a Clinical Problem? A Systematic Review of Total Joint Arthroplasty Procedures With Implications for Patient Safety and Antibiotic Stewardship.

BACKGROUND: Patients undergoing total joint arthroplasty (TJA) who report penicillin allergy (PA) are frequently administered second-line antibiotics, although recent evidence suggests that this may be unnecessary and could increase infection risk. Many institutions have aimed to improve antibiotic deployment via allergy testing and screening; however, there is little standardization to this process. This review aimed to evaluate (1) antibiotic selection in patients who report PA and assess the impact of screening and testing interventions, (2) rates of allergic reactions in patients who report PA, and (3) the association between reported PA and screening or testing programs and odds of surgical site infection or periprosthetic joint infection. METHODS: PubMed, EBSCOhost, and Google Scholar electronic databases were searched on February 4, 2023 to identify all studies published since January 1, 2000 that evaluated the impact of PA on patients undergoing TJA (PROSPERO study protocol registration: CRD42023394031). Articles were included if full-text manuscripts in English were available, and the study analyzed the impact of PA and related interventions on TJA patients. There were 11 studies evaluating 1,276,663 patients included. Interventions were compared via presentation of key findings regarding rates of clinically relevant or high-risk PA reported upon screenings or testings, cephalosporin utilizations, allergic reactions, and postoperative infections (surgical site infection and periprosthetic joint infection). RESULTS: All 6 studies found that PA screening and testing markedly increase the use of first-line antibiotics. Testing showed low rates of true allergy (0.7 to 3%) and allergic reaction frequency for patients who have reported PA receiving cephalosporins was between 0% and 2%. Although there were mixed findings across studies, there was a trend toward second-line antibiotic prophylaxis being associated with a slightly higher rate of infection in PA patients. CONCLUSIONS: Using PA screening and testing can promote antibiotic stewardship by safely increasing the use of first-line antibiotics in patients who have a reported PA. LEVEL OF EVIDENCE: Level III, Therapeutic Study.

Readability of Online Patient Education Materials for Total Joint Arthroplasty: A Systematic Review.

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.

Impact of social disadvantage among total knee arthroplasty places of service on procedural volume: a nationwide Medicare analysis.

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.

What is the utility of hip arthroscopy in patients with joint laxity? A contemporary systematic review of patient-reported and surgical outcomes.

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.