Medicaid and Indigent Patients Experience Delayed Fixation of Distal Radius Fractures, Resulting in Worse Consequential Radiographic Outcomes.

Distal radius fractures are the most common upper extremity injury. Patients referred to safety-net tertiary facilities following a fracture experience significant delays in treatment because of financial and language barriers as well as poor access to care at outlying community hospitals. This delay in treatment can affect postoperative functional outcomes and complication rates because of failure to restore anatomic alignment. The purpose of this multicenter study was to assess for risk factors associated with delayed fixation of distal radius fractures and evaluate the impact of delayed treatment on radiographic alignment. Patients with a distal radius fracture treated surgically during a 2-year period were identified. Measures included time from injury to surgery, demographic information, fracture classification, and radiographic parameters. The effect of surgery delay on radiographic outcomes was assessed with delayed surgery defined as 11 or more days out from injury. A total of 183 patients met study inclusion criteria. Medicaid and indigent patients were more likely to experience a delay in surgical treatment. Specifically, 70% of these patients were treated in a delayed fashion. Delayed treatment of 11 days or more was associated with worse radial height and inclination on postoperative radiographic imaging. Medicaid and indigent patients are more likely to experience delayed fixation in the treatment of distal radius fractures. This delayed surgery negatively affects postoperative radiographic outcomes. These findings suggest a need to improve access to care for Medicaid and indigent patients and to proceed with operative intervention within 10 days for distal radius fractures. [Orthopedics. 2024;47(2):e93-e97.].

Outcomes of Humerus Nonunion Surgery in Patients With Initial Operative Fracture Fixation.

OBJECTIVES: To describe outcomes following humerus aseptic nonunion surgery in patients whose initial fracture was treated operatively and to identify risk factors for nonunion surgery failure in the same population. DESIGN: Retrospective case series. SETTING: Eight, academic, level 1 trauma centers. PATIENTS SELECTION CRITERIA: Patients with aseptic humerus nonunion (OTA/AO 11 and 12) after the initial operative management between 1998 and 2019. OUTCOME MEASURES AND COMPARISONS: Success rate of nonunion surgery. RESULTS: Ninety patients were included (56% female; median age 50 years; mean follow-up 21.2 months). Of 90 aseptic humerus nonunions, 71 (78.9%) united following nonunion surgery. Thirty patients (33.3%) experienced 1 or more postoperative complications, including infection, failure of fixation, and readmission. Multivariate analysis found that not performing revision internal fixation during nonunion surgery (n = 8; P = 0.002) and postoperative de novo infection (n = 9; P = 0.005) were associated with an increased risk of recalcitrant nonunion. Patient smoking status and the use of bone graft were not associated with differences in the nonunion repair success rate. CONCLUSIONS: This series of previously operated aseptic humerus nonunions found that more than 1 in 5 patients failed nonunion repair. De novo postoperative infection and failure to perform revision internal fixation during nonunion surgery were associated with recalcitrant nonunion. Smoking and use of bone graft did not influence the success rate of nonunion surgery. These findings can be used to give patients a realistic expectation of results and complications following humerus nonunion surgery. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

A scoping review of operative and non-invasive management in the treatment of non-unions.

INTRODUCTION: Non-union occurs when a fracture fails to adequately heal, and requires additional intervention to achieve union. The purpose of this scoping review is to provide a high-level overview of the existing non-union management literature. This review aims to highlight the current literature on non-union management, as well as identify key areas that require future research to provide a better understanding of potential non-union management strategies. METHODS: This study utilized the scoping review framework from Arksey and O'Malley All relevant literature on non-union management was systematically searched for within the OVID Medline, OVID Embase, and Web of Science databases. As a scoping review, this study aimed to identify the high-level trends in non-union literature. This was assessed through a visual and numerical summary of the general themes in non-union literature, as well as the timeline in which these trends have occurred. RESULTS: The literature search identified 8081 articles, of which 2210 articles were included. There is a large body of evidence for various surgical treatment options for non-union. The literature suggests healing rates between 80 and 100 percent for commonly utilized surgical procedures, such as plating with bone graft for long bones. Despite these beneficial healing rates, the requirement of a surgery creates a large socioeconomic burden. The possibility for bone growth stimulator (BGS) options to achieve non-union healing rates in a similar realm as surgical options suggests that the use of a BGS may be a beneficial option prior to surgical intervention, as this would potentially reduce the number of patients who would otherwise require surgery. CONCLUSION: A large body of evidence exists on non-union management, which is largely comprised of case series and reports. The most commonly assessed non-unions include the tibia, wrist, and femur. Bone grafting, plating, and nailing are the most investigated treatment options. BGS are a non-operative treatment options for non-union that provide similar healing rates to surgical options in certain indications within initial observational data. BGS are a potential option for non-operative management of non-unions to reduce socioeconomic burdens of surgical intervention, with a need for further high-quality investigation in this therapeutic area.

Risk factors for nonunion following surgically managed, traumatic, diaphyseal fractures: a systematic review and meta-analysis.

Background: There are several studies on nonunion, but there are no systematic overviews of the current evidence of risk factors for nonunion. The aim of this study was to systematically review risk factors for nonunion following surgically managed, traumatic, diaphyseal fractures. Methods: Medline, Embase, Scopus, and Cochrane were searched using a search string developed with aid from a scientific librarian. The studies were screened independently by two authors using Covidence. We solely included studies with at least ten nonunions. Eligible study data were extracted, and the studies were critically appraised. We performed random-effects meta-analyses for those risk factors included in five or more studies. PROSPERO registration number: CRD42021235213. Results: Of 11,738 records screened, 30 were eligible, and these included 38,465 patients. Twenty-five studies were eligible for meta-analyses. Nonunion was associated with smoking (odds ratio (OR): 1.7, 95% CI: 1.2-2.4), open fractures (OR: 2.6, 95% CI: 1.8-3.9), diabetes (OR: 1.6, 95% CI: 1.3-2.0), infection (OR: 7.0, 95% CI: 3.2-15.0), obesity (OR: 1.5, 95% CI: 1.1-1.9), increasing Gustilo classification (OR: 2.2, 95% CI: 1.4-3.7), and AO classification (OR: 2.4, 95% CI: 1.5-3.7). The studies were generally assessed to be of poor quality, mainly because of the possible risk of bias due to confounding, unclear outcome measurements, and missing data. Conclusion: Establishing compelling evidence is challenging because the current studies are observational and at risk of bias. We conclude that several risk factors are associated with nonunion following surgically managed, traumatic, diaphyseal fractures and should be included as confounders in future studies.

High Return to Play and Low Reinjury Rates in National Collegiate Athletic Association Division I Football Players Following Anterior Cruciate Ligament Reconstruction Using Quadrupled Hamstring Autograft.

PURPOSE: The purpose of this study was to examine the outcomes of anterior cruciate ligament (ACL) reconstruction using quadrupled hamstring (QH) autograft in a cohort of National Collegiate Athletic Association (NCAA) Division I football players. METHODS: A retrospective analysis was performed on NCAA Division I football players at a single institution who had transtibial ACL reconstruction using QH autograft between 2001 and 2016. Primary outcomes were ACL reinjury and return to play (RTP). Secondary outcomes were position, percent of eligibility used after surgery, graft diameter, Tegner-Lysholm scores, concomitant injuries/surgeries, and postcollegiate professional play. RESULTS: Between 2001 and 2016, 34 players had QH autograft ACL reconstruction, and 29 players achieved RTP. Of the 29, 2 (6.9%) sustained ACL reinjuries. The average RTP was 318 days (range 115-628) after surgery. Players used 79.5% of their remaining collegiate eligibility after surgery. Nine players sustained multiligamentous knee injuries. This did not have a significant effect on RTP (P = 0.709; mean 306±24 days for isolated ACL, mean of 353±51 for 2 ligaments, mean of 324±114 for 3 + ligaments) and none sustained reinjury. Associated meniscal injuries were sustained by 28, and 8 sustained chondral injuries. The mean postoperative Tegner-Lysholm score was 90.7 of 100, with mean follow-up of 102 months. Of these players, 18 went on to play professionally, with 17 joining National Football League rosters and 1 an arena team roster. CONCLUSION: QH demonstrated an ACL reinjury and RTP rates similar to those in previously published, predominantly bone-patella tendon-bone ACL reinjury data in elite athletes. This study demonstrates that QH autograft may be a viable option in elite athletes. LEVEL OF EVIDENCE: IV, case series.

Low intensity pulsed ultrasound (LIPUS) use for the management of instrumented, infected, and fragility non-unions: a systematic review and meta-analysis of healing proportions.

BACKGROUND: Non-union occurs in approximately 5 to 10% of fracture patients, with certain bones at greater risk of failing to heal. Non-unions have a significant impact on socioeconomic costs and the patients short and long-term quality of life. Low intensity pulsed ultrasound (LIPUS) is a non-invasive therapy for non-union treatment that can improve the long-term outcome. The purpose of this study is to summarize the available literature assessing LIPUS potential to improve the union rate in instrumented, infected, and fragility non-unions. METHODS: A literature search was conducted in the MEDLINE, EMBASE, and CINAHL databases for all relevant literature on the healing rates of LIPUS utilized in instrumented, infected, and fragility non-unions. Study characteristics were summarized for each of the included studies. The percentage of healed patients (healing rate), for instrumented, infected, and fragility fracture non-union patients were pooled from each included study. RESULTS: The literature search identified a total of 326 articles, while searching reference lists and grey literature identified an additional 3 articles. There was a total of 29 articles included in this review, with 20 articles included within the quantitative synthesis of healing rates. The most common design of included studies was case series (17 articles), followed by case reports (9 articles). Studies were primarily retrospective (18 studies), with an additional 10 prospective studies. Non-union healing rates were 82% (95% CI: 76 to 87%) in instrumented, 82% (95% CI: 70 to 95%) in infected, and 91% (95% CI: 87 to 95%) in fragility fracture patients with non-unions. CONCLUSION: This study has provided a thorough overview of the current literature on LIPUS treatment for instrumented, infected, and fragility fracture non-unions. The healing rates for non-unions in these subgroups were comparable to healing rates observed with LIPUS use in general non-union literature. LIPUS treatment should be considered as a conservative non-surgical treatment option to potentially reduce the socioeconomic impact and improve the quality of life of these unfortunate patients. LEVEL OF EVIDENCE: 4 (systematic review of primarily case series data).

Serious adverse events and 30-day hospital readmission rate following elective total knee arthroplasty: a systematic review and meta-analysis.

BACKGROUND: Elective total knee arthroplasty (TKA) is a common surgery which has evolved rapidly. However, there are no recent large systematic reviews of serious adverse event (SAE) rate and 30-day readmission rate (30-dRR) or an indication of whether surgical methods have improved. METHODS: To obtain a pooled estimate of SAE rate and 30-dRR following TKA, we searched Medline, Web of Science, Cochrane Library, and Google Scholar databases. Data were extracted by two authors following PRISMA guidelines. Eligibility criteria were defined prior to a comprehensive search. Studies were eligible if they were published in 2007 or later, described sequelae of TKA with patient N > 1000, and the SAE or 30-dRR rate could be calculated. SAEs included return to operating room, death or coma, venous thromboembolism (VTE), deep infection or sepsis, myocardial infarction, heart failure or cardiac arrest, stroke or cerebrovascular accident, or pneumonia. RESULTS: Of 248 references reviewed, 28 are included, involving 10,153,503 patients; this includes 9,483,387 patients with primary TKA (pTKA), and 670,116 patients with revision TKA (rTKA). For pTKA, the SAE rate was 5.7% (95% CI 4.4-7.2%, I2 = 100%), and the 30-dRR was 4.8% (95% CI 4.3-5.4%, I2 = 100%). For rTKA, the SAE rate was 8.5% (95% CI 8.3-8.7%, I2 = 77%), while the 30-dRR was 7.2% (95% CI 6.4-8.0%, I2 = 81%). Odds of 30-dRR following pTKA were about half that of rTKA (OR 0.57, 95% CI 0.53-0.62%, p < 0.001, I2 = 45%). Of patients who received pTKA, the commonest SAEs were VTE (1.22%; 95% CI 0.83-1.70%) and genitourinary complications including renal insufficiency or renal failure (1.22%; 95% CI 0.83-1.67%). There has been significant improvement in SAE rate and 30-dRR since 2010 (χ2 test < 0.001). CONCLUSIONS: TKA procedures have a relatively low complication rate, and there has been a significant improvement in SAE rate and 30-dRR over the past decade.

Heterotopic Ossification Following Arthroplasty for Femoral Neck Fracture.

BACKGROUND: Heterotopic ossification (HO) is a frequent complication following hip surgery. Using data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial, we aimed to (1) determine the prevalence of HO following total hip arthroplasty (THA) for femoral neck fracture in patients ≥50 years of age, (2) identify whether HO is associated with an increased risk of revision surgery within 24 months after the fracture, and (3) determine the impact of HO on functional outcomes. METHODS: We performed a multivariable Cox regression analysis using revision surgery as the dependent variable and HO as the independent variable. We compared Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores between participants with and those without HO at 24 months. RESULTS: Of 1,441 participants in the study, 287 (19.9%) developed HO within 24 months. HO was not associated with subsequent revision surgery. Grade-III HO was associated with statistically significant and clinically relevant deterioration in the total WOMAC score, which was mainly related to the function component of the score, compared with grade I or II. CONCLUSIONS: The impact of grade-III HO on the functional outcomes and quality of life after THA for hip fracture is clinically important, and HO prophylaxis for selected high-risk patients may be appropriate. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial.

Importance: Despite the widespread use of systemic antibiotics to prevent infections in surgically treated patients with fracture, high rates of surgical site infection persist. Objective: To examine the effect of intrawound vancomycin powder in reducing deep surgical site infections. Design, Setting, and Participants: This open-label randomized clinical trial enrolled adult patients with an operatively treated tibial plateau or pilon fracture who met the criteria for a high risk of infection from January 1, 2015, through June 30, 2017, with 12 months of follow-up (final follow-up assessments completed in April 2018) at 36 US trauma centers. Interventions: A standard infection prevention protocol with (n = 481) or without (n = 499) 1000 mg of intrawound vancomycin powder. Main Outcomes and Measures: The primary outcome was a deep surgical site infection within 182 days of definitive fracture fixation. A post hoc comparison assessed the treatment effect on gram-positive and gram-negative-only infections. Other secondary outcomes included superficial surgical site infection, nonunion, and wound dehiscence. Results: The analysis included 980 patients (mean [SD] age, 45.7 [13.7] years; 617 [63.0%] male) with 91% of the expected person-time of follow-up for the primary outcome. Within 182 days, deep surgical site infection was observed in 29 of 481 patients in the treatment group and 46 of 499 patients in the control group. The time-to-event estimated probability of deep infection by 182 days was 6.4% in the treatment group and 9.8% in the control group (risk difference, -3.4%; 95% CI, -6.9% to 0.1%; P = .06). A post hoc analysis of the effect of treatment on gram-positive (risk difference, -3.7%; 95% CI, -6.7% to -0.8%; P = .02) and gram-negative-only (risk difference, 0.3%; 95% CI, -1.6% to 2.1%; P = .78) infections found that the effect of vancomycin powder was a result of its reduction in gram-positive infections. Conclusions and Relevance: Among patients with operatively treated tibial articular fractures at a high risk of infection, intrawound vancomycin powder at the time of definitive fracture fixation reduced the risk of a gram-positive deep surgical site infection, consistent with the activity of vancomycin. Trial Registration: ClinicalTrials.gov Identifier: NCT02227446.

Real-World Evidence: A Primer.

SUMMARY: The insights that real-world data (RWD) can provide, beyond what can be learned within the traditional clinical trial setting, have gained enormous traction in recent years. RWD, which are increasingly available and accessible, can further our understanding of disease, disease progression, and safety and effectiveness of treatments with the speed and accuracy required by the health care environment and patients today. Over the decades since RWD were first recognized, innovation has evolved to take real-world research beyond finding ways to identify, store, and analyze large volumes of data. The research community has developed strong methods to address challenges of using RWD and as a result has increased the acceptance of RWD in research, practice, and policy. Historic concerns about RWD relate to data quality, privacy, and transparency; however, new tools, methods, and approaches mitigate these challenges and expand the utility of RWD to new applications. Specific guidelines for RWD use have been developed and published by numerous groups, including regulatory authorities. These and other efforts have shown that the more RWD are used and understood and the more the tools for handling it are refined, the more useful it will be.

Randomized Clinical Trial or Real-World Evidence: How Historical Events, Public Demand, and the Resulting Laws and Regulations Shaped the Body of Medical Evidence.

SUMMARY: The signing of the 21st Centuries Cures Act in 2016 was a confirmational step in a long journey toward an understood use and need for real-world evidence (RWE), even though the Food and Drug Administration (FDA) had the legislative authority to accept RWE since 1962 to demonstrate efficacy. The 21st Century Cures Act, as well as the subsequent FDA guidance published in 2017 and other supporting guidance, documents that since are opening the doors for the clinical and research community. They specifically allow for labeling changes and indication expansion based on RWE. The legislative discussion of efficacy requirements started in the late 1950s, when evidence of effectiveness was not required in the United States before the marketing of a drug or medical device, and calls for the real-world comparative effectiveness research were being made by Senator Estes Kefauver. When the thalidomide tragedy stuck, Congress and the Kennedy Administration rushed to pass a new law to require that drugs be "effective in use." The regulations subsequently drafted by the FDA to enforce the law often required placebo-controlled, randomized clinical trials (RCTs). In the 1980s, some started to label the RCT as the gold standard for medical evidence. The use of real-world data for new indication approval was not specifically prohibited by the 1962 law, but the new 2016 law sent a clear mandate to FDA, requiring the agency to review new forms of evidence such as RWE.

Breaking Barriers: Studying Fracture Healing in the BONES Program.

SUMMARY: The Bioventus Observational Noninterventional EXOGEN Studies (BONES) Program includes 3 concurrent studies designed to estimate the incidence of fracture nonunions in patients treated with the EXOGEN Ultrasound Bone Healing System compared with those receiving standard fracture care. This article outlines the design and methodology within the fifth metatarsal fracture study; similar approaches are taken in the second and third BONES Program studies, which examine nonunions of the tibia and scaphoid. The BONES Program is an external comparator design and incorporates several unique, fit-for-purpose components to strengthen the approach and allow it to be submitted to the US Food and Drug Administration (FDA) to be considered for a label expansion. BONES consisted of 2 cohorts: (1) EXOGEN-treated patients recruited into a patient registry and (2) comparator patients from a large administrative health claims database. The study used International Classification of Diseases, Tenth Revision, nonunion diagnosis codes reported by the treating clinician for the primary outcome measure. Many data sources (medical and billing records, patient-reported health data, usage data from the device itself, and commercial product complaint system) were used on the registry side, alongside insurance claims data to source the external comparator cohort, to achieve broader understanding of factors predisposing patients to the development of nonunions. In step with the FDA's increasing acceptance of real-world evidence for use in regulatory decision making and coupled with the infeasibility of a randomized clinical trial in this setting, the innovative study design of the BONES Program allowed for both an evaluation of the effect of EXOGEN in mitigating nonunions in a real-world setting and an assessment of the patient experience with EXOGEN treatment.

Methodologies for Validation of Diagnoses in Real-World Data: BONES-A Case Study.

SUMMARY: The accuracy of any claim-based study is dependent on the quality of real-world coding of the condition of interest. This retrospective, administrative claims analysis presents a method for using a real-world data source to evaluate the accuracy of coding for nonunion of a fifth metatarsal fracture. Patients 21-80 years old with a diagnosis of a fifth metatarsal fracture between January 1, 2016, and October 31, 2016, and a nonunion of the fifth metatarsal fracture within the next 9 months were identified in the MarketScan Databases. Patient health care claims in the 12 months after the nonunion diagnosis were examined for health care encounters and pharmaceutical treatments considered indicative of treatment for nonunion, such as claims for bone growth stimulation or a second claim with a diagnosis of nonunion. Of the 230 patients who had at least one health care encounter attributable to a nonunion of the fifth metatarsal, 95.2% had at least one subsequent health care encounter confirming nonunion diagnosis. The mean number of supporting health care claims was 5.8, and the mean time between nonunion and first confirmatory claim was 33 days. This analysis demonstrated a method for evaluating the quality of coding for a specific condition when a traditional medical chart comparison is not feasible.

Association of COVID-19 With Achieving Time-to-Surgery Benchmarks in Patients With Musculoskeletal Trauma.

Importance: In response to the COVID-19 pandemic, many hospital systems were forced to reduce operating room capacity and reallocate resources. The outcomes of these policies on the care of injured patients and the maintenance of emergency services have not been adequately reported. Objective: To evaluate whether the COVID-19 pandemic was associated with delays in urgent fracture surgery beyond national time-to-surgery benchmarks. Design Setting and Participants: This retrospective cohort study used data collected in the Program of Randomized Trials to Evaluate Preoperative Antiseptic Skin Solutions in Orthopaedic Trauma among at 20 sites throughout the US and Canada and included patients who sustained open fractures or closed femur or hip fractures. Exposure: COVID-19-era operating room restrictions were compared with pre-COVID-19 data. Main Outcomes and Measures: Surgery within 24 hours after injury. Results: A total of 3589 patients (mean [SD] age, 55 [25.4] years; 1913 [53.3%] male) were included in this study, 2175 pre-COVID-19 and 1414 during COVID-19. A total of 54 patients (3.1%) in the open fracture cohort and 407 patients (21.8%) in the closed hip/femur fracture cohort did not meet 24-hour time-to-surgery benchmarks. We were unable to detect any association between time to operating room and COVID-19 era in either open fracture (odds ratio [OR], 1.40; 95% CI, 0.77-2.55; P = .28) or closed femur/hip fracture (OR, 1.01; 95% CI, 0.74-1.37; P = .97) cohorts. In the closed femur/hip fracture cohort, there was no association between time to operating room and regional COVID-19 prevalence (OR, 1.07; 95% CI, 0.70-1.64; P = .76). Conclusions and Relevance: In this cohort study, there was no association between meeting time-to-surgery benchmarks in either open fracture or closed femur/hip fracture during the COVID-19 pandemic compared with before the pandemic. This is counter to concerns that the unprecedented challenges associated with managing the COVID-19 pandemic would be associated with clinically significant delays in acute management of urgent surgical cases and suggests that many hospital systems within the US were able to effectively implement policies consistent with time-to-surgery standards for orthopedic trauma in the context of COVID-19-related resource constraints.

Gunshot Wounds to the Hip: Doomed to Failure?

The purpose is to evaluate hip fractures due to gunshot wounds (GSW) to the hip, which are treated surgically, and the complications. Patients who sustained a low velocity GSW with fracture to the femoral head/neck and intertrochanteric/peritrochantric region at three Level 1 Trauma Centers were eligible. There were 69 patients (63 males-91%), with an average age of 29 (18-60). Nine patients had orthopaedic surgical site infections. There were 6 nonunions, 4 patients with hardware failure, 2 cases of avascular necrosis (AVN), 3 patients with post traumatic arthritis (PTA) and 20 patients with heterotopic ossification (HO). There was no significant difference found regarding fracture site or type of fixation with regards to complications. This represents the largest study of surgically treated GSW to the hip. Of patients studied, 61% sustained additional GSW. These injuries are not benign; the main complications being infection and heterotopic ossification. (Journal of Surgical Orthopaedic Advances 29(3):135-140, 2020).

Impact of COVID-19 on orthopaedic care: a call for nonoperative management.

BACKGROUND: Surgical specialties face unique challenges caused by SARS-COV-2 (COVID-19). These disruptions will call on clinicians to have greater consideration for non-operative treatment options to help manage patient symptoms and provide therapeutic care in lieu of the traditional surgical management course of action. This study aimed to summarize the current guidance on elective surgery during the COVID-19 pandemic, assess how this guidance may impact orthopaedic care, and review any recommendations for non-operative management in light of elective surgery disruptions. METHODS: A systematic search was conducted, and included guidance were categorized as either "Selective Postponement" or "Complete Postponement" of elective surgery. Selective postponement was considered as guidance that suggested elective cases should be evaluated on a case-by-case basis, whereas complete postponement suggested that all elective procedures be postponed until after the pandemic, with no case-by-case consideration. In addition, any statements regarding conservative/non-operative management were summarized when provided by included reports. RESULTS: A total of 11 reports from nine different health organizations were included in this review. There were seven (63.6%) guidance reports that suggested a complete postponement of non-elective surgical procedures, whereas four (36.4%) reports suggested the use of selective postponement of these procedures. The guidance trends shifted from selective to complete elective surgery postponement occurred throughout the month of March. The general guidance provided by these reports was to have an increased consideration for non-operative treatment options whenever possible and safe. As elective surgery begins to re-open, non-operative management will play a key role in managing the surgical backlog caused by the elective surgery shutdown. CONCLUSION: Global guidance from major medical associations are in agreement that elective surgical procedures require postponement in order to minimize the risk of COVID-19 spread, as well as increase available hospital resources for managing the influx of COVID-19 patients. It is imperative that clinicians and patients consider non-operative, conservative treatment options in order to manage conditions and symptoms until surgical management options become available again, and to manage the increased surgical waitlists caused by the elective surgery shutdowns.

Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol.

Importance: The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair. Objective: To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair. Design, Setting, and Participants: The PREP-IT (Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma) master protocol will be followed to conduct 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities). The Aqueous-PREP trial will compare 4% aqueous chlorhexidine vs 10% povidone-iodine for patients with open extremity fractures. The PREPARE trial will compare 2% chlorhexidine in 70% isopropyl alcohol vs 0.7% iodine povacrylex in 74% isopropyl alcohol for patients with open extremity fractures and patients with closed lower extremity or pelvic fractures. Both trials will share key aspects of study design and trial infrastructure. The studies will follow a pragmatic cluster randomized crossover design with alternating treatment periods of approximately 2 months. The primary outcome will be surgical site infection and the secondary outcome will be unplanned fracture-related reoperations within 12 months. The Aqueous-PREP trial will enroll a minimum of 1540 patients with open extremity fractures from at least 12 hospitals; PREPARE will enroll a minimum of 1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals. The primary analyses will adhere to the intention-to-treat principle and account for potential between-cluster and between-period variability. The patient-centered design, implementation, and dissemination of results are guided by a multidisciplinary team that includes 3 patients and other relevant stakeholders. Discussion: The PREP-IT master protocol increases efficiency through shared trial infrastructure and study design components. Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results of the PREP-IT trials are poised to inform clinical guidelines and bring about an immediate change in clinical practice. Trial Registration: ClinicalTrials.gov Identifiers: NCT03385304 and NCT03523962.