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.

Association Between Digitally Provided Education and 90-Day Return to Sexual Activity Following Total Knee Arthroplasty: A Randomized Controlled Trial.

BACKGROUND: Contemporary total knee arthroplasty patients have increased expectations of returning to predisease function, including sexual activity (SA). The purpose of this study was to determine whether patients using a digital care management platform (DCMP) were more likely to have a higher rate and frequency of return to SA. METHODS: We conducted an exploratory analysis of a prospective, multicenter, randomized controlled trial that enrolled patients undergoing total knee arthroplasty. A total of 304 patients were randomized to a DCMP (n = 119) providing preoperative and postoperative education regarding return to SA or standard postoperative care (control group; n = 185). Return to SA, assessed via questionnaire, patient-reported outcome measures, Timed Up and Go test, single leg stance, active range of motion and need for manipulation under anesthesia were assessed at 90 days postoperatively. RESULTS: More patients in the DCMP group returned to SA compared to control at 90 days (58.4 versus 39.6%, P = .018); however, the control group resumed SA sooner (33.1 versus 42.0 days, P = .023). Patients who returned to SA were younger (61.6 versus 65.9 year), more often men (56 versus 35%) (P < .001), higher performing on the Timed Up and Go and single leg stance tests (P < .001), and had greater active range of motion (P = .007). There were no differences in patient-reported outcome measures or need for manipulation under anesthesia between patients that returned to SA and those who did not. CONCLUSIONS: More patients using a DCMP resumed SA at 90 days; however, patients in the control group returned to SA sooner. Those who returned to SA were younger, possessed greater physical function, and were more often men.

Five-Year Incidence of Progression to Osteoarthritis and Total Joint Arthroplasty in Patients Prescribed Glucagon-Like Peptide 1 Receptor Agonists.

BACKGROUND: Research has suggested that glucagon-like peptide-1 receptor agonists (GLP-1-RAs) may have therapeutic effects on osteoarthritis of the hip and knee, in addition to managing diabetes and obesity. However, there is a lack of understanding regarding the association between GLP-1-RA use and the diagnosis of osteoarthritis (OA) of the hip and knee. METHODS: A collaborative network analytics platform was queried for obese diabetic (n = 1,094,198), obese nondiabetic (n = 916,235), and nonobese diabetic (n = 157,305) patients who had an index visit between 2015 and 2017. Patients who had pre-existing hip and/or knee OA were excluded. A 1:1 propensity score matching was used to balance GLP-1-RA use in stratified cohorts for age, sex, race, body mass index, and hemoglobin A1c. The primary outcomes were rates of progression to hip OA, knee OA, major joint injections, total hip arthroplasty, and total knee arthroplasty. Cox proportional hazards models determined hazard ratios (HRs) between cohorts prescribed and not prescribed GLP-1-RAs. RESULTS: All patients had a five-year follow-up. Rates of progression to hip and knee OA were higher among the GLP-1-RA users in both obese diabetic (hip HR: 1.63, 95% confidence interval [CI]: 1.46 to 1.82; knee HR: 1.52, CI: 1.41 to 1.64) and nonobese diabetic (hip HR: 1.78, CI: 1.50 to 2.10; knee HR: 1.58, CI: 1.39 to 1.80) cohorts. These diabetic cohorts received higher rates of major joint injections, though there was no difference in rates of total hip arthroplasty or total knee arthroplasty. No differences in five-year outcomes were seen when comparing obese, nondiabetic patients who were prescribed GLP-1-RAs with obese, nondiabetic patients not exposed to GLP-1-RAs. CONCLUSIONS: This five-year analysis found a greater risk of progression to hip and knee OA among obese and non-obese diabetic GLP-1-RA users. Further studies should explore GLP-1-RA effects upon glucose management, weight loss, and lower extremity arthritis development. LEVEL OF EVIDENCE: III, retrospective cohort 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.

Improved short-term outcomes for a novel, fluoroscopy-based robotic-assisted total hip arthroplasty system compared to manual technique with fluoroscopic assistance.

BACKGROUND: While robotic-assisted total hip arthroplasty (RA-THA) has been associated with improved accuracy of component placement, the perioperative and early postoperative outcomes of fluoroscopy-based RA-THA systems have yet to be elucidated. METHODS: This retrospective cohort analysis included a consecutive series of patients who received manual, fluoroscopy-assisted THA (mTHA) and fluoroscopy-based RA-THA at a single institution. We compared rates of complications within 90 days of surgery, length of hospital stay (LOS), and visual analog scale (VAS) pain scores. RESULTS: No differences existed between groups with respect to demographic data or perioperative recovery protocols. The RA-THA cohort had a significantly greater proportion of outpatient surgeries compared to the mTHA cohort (37.4% vs. 3.8%; p < 0.001) and significantly lower LOS (26.0 vs. 39.5 h; p < 0.001). The RA-THA cohort had a smaller 90-day postoperative complication rate compared to the mTHA cohort (0.9% vs. 6.7%; p = 0.029). The RA-THA cohort had significantly lower patient-reported VAS pain scores at 2-week follow-up visits (2.5 vs. 3.3; p = 0.048), but no difference was seen after 6-week follow visits (2.5 vs. 2.8; p = 0.468). CONCLUSION: Fluoroscopy-based RA-THA demonstrates low rates of postoperative complications, improved postoperative pain profiles, and shortened LOS when compared to manual, fluoroscopy-assisted THA.

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.

Use of a fluoroscopy-based robotic-assisted total hip arthroplasty system produced greater improvements in patient-reported outcomes at one year compared to manual, fluoroscopic-assisted technique.

INTRODUCTION: The adoption of new technology should be supported by improvements in patient-reported outcomes (PROMs). The purpose of this study was to assess the one-year PROMs of patients who underwent total hip arthroplasty (THA) using a novel, fluoroscopy-based, robotic-assisted (RA-THA) system when compared to a manual, fluoroscopic-assisted technique (mTHA). MATERIALS AND METHODS: A review of 91 consecutive mTHA and 85 consecutive RA-THA via a direct anterior approach was conducted. All cases were performed by the same surgeon at the same institution, for a pre-operative diagnosis of osteoarthritis, avascular necrosis, or rheumatoid arthritis. Outcomes included one-year Veterans RAND-12 (VR-12) Physical/Mental, Hip Disability and Osteoarthritis Outcome (HOOS) Pain/Physical Function/Joint Replacement, and University of California Los Angeles (UCLA) Activity scores, as well as the difference between pre-operative and one-year post-operative PROMs. RESULTS: Patients in the RA-THA cohort had lower pre-operative HOOS-JR scores compared to patients in the mTHA cohort (37.0 vs. 43.1; p = 0.031). Cohorts experienced similar one-year post-operative VR-12, HOOS, and UCLA Activity scores. Patients in the RA-THA cohort experienced greater improvements across all pre- and post-operative HOOS scores compared to patients in the mTHA cohort: Pain (+ 54.7 vs. +42.1; p = 0.009), Physical Function (-41.6 vs. -28.7; p = 0.007), and Joint Replacement (+ 46.6 vs. +33.0; p = 0.002). These differences exceeded minimum clinically important difference (MCID). CONCLUSIONS: Both manual and robotic cohorts experienced benefit from THA at one-year post-operative. Importantly, the use of a novel, fluoroscopy-based robotic assistance system for primary THA resulted in greater improvements in PROMs at one-year relative to manual technique.

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.

Do Americans Lacking a Local Orthopaedic Surgeon Have Adequate Broadband for Telehealth?

BACKGROUND: Although telehealth holds promise in expanding access to orthopaedic surgical care, high-speed internet connectivity remains a major limiting factor for many communities. Despite persistent federal efforts to study and address the health information technology needs of patients, there is limited information regarding the current high-speed internet landscape as it relates to access to orthopaedic surgical care. QUESTIONS/PURPOSES: (1) What is the distribution of practicing orthopaedic surgeons in the United States relative to the presence of broadband internet access? (2) What geographic, demographic, and socioeconomic factors are associated with the absence of high-speed internet and access to a local orthopaedic surgeon? METHODS: The Federal Communications Commission (FCC) Mapping Broadband in America interactive tool was used to determine the proportion of county residents with access to broadband-speed internet for all 3141 US counties. Data regarding the geographic distribution of orthopaedic surgeons and county-level characteristics were obtained from the 2015 Physician Compare National Downloadable File and the Area Health Resource File, respectively. The FCC mapping broadband public use files are considered the most comprehensive datasets describing high-speed internet infrastructure within the United States. The year 2015 represents the most recently available FCC data for which county-level broadband penetration estimates are available. Third-party audits of the FCC data have shown that broadband expansion has been slow over the past decade and that many large improvements have been driven by changes in the reporting methodology. Therefore, we believe the 2015 FCC data still hold relevance. The primary outcome measure was the simultaneous absence of at least 50% broadband penetration and at least one orthopaedic surgeon practicing in county limits. Statistical analyses using Kruskal-Wallis tests and multivariable logistic regression were conducted to assess for factors associated with inaccessibility to orthopaedic telehealth. All statistical tests were two-sided with a significance threshold of p < 0.05. RESULTS: In 2015, 14% (448 of 3141) of counties were considered "low access" in that they both had no orthopaedic surgeons and possessed less than 50% broadband access. A total of 4,660,559 people lived within these low-access counties, representing approximately 1.4% (4.6 million of 320.7 million) of the US population. After controlling for potential confounding variables, such as the age, sex, income level, and educational attainment, lower population density per square mile (OR 0.92 [95% confidence interval (CI) 0.90 to 0.94]; p < 0.01), a lower number of primary care physicians per 100,000 (OR 0.88 [95% CI 0.81 to 0.97]; p < 0.01), a higher unemployment level (OR 1.3 [95% CI 1.2 to 1.4]; p < 0.01), and greater number preventable hospital stays per 100,000 (OR 1.01 [95% CI 1.01 to 1.02]; p < 0.01) were associated with increased odds of being a low-access county (though the effect size of the finding was small for population density and number of primary care physicians). Stated another way, each additional person per square mile was associated with an 8% (95% CI 6% to 10%; p < 0.01) decrease in the odds of being a low-access county, and each additional percentage point of unemployment was associated with a 30% (95% CI 20% to 40%) increase in the odds of being a low-access county. CONCLUSION: Despite the potential for telehealth programs to improve the delivery of high-quality orthopaedic surgical care, broadband internet access remains a major barrier to implementation. Until targeted investments are made to expand broadband infrastructure across the country, health systems, policymakers, and surgeon leaders must capitalize on existing federal subsidy programs, such as the lifeline or affordability connectivity initiatives, to reach unemployed patients living in economically depressed regions. The incorporation of internet access questions into clinic-based social determinants screening may facilitate the development of alternative follow-up protocols for patients unable to participate in synchronous videoconferencing. CLINICAL RELEVANCE: Some orthopaedic patients lack the broadband capacity necessary for telehealth visits, in which case surgeons may pursue alternative methods of follow-up such as mobile phone-based surveillance of postoperative wounds, surgical sites, and clinical symptoms.

Characterization and Reach of Orthopaedic Research Posted to Preprint Servers: Are We "Undercooking" Our Science?

BACKGROUND: Although biomedical preprint servers have grown rapidly over the past several years, the harm to patient health and safety remains a major concern among several scientific communities. Despite previous studies examining the role of preprints during the Coronavirus-19 pandemic, there is limited information characterizing their impact on scientific communication in orthopaedic surgery. QUESTIONS/PURPOSES: (1) What are the characteristics (subspecialty, study design, geographic origin, and proportion of publications) of orthopaedic articles on three preprint servers? (2) What are the citation counts, abstract views, tweets, and Altmetric score per preprinted article and per corresponding publication? METHODS: Three of the largest preprint servers (medRxiv, bioRxiv, and Research Square) with a focus on biomedical topics were queried for all preprinted articles published between July 26, 2014, and September 1, 2021, using the following search terms: "orthopaedic," "orthopedic," "bone," "cartilage," "ligament," "tendon," "fracture," "dislocation," "hand," "wrist," "elbow," "shoulder," "spine," "spinal," "hip," "knee," "ankle," and "foot." Full-text articles in English related to orthopaedic surgery were included, while nonclinical studies, animal studies, duplicate studies, editorials, abstracts from conferences, and commentaries were excluded. A total of 1471 unique preprints were included and further characterized in terms of the orthopaedic subspecialty, study design, date posted, and geographic factors. Citation counts, abstract views, tweets, and Altmetric scores were collected for each preprinted article and the corresponding publication of that preprint in an accepting journal. We ascertained whether a preprinted article was published by searching title keywords and the corresponding author in three peer-reviewed article databases (PubMed, Google Scholar, and Dimensions) and confirming that the study design and research question matched. RESULTS: The number of orthopaedic preprints increased from four in 2017 to 838 in 2020. The most common orthopaedic subspecialties represented were spine, knee, and hip. From 2017 to 2020, the cumulative counts of preprinted article citations, abstract views, and Altmetric scores increased. A corresponding publication was identified in 52% (762 of 1471) of preprints. As would be expected, because preprinting is a form of redundant publication, published articles that are also preprinted saw greater abstract views, citations, and Altmetric scores on a per-article basis. CONCLUSION: Although preprints remain an extremely small proportion of all orthopaedic research, our findings suggest that nonpeer-reviewed, preprinted orthopaedic articles are being increasingly disseminated. These preprinted articles have a smaller academic and public footprint than their published counterparts, but they still reach a substantial audience through infrequent and superficial online interactions, which are far from equivalent to the engagement facilitated by peer review. Furthermore, the sequence of preprint posting and journal submission, acceptance, and publication is unclear based on the information available on these preprint servers. Thus, it is difficult to determine whether the metrics of preprinted articles are attributable to preprinting, and studies such as the present analysis will tend to overestimate the apparent impact of preprinting. Despite the potential for preprint servers to function as a venue for thoughtful feedback on research ideas, the available metrics data for these preprinted articles do not demonstrate the meaningful engagement that is achieved by peer review in terms of the frequency or depth of audience feedback. CLINICAL RELEVANCE: Our findings highlight the need for safeguards to regulate research dissemination through preprint media, which has never been shown to benefit patients and should not be considered as evidence by clinicians. Clinician-scientists and researchers have the most important responsibility of protecting patients from the harm of potentially inaccurate biomedical science and therefore must prioritize patient needs first by uncovering scientific truths through the evidence-based processes of peer review, not preprinting. We recommend all journals publishing clinical research adopt the same policy as Clinical Orthopaedics and Related Research® , The Bone & Joint Journal, The Journal of Bone and Joint Surgery, and the Journal of Orthopaedic Research , removing any papers posted to preprint servers from consideration.

Dual-Mobility Articulations in Total Hip Arthroplasty: A Durable Game Changer or the Next Cause for Concern?

The use of dual-mobility articulations in total hip arthroplasty (THA) is increasing. The appeal of dual-mobility implants rests in their ability to increase the effective ball head size for a given THA construct compared with conventional bearings, thereby reducing the risk of postoperative instability. Although the concept of dual-mobility articulation in THA is not new and early clinical experience dates back to the 1970s, its widespread use is a relatively recent phenomenon. Furthermore, unlike European surgeons who routinely use monoblock dual-mobility acetabular components in THA, the most common dual-mobility implants used in North America and worldwide are of a modular nature in which a metallic liner is coupled to a multibearing acetabular component and thus creating a metal-on-metal interface. It is important to review the evidence for the indications for dual-mobility implants in both primary and revision THA; present basic science data on the risk of corrosion in modular dual-mobility implants; and highlight the possible ongoing questions and concerns with dual-mobility implants. The goal is to provide a balanced critical review of this technology and define its current place in the hip surgeon's armamentarium.

Use of intraoperative technology in total knee arthroplasty is not associated with reductions in postoperative pain.

PURPOSE: Our systematic review and meta-analysis sought to assess how technology-assistance impacts (1) post-operative pain and (2) opioid use in patients undergoing primary total knee arthroplasty (TKA). METHODS: Four online databases were queried for studies published up to October 2021 that reported on pain and opioid usage between technology-assisted and manual TKA (mTKA) patients. Mantel-Haenszel (M-H) models were utilized to calculate pooled mean difference (MDs) and 95% confidence interval (CIs). Subgroup analyses were conducted to isolate robotic-arm assisted (RAA) and computed-assisted navigation (CAN) cohorts. Risk of bias was assessed for all included non-randomized studies with the Methodological Index for Non-Randomized Studies (MINORS) tool. For the randomized control trials included in our study, the Detsky scale was applied. RESULTS: Our analysis included 31 studies, reporting on a total of 761,300 TKAs (mTKA: n = 753,554; Computer-Assisted Navigation (CAN): n = 1,309; Robotic-Arm Assisted (RAA): n = 6437). No differences were demonstrated when evaluating WOMAC (MD: 0.00, 95% CI - 0.69 to 0.69; p = 1.00), KSS (MD: 0.01, 95% CI - 1.46 to 1.49; p = 0.99), KOOS (MD - 2.91, 95% CI - 6.17 to 0.34; p = 0.08), and VAS (MD - 0.54, 95% CI - 1.01 to - 0.007; p = 0.02) pain scores between cohorts. There was mixed evidence regarding how opioid consumption differed between TKA techniques. CONCLUSION: The present analysis demonstrated no difference in terms of pain across a variety of utilized patient-reported pain measurements. However, there were mixed results regarding how opioid consumption varied between manual and technology-assisted cohorts, particularly in the immediate post-operative period. LEVEL OF EVIDENCE: III.

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.