Hip Surgery is Not More Painful Than Spine Surgery in Children With Cerebral Palsy.

BACKGROUND: Posterior spinal fusion (PSF) and hip reconstruction are commonly indicated surgeries in children with cerebral palsy (CP), particularly those functioning at GMFCS levels IV and V. These are large and often painful procedures, and previous literature suggests that hip surgery is more painful than spine surgery in this patient population. The purpose of this study is to investigate pain scores and opioid use following hip and spine surgery in a large cohort of children with CP, including many patients who have undergone both types of surgery. METHODS: A retrospective chart review was performed to identify children with CP who underwent hip reconstruction and/or PSF at a tertiary children's hospital between 2004 and 2022. Charts were reviewed for demographic data, pain scores, pain medication usage, duration of hospital stay, and complications. RESULTS: Data were collected for 200 patients (101 male, 99 female) who met inclusion criteria. Eighty-seven patients underwent hip reconstruction, 62 spinal fusion, and 51 both hip and spine surgery asynchronously. Median (interquartile range) age at the time of surgery was significantly older for spinal fusion compared with hip surgery [13.1 (4.9) vs. 8.1 (5.7) y, P<0.0001]. Length of stay was significantly longer after PSF, with a median of 6 (4) days compared with 2 (1) days after hip surgery (P<0.0001). Both maximum and average daily pain scores were similar following hip and spine surgery, with the exception that average pain scores for hip surgery were slightly higher on postoperative day 1, hip=1.73 vs. spine=1.0 (P<0.0001). The amount of opioids used, expressed as morphine milligram equivalents (MME)/kg were similar in the hip and spine surgery groups; however, it was significantly lower in the hip surgery group on postoperative day 0, hip=0.06 versus spine=0.17 (P<0.0001). For the 51 patients who underwent both hip and spine surgery, the amount of opioids used mirrored that for the entire group (similar MME/kg, though only statistically significantly less on POD 0 and 3), and pain scores were not significantly different between the 2 groups except in 2 circumstances. The 2 exceptions in these 51 patients both demonstrated lower pain scores in patients after hip surgery, including lower maximum pain scores on POD 1 (P=0.041), and lower average pain scores on POD3 (P=0.043). CONCLUSIONS: This is the largest series to date comparing postoperative pain in children with CP after hip and spine surgery, including 51 of 200 patients who underwent both types of surgery. The results of this study demonstrate that hip surgery is not more painful than spine surgery in children with CP, and conflict with the traditional belief that hip surgery is more painful. This is important information for health care providers when counseling patients and families regarding these surgeries in children with CP. LEVEL OF EVIDENCE: Level 3.

How Many Imaging Studies Do Patients With Neuromuscular Early Onset Scoliosis (EOS) Receive?

BACKGROUND: Children with neuromuscular early onset scoliosis (EOS) receive numerous radiographic studies both from orthopaedic and other specialties. Ionizing radiation doses delivered by computed tomography (CT) are reportedly 100 times higher than conventional radiography. The purpose of this study was to evaluate the number of radiographic studies ordered for neuromuscular EOS patients during their care. METHODS: Retrospective review at a tertiary children's hospital from January 2010 to June 2021 included all patients with neuromuscular EOS followed by an orthopaedic specialist for a minimum of 3 years. Patients were excluded if the majority of their nonorthopaedic care was provided by outside institutions. RESULTS: Eighteen patients met inclusion criteria with mean follow up of 6.4±2.3 years. A total of 1312 plain radiographs and 35 CT scans were performed. Of the plain radiographs, 34.7% were ordered by orthopaedic providers and 65.3% (857/1312) were ordered by other providers. Of the CT scans, 4 were ordered by orthopaedic providers, while 88.5% (21/35) were ordered by other providers. An average of 74.7 (range: 29 to 124) radiographs and 1.9 (range: 0 to 9) CT scans ordered over the course of each patient's treatment for an average of 13.0±6.0 radiographs and 0.3 CT scans per year. CONCLUSIONS: With an average of 75 radiographs and 1.9 CT scans performed per patient, consideration for steps to limit exposure to ionizing radiation should be made a particularly high priority in this unique subset of patients. This requires interdisciplinary coordination as 65% of the radiographs and over 80% of the CT scans were ordered by nonorthopaedic providers. LEVEL OF EVIDENCE: Level III.

Highly Specific Detection of Oxytocin in Saliva.

Oxytocin is a peptide neurophysin hormone made up of nine amino acids and is used in induction of one in four births worldwide (more than 13 percent in the United States). Herein, we have developed an antibody alternative aptamer-based electrochemical assay for real-time and point-of-care detection of oxytocin in non-invasive saliva samples. This assay approach is rapid, highly sensitive, specific, and cost-effective. Our aptamer-based electrochemical assay can detect as little as 1 pg/mL of oxytocin in less than 2 min in commercially available pooled saliva samples. Additionally, we did not observe any false positive or false negative signals. This electrochemical assay has the potential to be utilized as a point-of-care monitor for rapid and real-time oxytocin detection in various biological samples such as saliva, blood, and hair extracts.

Transforming Your Operating Room into a High Functioning Team: A Survival Guide for Junior Attendings in the OR.

In this article, we outline several key concepts to help develop your operating room team. This is an evolutionary process with numerous benefits to the team members, surgeon, and most importantly the patients. We outline strategies for engaging and preparing your team members so that the operating room runs more efficiently. We also outline the do's and don'ts of building trust amongst team members which is critical to transforming into a high functioning team.

Disparities in Pediatric Scoliosis: The Impact of Race and Insurance Type on Access to Nonoperative Treatment for Adolescent Idiopathic Scoliosis.

BACKGROUND: Adolescent idiopathic scoliosis (AIS) has evidence-based, nonoperative treatments proven to be effective with early diagnosis and prompt treatment. The purpose of this study was to identify potential disparities in access to nonoperative treatment for AIS. Specifically, we sought to determine the interaction of socioeconomic factors on a major curve magnitude and recommend treatment at the initial presentation. METHODS: A retrospective review of AIS patients who underwent surgery at a single tertiary pediatric hospital between January 1, 2013 and December 31, 2018 was conducted. Patients were divided into 2 groups for comparison: patients with public insurance (PUB) and those with private insurance (PRV). Primary variables analyzed were patient race, Area Deprivation Index (ADI), major curve magnitude, and treatment recommendation at the initial presentation. Univariate and multivariate analyses were conducted to identify the predictors of the major curve magnitude at presentation. RESULTS: A total of 341 patients met the inclusion criteria; PUB and PRV groups consisted of 182 (53.4%) and 159 (46.6%) children, respectively. Overall, the major curve magnitude at presentation was significantly higher in PUB compared with PRV patients (50.0° vs. 45.1°; P =0.004) and higher in Black patients compared to White patients (51.8 vs. 47.0, P =0.042). Surgery was recommended for 49.7% of the PUB group and 43.7% of the PRV group. A lesser number of PUB patients had curve magnitudes within the range of brace indications (≤40°) compared to PRV patients (22.5% vs. 35.2%, respectively; P =0.010). The odds of having an initial major curve magnitude <40 degrees were 67% lower among Black patients with public insurance compared to Black patients with private insurance (OR=0.33; 95% CI: 0.13-0.83; P =0.019). CONCLUSION: This study demonstrated disparity in access to nonoperative treatment for pediatric scoliosis. Black patients with public insurance were the most at-risk to present with curve magnitudes exceeding brace indications. Future work focused on understanding the reasons for this significant disparity may help to promote more equitable access to effective nonoperative treatment for adolescent idiopathic scoliosis. LEVEL OF EVIDENCE: III.

The Feasibility of Utilizing Malunion Criteria to Limit Radiographs After Spica Casting for Pediatric Femur Fractures.

BACKGROUND: There are no existing guidelines regarding the timing or frequency of postoperative radiographs following spica casting for pediatric femur fractures. The purpose of this study was to evaluate established femoral malunion criteria as a potential screening tool to limit postoperative radiographs by identifying patients at risk for unacceptable alignment in the early treatment period. METHODS: A retrospective chart review was conducted for pediatric femoral shaft fractures presenting to a tertiary pediatric referral hospital from 2012 to 2017. Pediatric femur malunion criteria were applied to radiographs at initial presentation, first follow-up visit, and final follow-up visit. The primary outcome was a change in management based on radiographic findings in the early postoperative period. Secondary outcomes included radiographic measures, number of follow-up visits, and complications. RESULTS: Of 449 consecutive pediatric femur fractures treated at our center, 149 patients aged 1 to 4 years (mean age: 2.5±1.6 y) met inclusion criteria. At initial presentation, 36.9% (55/149) of patients met malunion criteria. Only 4.0% (6/149) of patients had a change in management following initial closed reduction and spica cast application due to radiographic findings at subsequent follow-up. Of these patients, 67% (4/6) were identified on preoperative imaging, and 83.3% (5/6) were identified by their first clinic appointment. Four of the 149 patients were converted to definitive surgical fixation, and 2 patients required cast wedging due to either unacceptable fracture shortening or coronal/sagittal angulation. CONCLUSIONS: Routine early postoperative radiographs may not be necessary for all pediatric femur fractures managed with closed reduction and spica casting. The value of this study is that it is the first to demonstrate the feasibility of limiting postoperative radiographs using a preoperative screening tool. However, the established femoral malunion criteria utilized in this study were limited in their predictive value, and further work is necessary to improve the sensitivity and specificity before widespread clinical application. LEVEL OF EVIDENCE: Level IV.

The Effect of Surgeon Experience on Outcomes Following Growth Friendly Instrumentation for Early Onset Scoliosis.

BACKGROUND: The purpose of this study was to utilize a multicenter, multisurgeon cohort to assess the effect of surgeon experience on outcomes of growth friendly instrumentation (GFI) in early onset scoliosis (EOS). We hypothesized that unplanned return to the operating room (UPROR), estimated blood loss (EBL), and surgical time would be greater amongst early career surgeons (ECSs) when compared with advanced career surgeons (ACSs). METHODS: An international pediatric spine database was queried for patients ages 2 to 10 years treated by posterior distraction-based GFI with at least of 2-year follow up. Two groups were created for analysis based on surgeon experience: ECSs (with ≤10 y of experience) and ACSs (with >10 y of experience). The primary outcome was UPROR. Additional outcomes included: operating room time, EBL, neurological deficits, infection rate, hardware failure, and the Early Onset Scoliosis Questionnaire (EOSQ-24). Subgroup analysis was performed for further assessment based on procedure type, superior anchor type, etiology, and curve severity. RESULTS: A total of 960 patients met inclusion criteria including 243 (25.3%) treated by ECS. Etiology, sex, superior anchor, and EOSQ-24 scores were similar between groups (P>0.05). There were no clinically significant differences in patient age or preoperative major coronal curve. UPROR (35.8% vs. 32.7%, P=0.532), infection (17.0% vs. 15.6%, P=0.698), operating room time (235 vs. 231 min, P=0.755), and EBL (151 vs. 155 mL, P=0.833) were comparable between ECS and ACS groups. The frequency of having at least 1 complication was relatively high but comparable among groups (60.7% vs. 62.6%, P=0.709). EOSQ-24 subdomain scores were similar between groups at 2-year follow-up (P>0.05). Subgroup analysis revealed that ECS had increased surgical time compared with ACS in severe curves >90 degrees (270 vs. 229 min, P=0.05). CONCLUSIONS: This study represents the first multicenter assessment of surgeon experience on outcomes in EOS. Overall, surgeon experience did not significantly influence UPROR, complication rates, EBL, or surgical time associated with GFI in this cohort of EOS patients. LEVEL OF EVIDENCE: Level III.

The ChorioAnchor: Design and Testing of a Novel Chorioamniotic Anchoring Device to Enable Percutaneous Fetoscopic Surgery.

INTRODUCTION: Percutaneous fetoscopic surgery is hampered by an increased risk of preterm prelabor rupture of membranes (PPROM). Recent surgical techniques have shown that suturing the chorioamniotic membranes following laparotomy and uterine exteriorization is associated with a lower risk of PPROM compared to percutaneous in utero surgery. This study presents the ChorioAnchor, a novel resorbable device that percutaneously anchors the chorioamniotic membranes to the uterine wall. METHODS: Human factors testing and peel tests were used to simulate the worst-case in-use loading conditions, establishing the device strength requirements. Tensile testing was used to measure the time-zero strength of the device. Porcine cadaver testing was used to examine ultrasound visibility and acute handling characteristics. Short-term host response was examined through an acute 7-day implantation study in a rabbit model. RESULTS: With a time-zero tensile strength of 47 N, the ChorioAnchor exceeded the established 4 N strength requirement. Both the ChorioAnchor and delivery device were seen to be clearly visible under ultrasound imaging. Short-term host response to the device was well within the range expected for this type of device. CONCLUSION: The ChorioAnchor meets its engineering requirements in the early stages of implantation. Future studies will examine the kinetics of degradation of the device in vitro and in vivo.

Comparison of Short-leg and Long-leg Casts for the Treatment of Distal Third Tibial Shaft Fractures in Children.

BACKGROUND: Long-leg casts (LLCs) are an established treatment for pediatric tibial shaft fractures including fractures involving the distal third. There is a paucity of literature assessing the use of short-leg cast (SLC) for tibial shaft fractures. The purpose of this study was to determine if SLC were as effective as LLC for the treatment of pediatric distal third tibial shaft fractures. METHODS: A retrospective review was conducted on consecutive distal third tibial shaft fractures treated at a tertiary pediatric hospital from 2013 to 2018. Exclusion criteria included midshaft and proximal fractures of the tibia, distal fractures that violated the tibial physis or plafond, and pathologic fractures. We compared primary outcomes of time to weight-bearing, time to union, and final angulation between LLC and SLC groups. RESULTS: Eighty-five patients aged 5 to 17 years (mean age: 9.2±3.2 y) met inclusion criteria, including 50 LLC and 35 SLC patients. Time to weight-bearing for SLC (3.3±0.6 wk) was shorter compared with LLC (6.4±0.7 wk, P<0.0001). Overall, fractures treated with SLC had a shorter time to the union (7.4±0.9 wk) compared with LLC (9.0±0.9 wk, P=0.026) without statistical differences in final angulation at the time of union. There was a higher percentage of cast complications in the LLC treatment group (12%) compared with SLC (6%). CONCLUSIONS: SLC demonstrated earlier time to weight-bearing and shorter time to fracture union when compared with LLC. Surgeons should consider SLC and early weight-bearing for the treatment of distal third tibial shaft fractures in children. LEVEL OF EVIDENCE: Level III-retrospective comparative study.

Assessing the Impact of the Pediatric Orthopaedic Society of North America (POSNA) Visiting Scholar Program.

BACKGROUND: The primary objective of the Pediatric Orthopaedic Society of North America (POSNA)-Children's Orthopaedics in Underserved Regions (COUR) Visiting Scholar Program is to engage emerging leaders from low-income and middle-income countries (LMICs) in POSNA educational offerings. This study aims to outline the educational and leadership activities pursued by the alumni of the POSNA-COUR Visiting Scholars Program. We hypothesized that there may be a discrepancy between visiting scholar interest level and actual participation in key follow-up educational and leadership activities. METHODS: A 32-question online survey developed by the POSNA-COUR committee was electronically delivered to the POSNA-COUR visiting scholarship recipients from 2007 to 2019. The survey inquired about scholars' educational background, clinical practice, and academic interests. Respondents also reported educational, research, and leadership activities that occurred following program participation. RESULTS: Fifty-seven percent (44/77) of the previous scholars participated in the survey. Sixty-eight percent reported that >75% of their practice was comprised of pediatric patients. The COUR scholarship afforded 15 scholars the opportunity to attend their first educational conference in North America. The majority (86%) of respondents consulted POSNA members on care-related issues, 52% organized a POSNA member's visit to their country, and 13% have become members of POSNA. Scholars shared their knowledge with colleagues through lectures (73%), demonstration of surgical skills (63%), mentorship (59%), hosting local courses (43%), and research (14%). There was a significant discrepancy between interest and actual participation in research (98% vs. 16%, P<0.0001), hosting a regional course (98% vs. 43%, P<0.0001), and becoming a member of POSNA (96% vs. 13%, P<0.0001). CONCLUSIONS: The POSNA-COUR Visiting Scholar Program is effective at providing beneficial educational opportunities to orthopaedic surgeons from LMICs. There is, however, a significant discrepancy between reported scholar interest and actual engagement in leadership endeavors including: research, organization of regional courses, and POSNA membership. The impact of the POSNA-COUR visiting scholar program can be enhanced through collaboration with scholarship alumni in these key areas. LEVEL OF EVIDENCE: Level IV-case series.

The Impact of Cast Immobilization on Return to Daycare.

BACKGROUND: Children who are prohibited from returning to daycare (RTD) after treatment with cast immobilization place an increased burden on parents and caregivers. The purpose of this study was to assess the impact of cast immobilization on RTD. Specifically, we sought to determine the prevalence of RTD after orthopaedic immobilization based on daycare facility policy. METHODS: This was a survey study of randomly selected daycare facilities servicing a total of 6662 children within 10 miles of a major metropolitan city center. The 40-question survey included information on daycare policies and experience caring for children treated with orthopaedic immobilization. The survey also included questions about daycare type, enrollment, and geographic location. Photographs of the types of immobilization were embedded in the survey to facilitate understanding. Daycare facilities were randomly selected based on a power analysis to estimate a 50% prevalence of RTD after spica casting within 10% margin of error. RESULTS: Seventy-three daycare facilities completed the survey study. The average child-staff ratio was 5:1 and most daycare facilities (78%) did not have a nurse on staff. Predetermined policies regarding RTD after injury were available at 81% of daycares. Twenty-eight (38.5%) facilities had encountered a child with a cast in the previous year. The rate of RTD for children with upper limb injuries was 90.5% compared with 79% for lower limb injuries (P=0.003). Spica casts showed the lowest RTD rate: single leg (22.5%), 1 and a half leg (18%), and 2 leg (16%) (P<0.0001). Experienced daycare facilities (>5 y) had a higher RTD rate compared with less experienced facilities (P=0.026). CONCLUSIONS: The ability to RTD is dependent on immobilization type. Children with long leg and spica casts are disproportionately restricted when compared with other cast types. At minimum, surgeons should consider the socioeconomic implications of orthopaedic immobilization. There is also a need for orthopaedic involvement in policy formation at the local level to provide standardized guidelines for re-entry into childcare facilities following orthopaedic immobilization. LEVEL OF EVIDENCE: Level IV.

Intraoperative Burden of Flexible Intramedullary Nailing and Spica Casting for Femur Fractures in Young Children.

BACKGROUND: Spica casting (Spica) remains the widely accepted treatment of closed femoral shaft fractures in young children aged 6 months to 5 years. In some centers, there has been a recent trend towards surgical fixation of these fractures with flexible intramedullary nails (FINs). Despite numerous studies evaluating both Spica and FIN treatment of femoral shaft fractures, there remains a paucity of data regarding patient burden during the intraoperative period. The purpose of this study was to compare the intraoperative burden, defined as anesthetic exposure, fluoroscopic duration, and radiation load, between Spica and FIN treatment of femoral shaft fractures in young children. METHODS: A retrospective chart review was conducted for pediatric femoral shaft fractures presenting to a tertiary pediatric referral hospital from 2012 to 2017. Comparison groups included pediatric femur fractures treated with Spica and those treated with FIN. Outcomes included anesthetic exposure, fluoroscopy duration, and radiation exposure. In addition, length of stay, clinic visits, and complications were recorded. RESULTS: Of 449 consecutive pediatric femur fractures treated at our center, 143 patients ages 2 to 6 years (mean age 3.8±1.4 y) met inclusion criteria. The Spica group contained 91 patients; FIN contained 52 patients. Mean anesthetic exposure was less for Spica compared with FIN [45.1 min, 95% confidence interval (CI): 38.0-52.3 vs. 90.7 min, 95% CI: 80.5-100.8 min; P<0.001]. On average, Spica procedures required less fluoroscopy time compared with FIN (15.4 s, 95% CI: 4.8-26.0 vs. 131.6 s, 95% CI: 117.6-145.6 s; P<0.001). Mean radiation load was less for Spica compared with FIN (1.6 mGy, 95% CI: 0.6-2.6 vs. 6.9 mGy, 95% CI: 5.7-8.1 mGy; P<0.001). There was no difference in length of hospital stay (P=0.831), follow-up visits (P=0.248), or complication rate (P=0.645) between Spica and FIN groups. The most common complication was skin irritation for Spica (18.7%) and symptomatic hardware for FIN (17.3%). CONCLUSIONS: The findings of this study suggest that pediatric patients with femoral shaft fractures experience an increased intraoperative burden when treated with FIN compared with Spica. Treatment with FIN was associated with increased exposure to anesthesia, fluoroscopic duration, and radiation load despite similar complication rates when compared with Spica. LEVEL OF EVIDENCE: Level III.

Surgical Outcomes of Obese Patients With Adolescent Idiopathic Scoliosis From Endemic Areas of Obesity in the United States.

BACKGROUND: Obesity rates continue to rise among children and adolescents across the globe. A multicenter research consortium composed of institutions in the Southern US, located in states endemic for childhood obesity, was formed to evaluate the effect of obesity on pediatric musculoskeletal disorders. This study evaluates the effect of body mass index (BMI) percentile and socioeconomic status (SES) on surgical site infections (SSIs) and perioperative complications in patients with adolescent idiopathic scoliosis (AIS) treated with posterior spinal fusion (PSF). METHODS: Eleven centers in the Southern US retrospectively reviewed postoperative AIS patients after PSF between 2011 and 2017. Each center contributed data to a centralized database from patients in the following BMI-for-age groups: normal weight (NW, 5th to <85th percentile), overweight (OW, 85th to <95th percentile), and obese (OB, ≥95th percentile). The primary outcome variable was the occurrence of an SSI. SES was measured by the Area Deprivation Index (ADI), with higher scores indicating a lower SES. RESULTS: Seven hundred fifty-one patients were included in this study (256 NW, 235 OW, and 260 OB). OB and OW patients presented with significantly higher ADIs indicating a lower SES (P<0.001). In addition, SSI rates were significantly different between BMI groups (0.8% NW, 4.3% OW, and 5.4% OB, P=0.012). Further analysis showed that superficial and not deep SSIs were significantly different between BMI groups. These differences in SSI rates persisted even while controlling for ADI. Wound dehiscence and readmission rates were significantly different between groups (P=0.004 and 0.03, respectively), with OB patients demonstrating the highest rates. EBL and cell saver return were significantly higher in overweight patients (P=0.007 and 0.002, respectively). CONCLUSION: OB and OW AIS patients have significantly greater superficial SSI rates than NW patients, even after controlling for SES. LEVEL OF EVIDENCE: Level III.

Predictors of Open Reduction in Pediatric Femur Fractures Treated With Flexible Nails.

BACKGROUND: Closed reduction (CR) is sufficient to reduce the majority of femur fractures treated with flexible intramedullary nailing (FIN). No previous study has examined factors associated with failed CR of pediatric femoral shaft fractures treated with FIN. We sought to determine preoperative factors associated with failed CR. We hypothesized that fracture, patient, and surgeon characteristics would impact the need for open reduction (OR). METHODS: A retrospective review of children treated for femur fracture between 2012 and 2017 at a tertiary pediatric hospital was performed. Comparisons were made between 2 groups: FIN with CR group and FIN that required OR group. Demographic and baseline characteristics were compared between treatment groups using either χ tests or Fisher exact tests for categorical variables and general linear models for continuous variables. Odds ratios with 95% confidence intervals were calculated using univariate logistic regression tests. RESULTS: Of 449 consecutive pediatric femur fractures treated at our center, 85 children were treated with FIN and constituted the study cohort. CR failed in 14 patients (16.5%) necessitating OR of the fracture site. Significant differences between study groups were found in fracture location (P=0.018), the mechanism (P=0.003), and displacement on the anteroposterior radiograph (P=0.027). Surgical time was found to be longer in the OR group (P=0.010). We identified 3 preoperative predictors of OR for FIN including fractures caused by high energy mechanisms (odds ratio=7.5), distal third fractures (odds ratio=15.3), and fracture displacement on the anteroposterior view (odds ratio=1.06). Surgeon years in practice, patient weight, age, and time from injury to surgery were not associated with OR. CONCLUSIONS: This study presents 3 preoperative risk factors that predict the need for OR of femur fractures treated with FIN. Surgical time was longer in cases that required OR. Our findings suggest that surgeons should avoid lengthy attempts at CR and consider a lower threshold for OR of at-risk fractures or use another technique other than flexible nails. LEVEL OF EVIDENCE: Level III-prognostic.

The Reverse Oblique Supracondylar Humerus Fracture: Description of a Novel Fracture Pattern.

BACKGROUND: Sagittal profile descriptions of supracondylar humerus fractures are limited. We describe a reverse oblique (RO) pattern in which the distal fragment has a prominent anterior spike that is displaced posterior to the proximal fragment. This pattern presents a challenge during closed manipulation utilizing traditional reduction maneuvers. The purpose of this study is to compare the clinical and radiographic characteristics of the RO and non-RO patterns of supracondylar humerus fractures. We hypothesized that the RO pattern would be associated with greater soft tissue trauma. METHODS: Retrospective evaluation of operative supracondylar humerus fractures treated at a tertiary pediatric hospital from 2014 to 2016. Patients were categorized into RO and non-RO groups for analysis. Associated neurovascular injuries were compared between groups. RESULTS: Two hundred ninety-nine consecutive patients were reviewed. The RO fracture pattern was seen in 12 patients. All displaced RO fractures were able to be closed reduced with a modification to the traditional reduction sequence. Overall cohort rates of preoperative soft tissue injury included antecubital ecchymosis 16.8%, nerve palsies 15%, and vascular compromise 6.4%. Compared with non-RO fractures, the RO fracture group had significantly higher rates of anterior interosseous nerve (AIN) palsies (P=0.013), antecubital ecchymosis (P=0.018), and compartment syndrome (P=0.043). When comparing RO with non-RO type II fractures, there were no differences in soft tissue injury (P=0.439). Compared with non-RO type III fractures, RO type III fractures had higher rates of AIN injury (P=0.047), antecubital ecchymosis (P=0.007), and overall soft tissue injury (P=0.009). CONCLUSIONS: This study introduces a previously undescribed supracondylar humerus fracture subtype: the RO fracture. We found increased rates of soft tissue compromise including antecubital ecchymosis and AIN palsy in this fracture type. Further, traditional reduction methods proved to be ineffectual for this fracture pattern. We utilized a simple modification that allowed for closed reduction and percutaneous pinning of displaced RO fractures. LEVEL OF EVIDENCE: Level III-prognostic.

Effect of Patient-Centered Transitional Care Services on Clinical Outcomes in Patients Hospitalized for Heart Failure: The PACT-HF Randomized Clinical Trial.

Importance: Health care services that support the hospital-to-home transition can improve outcomes in patients with heart failure (HF). Objective: To test the effectiveness of the Patient-Centered Care Transitions in HF transitional care model in patients hospitalized for HF. Design, Setting, and Participants: Stepped-wedge cluster randomized trial of 2494 adults hospitalized for HF across 10 hospitals in Ontario, Canada, from February 2015 to March 2016, with follow-up until November 2016. Interventions: Hospitals were randomized to receive the intervention (n = 1104 patients), in which nurse-led self-care education, a structured hospital discharge summary, a family physician follow-up appointment less than 1 week after discharge, and, for high-risk patients, structured nurse homevisits and heart function clinic care were provided to patients, or usual care (n = 1390 patients), in which transitional care was left to the discretion of clinicians. Main Outcomes and Measures: Primary outcomes were hierarchically ordered as composite all-cause readmission, emergency department (ED) visit, or death at 3 months; and composite all-cause readmission or ED visit at 30 days. Secondary outcomes were B-PREPARED score for discharge preparedness (range: 0 [most prepared] to 22 [least prepared]); the 3-Item Care Transitions Measure (CTM-3) for quality of transition (range: 0 [worst transition] to 100 [best transition]); the 5-level EQ-5D version (EQ-5D-5L) for quality of life (range: 0 [dead] to 1 [full health]); and quality-adjusted life-years (QALY; range: 0 [dead] to 0.5 [full health at 6 months]). Results: Among eligible patients, all 2494 (mean age, 77.7 years; 1258 [50.4%] women) completed the trial. There was no significant difference between the intervention and usual care groups in the first primary composite outcome (545 [49.4%] vs 698 [50.2%] events, respectively; hazard ratio [HR], 0.99 [95% CI, 0.83-1.19]) or in the second primary composite outcome (304 [27.5%] vs 408 [29.3%] events, respectively; HR, 0.93 [95% CI, 0.73-1.18]). There were significant differences between the intervention and usual care groups in the secondary outcomes of mean B-PREPARED score at 6 weeks (16.6 vs 13.9; difference, 2.65 [95% CI, 1.37-3.92]; P < .001); mean CTM-3 score at 6 weeks (76.5 vs 70.3; difference, 6.16 [95% CI, 0.90-11.43]; P = .02); and mean EQ-5D-5L score at 6 weeks (0.7 vs 0.7; difference, 0.06 [95% CI, 0.01 to 0.11]; P = .02) and 6 months (0.7 vs 0.6; difference, 0.06 [95% CI, 0.01-0.12]; P = .02). There was no significant difference in mean QALY between groups at 6 months (0.3 vs 0.3; difference, 0.00 [95% CI, -0.02 to 0.02]; P = .98). Conclusions and Relevance: Among patients with HF in Ontario, Canada, implementation of a patient-centered transitional care model compared with usual care did not improve a composite of clinical outcomes. Whether this type of intervention could be effective in other health care systems or locations would require further research. Trial Registration: ClinicalTrials.gov Identifier: NCT02112227.

Knowledge to action: Rationale and design of the Patient-Centered Care Transitions in Heart Failure (PACT-HF) stepped wedge cluster randomized trial.

INTRODUCTION: Heart Failure (HF) is a common cause of hospitalization in older adults. The transition from hospital to home is high-risk, and gaps in transitional care can increase the risk of re-hospitalization and death. Combining health care services supported by meta-analyses, we designed the PACT-HF transitional care model. METHODS: Adopting an integrated Knowledge Translation (iKT) approach in which decision-makers and clinicians are partners in research, we implement and test the effectiveness of PACT-HF among patients hospitalized for HF. We use a pragmatic stepped wedge cluster randomized trial design to introduce the complex health service intervention to 10 large hospitals in a randomized sequence until all hospitals initiate the intervention. The goal is for all patients hospitalized with HF to receive self-care education, multidisciplinary care, and early follow-up with their health care providers; and in addition, for high-risk patients to receive post-discharge nurse-led home visits and outpatient care in Heart Function clinics. This requires integration of care across hospitals, home care agencies, and outpatient clinics in our publicly funded health care system. While hospitals are the unit of recruitment and analysis, patients (estimated sample size of 3200) are the unit of analysis. Primary outcomes are hierarchically ordered as time to composite all-cause readmissions / emergency department (ED) visits / death at 3 months and time to composite all-cause readmissions / ED visits at 30 days. In a nested study of 8 hospitals, we measure the patient-centered outcomes of Discharge Preparedness, Care Transitions Quality, and Quality Adjusted Life Years (QALY); and the 6-month health care resource use and costs. We obtain all clinical and cost outcomes via linkages to provincial administrative databases. CONCLUSIONS: This protocol describes the implementation and testing of a transitional care model comprising health care services informed by high-level evidence. The study adopts an iKT and pragmatic approach, uses a robust study design, links clinical trial data with outcomes held in administrative databases, and includes patient-reported outcomes. Findings will have implications on clinical practice, health care policy, and Knowledge Translation (KT) research methodology.

Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials.

BACKGROUND: Ixekizumab is a humanised monoclonal antibody against the proinflammatory cytokine interleukin 17A. We report two studies of ixekizumab compared with placebo or etanercept to assess the safety and efficacy of specifically targeting interleukin 17A in patients with widespread moderate-to-severe psoriasis. METHODS: In two prospective, double-blind, multicentre, phase 3 studies (UNCOVER-2 and UNCOVER-3), eligible patients were aged 18 years or older, had a confirmed diagnosis of chronic plaque psoriasis at least 6 months before baseline (randomisation), 10% or greater body-surface area involvement at both screening and baseline visits, at least a moderate clinical severity as measured by a static physician global assessment (sPGA) score of 3 or more, and a psoriasis area and severity index (PASI) score of 12. Participants were randomly assigned (1:2:2:2) by computer-generated random sequence with an interactive voice response system to receive subcutaneous placebo, etanercept (50 mg twice weekly), or one injection of 80 mg ixekizumab every 2 weeks, or every 4 weeks after a 160 mg starting dose. Blinding was maintained with a double-dummy design. Coprimary efficacy endpoints were proportions of patients achieving sPGA score 0 or 1 and 75% or greater improvement in PASI at week 12. Analysis was by intention to treat. These trials are registered with ClinicalTrials.gov, numbers NCT01597245 and NCT01646177. FINDINGS: Between May 30, 2012, and Dec 30, 2013, 1224 patients in UNCOVER-2 were randomly assigned to receive subcutaneous placebo (n=168), etanercept (n=358), or ixekizumab every 2 weeks (n=351) or every 4 weeks (n=347); between Aug 11, 2012, and Feb 27, 2014, 1346 patients in UNCOVER-3 were randomly assigned to receive placebo (n=193), etanercept (n=382), ixekizumab every 2 weeks (n=385), or ixekizumab every 4 weeks (n=386). At week 12, both primary endpoints were met in both studies. For UNCOVER-2 and UNCOVER-3 respectively, in the ixekizumab every 2 weeks group, PASI 75 was achieved by 315 (response rate 89·7%; [effect size 87·4% (97·5% CI 82·9-91·8) vs placebo; 48·1% (41·2-55·0) vs etanercept]) and 336 (87·3%; [80·0% (74·4-85·7) vs placebo; 33·9% (27·0-40·7) vs etanercept]) patients; in the ixekizumab every 4 weeks group, by 269 (77·5%; [75·1% (69·5-80·8) vs placebo; 35·9% (28·2-43·6) vs etanercept]) and 325 (84·2%; [76·9% (71·0-82·8) vs placebo; 30·8% (23·7-37·9) vs etanercept]) patients; in the placebo group, by four (2·4%) and 14 (7·3%) patients; and in the etanercept group by 149 (41·6%) and 204 (53·4%) patients (all p<0·0001 vs placebo or etanercept). In the ixekizumab every 2 weeks group, sPGA 0/1 was achieved by 292 (response rate 83·2%; [effect size 80·8% (97·5% CI 75·6-86·0) vs placebo; 47·2% (39·9-54·4) vs etanercept]) and 310 (80·5%; [73·8% (67·7-79·9) vs placebo; 38·9% (31·7-46·1) vs etanercept]) patients; in the ixekizumab every 4 weeks group by 253 (72·9%; [70·5% (64·6-76·5) vs placebo; 36·9% (29·1-44·7) vs etanercept]) and 291 (75·4%; [68·7% (62·3-75·0) vs placebo; 33·8% (26·3-41·3) vs etanercept]) patients; in the placebo group by four (2·4%) and 13 (6·7%) patients; and in the etanercept group by 129 (36·0%) and 159 (41·6%) patients (all p<0·0001 vs placebo or etanercept). In combined studies, serious adverse events were reported in 14 (1·9%) of 734 patients given ixekizumab every 2 weeks, 14 (1·9%) of 729 given ixekizumab every 4 weeks, seven (1·9%) of 360 given placebo, and 14 (1·9%) of 739 given etanercept; no deaths were noted. INTERPRETATION: Both ixekizumab dose regimens had greater efficacy than placebo and etanercept over 12 weeks in two independent studies. These studies show that selectively neutralising interleukin 17A with a high affinity antibody potentially gives patients with psoriasis a new and effective biological therapy option. FUNDING: Eli Lilly and Co.