Disease-associated comorbidities, medication records and anthropometric measures in adults with Duchenne muscular dystrophy.

We investigated the comorbidities, associated factors, and the relationship between anthropometric measures and respiratory function and functional abilities in adults with Duchenne muscular dystrophy (DMD). This was a single-centre cross-sectional study in genetically diagnosed adults with DMD (>16 years old). Univariate and multivariate analyses identified factors associated with dysphagia, constipation, Body Mass Index (BMI), and weight. Regression analysis explored associations between BMI, weight, and respiratory/motor abilities. We included 112 individuals (23.4 ± 5.2 years old), glucocorticoid-treated 66.1 %. The comorbidities frequency was 61.6 % scoliosis (61.0 % of them had spinal surgery), 36.6 % dysphagia, 36.6 % constipation, and 27.8 % urinary conditions. The use of glucocorticoids delayed the time to spinal surgery. The univariate analysis revealed associations between dysphagia and constipation with age, lack of glucocorticoid treatment, and lower respiratory and motor function. In the multivariate analysis, impaired cough ability remained as the factor consistently linked to both conditions. Constipation associated with lower BMI and weight. BMI and weight positively correlated with respiratory parameters, but they did not associate with functional abilities. Glucocorticoids reduce the frequency of comorbidities in adults with DMD. The ability to cough can help identifying dysphagia and constipation. Lower BMI and weight in individuals with DMD with compromised respiratory function may suggest a higher calories requirement.

Multicenter, Prospective, Observational Study of Nonoperative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures.

OBJECTIVES: Evaluate if nonoperative or operative treatment of displaced clavicle fractures delivers reduced rates of nonunion and improved Disability of the Arm, Shoulder, and Hand (DASH) scores. DESIGN: Multicenter, prospective, observational. SETTING: Seven Level 1 Trauma Centers in the United States. PATIENT SELECTION CRITERIA: Adults with closed, displaced (100% displacement/shortened >1.5 cm) midshaft clavicle fractures (Orthopaedic Trauma Association 15.2) were treated nonoperatively, with plates and screw fixation, or with intramedullary fixation from 2003 to 2018. OUTCOME MEASURES AND COMPARISONS: DASH scores (2, 6 weeks, 3, 6, 12, and 24 months), reoperation, and nonunion were compared between the nonoperative, plate fixation, and intramedullary fixation groups. RESULTS: Four hundred twelve patients were enrolled, with 203 undergoing plate fixation, 26 receiving intramedullary fixation, and 183 treated nonoperatively. The average age of the nonoperative group was 40.1 (range 18-79) years versus 35.8 (range 18-74) in the plate group and 39.3 (range 19-56) in the intramedullary fixation group (P = 0.06). One hundred forty (76.5%) patients in the nonoperative group were male compared with 154 (75.9%) in the plate group and 18 (69.2%) in the intramedullary fixation group (P = 0.69). All groups showed similar DASH scores at 2 weeks, 12 months, and 24 months (P > 0.05). Plate fixation demonstrated better DASH scores (median = 20.8) than nonoperative (median = 28.3) at 6 weeks (P = 0.04). Intramedullary fixation had poorer DASH scores at 6 weeks, 3 months, and 6 months than plate fixation and worse DASH scores than nonoperative at 6 months (P < 0.05). The nonunion rate for nonoperative treatment (14.6%) was significantly higher than the plate group (0%) (P < 0.001). CONCLUSIONS: Operative treatment of displaced clavicle fractures provided lower rates of nonunion than nonoperative treatment. Except at 6 weeks, no difference was observed in DASH scores between plate fixation and nonoperative treatment. Intramedullary fixation resulted in worse DASH scores than plate fixation at 6 weeks, 3 months, and 6 months and worse DASH scores than nonoperative at 6 months. Implant removal was the leading reason for reoperation in the plate and intramedullary fixation groups, whereas surgery for nonunion was the primary reason for surgery in the nonoperative group. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

The Impact of Virtual Reality on Anxiety and Pain During US-Guided Breast Biopsies: A Randomized Controlled Clinical Trial.

OBJECTIVE: To investigate the efficacy of immersive virtual reality (VR) in combination with standard local anesthetic for mitigating anxiety and pain during US-guided breast biopsies compared to local anesthetic alone. METHODS: Patients scheduled for US-guided biopsy were invited to participate. Eligible patients were females 18 years of age or older. Patients were randomized to VR or control group at a 1:1 ratio. Patients in the VR group underwent biopsy with the addition of a VR experience and patients in the control group underwent usual biopsy. Patient-perceived levels of anxiety and pain were collected before and after biopsy via the State-Trait Anxiety Inventory (STAI) and Visual Analog Scale (VAS). Physiological data were captured during biopsy using a clinically validated wristband. Differences in anxiety, pain, and physiologic data were compared between the VR and control group. RESULTS: Sixty patients were enrolled. After excluding 2 patients with VR device malfunction, there were 29 patients in the VR and 29 patients in the control group for analysis. The VR group had reduced anxiety compared to the control group based on postintervention STAI (P <.001) and VAS (P = .036). The VR group did not have lower pain based on postintervention VAS (P = .555). Physiological measures showed higher RR intervals and decreased skin conductance levels, which are associated with lower anxiety levels in the VR group. CONCLUSION: Use of VR in addition to standard local anesthetic for US-guided breast biopsies was associated with reduced patient anxiety. Virtual reality may be a useful tool to improve the patient biopsy experience.

Midshaft clavicle fractures: is anterior plating an acceptable alternative to superior plating?

PURPOSE: The purpose of this study was to determine whether anterior plating is better tolerated than superior plating for midshaft clavicle fractures. METHODS: This was a prospective non-randomized observational cohort study following operative vs. non-operative management of clavicle fractures from 2003 to 2018 at 7 level 1 academic trauma centers in the USA. The subset of patients treated with plate and screws is the basis for this comparative study. Adults aged 18-85 with closed clavicle fractures displaced over 100% or shortened by more than 1.5 cm were eligible for enrollment. Patients were followed for 2 years following enrollment. Allowable fixation methods at the discretion of the surgeon consisted of anterior-inferior or superior plating. A total of 412 patients were enrolled. Of these, 192 patients received either superior or anterior plating for a displaced clavicle fracture with complete documented prospective research forms capturing type of plating technique. The primary outcome measure was hardware removal (HWR). Secondary outcomes were Disability of the Arm Shoulder and Hand (DASH) score and Visual Analog Pain (VAP) score, and satisfaction score (1 = high satisfaction; 5 = low satisfaction). RESULTS: There was no difference in HWR rates (7.1% superior 9/127; 6.2% anterior 4/65, p = 0.81), VAP score (mean 1.5 SD 1.0 superior; mean 1.7 SD 0.6 anterior, p = 0.21), DASH score (mean 7.5 SD 12.4 superior; mean 5.2 SD 15.2 anterior; p = 0.18) or satisfaction score (mean 1.6 SD 1.0 superior; mean 1.7 SD 0.60 anterior, p = 0.18). CONCLUSION: There is no difference in HWR rates or functional outcomes when using a superior vs. anterior plating technique.

High Complication Rate After Percutaneous Screw Fixation for Valgus-Impacted Femoral Neck Fractures Without Sagittal Malalignment.

OBJECTIVES: To evaluate the rate of reoperation in patients without sagittal plane malalignment who underwent percutaneous screw fixation of a valgus-impacted femoral neck fracture. DESIGN: Retrospective case series. SETTING: Two Level 1 academic trauma centers. PATIENTS AND INTERVENTION: Two hundred seven patients >50 years of age with valgus-impacted femoral neck fractures treated with at least 3 large-diameter (>6.5 mm) cancellous screws from 2013 to 2019. Patients were excluded if there was a sagittal plane fracture deformity. MAIN OUTCOME MEASUREMENTS: The primary outcome was reoperation. Secondary outcomes considered "major complications" included: avascular necrosis, varus collapse or implant cutout, nonunion, deep infection, and hematoma requiring reoperation. Surgical fixation strategies (screw configuration, aim) and implant type (partial vs. fully threaded cancellous screws) were secondarily compared. RESULTS: Average patient age was 77 years, and median clinical follow-up was 658 days. Thirty-one patients (15%) required reoperation, and the major complication rate was 17.3% (36 complications in 33 patients). Logistic regression analysis demonstrated a higher risk of reoperation with constructs consisting of all partially threaded screws (17.0%) compared with the use of at least 1 fully threaded screw (7.5%) when an inverted triangle configuration was used (odds ratio, 2.50; 95% CI, 0.81-7.77). CONCLUSIONS: This study demonstrated a relatively high rate of reoperation and major complications in patients with valgus-impacted femoral neck fractures without sagittal malalignment treated with in situ percutaneous screw fixation. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Evaluating safe time to discharge after closed reduction and percutaneous pinning of uncomplicated type III supracondylar humerus fractures: a single-center retrospective review.

The purpose of this retrospective study was to review complications following closed reduction, percutaneous pinning of isolated, type III supracondylar fractures without associated injuries to evaluate if patients may be discharged safely on the day of surgery. We performed a retrospective chart and radiographic review of patients with isolated Gartland type III supracondylar humerus fractures who underwent closed reduction and percutaneous pinning over a 4-year period. We reviewed admission time to the emergency department, time and length of surgery, time to discharge, postoperative complications, readmission rate and office visits. Of the 110 patients included, 19 patients were discharged in less than 6 h, 45 patients between 6 and 12 h and 46 patients greater than 12 h. A total of 61 patients were discharged on the same day as surgery and 49 were discharged the next day. There were 11 postoperative complications. No postoperative complications were found in patients discharged less than 6 hours from surgery. For patients discharged between 6 and 12 hours postoperatively, one patient returned to the office earlier than scheduled. The result of our review suggests that patients can be safely discharged within the 12-h postoperative period with no increased risk of complications. This is contingent upon the patient having a stable neurovascular examination, pain control and caregiver's comfort level. This can decrease medical cost, family stress and burden to the hospital system. Time to discharge should still be evaluated on a case-by-case basis after evaluating medical and social barriers.

Observation versus Cast Treatment of Toddler's Fracture: A Prospective Pilot Study.

"Toddler's fractures" are common in the pediatric population. Traditional treatment recommends casting these fractures, although with their inherent stability, may be unnecessary. This study evaluated if toddler's fractures can be treated with observation alone as opposed to casts. A prospective pilot study was performed with randomization and observational arms. Children were placed in short casts or observed without immobilization. A 21-day log was given to families to record walking. Follow up with radiographs occurred at 3 and 12 weeks. Twenty-one patients enrolled, three randomized and 18 chose their treatment. Thirteen patients were casted, and eight went without immobilization. Ambulation time was similar between groups (p = 0.260). Three without immobilization returned early but none converted to cast. All fractures healed uneventfully. There were no cast complications. Toddler's fractures treated with or without cast immobilization appears to be safe and effective but should be a shared decision between physician and parents. (Journal of Surgical Orthopaedic Advances 32(3):207-211, 2023).

Infection Rate in Type I Open Distal Radius Fractures Surgically Treated >24 Hours Post-Injury: A Comparison Study.

PURPOSE: To determine how time to surgical debridement and fixation affects infection and complication rate in type I open distal radius fractures by comparing patients treated within 24 hours with those treated >24 hours post-injury. METHODS: A retrospective review identified 62 patients who sustained a type I open distal radius fracture that was treated surgically. Patients were stratified into groups based on time to surgical intervention. An additional analysis was performed on patients with an isolated type I open distal radius fracture treated as an inpatient or outpatient. The primary outcome measure was infection rate. Secondary outcome measures were complications, reoperations, and readmissions. RESULTS: Thirty-eight patients underwent surgery ≤24 hours post-injury at an average of 14 hours. Twenty-four patients underwent surgery >24 hours post-injury at an average of 72 hours. There were a total of 9 complications in 8 patients (14.5%). The overall infection rate was 1.6%, with only 1 deep infection occurring in the group treated ≤24 hours post-injury. There were 7 reoperations (11.3%) and 1 readmission (1.6%). No differences were found between groups in any outcome measure. In the 27 patients with an isolated fracture, there were no differences in any outcome measure when treated as an inpatient or outpatient. CONCLUSIONS: We suggest that type I open distal radius fractures could be safely treated surgically >24 hours post-injury without increased risk of infection.

Impact of an Opioid Stewardship Initiative Involving Early Conversion to Oral Narcotics in Postoperative Orthopaedic Patients.

The objective of this study was to determine if the implementation of an opioid stewardship initiative involving early conversion to oral opioids improves outcomes in postoperative orthopaedic patients. This single-center retrospective chart review compared adult patients undergoing lower extremity orthopaedic procedures during a specified six-month time period. The primary outcome was total opioid utilization in morphine milligram equivalence (MME) at 48-hours post-surgery. Four hundred ninety-five patients were included in the study, 233 in the intervention group and 262 in the pre-intervention group. The average pain scores at 12, 24 and 48 hours postoperatively were similar among the two groups. After a multivariate linear regression was performed, a 22.9 MME reduction was estimated in the post-implementation group compared to the pre-implementation group (p = 0.003). Based on these results, it appears that converting from intravenous to oral narcotics 24-hours post-orthopaedic surgery reduces total mean MMEs while providing similar pain control. (Journal of Surgical Orthopaedic Advances 31(2):086-089, 2022).

Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial.

INTRODUCTION: Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow. METHODS: Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients. RESULTS: 7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p < 0.001). CONCLUSIONS: Implementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.

Intraosseous Plate Reduction and Fixation of Complex Proximal Ulnar Fractures: A Report of 2 Cases.

CASE: We describe 2 cases using a novel technique of intraosseous plating of the coronoid as a reduction tool and fixation construct for complex elbow fracture dislocations. Each patient sustained traumatic, complex injuries of the elbow and were radiographically healed at the final follow-up. CONCLUSION: Elbow fracture dislocations are complex injuries because of the interplay between primary and secondary stabilizers. This technique provides access to fracture fragments with minimal to no soft-tissue disruption and does not obstruct additional reduction or fixation of the injury.

Predicting Pathologic Bone Lesions Using Scout Computed Tomography (CT) Imaging.

The purpose of this study is to evaluate the benefit of reviewing scout CT images, obtained for routine oncologic surveillance, for the early identification of pathologic bony lesions. A retrospective review was conducted on patients who previously underwent surgical treatment by two orthopedic oncology surgeons at a tertiary care institution from 2009-2019 for pathologic lesions or fractures of the humerus or femur. Radiographic records were reviewed to identify patients in this cohort who had available scout views from CT imaging prior to official diagnosis of the bony lesion or fracture. CT scout images were assessed by two independent reviewers to identify any pathologic lesions, and radiographic reports were reviewed to identify if the lesions were noted by radiology at the time of the initial scan interpretation. One hundred and forty-four patients were identified, and thirty-nine had an available scout CT image prior to official diagnosis of the lesion. Twenty-five patients (64.1%) had lesions identified by authors on scout CT versus only 9 (23.1%) who had lesions that were documented in the initial CT radiologic report. There was a total of 29 lesions identified by the study authors on scout CT, and 19 (65.5%) were not reported in the initial radiographic interpretation with an average interval between observation by authors and official diagnosis of 202 days. Of the impending fractures, three patients (16.7%) went on to complete fracture prior to referral to orthopedics with an average interval between these missed lesions on scout CT and their presentation with fracture of 68 days. This study advocates for the careful review of all scout CT imaging as an essential part of the work up for metastatic disease and encourages all practitioners to utilize this screening tool for the identification of pathologic bony lesions which may help expedite early treatment to reduce patient morbidity.

Intramedullary Nail Fixation for the Treatment of Pathologic Humeral Shaft Fractures.

The goal of this study was to report the clinical outcomes of pathologic humeral shaft fractures treated with reamed or unreamed intramedullary nail fixation in an era of longer patient survival. A retrospective review was conducted of all patients who underwent intramedullary nail fixation performed by a single surgeon for pathologic humeral shaft fractures at a Level I trauma center from 2009 to 2017. Of the 25 patients who were identified, 9 were excluded. Groups were categorized according to whether they underwent reamed or unreamed fixation, and they were evaluated for evidence of union, complications, and reoperation. Of the patients, 11 underwent an unreamed procedure and 5 underwent a reamed procedure. Mean length of follow-up was 51.5 weeks. Of the patients who participated, 12 (75%) showed evidence of union and 2 patients (12.5%) showed evidence of nonunion, with no statistical difference between the groups. Five patients (31.3%) had complications. One nonunion occurred in the reamed group and did not require reoperation. In the unreamed group, complications consisted of 1 delayed union, 1 nonunion treated with revision intramedullary nail fixation, and 2 cases of disease progression that required reoperation. Intramedullary nail fixation of pathologic humeral shaft fractures achieves rates of union parallel to those seen with fixation in a healthy population. The length of follow-up in the current study was longer than the life expectancy reported by previous authors, which can be attributed to improvements in the treatment of cancer. The current authors argue that unreamed fixation is the optimal technique because it yields similar outcomes to a reamed approach and is faster and potentially safer. [Orthopedics. 2020;43(5):e389-e398.].

How Successful Is Antibiotic Treatment for Superficial Surgical Site Infections After Open Fracture? A Fluid Lavage of Open Wounds (FLOW) Cohort Secondary Analysis.

BACKGROUND: Although many studies report the incidence and prevalence of surgical site infections (SSIs) after open fractures, there is limited information on the treatment and subsequent outcomes of superficial SSIs in patients with open fractures. Additionally, clinical studies describing the factors that are associated with persistent infection after nonoperative treatment with antibiotics for patients with superficial SSIs are lacking. QUESTIONS/PURPOSES: Therefore, we asked: (1) What proportion of patients with superficial SSIs after open fracture treatment developed persistent infection after nonoperative treatment (that is, treatment with antibiotics alone)? (2) What risk factors are associated with SSIs that do not resolve with nonoperative (antibiotic) treatment? As a secondary objective, we planned to analyze the microbiological information about participants wound cultures, when these were available, and the proportion of positive cultures for patients whose SSIs were not resolved by antibiotics alone. METHODS: This is a secondary analysis of the Fluid Lavage of Open Wounds (FLOW) trial dataset. The FLOW trial included 2445 patients with operatively managed open fractures. FLOW participants who had a nonoperatively managed superficial SSI diagnosed in the 12 months post-fracture were included in this analysis. Superficial SSIs were diagnosed in 168 participants within 12 months of their fracture. Of these, 83% (139) had their superficial SSI treated with antibiotics alone. Participants were grouped into two categories: (1) 97 participants whose treatment with antibiotics alone resolved the superficial SSI and (2) 42 participants whose treatment with antibiotics alone did not resolve the SSI (defined as undergoing surgical management or the SSI being unresolved at latest follow-up [12-months post-fracture for the FLOW trial]). Of the participants whose treatment with antibiotics alone resolved the SSI, 92% (89 of 97) had complete follow-up, 6% (6 of 97) were lost to follow-up before 12 months, 1% (1 of 97) withdrew consent from the study before 12 months, and 1% (1 of 97) experienced mortality before 12 months. Of the participants whose treatment with antibiotics alone did not resolve the SSI, 90% (38 of 42) had complete follow-up, 7% (3 of 42) were lost to follow-up before 12 months, and 2% (1 of 42) withdrew consent from the study before 12 months. A logistic binary regression analysis was conducted to identify factors associated with persistent infection despite superficial SSI antibiotic treatment. Based on biologic rationale and previous evidence, we identified a priori 13 potential factors (corresponding to 14 levels) to be included in the regression model. RESULTS: The antibiotic treatment resolved the superficial SSI in 70% (97 of 139) of patients and did not resolve the SSI in 30% (42 of 139). After controlling for potential confounding variables, such as age, fracture severity, and time from injury to initial surgical irrigation and débridement, superficial SSIs diagnosed later in follow-up were associated with antibiotics not resolving the SSI (odds ratio 1.05 [95% CI 1.004 to 1.009] for every week of follow-up; p = 0.03). Sex, fracture pattern, and wound size were not associated with antibiotics not resolving the SSI. CONCLUSIONS: Our secondary analysis of prospectively collected FLOW data suggests that antibiotics alone can be an appropriate treatment option when treating superficial SSIs after an open fracture wound, especially when promptly diagnosed. Further research with longer follow-up time is needed to better identify the natural history of superficial SSIs and possibly some dormant or subclinical infections to help clinicians in the treatment decision-making process. LEVEL OF EVIDENCE: Level III, therapeutic study.

Early Return to Play After Intramedullary Screw Fixation of Acute Jones Fractures in Collegiate Athletes: 22-Year Experience.

BACKGROUND: There is disagreement among team physicians, without conclusive evidence, as to when high-level athletes with a Jones fracture should be allowed to return to play after being treated operatively with an intramedullary screw. PURPOSE: To report our experience of early return to sport in collegiate athletes after intramedullary screw fixation of Jones fractures. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: We identified all collegiate athletes with an acute fracture at the base of the fifth metatarsal treated by 1 of 2 orthopaedic surgeons with intramedullary screw fixation over a 22-year period (1994-2015), and we performed a retrospective review of their records. Fixation consisted of a single intramedullary screw. Athletes were allowed to bear weight as tolerated in a walking boot immediately postoperatively and return to play as soon as they could tolerate activity. Patients were contacted to complete patient-reported outcome scores that included the Foot and Ankle Ability Measure (FAAM) score, a brief survey specific to our study, and follow-up radiographs. RESULTS: A total of 26 acute Jones fractures were treated in 25 collegiate athletes (mean age, 20 years; range, 18-23 years). Overall, the athletes returned to play at an average of 3.6 weeks (range, 1.5-6 weeks). Three screws were removed for symptomatic skin irritation. There was 1 refracture after screw removal that was done after radiographic and clinical documentation of fracture union, which was treated with repeat cannulated percutaneous screw fixation. One screw was observed on radiographs to be broken at 1 year postoperatively, but the fracture was healed and the athlete was playing National Collegiate Athletic Association Division I sports without symptoms and continued to play professionally without symptoms. Of 25 athletes, 19 completed the FAAM at an average follow-up of 8.6 years (range, 1.5-20.0 years). They reported scores of 94.9% (range, 70.2%-100%) for the activities of daily living subscale and 89.1% (range, 42.9%-100%) for the sports subscale. Follow-up radiographs were obtained, and no nonunion, malunion, or additional hardware complications were identified. CONCLUSION: Athletes with acute Jones fractures can safely be allowed to return to play after intramedullary screw fixation as soon as their symptoms allow, without significant complications. In our experience, this is usually within 4 weeks from injury.

The Dislocated Hip on CT Scan: An Argument for the Initial Pelvic Radiograph in Trauma Patients.

This study evaluated the frequency in which a hip dislocation is first diagnosed by computed tomography (CT) scan. A retrospective review was conducted of orthopaedic trauma patients presenting with hip dislocation to a Level 1 trauma center over three years. We recorded whether the patient first received pelvic radiograph (PXR) or CT scan of the pelvis, if the patient underwent closed reduction of the hip prior to CT scan, and if repeat pelvis CT scan was done. Of 83 hip dislocations, 64 patients were sent to CT scanner dislocated; 19 patients first had PXR and underwent closed reduction of the hip prior to CT scan. By obtaining a PXR, reducing the hip prior to CT, the incidence of repeat CT scan decreased from 37% to 11% (p = 0.046). By diagnosing hip dislocation, reducing prior to CT scan, repeat scans can be reduced, thus decreasing cost and radiation exposure to patients. (Journal of Surgical Orthopaedic Advances 29(1):4345, 2020).

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

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

An unusually impressive atorvastatin-induced elevation of serum alkaline phosphatase.

A 90-year-old woman is referred six months after a transient ischaemic attack (TIA) with asymptomatic cholestatic liver function test (LFT) derangement. Following the TIA, atorvastatin and clopidogrel therapy are initiated. This is added to pre-existent once daily nifedipine for hypertension. Nifedipine (a weak inhibitor of CYP3A4 and competing substrate) and clopidogrel (a competitive inhibitor of CYP3A4) may have affected the metabolism of atorvastatin, resulting in the elevation of serum alkaline phosphatase levels to over six times the upper limit of normal. More often, statin therapy elevates serum alanine aminotransferase levels. Drug-induced liver injury (DILI) was deemed 'probable' as judged by the Roussel Uclaf Causality Assessment Method score. Statin therapy remains overwhelmingly safe, with benefits outweighing risks in the vast majority. The UK recommended LFT monitoring regime facilitates early recognition of DILI. Case reports are examined where similar drug combinations resulted in severe morbidity and mortality.