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.

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.

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.

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.

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.

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.

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.

Immobilization Versus Observation in Children With Toddler's Fractures: A Retrospective Review.

While long leg casts have been historically recommended for immobilization of toddler's fractures, short leg casts are often used by treating physicians. Others question whether any immobilization is necessary because of the internal stability provided by the thickened periosteum of pediatric bones. The purpose of this study is to review the results of toddler's fractures treated with long leg casts, short leg casts, or without immobilization. Eighty-five patients were included in a retrospective review of nondisplaced spiral or oblique tibial shaft fractures in children under 6 years old from 2007 to 2012. Treatments included long leg casts (19), short leg casts (59), and no immobilization (7). Average time to ambulation was 15.5 days. There were 11 casting complications. Only one patient, in a short leg cast, had measurable displacement or angulation. There were no complications reported in the nonimmobilized group. The results suggest that toddler's fractures can be effectively treated with short leg casts or without immobilization. (Journal of Surgical Orthopaedic Advances 27(2):142-147, 2018).

Does Traction Decrease the Need for Open Reduction in Femoral Shaft Fractures Treated Within 24 Hours?

This study evaluates whether preoperative skeletal traction reduces the need for open reduction in femoral shaft fractures treated with intramedullary nailing (IMN) within 24 hours. A retrospective review was conducted of femoral shaft fractures undergoing IMN within 1 day of admission. Primary outcome was an open reduction at the time of IMN. Secondary outcomes were blood loss and transfusion requirements. One hundred eighty-four patients were analyzed, 106 in the knee immobilizer group and 78 in the skeletal traction group. Skeletal traction did not reduce the need for an open reduction. The knee immobilizer group required open reduction in 13% (14/106) compared with 14% (11/78) in the skeletal traction group, which was not significant (p $=$ .89). Blood loss and transfusion rates were similar between groups. Skeletal traction does not appear to reduce the need for open reduction at the time of IMN for femoral shaft fractures treated within 1 day of admission. (Journal of Surgical Orthopaedic Advances 27(4):303-306, 2018).

Tourniquet Deflation Prior to 20 Minutes in Upper Extremity Intravenous Regional Anesthesia.

BACKGROUND: Bier blocks, or intravenous regional anesthesia (IVRA), are a method of anesthesia for upper extremity surgeries. This study reports our experience with tourniquet deflation prior to 20 minutes with upper extremity IVRA. METHODS: This study was designed as a retrospective cohort analysis. Records, including intraoperative and immediate postoperative anesthesia notes, of 430 patients who underwent IVRA with an upper extremity Bier block and a corresponding tourniquet time of less than 20 minutes were reviewed. Patient demographics, procedure(s) performed, American Society of Anesthesiologists scores, volume of lidocaine used in Bier block, tourniquet time, and any complications were recorded. RESULTS: This cohort consisted of 127 males and 303 females. The 3 most common procedures performed were carpal tunnel release (315), trigger finger release (47), and excision of masses (34). The average tourniquet time for this cohort was 16 minutes (range, 9-19 minutes), and the average volume of lidocaine (0.5% plain) injected was 44 mL (range, 30-70 mL). A tourniquet time of 17 minutes or less was observed in 339 patients, and 170 patients had tourniquet times of 15 minutes or less. Five complications were recorded: intraoperative vomiting, mild postoperative nausea/vomiting, severe postoperative nausea and vomiting, and transient postoperative hypotension that responded to a fluid bolus. CONCLUSIONS: No major complications were observed in our cohort of upper extremity IVRA and tourniquet times of less than 20 minutes. Several variables play a role in the safety of upper extremity IVRA.

Effects of Upper Extremity Immobilization and Use of a Spinner Knob on Vehicle Steering.

BACKGROUND: A person's ability to safely drive while immobilized is not well defined. Steering ability with a spinner knob during immobilization is unknown. The goal of this study is to further clarify the effect of immobilization on steering reaction time and accuracy with and without a steering wheel spinner knob. METHODS: Twenty participants were enrolled in this crossover trial using a driving simulator with an automatic transmission. Five conditions were tested in a counterbalanced order. Steering reaction time and accuracy (number of errors on a dynamic steering task at 2 difficulty levels) were measured. Participants were allowed to steer with the immobilized extremity. RESULTS: No significant differences in reaction time were observed between any conditions. Both immobilized conditions and difficulty level of the steering task led to diminished accuracy compared with controls, resulting in significantly more errors. The use of a spinner knob significantly improved the accuracy for the condition with the sugar-tong splint during the easier steering task, but this improvement was not observed in the harder steering task. There were no differences between conditions based on gender or observed use of the immobilized arm. CONCLUSIONS: Immobilization had a negative effect on steering accuracy for both the wrist splint and the sugar-tong splint condition, which may negatively impact driving ability of immobilized patients. Immobilization, regardless of spinner knob use, did not significantly impact steering reaction time. The steering wheel spinner knob did not consistently improve accuracy, and further study is needed to determine its utility.

Predicting and Preventing Loss to Follow-up of Adult Trauma Patients in Randomized Controlled Trials: An Example from the FLOW Trial.

BACKGROUND: High loss-to-follow-up rates are a risk in even the most rigorously designed randomized controlled trials (RCTs). Consequently, predicting and preventing loss to follow-up are important methodological considerations. We hypothesized that certain baseline characteristics are associated with a greater likelihood of patients being lost to follow-up. Our primary objective was to determine which baseline characteristics are associated with loss to follow-up within 12 months after an open fracture in adult patients participating in the Fluid Lavage of Open Wounds (FLOW) trial. We also present strategies to reduce loss to follow-up in trauma trials. METHODS: Data for this study were derived from the FLOW trial, a funded trial in which payments to clinical sites were tied to participant retention. We conducted a binary logistic regression analysis with loss to follow-up as the dependent variable to determine participant characteristics associated with a higher risk of loss to follow-up. RESULTS: Complete data were available for 2,381 of 2,447 participants. One hundred and sixty-three participants (6.7%) were lost to follow-up. Participants who received treatment in the U.S. were more likely to be lost to follow-up than those who received treatment in other countries (odds ratio [OR] = 3.56, 95% confidence interval [CI]: 2.46 to 5.17, p < 0.001). Male sex (OR = 1.75, 95% CI: 1.15 to 2.67, p = 0.009), current smoking (OR = 1.82, 95% CI: 1.28 to 2.58, p = 0.001), high-risk alcohol consumption (OR = 1.88, 95% CI: 1.16 to 3.05, p = 0.010), and an age of <30 years (OR = 2.16, 95% CI: 1.19 to 3.95, p = 0.012) all significantly increased the odds of a patient being lost to follow-up. Conversely, participants who had sustained polytrauma (OR = 0.52, 95% CI: 0.37 to 0.73, p < 0.001) or had a Gustilo-Anderson type-IIIA, B, or C fracture (OR = 0.60, 95% CI: 0.38 to 0.94, p = 0.024) had lower odds of being lost to follow-up. CONCLUSIONS: Using a number of strategies, we were able to reduce the loss-to-follow-up rate to <7%. Males, current smokers, young participants, participants who consumed a high-risk amount of alcohol, and participants in the U.S. were more likely to be lost to follow-up even after these strategies had been employed; therefore, additional strategies should be developed to target these high-risk participants. CLINICAL RELEVANCE: This study highlights an important need to develop additional strategies to minimize loss to follow-up, including targeted participant-retention strategies. Male sex, an age of <30 years, current smoking, high-risk alcohol consumption, and treatment in a developed country with a predominantly privately funded health-care system increased the likelihood of participants being lost to follow-up. Therefore, strategies should be targeted to these participants. Use of the planning and prevention strategies outlined in the current study can minimize loss to follow-up in orthopaedic trials.

Outcomes of Low-Energy Basicervical Proximal Femoral Fractures Treated with Cephalomedullary Fixation.

BACKGROUND: Basicervical peritrochanteric fractures are relatively rare, with 1.8% to 7.6% of hip fractures being identified as true basicervical fractures. The compression hip screw traditionally has been considered the "gold standard" for operative fixation of peritrochanteric fractures, with generally good results. The purpose of this study was to report the outcomes of basicervical peritrochanteric fractures of the proximal part of the femur treated with cephalomedullary nailing (CMN). METHODS: We reviewed medical records and radiographs of all patients at our institution with a peritrochanteric fracture treated with CMN from 2010 to 2012 (246 patients). Fourteen patients with a 2-part basicervical fracture were identified. Two of them died less than 6 weeks after injury and another patient did not return for follow-up. Eleven patients were included in the reported series. RESULTS: Five of the 11 patients had fracture-healing without complications. Their average tip-apex distance was 14.9 mm. The fixation failed in the remaining six patients, all of whom had a tip-apex distance of <25 mm, with an average of 17.4 mm. Four of the failures followed an anatomic reduction, and the other 2 followed a nearly anatomic reduction. CONCLUSIONS: CMN may be inadequate for fixation of 2-part basicervical fractures. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds.

BACKGROUND: The management of open fractures requires wound irrigation and débridement to remove contaminants, but the effectiveness of various pressures and solutions for irrigation remains controversial. We investigated the effects of castile soap versus normal saline irrigation delivered by means of high, low, or very low irrigation pressure. METHODS: In this study with a 2-by-3 factorial design, conducted at 41 clinical centers, we randomly assigned patients who had an open fracture of an extremity to undergo irrigation with one of three irrigation pressures (high pressure [>20 psi], low pressure [5 to 10 psi], or very low pressure [1 to 2 psi]) and one of two irrigation solutions (castile soap or normal saline). The primary end point was reoperation within 12 months after the index surgery for promotion of wound or bone healing or treatment of a wound infection. RESULTS: A total of 2551 patients underwent randomization, of whom 2447 were deemed eligible and included in the final analyses. Reoperation occurred in 109 of 826 patients (13.2%) in the high-pressure group, 103 of 809 (12.7%) in the low-pressure group, and 111 of 812 (13.7%) in the very-low-pressure group. Hazard ratios for the three pairwise comparisons were as follows: for low versus high pressure, 0.92 (95% confidence interval [CI], 0.70 to 1.20; P=0.53), for high versus very low pressure, 1.02 (95% CI, 0.78 to 1.33; P=0.89), and for low versus very low pressure, 0.93 (95% CI, 0.71 to 1.23; P=0.62). Reoperation occurred in 182 of 1229 patients (14.8%) in the soap group and in 141 of 1218 (11.6%) in the saline group (hazard ratio, 1.32, 95% CI, 1.06 to 1.66; P=0.01). CONCLUSIONS: The rates of reoperation were similar regardless of irrigation pressure, a finding that indicates that very low pressure is an acceptable, low-cost alternative for the irrigation of open fractures. The reoperation rate was higher in the soap group than in the saline group. (Funded by the Canadian Institutes of Health Research and others; FLOW ClinicalTrials.gov number, NCT00788398.).

Far cortical locking screws in distal femur fractures.

Distal femur fractures routinely heal by secondary bone healing, which relies on interfragmentary motion. Periarticular locking plates are commonly used for fixation in distal femur fractures but are associated with a high nonunion rate, likely due to the stiffness of the constructs. Far cortical locking (FCL) screws are designed to allow micromotion at the near cortex while maintaining purchase in only the far cortex. Although clinical data are limited, these screws have been shown in biomechanical studies to provide excellent interfragmentary motion, and animal models have shown increased callus formation compared with traditional locking screws. The purpose of this study was to examine the clinical effects that FCL screws have on healing in distal femur fractures treated with locked constructs. In this retrospective case series, 15 patients with a distal femur fracture treated with MotionLoc screws (Zimmer, Warsaw, Indiana) were analyzed. Serial radiographs were evaluated for callus presence and time to union. All fractures were either 33-A3 or 33-C2 according to the AO classification system, and 5 (33%) were open. Bone loss was recorded in 2 patients. There were no nonunions, and average time to union was 24 weeks. There were no implant failures, and all 5 open fractures, including the 2 with bone loss, healed without intervention. There was 1 reoperation due to painful hardware. Although this is a small case series, these results are promising. Far cortical locking screws may provide the answer to the high nonunion rate associated with distal femur fractures treated with traditional locked constructs.

Fat Layer from Medullary Canal Reamer Aspirate for Potential Use as a Supplemental Osteoinductive Bone Graft Material.

Mesenchymal stem cells (MSCs) are of therapeutic interest to clinicians and researchers, as they have been shown to augment the osteogenic properties of bone grafts. MSCs are known to be prevalent in bone marrow, but are still limited in numbers. Hence, additional sources of MSCs are beneficial to increasing grafting potential. Aspirate material collected using the Reamer/Irrigator/Aspirator (RIA) device (Synthes; Paoli, PA) during reaming of the femoral shaft consists of three main components: bone fragments, liquid flow-through, and a fat layer. Currently, only the bone and liquid layers have been examined for osteoinductive elements, and the bone fragments are exclusively used as autologous bone graft. In the present study, a method to promote cellular outgrowth, tapping proliferative capacity from the previously discarded fatty layer of RIA aspirate, is described. Proliferating cells were successfully isolated from the bone and fatty layers of a consenting patient and found to be viable after liquid nitrogen storage. The osteogenic differentiation potential of the cells isolated from the fat and bone layers was assessed. Cells from both layers of the aspirate expressed statistically significant levels (p < 0.05) of the bone cell marker alkaline phosphatase compared to the control cells, suggesting differentiation along the osteoblastic pathway. Results from this pilot study indicate that the traditionally discarded fatty element of RIA aspirate may be a source of MSCs with bone-forming capabilities and the described isolation technique is effective. Combining the aspirate fatty and bony elements may enhance the clinical success of the RIA autograft.