An In-Depth Analysis of Public and Private Research Funding in Orthopaedic Surgery from 2015 to 2021.

BACKGROUND: Understanding the trends and patterns of research funding can aid in enhancing growth and innovation in orthopaedic research. We sought to analyze financial trends in public orthopaedic surgery funding and characterize trends in private funding distribution among orthopaedic surgeons and hospitals to explore potential disparities across orthopaedic subspecialties. METHODS: We conducted a cross-sectional analysis of private and public orthopaedic research funding from 2015 to 2021 using the Centers for Medicare & Medicaid Services Open Payments database and the National Institutes of Health (NIH) RePORTER through the Blue Ridge Institute for Medical Research, respectively. Institutions receiving funds from both the NIH and the private sector were classified separately as publicly funded and privately funded. Research payment characteristics were categorized according to their respective orthopaedic fellowship subspecialties. Descriptive statistics, Wilcoxon rank-sum tests, and Mann-Kendall tests were employed. A p value of <0.05 was considered significant. RESULTS: Over the study period, $348,428,969 in private and $701,078,031 in public research payments were reported. There were 2,229 unique surgeons receiving funding at 906 different institutions. The data showed that a total of 2,154 male orthopaedic surgeons received $342,939,782 and 75 female orthopaedic surgeons received $5,489,187 from 198 different private entities. The difference in the median payment size between male and female orthopaedic surgeons was not significant. The top 1% of all practicing orthopaedic surgeons received 99% of all private funding in 2021. The top 20 publicly and top 20 privately funded institutions received 77% of the public and 37% of the private funding, respectively. Private funding was greatest (31.5%) for projects exploring adult reconstruction. CONCLUSION: While the amount of public research funding was more than double the amount of private research funding, the distribution of public research funding was concentrated in fewer institutions when compared with private research funding. This suggests the formation of orthopaedic centers of excellence (CoEs), which are programs that have high concentrations of talent and resources. Furthermore, the similar median payment by gender is indicative of equitable payment size. In the future, orthopaedic funding should follow a distribution model that aligns with the existing approach, giving priority to a nondiscriminatory stance regarding gender, and allocate funds toward CoEs. CLINICAL RELEVANCE: Securing research funding is vital for driving innovation in orthopaedic surgery, which is crucial for enhancing clinical interventions. Thus, understanding the patterns and distribution of research funding can help orthopaedic surgeons tailor their future projects to better align with current funding trends, thereby increasing the likelihood of securing support for their work.

Women's Representation as Principal Investigators Among Pediatric Orthopaedic Clinical Trials: An Analysis of ClinicalTrials.Gov.

INTRODUCTION: Despite recent efforts to increase the participation of women in orthopaedic surgery, there remains a gender gap, particularly when compared with other medical specialties. Acting as a principal investigator (PI) in a clinical trial can give physicians notable exposure and national recognition, which can improve their chances of promotion and tenure. This study aims to assess the proportion of women serving as PIs in pediatric orthopaedic clinical trials, examine associated trial characteristics, and explore geographic distribution. METHODS: A cross-sectional analysis of clinical trials was conducted using data from the ClinicalTrials.gov registry. Specific search terms were used to identify pediatric orthopaedic trials. Data on trial characteristics, including phase, status, funding source, and intervention type, were collected. PI sex was determined using Genderize.io, an application program interface that predicts the sex of individuals based on their name, and the geographic distribution of women PIs was examined. RESULTS: From 2007 to 2022, women PIs increased from zero to 26.86%. The United States saw no significant increase (ß = 1.553; P = 0.125), but international trials did (ß = 2.845; P = 0.008). Women PIs led more active/completed trials and trials with behavioral/other interventions. Geographic analysis showed higher representation in North America (38.47%), especially the Northeast (28.17%) and West (25.35%). The United States had 28.74% women PIs, with California (15.49%) leading. CONCLUSION: Progress toward gender parity in pediatric orthopaedic research is evident; however, disparities still exist. Efforts to provide additional research opportunities for women in orthopaedics may be crucial in attracting and retaining diverse talent in the field. Targeted initiatives may have potential in achieving equal representation in orthopaedics.

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.

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.

Does rickets carry an increased risk of osteomyelitis and septic arthritis? An aggregated electronic health record data study.

To investigate the prevalence of osteomyelitis and septic arthritis in pediatric patients with rickets, compared to the general population. A retrospective cohort study was conducted using the TriNetX analytics network, which aggregates deidentified electronic health record data from over 105 million US patients. We queried pediatric patients with rickets, based on ICD-10-CM (International Classification of Diseases, Tenth Revision, Clinical Modification) encounter diagnoses. Patients with any ICD-10-CM encounter diagnoses of osteomyelitis or septic arthritis were reported. We established a control cohort of pediatric patients without rickets. Of 7337 pediatric patients (≤18 years old) with a rickets diagnosis, 96 [1.31%, 95% confidence interval (CI): 1.05%-1.57%] had a diagnosis of osteomyelitis and 28 (0.38%, 95% CI: 0.24%-0.52%) had a diagnosis of septic arthritis. In comparison, of the 17 240 604 pediatric patients without a rickets diagnosis, 16 995 (0.10%, 95% CI: 0.10%-0.10%) had a diagnosis of osteomyelitis and 8521 (0.05%, 95% CI: 0.05%-0.05%) had a diagnosis of septic arthritis. The relative risk for an osteomyelitis diagnosis in pediatric patients with a rickets diagnosis was 13.27 (95% CI: 10.86-16.23), while the relative risk for a septic arthritis diagnosis was 7.72 (95% CI: 5.33-11.18). Pediatric patients with a diagnosis of rickets have over 10- and 5-times higher relative risks for having a diagnosis of osteomyelitis and septic arthritis, respectively, compared to those without a diagnosis of rickets. This is the first study to explore musculoskeletal infections in rickets patients, highlighting the importance of clinicians being vigilant about these conditions.

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.

Less common than expected: late displacement after minimally displaced pediatric lateral condyle fractures of the elbow.

The incidence of late displacement among pediatric lateral condyle fractures has been described as 1.3-26%. However, prior studies are limited by small cohort sizes. The aim of this study was to determine the rate of late displacement and delayed union among lateral condyle fractures following immobilization in a large cohort and to establish additional radiographic criteria to help surgeons choose between immobilization and operative fixation for minimally displaced fractures. We performed a dual-center retrospective study of patients with lateral condyle fractures between 1999 and 2020. Patient demographics, injury mechanism, time to orthopedic presentation, duration of cast immobilization, and complications following casting were recorded. There were 290 patients with lateral condyle fractures included. The initial management in 61% of patients (178/290) was nonoperative, of which four had delayed displacement at follow-up and two developed delayed union requiring surgery (failure in 6/178, 3.4%). The mean displacement on the anteroposterior view was 1.3 ±â€…1.1 mm and the lateral view was 0.50 ±â€…1.0 mm in the nonoperative cohort. In the operative cohort, the mean displacement on AP was 6.6 ±â€…5.4 mm and the lateral view was 5.3 ±â€…4.1 mm. Our analysis found the rate of late displacement in patients treated with immobilization was lower than previously reported (2.5%; 4/178). The mean displacement on the lateral film in the cast immobilization cohort was 0.5 mm, suggesting that necessitating near anatomic alignment on the lateral film to consider nonoperative management may lead to a lower incidence of late displacement than previously reported. Level of evidence: Level III, retrospective comparative study.

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.

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.

Understanding the use of artificial intelligence for implant analysis in total joint arthroplasty: a systematic review.

INTRODUCTION: In recent years, there has been a significant increase in the development of artificial intelligence (AI) algorithms aimed at reviewing radiographs after total joint arthroplasty (TJA). This disruptive technology is particularly promising in the context of preoperative planning for revision TJA. Yet, the efficacy of AI algorithms regarding TJA implant analysis has not been examined comprehensively. METHODS: PubMed, EBSCO, and Google Scholar electronic databases were utilized to identify all studies evaluating AI algorithms related to TJA implant analysis between 1 January 2000, and 27 February 2023 (PROSPERO study protocol registration: CRD42023403497). The mean methodological index for non-randomized studies score was 20.4 ± 0.6. We reported the accuracy, sensitivity, specificity, positive predictive value, and area under the curve (AUC) for the performance of each outcome measure. RESULTS: Our initial search yielded 374 articles, and a total of 20 studies with three main use cases were included. Sixteen studies analyzed implant identification, two addressed implant failure, and two addressed implant measurements. Each use case had a median AUC and accuracy above 0.90 and 90%, respectively, indicative of a well-performing AI algorithm. Most studies failed to include explainability methods and conduct external validity testing. CONCLUSION: These findings highlight the promising role of AI in recognizing implants in TJA. Preliminary studies have shown strong performance in implant identification, implant failure, and accurately measuring implant dimensions. Future research should follow a standardized guideline to develop and train models and place a strong emphasis on transparency and clarity in reporting results. LEVEL OF EVIDENCE: Level III.

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.

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.

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.

What Factors Are Associated with Clinical Trial Discontinuation in Orthopaedic Surgery: An Analysis of Clinical Trials Between 2007 and 2022.

BACKGROUND: Clinical trials play a crucial role in advancing medical knowledge and have the potential to change standards of care. The present study evaluated the prevalence of discontinued clinical trials in orthopaedic surgery. Additionally, we sought to identify the study characteristics associated with and the rationale behind trial discontinuation. METHODS: A cross-sectional survey of orthopaedic clinical trials using the ClinicalTrials.gov registry and results database was performed for trials between October 1, 2007, and October 7, 2022. Interventional trials listed as "completed," "terminated," "withdrawn," or "suspended" were included. Study characteristics were collected and clinical trial abstracts were reviewed in order to assign the appropriate subspecialty category. A univariate linear regression analysis was performed to determine whether the percentage of discontinued trials changed between 2008 and 2021. Univariate and multivariable hazard ratios (HRs) were calculated to identify factors associated with trial discontinuation. RESULTS: A total of 8,603 clinical trials were included in the final analysis, of which 1,369 (16%) were discontinued, with the highest rates of discontinuation found in oncology (25%) and trauma (23%). The most common rationales for discontinuation were insufficient patient accrual (29%), technical or logistical issues (9%), business decision (9%), and lack of funding or resources (9%). Industry-funded studies were more likely than government-funded studies to be discontinued (HR: 1.81; p < 0.001). There was no change in the percentage of discontinued trials for each orthopaedic subspecialty between 2008 and 2021 (p = 0.21). As shown on multivariable regression analysis, trials for devices (HR: 1.63 [95% confidence interval, 1.20 to 2.21]; p = 0.002) and drugs (HR: 1.48 [1.10 to 2.02]; p = 0.013) as well as Phase-2 trials (HR: 1.35 [1.09 to 1.69]; p = 0.010), Phase-3 trials (HR: 1.39 [1.09 to 1.78]; p = 0.010), and Phase-4 trials (HR: 1.44 [1.14 to 1.81]; p = 0.010) had a higher likelihood of early discontinuation. However, pediatric trials were less likely to be discontinued (HR: 0.58 [0.40 to 0.86]; p = 0.007). CONCLUSIONS: The results of the present study suggest the need for continued efforts to ensure the completion of orthopaedic clinical trials in order to limit publication bias and to employ resources and patient contributions more efficiently for research. CLINICAL RELEVANCE: Discontinued trials contribute to publication bias, which limits the comprehensiveness of the literature available to support evidence-based patient care interventions. Therefore, identifying the factors associated with and the prevalence of orthopaedic trial discontinuation encourages orthopaedic surgeons to design future trials to be more resistant to early discontinuation.

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.

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.

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.