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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.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.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.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.

Background Most children with steroid-sensitive nephrotic syndrome have relapses that are triggered by upper respiratory tract infections. Four small trials, mostly in children already taking maintenance corticosteroid in countries of different upper respiratory tract infection epidemiology, showed that giving daily low-dose prednisone/prednisolone for 5–7 days during an upper respiratory tract infection reduces the risk of relapse. Objectives To determine if these findings were replicated in a large UK population of children with relapsing steroid-sensitive nephrotic syndrome on different background medication or none. Design A randomised double-blind placebo-controlled trial, including a cost-effectiveness analysis. Setting A total of 122 UK paediatric departments, of which 91 recruited patients. Participants A total of 365 children with relapsing steroid-sensitive nephrotic syndrome (mean age 7.6 ± 3.5 years) were randomised (1 : 1) according to a minimisation algorithm based on background treatment. Eighty children completed 12 months of follow-up without an upper respiratory tract infection. Thirty-two children were withdrawn from the trial (14 prior to an upper respiratory tract infection), leaving a modified intention-to-treat analysis population of 271 children (134 and 137 children in the prednisolone and placebo arms, respectively). Interventions At the start of an upper respiratory tract infection, children received 6 days of prednisolone (15 mg/m2) or an equivalent dose of placebo. Main outcome measures The primary outcome was the incidence of first upper respiratory tract infection-related relapse following any upper respiratory tract infection over 12 months. The secondary outcomes were the overall rate of relapse, changes in background treatment, cumulative dose of prednisolone, rates of serious adverse events, incidence of corticosteroid adverse effects, change in Achenbach Child Behaviour Checklist score and quality of life. Analysis was by intention-to-treat principle. The cost-effectiveness analysis used trial data and a decision-analytic model to estimate quality-adjusted life-years and costs at 1 year, which were then extrapolated over 16 years. Results There were 384 upper respiratory tract infections and 82 upper respiratory tract infection-related relapses in the prednisolone arm, and 407 upper respiratory tract infections and 82 upper respiratory tract infection-related relapses in the placebo arm. The number of patients experiencing an upper respiratory tract infection-related relapse was 56 (42.7%) and 58 (44.3%) in the prednisolone and placebo arms, respectively (adjusted risk difference –0.024, 95% confidence interval –0.14 to 0.09; p = 0.70). There was no evidence that the treatment effect differed when data were analysed according to background treatment. There were no significant differences in secondary outcomes between treatment arms. Giving daily prednisolone at the time of an upper respiratory tract infection was associated with increased quality-adjusted life-years (0.9427 vs. 0.9424) and decreased average costs (£252 vs. £254), when compared with standard care. The cost saving was driven by background therapy and hospitalisations after relapse. The finding was robust to sensitivity analysis. Limitations A larger number of children than expected did not have an upper respiratory tract infection and the sample size attrition rate was adjusted accordingly during the trial. Conclusions The clinical analysis indicated that giving 6 days of daily low-dose prednisolone at the time of an upper respiratory tract infection does not reduce the risk of relapse of steroid-sensitive nephrotic syndrome in UK children. However, there was an economic benefit from costs associated with background therapy and relapse, and the health-related quality-of-life impact of having a relapse. Future work Further work is needed to investigate the clinical and health economic impact of relapses, interethnic differences in treatment response, the effect of different corticosteroid regimens in treating relapses, and the pathogenesis of individual viral infections and their effect on steroid-sensitive nephrotic syndrome. Trial registration Current Controlled Trials ISRCTN10900733 and EudraCT 2012-003476-39. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 3. See the NIHR Journals Library website for further project information.

Background and objectives In a randomized double-blind, placebo-controlled trial, treatment with spironolactone in early-stage CKD reduced left ventricular mass and arterial stiffness compared with placebo. It is not known if these effects were due to BP reduction or specific vascular and myocardial effects of spironolactone. Design, setting, participants, & measurements A prospective, randomized, open-label, blinded end point study conducted in four UK centers (Birmingham, Cambridge, Edinburgh, and London) comparing spironolactone 25 mg to chlorthalidone 25 mg once daily for 40 weeks in 154 participants with nondiabetic stage 2 and 3 CKD (eGFR 30–89 ml/min per 1.73 m2). The primary end point was change in left ventricular mass on cardiac magnetic resonance imaging. Participants were on treatment with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker and had controlled BP (target ≤130/80 mm Hg). Results There was no significant difference in left ventricular mass regression; at week 40, the adjusted mean difference for spironolactone compared with chlorthalidone was −3.8 g (95% confidence interval, −8.1 to 0.5 g, P=0.08). Office and 24-hour ambulatory BPs fell in response to both drugs with no significant differences between treatment. Pulse wave velocity was not significantly different between groups; at week 40, the adjusted mean difference for spironolactone compared with chlorthalidone was 0.04 m/s (−0.4 m/s, 0.5 m/s, P=0.90). Hyperkalemia (defined ≥5.4 mEq/L) occurred more frequently with spironolactone (12 versus two participants, adjusted relative risk was 5.5, 95% confidence interval, 1.4 to 22.1, P=0.02), but there were no patients with severe hyperkalemia (defined ≥6.5 mEq/L). A decline in eGFR >30% occurred in eight participants treated with chlorthalidone compared with two participants with spironolactone (adjusted relative risk was 0.2, 95% confidence interval, 0.05 to 1.1, P=0.07). Conclusions Spironolactone was not superior to chlorthalidone in reducing left ventricular mass, BP, or arterial stiffness in nondiabetic CKD.

Renin-angiotensin system (RAS) inhibitors - including angiotensin-converting-enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs) - slow the progression of mild or moderate chronic kidney disease. However, the results of some studies have suggested that the discontinuation of RAS inhibitors in patients with advanced chronic kidney disease may increase the estimated glomerular filtration rate (eGFR) or slow its decline.In this multicenter, open-label trial, we randomly assigned patients with advanced and progressive chronic kidney disease (eGFR,30 ml per minute per 1.73 mAt 3 years, among the 411 patients who were enrolled, the least-squares mean (±SE) eGFR was 12.6±0.7 ml per minute per 1.73 mAmong patients with advanced and progressive chronic kidney disease, the discontinuation of RAS inhibitors was not associated with a significant between-group difference in the long-term rate of decrease in the eGFR. (Funded by the National Institute for Health Research and the Medical Research Council; STOP ACEi EudraCT number, 2013-003798-82; ISRCTN number, 62869767.).

Chlorhexidine skin antisepsis is frequently recommended for most surgical procedures; however, it is unclear if these recommendations should apply to surgery involving traumatic contaminated wounds where povidone-iodine has previously been preferred. We aimed to compare the effect of aqueous 10% povidone-iodine versus aqueous 4% chlorhexidine gluconate on the risk of surgical site infection in patients who required surgery for an open fracture.We conducted a multiple-period, cluster-randomised, crossover trial (Aqueous-PREP) at 14 hospitals in Canada, Spain, and the USA. Eligible patients were adults aged 18 years or older with an open extremity fracture treated with a surgical fixation implant. For inclusion, the open fracture required formal surgical debridement within 72 h of the injury. Participating sites were randomly assigned (1:1) to use either aqueous 10% povidone-iodine or aqueous 4% chlorhexidine gluconate immediately before surgical incision; sites then alternated between the study interventions every 2 months. Participants, health-care providers, and study personnel were aware of the treatment assignment due to the colour of the solutions. The outcome adjudicators and data analysts were masked to treatment allocation. The primary outcome was surgical site infection, guided by the 2017 US Centers for Disease Control and Prevention National Healthcare Safety Network reporting criteria, which included superficial incisional infection within 30 days or deep incisional or organ space infection within 90 days of surgery. The primary analyses followed the intention-to-treat principle and included all participants in the groups to which they were randomly assigned. This study is registered with ClinicalTrials.gov, NCT03385304.Between April 8, 2018, and June 8, 2021, 3619 patients were assessed for eligibility and 1683 were enrolled and randomly assigned to povidone-iodine (n=847) or chlorhexidine gluconate (n=836). The trial's adjudication committee determined that 45 participants were ineligible, leaving 1638 participants in the primary analysis, with 828 in the povidone-iodine group and 810 in the chlorhexidine gluconate group (mean age 44·9 years [SD 18·0]; 629 [38%] were female and 1009 [62%] were male). Among 1571 participants in whom the primary outcome was known, a surgical site infection occurred in 59 (7%) of 787 participants in the povidone-iodine group and 58 (7%) of 784 in the chlorhexidine gluconate group (odds ratio 1·11, 95% CI 0·74 to 1·65; p=0·61; risk difference 0·6%, 95% CI -1·4 to 3·4).For patients who require surgical fixation of an open fracture, either aqueous 10% povidone-iodine or aqueous 4% chlorhexidine gluconate can be selected for skin antisepsis on the basis of solution availability, patient contraindications, or product cost. These findings might also have implications for antisepsis of other traumatic wounds.US Department of Defense, Canadian Institutes of Health Research, McMaster University Surgical Associates, PSI Foundation.

The REGAIN (Regional versus General Anesthesia for Promoting Independence after Hip Fracture) trial found similar ambulation and survival at 60 days with spinal versus general anesthesia for hip fracture surgery. Trial outcomes evaluating pain, prescription analgesic use, and patient satisfaction have not yet been reported.To compare pain, analgesic use, and satisfaction after hip fracture surgery with spinal versus general anesthesia.Preplanned secondary analysis of a pragmatic randomized trial. (ClinicalTrials.gov: NCT02507505).46 U.S. and Canadian hospitals.Patients aged 50 years or older undergoing hip fracture surgery.Spinal or general anesthesia.Pain on postoperative days 1 through 3; 60-, 180-, and 365-day pain and prescription analgesic use; and satisfaction with care.A total of 1600 patients were enrolled. The average age was 78 years, and 77% were women. A total of 73.5% (1050 of 1428) of patients reported severe pain during the first 24 hours after surgery. Worst pain over the first 24 hours after surgery was greater with spinal anesthesia (rated from 0 [no pain] to 10 [worst pain imaginable]; mean difference, 0.40 [95% CI, 0.12 to 0.68]). Pain did not differ across groups at other time points. Prescription analgesic use at 60 days occurred in 25% (141 of 563) and 18.8% (108 of 574) of patients assigned to spinal and general anesthesia, respectively (relative risk, 1.33 [CI, 1.06 to 1.65]). Satisfaction was similar across groups.Missing outcome data and multiple outcomes assessed.Severe pain is common after hip fracture. Spinal anesthesia was associated with more pain in the first 24 hours after surgery and more prescription analgesic use at 60 days compared with general anesthesia.Patient-Centered Outcomes Research Institute

Introduction Ankle fractures are the most common fracture of the foot and ankle treated at trauma hospitals in the United States, costing millions of dollars yearly. The purpose of this study was to determine whether a standardized care pathway led to a difference in the direct and indirect costs of surgical fixation of ankle fractures at one Level I Trauma Center and tertiary care medical center. Methods We analyzed cost, volume, length of stay, and collections for surgical treatment of ankle fractures in inpatient and outpatient settings by the orthopaedics and podiatry departments during fiscal years 2016 to 2018. Based on these data, we compared projected costs and collections across a 5-year period with the procedure being done by a single department (orthopaedics only and podiatry only). Results Total costs per case fell by 18% in the orthopaedics department and 8% in the podiatry department over the 3-year period. The podiatry department spent an average of $1,296 (46%) more per case than the orthopaedics department, driven by increased average supply costs. Both departments had significantly decreased direct costs (P = 0.0039 orthopaedics and P = 0.033 podiatry) in the outpatient setting. The orthopaedics department also had significantly lower average supply costs than the podiatry department (P = 0.045) and significantly decreased total costs in the outpatient setting (P = 0.0084). Discussion The orthopaedics department performed a higher volume of cases at a lower cost per case than the podiatry department. These savings were driven by a standardized ankle fracture treatment pathway that we propose decreased direct and supply costs. Our results suggest that surgical treatment of ankle fracture cases using a standardized care pathway is economically advantageous because of limiting variations in care and creating manageable workflows.

Background Despite interest among North American orthopaedic residents to pursue rotations in resource-limited settings, little is known regarding resident motivations and impact on host surgeons. Methods Surveys were distributed to North American orthopaedic surgeons and trainees who participated in international rotations during residency to assess motivations for participation and to orthopaedic surgeons at partnering low- and middle-income country (LMIC) institutions to assess impact of visiting trainees. Results Responses were received from 136 North American resident rotators and 51 LMIC host surgeons and trainees. North American respondents were motivated by a desire to increase surgical capacity at the LMIC while host surgeons reported a greater impact from learning from residents than on surgical capacity. Negative aspects reported by hosts included selfishness, lack of reciprocity, racial discrimination, competition for surgical experience, and resource burdens. Conclusions The motivations and impact of orthopaedic resident rotations in LMICs need to be aligned. Host perceptions and bidirectional educational exchange should be incorporated into partnership guidelines.

Supplemental Digital Content is Available in the Text., Summary: The challenging problem of long bone infection and limb length difference cannot be addressed using only an antibiotic-coated nonmagnetic static nail. The combined use of resorbable calcium sulfate and magnetic lengthening nails offers a possible solution to this dilemma, as well as for infected nonunions that require compression. We present a combined technique to treat or prevent infection using femoral or tibial intramedullary antibiotic delivery with an absorbable calcium sulfate depot and concomitant internal lengthening or compression using a nail. Adequate débridement is required in cases of established infection and is a prerequisite for this technique.

Suicide and depression among orthopaedic surgeons have recently emerged as rising concerns. Prior research has suggested that orthopaedic surgeons have the highest prevalence of suicide among surgical specialties. We sought to determine the factors associated with depression and suicidal ideation (SI) in orthopaedics, including subspecialty.A survey including demographic questions, the Beck Depression Inventory, and the Columbia-Suicide Severity Rating Scale was administered electronically via a listserv to the orthopaedic subspecialties of trauma, adult reconstruction, hand and upper extremity, shoulder and elbow, foot and ankle, spine, pediatrics, sports medicine, and oncology. The responses were quantified according to previously published criteria. The associations of demographic factors, training, and current practice environment with depression and suicidality were assessed using Fisher exact tests. Reverse stepwise multivariable logistic regression models were developed to identify factors associated with depression and SI.The responses were obtained from 661 board-certified, practicing orthopaedic surgeons. In this study, 156 surgeons (23.6%) endorsed some level of active SI in their lifetime, 200 surgeons (30.3%) reported either active or passive SI in their lifetime, and 33 surgeons (5%) reported that, on at least 1 occasion in their lifetime, they had experienced active SI with a specific plan and intention to harm themselves. Gender, relationship status, having children, and residency and/or current practice region were significantly associated with depression and/or SI. Younger age, divorce, adult reconstruction and foot and ankle subspecialties, and attending residency in the Western U.S. were found on multivariable testing to be associated with symptoms of depression and SI (odds ratios, 1.03 [per 1-year decrease in age] to 8.28).Symptoms of depression and suicidality are not uncommon among orthopaedic surgeons, and variation by gender, relationship status, and geographic location are supported by prior research. Based on our results, depression and/or SI likely affect someone close to you or someone with whom you work. The normalization of discussions surrounding emotional well-being, depression, and SI is imperative.

Background: Hyperpronation of the first metatarsal in hallux valgus (HV) is poorly understood by conventional weightbearing radiography. We aimed to evaluate this parameter using weightbearing computed tomography (WBCT) and to understand its association with other standard measurements. Methods: Retrospective evaluation of WBCT and weightbearing radiographs (WBXRs) was performed for 20 patients with HV feet and 20 controls with no such deformity. Axial computed tomography images of both groups were compared for the first metatarsal pronation angle (alpha angle) and tibial sesamoid subluxation (TSS) grades. The HV angle (HVA), first-second intermetatarsal angle (IMA), first metatarsal-medial cuneiform angle (MMCA), Meary’s angle, and calcaneal pitch (CP) angle of the study and control groups were compared on both WBXR and the corresponding 2-dimensional images of WBCT. All measurements were independently performed by 1 musculoskeletal radiology fellow and 1 foot and ankle surgical fellow. Measurements were averaged and interobserver reliability was calculated. Results: The HV group demonstrated significantly higher values for TSS grade ( P < .001) but not for alpha angle ( P = .121) compared with controls. Likewise, significantly elevated HVA and IMA were noted in the HV group on both imaging modalities, while no such differences were observed for the CP angle. Higher MMCA and Meary’s angle in the HV group were evident only on WBXR (MMCA, P = .039; Meary’s, P = .009) but not on WBCT (MMCA, P = .183; Meary’s, P = .171). Among all, the receiver operating characteristic (ROC) curves demonstrated the greatest area under the curve (AUC) for HVA, followed by IMA. The alpha angle performed only just outside the range of chance (AUC, 0.65; 95% CI, 0.52-0.69). The Pearson’s correlations of the alpha angle, in the HV group, revealed a significant linear relationship with TSS grade and with HVA on WBXR, and only trended toward a weak linear relationship with IMA and with HVA on WBCT. Conclusion: The alpha angle, a measure of abnormal hyperpronation of the first metatarsal, was an independent factor that may coexist with other parameters in HV, but in isolation had limited diagnostic utility. “Abnormal” alpha angles were even observed in individuals without HV. Increases in IMA and MMCA were not necessarily associated with similar increases in alpha angle, despite moderate correlations with TSS grade and HVA on WBXR. Nevertheless, the WBCT was a useful method for assessing hyperpronation and guiding surgical management in individual cases. Level of Evidence: Level III, retrospective comparative study.

Objectives This study compares outcomes for patients with displaced femoral neck fractures undergoing hemiarthroplasty (HA) or total hip arthroplasty (THA) by surgeons of different fellowship training. Design Retrospective review of HEALTH trial data. Setting Eighty clinical sites across 10 countries. Patients/participants One thousand four hundred forty-one patients ≥50 years with low-energy hip fractures requiring surgical intervention. Intervention Patients were randomized to either HA or THA groups in the initial data set. Surgeons' fellowship training was ascertained retrospectively, and outcomes were compared. Main outcome measurements The main outcome was an unplanned secondary procedure at 24 months. Secondary outcomes included death, serious adverse events, prosthetic joint infection (PJI), dislocation, discharge disposition, and use of ambulatory devices postoperatively. Results There was a significantly higher risk of PJI in patients treated by surgeons without fellowship training in arthroplasty (P = 0.01), surgeons with unknown fellowship training (P = 0.03), and surgeons with no fellowship training (P = 0.02) than those treated by an arthroplasty-trained surgeon. There were significantly higher odds of being discharged to a facility rather than home in patients who underwent surgery by a surgeon with no fellowship training compared with arthroplasty-fellowship-trained surgeons (P = 0.03). Conclusions Arthroplasty for hip fracture can be performed by all orthopaedic surgeons with equivalent reoperation rates. Infection prevention strategies and use of "care pathways" by arthroplasty-fellowship-trained surgeons may account for the lower risk of PJI and higher rate of discharge to home. The authors advocate for the use of evidence-based infection prevention initiatives and standardized care pathways in this patient population. Level of evidence Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Objective The influence of residency programs on teaching hospital outcomes in total joint arthroplasty (TJA) has recently been debated. This study investigates how complication and readmission rates for primary elective total hip (THA) and total knee arthroplasty (TKA) changed before and after new orthopedic surgery residency programs meeting ACGME accreditation requirements were introduced at hospitals. Design We conducted a retrospective cohort study using the CMS Hospital Compare database, which contains hospital-level data on risk-standardized complication and readmission rates (2013-2018) for primary elective THA and TKA in Medicare beneficiaries. Orthopedic surgery residency programs that were newly accredited during this time were identified using ACGME publicly available data. Setting Eight primary adult teaching hospitals with complication and readmission data in the CMS database available prior to the first full year its affiliated residency program was implemented, and with subsequent program data also available. Participants Six ACGME accredited orthopedic surgery residency programs. Results Even after controlling for annual variation in surrounding hospital rates, the at-risk patient volume, and variation in starting rates for a given hospital in the first available year, multivariate linear regression demonstrated that complication rates for lower extremity TJA in Medicare beneficiaries decreased by 0.20 per year (R2 = 0.78, p = 0.005) after hospitals introduced new orthopedic surgery residency programs meeting ACGME accreditation requirements. There were no significant differences in readmission rates after the addition of newly accredited programs to these same hospitals (R2 = 0.51; p = 0.706). Conclusions Starting an orthopedic surgery residency program meeting ACGME accreditation requirements was associated with significantly reduced complication rates for primary elective lower extremity TJA in Medicare beneficiaries at teaching hospitals where these programs began rotating residents. These findings raise awareness regarding the potential for residency programs to contribute to improved patient care outside of the operating room as well as through direct resident involvement in procedures.

OBJECTIVES Although peripheral nerve blocks are associated with improved pain control and end outcomes among older adults with hip fracture, their current utilization among US hip fracture patients is not well understood. We characterized contemporary use of peripheral nerve blocks after hip fracture over time and identified predictors of nerve block receipt. DESIGN Retrospective cohort study of claims data from one large national private US insurer. SETTING US acute care hospitals. PARTICIPANTS A total of 94 985 adults aged 50 years and older hospitalized for a femoral neck, intertrochanteric, or subtrochanteric fracture; 409 263 adults aged 50 years and older hospitalized for elective hip or knee arthroplasty between 2004 and 2016. MEASUREMENTS Receipt of a peripheral nerve block for pain control, based on Current Procedural Terminology codes in physician service claims. RESULTS Overall, 2874 hip fracture patients (3.0%; 95% confidence interval [CI] = 2.9-3.1) received a nerve block for pain control, and the percentage receiving a block increased from .4% in 2004-2006 (95% CI = .3%-.6%) to 4.6% in 2013-2016 (95% CI = 4.4%-4.8%; P

Key Points Question In children with relapsing corticosteroid-sensitive nephrotic syndrome, does daily low-dose corticosteroid given at the time of upper respiratory tract infection prevent upper respiratory tract infection–related relapse? Findings In this randomized clinical trial of 365 children, daily low-dose corticosteroid therapy resulted in no difference in the frequency of upper respiratory tract infection–related relapses compared with placebo. Meaning Results of this study suggest that low-dose corticosteroid treatment is not beneficial as a strategy to prevent upper respiratory tract infection–related relapses., Importance In children with corticosteroid-sensitive nephrotic syndrome, many relapses are triggered by upper respiratory tract infections. Four small studies found that administration of daily low-dose prednisolone for 5 to 7 days at the time of an upper respiratory tract infection reduced the risk of relapse, but the generalizability of their findings is limited by location of the studies and selection of study population. Objective To investigate the use of daily low-dose prednisolone for the treatment of upper respiratory tract infection–related relapses. Design, Setting, and Participants This double-blind, placebo-controlled randomized clinical trial (Prednisolone in Nephrotic Syndrome [PREDNOS] 2) evaluated 365 children with relapsing steroid-sensitive nephrotic syndrome with and without background immunosuppressive treatment at 122 pediatric departments in the UK from February 1, 2013, to January 31, 2020. Data from the modified intention-to-treat population were analyzed from July 1, 2020, to December 31, 2020. Interventions At the start of an upper respiratory tract infection, children received 6 days of prednisolone, 15 mg/m2 daily, or matching placebo preparation. Those already taking alternate-day prednisolone rounded their daily dose using trial medication to the equivalent of 15 mg/m2 daily or their alternate-day dose, whichever was greater. Main Outcomes and Measures The primary outcome was the incidence of first upper respiratory tract infection–related relapse. Secondary outcomes included overall rate of relapse, changes in background immunosuppressive treatment, cumulative dose of prednisolone, rates of serious adverse events, incidence of corticosteroid adverse effects, and quality of life. Results The modified intention-to-treat analysis population comprised 271 children (mean [SD] age, 7.6 [3.5] years; 174 [64.2%] male), with 134 in the prednisolone arm and 137 in the placebo arm. The number of patients experiencing an upper respiratory tract infection–related relapse was 56 of 131 (42.7%) in the prednisolone arm and 58 of 131 (44.3%) in the placebo arm (adjusted risk difference, −0.02; 95% CI, −0.14 to 0.10; P = .70). No evidence was found that the treatment effect differed according to background immunosuppressive treatment. No significant differences were found in secondary outcomes between the treatment arms. A post hoc subgroup analysis assessing the primary outcome in 54 children of South Asian ethnicity (risk ratio, 0.66; 95% CI, 0.40-1.10) vs 208 children of other ethnicity (risk ratio, 1.11; 95% CI, 0.81-1.54) found no difference in efficacy of intervention in those of South Asian ethnicity (test for interaction P = .09). Conclusions and Relevance The results of PREDNOS 2 suggest that administering 6 days of daily low-dose prednisolone at the time of an upper respiratory tract infection does not reduce the risk of relapse of nephrotic syndrome in children in the UK. Further work is needed to investigate interethnic differences in treatment response. Trial Registration isrctn.org Identifier: ISRCTN10900733; EudraCT 2012-003476-39, This randomized clinical trial investigates whether a low daily dose of prednisolone in children with relapsing steroid-sensitive nephrotic syndrome prevents upper respiratory tract infection–related relapse.

Introduction The burden of atrial fibrillation (AF) in Thailand is high and associated with increased morbidity, mortality and healthcare costs. Vitamin K antagonists (eg, warfarin), commonly used for stroke prevention in patients with AF in Thailand, are effective but are often suboptimally controlled. We aim to evaluate the impact of an SAMe-TT2R2 score-guided strategy and educational intervention compared to usual care on anticoagulation control expressed by the time in therapeutic range (TTR) at 12 months, in anticoagulant-naïve Thai patients with AF. Methods and analysis Multicentre, open-label, parallel-group, randomised controlled trial conducted in Thailand among adult patients (age: 18 years) with AF who are anticoagulant naïve. Patients will be randomised to one of two groups; an SAMe-TT2R2 score-guided strategy with educational intervention and usual care versus usual care alone. The planned follow-up period is 12 months. The primary outcome is TTR at 12 months. Secondary outcomes include: (1) TTR at 6 months; (2) thromboembolic and bleeding events at 12 months; (3) composite major adverse cardiovascular events at 12 months; (4) change in patients’ knowledge of AF between baseline and 6 months and 12 months; (5) cost effectiveness; (6) quality of life at baseline, 6 months and 12 months using EQ-5D-5L (Thai version) and (7) patient satisfaction/perceptions of the TREAT intervention. An embedded qualitative study will assess patient perceptions of the TREAT intervention. Ethics and dissemination The study has been approved by the Ethical Review Committee, Ministry of Public Health of Thailand, and registered in the Thai Clinical Trials Registry. The results of this trial will be submitted for publication in a peer-reviewed journal. Participants will be informed via a link to a preview of the publication. A lay summary will also be provided to all participants prior to publication. Trial registration number TCTR20180711003.

The effects of spinal anesthesia as compared with general anesthesia on the ability to walk in older adults undergoing surgery for hip fracture have not been well studied.We conducted a pragmatic, randomized superiority trial to evaluate spinal anesthesia as compared with general anesthesia in previously ambulatory patients 50 years of age or older who were undergoing surgery for hip fracture at 46 U.S. and Canadian hospitals. Patients were randomly assigned in a 1:1 ratio to receive spinal or general anesthesia. The primary outcome was a composite of death or an inability to walk approximately 10 ft (3 m) independently or with a walker or cane at 60 days after randomization. Secondary outcomes included death within 60 days, delirium, time to discharge, and ambulation at 60 days.A total of 1600 patients were enrolled; 795 were assigned to receive spinal anesthesia and 805 to receive general anesthesia. The mean age was 78 years, and 67.0% of the patients were women. A total of 666 patients (83.8%) assigned to spinal anesthesia and 769 patients (95.5%) assigned to general anesthesia received their assigned anesthesia. Among patients in the modified intention-to-treat population for whom data were available, the composite primary outcome occurred in 132 of 712 patients (18.5%) in the spinal anesthesia group and 132 of 733 (18.0%) in the general anesthesia group (relative risk, 1.03; 95% confidence interval [CI], 0.84 to 1.27; P = 0.83). An inability to walk independently at 60 days was reported in 104 of 684 patients (15.2%) and 101 of 702 patients (14.4%), respectively (relative risk, 1.06; 95% CI, 0.82 to 1.36), and death within 60 days occurred in 30 of 768 (3.9%) and 32 of 784 (4.1%), respectively (relative risk, 0.97; 95% CI, 0.59 to 1.57). Delirium occurred in 130 of 633 patients (20.5%) in the spinal anesthesia group and in 124 of 629 (19.7%) in the general anesthesia group (relative risk, 1.04; 95% CI, 0.84 to 1.30).Spinal anesthesia for hip-fracture surgery in older adults was not superior to general anesthesia with respect to survival and recovery of ambulation at 60 days. The incidence of postoperative delirium was similar with the two types of anesthesia. (Funded by the Patient-Centered Outcomes Research Institute; REGAIN ClinicalTrials.gov number, NCT02507505.).

Overstating the impact of interventions through incomplete or inaccurate reporting can lead to inappropriate scale-up of interventions with low impact. Accurate reporting of the impact of interventions is of great importance in global health research to protect scarce resources. In global health, the cluster randomised trial design is commonly used to evaluate complex, multicomponent interventions, and outcomes are often binary. Complete reporting of impact for binary outcomes means reporting both relative and absolute measures. We did a systematic review to assess reporting practices and potential to overstate impact in contemporary cluster randomised trials with binary primary outcome. We included all reports registered in the Cochrane Central Register of Controlled Trials of two-arm parallel cluster randomised trials with at least one binary primary outcome that were published in 2017. Of 73 cluster randomised trials, most (60 [82%]) showed incomplete reporting. Of 64 cluster randomised trials for which it was possible to evaluate, most (40 [63%]) reported results in such a way that impact could be overstated. Care is needed to report complete evidence of impact for the many interventions evaluated using the cluster randomised trial design worldwide.

To describe evidenced-based treatment options for patients who sustained trauma and/or posttraumatic osteomyelitis of the tibia resulting in diaphyseal bone defects and to compare outcomes between patients treated with nonvascularized bone grafts (NBGs), bone transport (BT), or vascularized bone grafts (VBGs).The Preferred Reporting Items for Systematic Review and Meta-Analyses of individual participant data and Cochrane guidelines were followed. PubMed, EMBASE, Cochrane Library, Web of Science, Scopus, and CINAHL were searched from inception to June 2020.Patients who were ≥18 years, had sustained trauma to the tibia resulting in fracture and/or osteomyelitis with measurable diaphyseal bone defects, and were treated by interventions such as NBGs, BT, or VBGs were eligible. Excluded studies were non-English, reviews, nonreviewed literature, cadavers, animals, unavailable full texts, nondiaphyseal defects, atrophic nonunions, malignancy, and replantations.A total of 108 studies were included with 826 patients. Two reviewers systematically/independently screened titles/abstracts, followed by full texts to ensure quality, accuracy, and consensus among authors for inclusion/exclusion of studies. A third reviewer addressed disagreements if investigators were unable to reach a consensus. Studies were quality assessed using "Methodological Quality and Synthesis of Case Series and Case Reports".Analyses were performed with IBM SPSS version 25.0 (IBM Corporation, Armonk, NY) and G*Power3.1.9.2.NBGs may be considered first line for trauma defect sizes ≤ 10 cm or posttraumatic osteomyelitis defect sizes5 cm. BT may be considered first line for posttraumatic osteomyelitis defect sizes5 cm. VBGs may be considered first line for trauma and posttraumatic osteomyelitis defect sizes ≥5 cm.Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Although image-guided biopsies of bone and soft tissue lesions have a low complication rate, there is limited data evaluating use of preprocedural laboratory tests. To address this issue, patients were not required to stop non-steroidal antiinflammatory drugs (NSAIDs) and aspirin or to obtain preprocedural laboratory tests [complete blood count (CBC) and international normalized ratio (INR)], except in special circumstances. The bleeding complication rate, rate of same day biopsies, and the time from when the biopsy was ordered to when it was performed were obtained. A total of 332 patients who underwent bone or soft tissue biopsies performed at our institution between 9/1/2017 and 1/9/2019 were prospectively analyzed. These data were compared to a retrospective biopsy cohort of 323 patients between 7/1/2015 and 7/1/2017. Data collected included method of image guidance and bleeding complication rate. The number of days from ordering to performing a biopsy and number of same day biopsies were recorded. There were no bleeding complications in either cohort (OR 1.00, P = 1). The mean time from ordering to performing a bone biopsy was significantly decreased in the prospective group (6.6 days) compared to the retrospective group (8.1 days) (P = 0.012). There were more same day biopsies in the prospective cohort (11.4% vs. 3.4%) (P

Dual-energy X-ray absorptiometry (DEXA) studies are used for screening patients for low bone mineral density (BMD). Patients with breast and prostate cancer are often treated with hormone-altering drugs that result in low BMD. These patients may have incidental osteoblastic metastases of the spine that may be detected on screening DEXA studies. The aim of this pilot study is to assess whether random forest classifiers or support vector machines can identify patients with incidental osteoblastic metastases of the spine from screening DEXA studies and to evaluate which technique is better. We retrospectively reviewed the DEXA studies from 200 patients (155 normal control patients and 45 patients with osteoblastic metastases of one or more lumbar vertebral bodies from L1 to L4). The dataset was split into training (80%) and validation (20%) datasets. The optimal random forest (RF) and support vector machine (SVM) classifiers were obtained. Receiver-operator-characteristic curves were compared with DeLong’s test. The sensitivity, specificity, accuracy and area under the curve (AUC) of the optimal RF classifier were 77.8%, 100.0%, 98.0% and 0.889, respectively, in the validation dataset. The sensitivity, specificity, accuracy and AUC of the optimal SVM classifier were 33.3%, 96.8%, 82.5% and 0.651 in the validation dataset. The RF classifier was significantly better than the SVM classifier (P = 0.008). Only 7 of the 45 patients with osteoblastic metastases (15.6%) were prospectively identified by the radiologist interpreting the study. RF classifiers can be used as a useful adjunct to identify incidental lumbar spine osteoblastic metastases in screening DEXA studies.

This quality improvement study used an automated test messaging system to assess the number of opioid tablets prescribed vs the self-reported number of tablets taken as well as self-reported pain intensity and ability to manage pain after orthopedic and urologic procedures., Key Points Question Are the quantities of short-term opioid prescriptions after common orthopedic and urologic surgical procedures adequate or excessive as measured using automated text messaging? Findings In this quality improvement study of 919 patients who underwent an orthopedic or urologic surgical procedure, most (61%) of the prescribed opioid tablets were reported as unused, and 28% of patients reported not using any opioids. Meaning The findings suggest that opportunities exist to tailor opioid prescriptions and reduce excess quantities of opioids prescribed., Importance Surgeons must balance management of acute postoperative pain with opioid stewardship. Patient-centered methods that immediately evaluate pain and opioid consumption can be used to guide prescribing and shared decision-making. Objective To assess the difference between the number of opioid tablets prescribed and the self-reported number of tablets taken as well as self-reported pain intensity and ability to manage pain after orthopedic and urologic procedures with use of an automated text messaging system. Design, Setting, and Participants This quality improvement study was conducted at a large, urban academic health care system in Pennsylvania. Adult patients (aged ≥18 years) who underwent orthopedic and urologic procedures and received postoperative prescriptions for opioids were included. Data were collected prospectively using automated text messaging until postoperative day 28, from May 1 to December 31, 2019. Main Outcomes and Measures The primary outcome was the difference between the number of opioid tablets prescribed and the patient-reported number of tablets taken (in oxycodone 5-mg tablet equivalents). Secondary outcomes were self-reported pain intensity (on a scale of 0-10, with 10 being the highest level of pain) and ability to manage pain (on a scale of 0-10, with 10 representing very able to control pain) after orthopedic and urologic procedures. Results Of the 919 study participants, 742 (80.7%) underwent orthopedic procedures and 177 (19.2%) underwent urologic procedures. Among those who underwent orthopedic procedures, 384 (51.8%) were women, 491 (66.7%) were White, and the median age was 48 years (interquartile range [IQR], 32-61 years); 514 (69.8%) had an outpatient procedure. Among those who underwent urologic procedures, 145 (84.8%) were men, 138 (80.7%) were White, and the median age was 56 years (IQR, 40-67 years); 106 (62%) had an outpatient procedure. The mean (SD) pain score on day 4 after orthopedic procedures was 4.72 (2.54), with a mean (SD) change by day 21 of −0.40 (1.91). The mean (SD) ability to manage pain score on day 4 was 7.32 (2.59), with a mean (SD) change of −0.80 (2.72) by day 21. The mean (SD) pain score on day 4 after urologic procedures was 3.48 (2.43), with a mean (SD) change by day 21 of −1.50 (2.12). The mean (SD) ability to manage pain score on day 4 was 7.34 (2.81), with a mean (SD) change of 0.80 (1.75) by day 14. The median quantity of opioids prescribed for patients who underwent orthopedic procedures was high compared with self-reported consumption (20 tablets [IQR, 15-30 tablets] vs 6 tablets used [IQR, 0-14 tablets]), similar to findings for patients who underwent urologic procedures (7 tablets [IQR, 5-10 tablets] vs 1 tablet used [IQR, 0-4 tablets]). Over the study period, 9452 of 15 581 total tablets prescribed (60.7%) were unused. A total of 589 patients (64.1%) used less than half of the amount prescribed, and 256 patients (27.8%) did not use any opioids (179 [24.1%] who underwent orthopedic procedures and 77 [43.5%] who underwent urologic procedures). Conclusions and Relevance In this quality improvement study of adult patients reporting use of opioids after common orthopedic and urologic surgical procedures through a text messaging system, the quantities of opioids prescribed and the quantity consumed differed. Patient-reported data collected through text messaging may support clinicians in tailoring prescriptions and guide shared decision-making to limit excess quantities of prescribed opioids.

Importance: There is little evidence to support selection of heart rate control therapy in patients with permanent atrial fibrillation, in particular those with coexisting heart failure. Objective: To compare low-dose digoxin with bisoprolol (a β-blocker). Design, Setting, and Participants: Randomized, open-label, blinded end-point clinical trial including 160 patients aged 60 years or older with permanent atrial fibrillation (defined as no plan to restore sinus rhythm) and dyspnea classified as New York Heart Association class II or higher. Patients were recruited from 3 hospitals and primary care practices in England from 2016 through 2018; last follow-up occurred in October 2019. Interventions: Digoxin (n = 80; dose range, 62.5-250 μg/d; mean dose, 161 μg/d) or bisoprolol (n = 80; dose range, 1.25-15 mg/d; mean dose, 3.2 mg/d). Main Outcomes and Measures: The primary end point was patient-reported quality of life using the 36-Item Short Form Health Survey physical component summary score (SF-36 PCS) at 6 months (higher scores are better; range, 0-100), with a minimal clinically important difference of 0.5 SD. There were 17 secondary end points (including resting heart rate, modified European Heart Rhythm Association [EHRA] symptom classification, and N-terminal pro-brain natriuretic peptide [NT-proBNP] level) at 6 months, 20 end points at 12 months, and adverse event (AE) reporting. Results: Among 160 patients (mean age, 76 [SD, 8] years; 74 [46%] women; mean baseline heart rate, 100/min [SD, 18/min]), 145 (91%) completed the trial and 150 (94%) were included in the analysis for the primary outcome. There was no significant difference in the primary outcome of normalized SF-36 PCS at 6 months (mean, 31.9 [SD, 11.7] for digoxin vs 29.7 [11.4] for bisoprolol; adjusted mean difference, 1.4 [95% CI, −1.1 to 3.8]; P = .28). Of the 17 secondary outcomes at 6 months, there were no significant between-group differences for 16 outcomes, including resting heart rate (a mean of 76.9/min [SD, 12.1/min] with digoxin vs a mean of 74.8/min [SD, 11.6/min] with bisoprolol; difference, 1.5/min [95% CI, −2.0 to 5.1/min]; P = .40). The modified EHRA class was significantly different between groups at 6 months; 53% of patients in the digoxin group reported a 2-class improvement vs 9% of patients in the bisoprolol group (adjusted odds ratio, 10.3 [95% CI, 4.0 to 26.6]; P Conclusions and Relevance: Among patients with permanent atrial fibrillation and symptoms of heart failure treated with low-dose digoxin or bisoprolol, there was no statistically significant difference in quality of life at 6 months. These findings support potentially basing decisions about treatment on other end points.

INTRODUCTION: The COVID-19 pandemic has influenced the resident workforce to a particularly powerful and unexpected extent. Given the drastic changes to resident roles, expectations, and responsibilities, many valuable lessons regarding resident concerns and wellness can be garnered from this unique experience. METHODS: A voluntary survey was sent to 179 Accreditation Council for Graduate Medical Education-accredited orthopaedic surgery residency program directors to distribute to their residents. Questions focused on issues that may have occurred, program's responses, and expectations of programs during the pandemic. RESULTS: In total, 507 residents completed the survey, and 10% reported being deployed to do nonorthopaedic-related care, with junior classes being more likely to receive this assignment (P < 0.001). The greatest concern for respondents was the possibility of getting family members sick (mean = 3.89, on scale of 1-5), followed by personally contracting the illness (mean = 3.38). DISCUSSION: The COVID-19 pandemic has resulted in numerous changes and novel sources of adversity for the orthopaedic surgery resident. Contrary to popular opinion, most residents are comfortable with the proposition of providing nonorthopaedic care. The possibility of bringing a pathogen to the home environment and infecting family members seems to be an overarching concern, and efforts to ensure resident and family safety are key.

Current implants for clavicle fractures are known to cause poor cosmesis and irritation, which may require implant removal. Low-profile shape-memory staples provide an attractive alternative, but their biomechanical utility in clavicle reconstruction is unknown. We hypothesized that shape-memory reconstructions would be more compliant compared to traditional constructs but would also outperform conventional plates during cyclic loading to failure.This study was performed with 36 synthetic clavicles and 12 matched pairs of cadaveric specimens. The synthetic study tested four reconstructions: a single superiorly placed staple (n = 6), a single anteroinferiorly-placed staple (n = 6), a 3.5 mm reconstruction plate (n = 12), and two orthogonally placed staples (n = 12). The cadaveric study tested three constructs: reconstruction plate (n = 8), two orthogonal staples (n = 8), and a 2.7 mm reconstruction plate combined with a superior staple (n = 8). Non-destructive 4-point bending, compression, and torsion assays were performed prior to destructive cantilever bending and cyclic torsion tests.The single staple and double staple groups demonstrated significantly decreased resistance to bending (p 0.001) and torsion (p ≤ 0.027) when compared to reconstruction plate groups. The double staple group sustained significantly fewer cycles to failure than the reconstruction plate group in cyclic torsional tests (p = 0.012). The synthetic models produced higher stiffness and failure mechanisms that were completely different from cadaveric specimens.Shape memory alloy implants provided inadequate stiffness for clavicle fixation but may have utility in other orthopaedic applications when used as a supplementary compression device in conjunction with traditional plated constructs. Synthetic bones have limited capacity for modeling fragility fractures.

Summary Engaging patients—defined broadly as individuals with lived experience of a given condition, family members, caregivers, and the organisations that represent them—as partners in research is a priority for policymakers, funders, and the public. Nonetheless, formal efforts to engage patients are absent from most studies, and models to support meaningful patient engagement in clinical anaesthesia research have not been previously described. Here, we review our experience in developing and implementing a multifaceted patient engagement strategy within the Regional Versus General Anesthesia for Promoting Independence After Hip Fracture (REGAIN) surgery trial, an ongoing randomised trial comparing spinal vs general anaesthesia for hip fracture surgery in 1600 older adults across 45 hospitals in the USA and Canada. This strategy engaged patients and their representatives at both the level of overall trial oversight and at the level of individual recruiting sites. Activities spanned a continuum ranging from events designed to elicit patients' input on key decisions to longitudinal collaborations that empowered patients to actively participate in decision-making related to trial design and management. Engagement activities were highly acceptable to participants and led to concrete changes in the design and conduct of the REGAIN trial. The REGAIN experience offers a model for future efforts to engage patients as partners in clinical anaesthesia research, and highlights potential opportunities for investigators to increase the relevance of anaesthesia studies by incorporating patient voices and perspectives into the research process.

Background Cyclooxygenase-2 (COX-2) has been found to be important for fracture-healing in animal models, raising concerns about use of nonsteroidal anti-inflammatory drugs (NSAIDs) and selective COX-2 inhibitors after fractures. We evaluated associations of NSAIDs, COX-2 inhibitors, and opioids with nonunion after long-bone fracture. Methods Using private health insurance claims data from Optum's de-identified Clinformatics Data Mart database from January 1, 2000, to September 30, 2015, we identified adults with a single long-bone fracture or commonly paired long-bone fractures who had 1 year of available follow-up data. Using multivariable logistic regression models, we examined associations between NSAID, COX-2-inhibitor, or opioid prescription fills after the fracture and the risk of nonunion within 1 year, defined as a nonunion diagnosis with a procedure to treat the nonunion. Results A nonunion diagnosis with a procedure to treat the nonunion was identified after 2,996 (0.9%) of the 339,864 fracture episodes, with rates varying by fracture site. The risk of that outcome was greater in patients who had filled COX-2-inhibitor prescriptions (adjusted odds ratio = 1.84 [95% confidence interval = 1.38 to 2.46]) or opioid prescriptions (1.69 [1.53 to 1.86]), but not in patients who had filled nonselective-NSAID prescriptions (1.07 [0.93 to 1.23]) after the fracture. Results were similar when the outcome definition was changed to just a nonunion diagnosis. Conclusions COX-2 inhibitors, but not nonselective NSAIDs, were associated with a greater risk of nonunion after fracture. Opioids were also associated with nonunion risk, although patients filling prescriptions for opioids may have had more severe fractures. Level of evidence Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Background In cluster randomized crossover (CRXO) trials, groups of participants (i.e., clusters) are randomly allocated to receive a sequence of interventions over time (i.e., cluster periods). CRXO trials are becoming more comment when they are feasible, as they require fewer clusters than parallel group cluster randomized trials. However, CRXO trials have not been frequently used in orthopedic fracture trials and represent a novel methodological application within the field. To disseminate the early knowledge gained from our experience initiating two cluster randomized crossover trials, we describe our process for the identification and selection of the orthopedic practices (i.e., clusters) participating in the PREP-IT program and present data to describe their key characteristics. Methods The PREP-IT program comprises two ongoing pragmatic cluster randomized crossover trials (Aqueous-PREP and PREPARE) which compare the effect of iodophor versus chlorhexidine solutions on surgical site infection and unplanned fracture-related reoperations in patients undergoing operative fracture management. We describe the process we used to identify and select orthopedic practices (clusters) for the PREP-IT trials, along with their characteristics. Results We identified 58 potential orthopedic practices for inclusion in the PREP-IT trials. After screening each practice for eligibility, we selected 30 practices for participation and randomized each to a sequence of interventions (15 for Aqueous-PREP and 20 for PREPARE). The majority of orthopedic practices included in the Aqueous-PREP and PREPARE trials were situated in level I trauma centers (100% and 87%, respectively). Orthopedic practices in the Aqueous-PREP trial operatively treated a median of 149 open fracture patients per year, included a median of 11 orthopedic surgeons, and had access to a median of 5 infection preventionists. Orthopedic practices in the PREPARE trial treated a median of 142 open fracture and 1090 closed fracture patients per year, included a median of 7.5 orthopedic surgeons, and had access to a median of 6 infection preventionists. Conclusions The PREP-IT trials provide an example of how to follow the reporting standards for cluster randomized crossover trials by providing a clear definition of the cluster unit, a thorough description of the cluster identification and selection process, and sufficient description of key cluster characteristics. Trial registration Both trials are registered at ClinicalTrials.gov (A-PREP: NCT03385304 December 28, 2017, and PREPARE: NCT03523962 May 14, 2018).

OBJECTIVES To make direct comparisons of the biomechanical properties of a control (CTL) group and implants that were augmented with far cortical locking (FCL), bone substitute material (BSM), and a combination of both (ALL) to determine which fixation is most effective in reducing implant failure. METHODS The constructs were tested with osteopenic cadaveric specimens in a two-part fracture model. Specimens were subjected to a battery of nondestructive torsion and axial compression tests, followed by a cyclic test. Construct stiffness and cycles to failure were documented, pre- and post-test fluoroscopy was performed, and implant and bone kinematics were quantified. RESULTS During nondestructive testing, the BSM group exhibited significantly increased torsional and axial stiffness compared with the FCL (P = 0.006, P < 0.001) group and ALL group (P < 0.001, P = 0.006). There were no significant differences in resistance to cyclic loading between groups. Fluoroscopic analysis indicated significant differences in the motions of nonlocked cannulated screws (used in BSM and ALL) versus locked screws (used in CTL and FCL). CONCLUSIONS Patients with poor bone quality and proximal humerus fracture may necessitate added compliance or rigidity to achieve fixation. Both have exhibited favorable biomechanical characteristics in this cadaveric 2-part proximal humerus fracture model.

Background: The opioid epidemic has spurred investigations for nonopioid options, yet limited research persists on medical marijuana's (MMJ) efficacy in managing cancer-related symptoms. Objective:...

Fractures of the clavicle are common injuries that occur across all age groups but are most frequently seen in the young, active patient population. Among the different types of clavicle fractures, those occurring in the middle third of the clavicular shaft are the most common. Historically, most of these fractures were treated by closed means even when notable displacement was present. Recently, there has been a renewed interest in assessing the best treatment option for these patients. Although nonsurgical treatment is a reliable method for treating many of these fractures, more recent data suggest that fractures with notable displacement (>2 cm of shortening or >100% displacement) and/or comminution have better short-term outcomes and lower rates of nonunion with surgical management. Current surgical options include superior plating, anterior-inferior plating, dual plating, and intramedullary nail fixation.

The purpose of this study is to evaluate the fluid volume required for a saline load test to detect intra-articular involvement of the glenohumeral joint after penetrating trauma. A human cadaver study was conducted with 22 thawed, fresh-frozen forequarter amputations. A standard posterior shoulder portal was made with an 11-blade scalpel. A 19-gauge needle was inserted into the anterior portal site, and intra-articular position of both the blade and needle was confirmed with fluoroscopy. The blade was removed and normal saline was injected through the needle until extravasation of fluid was observed through the posterior portal. Injection volume required for extravasation was recorded. A logarithmic distribution of the volumes was then calculated in order to obtain estimated sensitivity ranges. Using a logarithmic distribution, 90%, 95% and 99% of simulated glenohumeral arthrotomies could be detected using injections of: 62 ml [41-96], 81 ml [50-133] and 136 ml [72-252], respectively. (Journal of Surgical Orthopaedic Advances 28(4):268-271, 2019).

Formal training for surgeons regarding intraoperative imaging is lacking. This project investigated the effect of an educational intervention focusing on obtaining and assessing a standardized lateral view of the proximal femur during intramedullary nailing of a pertrochanteric fracture.Anatomical landmarks of the proximal femur that can be identified using intraoperative fluoroscopy and criteria for image quality, i.e. quality of projection were defined in a consensus process, followed by the development of educational materials and a 7-item checklist. Five surgeons from 5 Trauma Centers in 4 countries participated. Each surgeon a) assessed 5 of their own retrospective cases and 5 retrospective cases from 4 colleagues from their clinic, b) viewed an educational video and poster and re-assessed the same cases, and c) assessed the intraoperative images of 5 prospectively collected consecutive cases of their own and of colleagues afterwards.The percentage of positive ratings for image quality increased from 72% prior to educational intervention to 88% after intervention (p0.001), and number of "not assessable" images decreased significantly. Percentage agreement between surgeons on the assessments increased from 75% to 87%. The proportion of best possible ratings for fracture reduction and implant position increased from 58% to 72% and from 49% to 66%, respectively. Percentage agreement between surgeons on assessment of reduction and implant position increased.A focused educational intervention can improve surgeons' ability to obtain and assess lateral view intraoperative images of the proximal femur and can improve the quality of reduction and implant positioning.

Introduction The American College of Surgeons' Statements on Principles requires attending surgeons to be present for the "key parts" of surgical procedures, but the term is not defined. The research question addressed in this study is whether a functional definition of the critical or key steps of common orthopaedic surgical procedures can be reliably constructed. We used the examples of hip and knee arthroplasty because these procedures are highly structured and divisible into distinct subroutines. Methods We surveyed 100 experienced orthopaedic surgeons regarding whether particular steps in knee and hip arthroplasty procedures were considered "key." The patterns of individual surgeons' responses were compared among surgeons for overall reliability. The steps frequently cited as key were also identified. Results The agreement rates among surgeons for the definitions of the key parts of hip and knee arthroplasty were 3.2% and 8.6%, respectively. For both procedures, five steps were identified as key by >90% of the respondents. Discussion The agreement rate on what constitutes the key parts of hip and knee arthroplasty was poor, despite the fact that these are highly structured procedures. Accordingly, defining the key parts for a given procedure must rely on either the operating surgeon's discretion or a consensus definition. Imposing a single surgeon's standard on others is not the optimal approach because such a standard is likely to be idiosyncratic. Conclusion A consensus standard articulated by the orthopaedic surgery community may be the best means for identifying the key parts of orthopaedic surgical operations. The data presented here suggest a foundation upon which a consensus definition for the key parts of arthroplasty procedures may be built.

BACKGROUND Future generations of orthopaedic surgeons must continue to be trained in the surgical management of hip fractures. This study assesses the effect of resident participation on outcomes for the treatment of intertrochanteric hip fractures. METHODS The National Surgical Quality Improvement Program (NSQIP) database (2010 to 2013) was queried for intertrochanteric hip fractures (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM] code 820.21) treated with either extramedullary (Current Procedural Terminology [CPT] code 27244) or intramedullary (CPT code 27245) fixation. Demographic variables, including resident participation, as well as primary (death and serious morbidity) and secondary outcome variables were extracted for analysis. Univariate, propensity score-matched, and multivariate logistic regression analyses were performed to evaluate outcome variables. RESULTS Data on resident participation were available for 1,764 cases (21.0%). Univariate analyses for all intertrochanteric hip fractures demonstrated no significant difference in 30-day mortality (6.3% versus 7.8%; p = 0.264) or serious morbidity (44.9% versus 43.2%; p = 0.506) between the groups with and without resident participation. Multivariate and propensity score-matched analyses gave similar results. Resident involvement was associated with prolonged operating-room time, length of stay, and time to discharge when a prolonged case was defined as one above the 90th percentile for time parameters. CONCLUSIONS Resident participation was not associated with an increase in morbidity or mortality but was associated with an increase in time-related secondary outcome measures. While attending surgeon supervision is necessary, residents can and should be involved in the care of these patients without concern that resident involvement negatively impacts perioperative morbidity and mortality. LEVEL OF EVIDENCE Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Objectives This study sought to examine fatigue characteristics of 2 polyaxial locking screw designs: locking cap (LC) and cross-threaded (CT). The goal was to compare LC and CT implants at 0, 10, and 15 degrees of angulation to determine the effect of locking mechanism on screw-plate interface failure. The hypothesis was that LC implants would have superior fatigue properties in comparison to CT designs and that increased angulation of the screw would have a negative impact on the fatigue life of CT implants, but would not have any effect on LC implants. Methods A total of 72 screws were tested in 4 upper extremity implants. Implants were subjected to cyclic shear loads and subsequent ramp to failure. Performance characteristics were statistically compared using nonparametric statistical methods. Results Fatigue testing demonstrated that LC designs were consistently able to sustain a significantly higher number of cyclic loads than CT designs. There were no significant differences in the number of cycles sustained by LC designs because of changes in screw angle, but CT implants exhibited decreases in screw stability with increasing angulation. Conclusions Likely because of the spherical screw head geometry, LC fatigue characteristics are not influenced by the orientation of the screw relative to the plate. Application of an LC in the operating room requires additional time, but provides significantly more robust fixation of the screw, especially at oblique angles to the plate and provides a more predictable and consistent biomechanical result.

Flail chest is a common injury sustained by patients who experience high-energy blunt chest trauma and results in severe respiratory compromise because of altered mechanics of respiration. There has been increased interest in operative fixation of these injuries with the intention of restoring the mechanical integrity of the chest wall, and several studies have shown that ventilation requirements and pulmonary complications may be decreased with operative intervention. The purpose of this study was to evaluate fixation of rib fractures in flail chest injuries using cost-effectiveness analysis, supported by systematic review and meta-analysis.This was a 2-part study in which we initially conducted a systematic literature review and meta-analysis on outcomes after operative fixation of flail chest injuries, evaluating intensive care unit (ICU) stay, hospital length of stay (LOS), mortality, pneumonia, and need for tracheostomy. The results were then applied to a decision-analysis model comparing the costs and outcomes of operative fixation versus nonoperative treatment. The validity of the results was tested using probabilistic sensitivity analysis.Operative treatment decreased mortality, pneumonia, and tracheotomy (risk ratios of 0.44, 0.59, and 0.52, respectively), as well as time in ICU and total LOS (3.3 and 4.8 days, respectively). Operative fixation was associated with higher costs than nonoperative treatment ($23,682 vs. $8629 per case, respectively) and superior outcomes (32.60 quality-adjusted life year (QALY) vs. 30.84 QALY), giving it an incremental cost-effectiveness ratio of $8577/QALY.Surgical fixation of rib fractures sustained from flail chest injuries decreased ICU time, mortality, pulmonary complications, and hospital LOS and resulted in improved health care-related outcomes and was a cost-effective intervention. These results were sensitive to overall complication rates, and operations should be conducted by surgeons or combined surgical teams comfortable with both thoracic anatomy and exposures as well as with the principles and techniques of internal fixation.Economic Level III. See Instructions for Authors for a complete description of levels of evidence.

BackgroundFracture nonunion risk is related to severity of injury and type of treatment, yet fracture healing is not fully explained by these factors alone. We hypothesize that patient demographic factors assessable by the clinician at fracture presentation can predict nonunion.MethodsA prospective cohort study design was used to examine ~2.5 million Medicare patients nationwide. Patients making fracture claims in the 5% Medicare Standard Analytic Files in 2011 were analyzed; continuous enrollment for 12months after fracture was required to capture the ICD-9-CM nonunion diagnosis code (733.82) or any procedure codes for nonunion repair. A stepwise regression analysis was used which dropped variables from analysis if they did not contribute sufficient explanatory power. In-sample predictive accuracy was assessed using a receiver operating characteristic (ROC) curve approach, and an out-of-sample comparison was drawn from the 2012 Medicare 5% SAF files.ResultsOverall, 47,437 Medicare patients had 56,492 fractures and 2.5% of fractures were nonunion. Patients with healed fracture (age 75.0±12.7SD) were older (p

The optimal treatment of open fractures continues to be an area of debate in the orthopedic literature. Recent research has challenged the dictum that open fractures should be debrided within 6 hours of injury. However, the expedient administration of intravenous antibiotics remains of paramount importance in infection prevention. Multiple factors, including fracture severity, thoroughness of debridement, time to initial treatment, and antibiotic administration, among other variables, contribute to the incidence of infection and complicate identifying an optimal time to debridement.

Summary Background Closure of an abdominal stoma, a common elective operation, is associated with frequent complications; one of the commonest and impactful is incisional hernia formation. We aimed to investigate whether biological mesh (collagen tissue matrix) can safely reduce the incidence of incisional hernias at the stoma closure site. Methods In this randomised controlled trial (ROCSS) done in 37 hospitals across three European countries (35 UK, one Denmark, one Netherlands), patients aged 18 years or older undergoing elective ileostomy or colostomy closure were randomly assigned using a computer-based algorithm in a 1:1 ratio to either biological mesh reinforcement or closure with sutures alone (control). Training in the novel technique was standardised across hospitals. Patients and outcome assessors were masked to treatment allocation. The primary outcome measure was occurrence of clinically detectable hernia 2 years after randomisation (intention to treat). A sample size of 790 patients was required to identify a 40% reduction (25% to 15%), with 90% power (15% drop-out rate). This study is registered with ClinicalTrials.gov, NCT02238964. Findings Between Nov 28, 2012, and Nov 11, 2015, of 1286 screened patients, 790 were randomly assigned. 394 (50%) patients were randomly assigned to mesh closure and 396 (50%) to standard closure. In the mesh group, 373 (95%) of 394 patients successfully received mesh and in the control group, three patients received mesh. The clinically detectable hernia rate, the primary outcome, at 2 years was 12% (39 of 323) in the mesh group and 20% (64 of 327) in the control group (adjusted relative risk [RR] 0·62, 95% CI 0·43–0·90; p=0·012). In 455 patients for whom 1 year postoperative CT scans were available, there was a lower radiologically defined hernia rate in mesh versus control groups (20 [9%] of 229 vs 47 [21%] of 226, adjusted RR 0·42, 95% CI 0·26–0·69; p

Introduction Postoperative delirium is associated with opioid use in the elderly and is a common complication of geriatric hip fractures, with reported incidences from 16% to 70%. Intravenous (IV) acetaminophen is a safe and efficacious medication in elderly patients and has been shown to reduce use of opioids after hip fracture. At our institution, IV acetaminophen was implemented for the first 24 hours postoperatively as part of a multimodal pain control regimen for geriatric hip fracture patients. Methods A retrospective review of 123 hip fragility fracture patients older than 60 years from January 2016 to December 2016 was performed. Delirium was identified using a validated chart-based review tool. The rate of delirium, as well as length of stay, pain scores, opioid administration, need for one-to-one supervision, and readmissions were analyzed. Results Sixty-five patients (52.8%) received IV acetaminophen during this period. No notable differences were found in baseline characteristics between groups. Ten of 65 patients receiving IV acetaminophen postoperatively experienced delirium compared with 19 of 58 who did not receive the medication (15.4% versus 32.8%, P = 0.024). The IV acetaminophen group also required fewer doses of IV opioids on postoperative day 1 (0.37 versus 1.19 doses, P = 0.008), were less likely to require one-to-one supervision (9.2% versus 24.1%, P = 0.025), and had shorter lengths of hospital stay (6.37 versus 8.47 days, P = 0.037). Readmission rates and discharge dispositions did not vary with significance between the two groups. Conclusion The inclusion of IV acetaminophen as part of a multimodal pain regimen led to fewer episodes of delirium in this study. The reduced use of opioids immediately after surgery may have been a large factor in this outcome. Lower delirium rates may reduce the utilization of inpatient resources for direct patient supervision and provide for shorter hospital stays.

Background: Concussion injuries are common in professional football players; however, their effect on player performance remains unclear. Purpose: To quantify the effect of concussions on the performance of running backs and wide receivers in professional football players. Study Design: Cohort study; Level of evidence, 3. Methods: Concussion data from the National Football League were collected for a period of 4 seasons (2012-2015) for running backs and wide receivers. Age, experience, position, time to return to play, yearly total yards, and touchdowns were recorded. A power rating (total yards divided by 10 plus touchdowns multiplied by 6) was calculated for each player’s injury season as well as for the 3 seasons before and after their respective injury. A control group of running backs and wide receivers without an identified concussion injury who competed in the 2012 season was assembled for comparison. Player performance up to 3 seasons before and after the injury season was examined to assess acute and longitudinal changes in player performance. Results: A total of 38 eligible running backs and wide receivers sustained a concussion during the study period. Thirty-four (89%) players were able to return to competition in the same season, missing an average of 1.5 ± 0.9 games; the remaining 4 players returned in the subsequent season. Power ratings for concussed players were similar to those of controls throughout the study period. Concussed players did not suffer an individual performance decline upon returning within the same season. Furthermore, no significant difference in change of power rating was observed in concussed players in the acute (±1 year from injury; −1.2 ± 4.8 vs –1.1 ± 3.9, P = .199) or chronic (±3 years from injury; –3.6 ± 8.0 vs –3.0 ± 4.5, P = .219) setting compared with controls. All concussed players successfully returned to competition in either the index or next season. Conclusion: A high rate of National Football League running backs and wide receivers are able to return to play after a concussion injury. These players were found to perform at a similar level in both the acute and long-term period after concussion.

Grit is a positive noncognitive trait that is based on an individual's passion for long-term goals, coupled with a powerful motivation to achieve. Grit has been shown to be a greater predictor of success than intelligence. As the curriculum for orthopaedic trainees continues to evolve, deliberate practice for surgical skills, encouraging a growth mindset, and enhancing grit may be as important as preparation for board examinations. Although talent and skill play a role in achievement, the effort put forth in developing a skill can dramatically affect the ultimate achievement. Therefore, grit is a trait that can be developed. As educators, we can encourage hard work, reflection, and appropriate risk-taking. Implicit biases and microaggressions occur on a daily basis within orthopaedics, and grit will be an important trait to possess in order to combat these biases. However, we also will have to work as a community to create a more welcoming culture to underrepresented groups so that we can provide the highest level of musculoskeletal care and improve patient outcomes.

Precision medicine offers potential for improved outcomes by tailoring interventions based on patient-specific demographics and disease-specific data. Precision methods are relatively unexplored in trauma patients. New research is being looked at for precision methods to treat patients with large extremity wounds, nonunions, and fractures associated with polytrauma. Precision-based clinical decision tools are being validated to optimize timing for open wound definitive closure. Early patient-specific biomarkers to stratify nonunion risk within 1 week of fracture are being explored. Patient-specific data to stage timing of major fracture interventions in multiply injured patients are being interrogated.

Objective To evaluate the effect of chemotherapy added to a surgical locoregional treatment (LRT) for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). Materials and Methods We studied the sub-group of trials with surgical LRT included in the meta-analysis on chemotherapy in head and neck cancer (MACH-NC). Data from published and unpublished randomized trials comparing the addition of chemotherapy to LRT in HNSCC patients were sought using electronic database searching for the period 1965–2000, hand searching and by contacting experts in the field. Trials with less than 60 patients, or preoperative radiotherapy or where the type of LRT could not be individually determined were excluded. All individual patient data were checked for internal consistency, compared with published reports, and validated with trialists. Data were pooled using a fixed-effect model. Heterogeneity was assessed using Cochrane test and I 2 statistic. Results Twenty-four trials were eligible (5000 patients). Chemotherapy improved overall survival (HR = 0.92 [95%CI: 0.85–0.99] p = 0.02). There was a significant interaction between treatment effect and timing of chemotherapy (p = 0.08 at pre-specified threshold of 0.10) with a greater effect for concomitant chemotherapy (HR = 0.79, 95%CI: 0.69–0.92). The benefit of chemotherapy was greater in women (HR women = 0.63, 95%CI: 0.50–0.80) compared to men (HR men = 0.96, 95%CI: 0.89–1.04; p for interaction = 0.001). Conclusions This analysis confirmed the benefit of concomitant chemotherapy added to surgical LRT. The role of induction therapy as yet to be determined as it did not improve OS. Women may benefit more than men from chemotherapy.

Background: The ideal volar locking plate for the treatment of distal radius fracture should anatomically fit the volar surface of the distal radius. The purpose of this study was to measure the volar cortical angle (VCA) of uninjured adult distal radii to determine how well the VCA matches that of modern volar locking plates and whether variations in the VCA are related to demographic factors. Methods: A retrospective radiographic analysis of 273 uninjured adult distal radii was performed. Patients were stratified into age quintiles: less than 27 years, 27 to 43 years, 44 to 51 years, 52 to 64 years, and 65 years or older. The VCA was measured on lateral wrist radiographs, and patient demographics, including age and sex, were collected. Multivariable linear regression analyses were performed to determine the relationship between VCA and demographic factors. Results: The VCA ranged from 23.2° to 42.6°, with a mean of 32.2° ( SD = 3.79). Mean VCA was 32.8 ( SD = 4.17) in the youngest cohort (65 years). Mean VCA decreased with age, approximately 0.04° per year after adjusting for sex. Men had a 1.6° greater VCA than women after adjusting for age. Conclusion: Mean VCA was greater than the VCA of modern volar locking plates. The VCA decreased with age in both men and women, and men had a greater VCA than women. Such differences must be taken into account to avoid malreduction, tendon irritation, or intra-articular screw placement using current volar plate designs.

Resident selection is integral to the graduate medical educational process and the future of our profession. There is no consensus among residency directors as to how to systematically and consistently screen and select applicants who would perform well as residents. The purpose of this study was to introduce and assess a high volume application screening tool and semistructured interview process.This study took place in an academic orthopedic surgery department over 2 years (2013-2014). Overall, 1382 applications were screened in 7 categories, with a maximum score of 100. A total of 14 faculty reviewed applications; 218 interviews were offered; 165 applicants accepted the interview. Overall, 4 interview domains (cognitive, affective, activities, and theme), and an impression score were ranked from 1 (Exceptional) to 6 (Concern). Each room had an assigned "theme" (ethics, affective, cognitive, research, and "fit") with standardized questions. A summary score was generated of all scores to determine the preliminary rank list; the final rank list was determined after group discussion. Correlation between preliminary rank, final rank, and screening scores were assessed.The average screening score was 62.5 (range: 0-100, median = 64). The average interview score was 69.5 (range: 32.24-95.0). Final rank lists correlated most highly with initial rank (0.912, p0.001), impression (0.847, p0.001), and affective domain (0.834, p0.001). Cognitive domain (0.628, p0.001) and screening scores (0.264, p0.001) less highly correlated with final rank position.A systematic approach was used to screen and evaluate a large number of orthopedic surgery applicants. Our system demonstrated excellent feasibility, reliability, and predictability for the final rank list.

Post-traumatic stiffness after open reduction and internal fixation of fractures about the knee can have dramatic effects on function. Traditionally, open quadricepsplasty has been the treatment of choice, but is associated with significant morbidity. The purpose of this study is to examine the immediate and sustainable range of motion (ROM) changes after surgical arthroscopic lysis of knee adhesions (SALKA) for post-traumatic knee stiffness after open reduction internal fixation (ORIF). We retrospectively reviewed a consecutive series of patients at a single institution who underwent SALKA for knee stiffness after intra-articular fractures about the knee treated with ORIF from 2009 to 2015. Pre-operative and immediate post-operative total ROM was assessed while patients were sedated during the SALKA procedure. Total ROM was assessed in the office pre-operatively and compared to the latest post-operative follow-up visit. Immediate post-operative ROM was also compared to the latest post-operative follow-up visit. Two-tailed paired Student’s t test was calculated for analysis. Of the 14 patients included in the study, 10 (71 %) had tibial plateau ORIF, 3 (21 %) had patella ORIF, and 1 (8 %) had intra-articular distal femur ORIF. The mean time between ORIF and SALKA was 244 days. The mean follow-up time after SALKA was 135 days. Under sedation during SALKA, the mean total ROM increased from 72° to 127° immediately post-operatively (p

Management of fracture nonunion in the setting of subacute or chronic bacterial infection is a clinical challenge. Treatment must concurrently manage fracture instability and bacterial contamination. When acute infection occurs following fracture fixation, surgical debridement, antibiotic suppression and retention of stable fracture fixation hardware have been shown to be successful [1]. When fracture healing has not occurred alongside deep infection, alternative tactics must be explored. A general approach involves implant removal, thorough excisional debridement and irrigation, fracture stabilisation and focused systemic antibiotic therapy with or without additional local antibiosis. The use of antibiotic impregnated poly-methylmethacrylate (PMMA) as a nonbiodegradable drug delivery vehicle is well described in the orthopaedic literature [2,3]. Antibiotic impregnated PMMA can be placed in open fractures, areas of bone loss, soft tissue wounds, as well as in the setting of acute and chronic orthopaedic infections. Multiple authors have also reported the success of antibiotic impregnated PMMA intramedullary (IM) implants to stabilise and treat infected long bone nonunions [4–6]. The stabilisation and management of infected peri-articular nonunions remains a clinical challenge. In some clinical scenarios, limb stability is best achieved with a plate and screw device. We describe the creation and use of an antibiotic impregnated PMMA cement covered periarticular plate for this problem. This approach is highly effective in the provisional or definitive treatment of infected periarticular nonunions. It provides local delivery of antibiotics, immediate osseous stability, complete soft tissue closure and early range of motion.