Introduction:Diagnosis-Related Groups (DRGs) have become the basis of the Center of Medicare & Medicaid Services (CMS) hospital reimbursement system. Wide variability of patient factors and procedures bundled into a single DRG may contribute to significant cost variation and limited usefulness when analyzing economic performance. This investigation sought to analyze variation in hip and femur fracture inpatient costs as assessed by DRG and Current Procedural Terminology (CPT) codes. Materials and Methods:Patients age ≥ 18 treated with operatively managed fractures of the hip and femur at a Level 1 trauma center from 2019 to 2021 were retrospectively reviewed. Patients categorized as DRG 480, with major comorbidity/complication; 481, with comorbidity/complication; and 482, without comorbidity/complication were eligible. Seven common CPT codes were analyzed after exclusion of patients with low frequency CPT codes (< 50 instances). The primary outcome was total direct costs by DRG and CPT codes. Total direct costs were compared among CPT codes within each DRG using an ANOVA model. Costs were also compared among DRGs for each CPT code. Secondary outcomes include comparison of total direct costs by surgeon within DRG and within each CPT code. Results:A total of 896 patients were analyzed. Significant variation in costs was observed among different DRGs for specific CPTs (p < 0.001). Similarly, notable variation in total direct costs was recorded among different CPTs within each given DRG (p < 0.001). Although cost variations were observed between surgeon and DRG (p < 0.001), no significant interaction was observed once specific procedural (CPT) data were included in the model (CPT 27245: F = 1.077, p = 0.378; CPT 27506: F = 0.934, p = 0.504). Conclusions:While direct costs are influenced by the complexity of DRG assignment within the hip and femur fracture DRG family, the data may be limited in its applicability given the heterogeneity of patients and procedures captured within each DRG. Evaluating costs using a DRG-CPT combination, instead of DRG alone, may provide a more comprehensive and accurate understanding of costs of care. Level of Evidence:Economic and Decision Analyses Level III.

PURPOSE:Exchange nailing is often used to treat femoral and tibial nonunions. Its success rate varies with reports of 50-100% success. We sought to determine the trajectory of healing and identify factors associated with the failure of exchange nailing in the treatment of nonunion. METHODS:This was a retrospective chart review at two level I trauma centers. Patients with aseptic femoral and tibial nonunions treated with exchange nailing were included. The primary outcome was union prior to or at 1 year following treatment. Treatment failure was defined as lack of union (defined as lack of bridging bone on 3 or more cortices) at 1 year or an additional procedure to promote union. RESULTS:138 patients with aseptic nonunion of tibia or femur fractures initially treated with intramedullary nailing were identified. 77% of patients went on to successful union within 1 year after exchange nailing. The overall union rate was 9.6% at 6 weeks, 36.2% at 3 months, and 67% at 6 months. In femurs, less than 100% cortical contact, diabetes mellitus, and use of bone graft was associated with failure of exchange nailing. On multivariate analysis, only less than 100% cortical contact was associated with an increased risk of failure. No predictors were identified in the tibia. Rates of union were comparable between nonunion at diaphyseal and non-diaphyseal fracture sites, regardless of morphological type. CONCLUSION:Exchange nailing is a valuable treatment option and may be considered for aseptic nonunions of long bones. Surgeons should consider avoiding this technique when treating femoral nonunions which have less than 100% cortical contact.

OBJECTIVES:To compare the effectiveness and safety of aspirin versus low-molecular-weight heparin (LMWH) for thromboprophylaxis in 11 high-risk or fracture location subpopulations. METHODS:Design: A post-hoc secondary analysis of the published PREVENT CLOT trial. SETTING:21 trauma centers. PATIENT SELECTION CRITERIA:Adult patients with an operatively treated extremity fracture or any pelvic or acetabular fracture were enrolled from April 2017 through August 2021. Patients with only hand or foot fractures, presenting >48 hours after injury, or with a history of VTE within 6 months of injury were excluded. The 11 subpopulations included i) a head injury, ii) an abdominal injury, iii) a spinal injury, iv) a thoracic injury, v) multiply injured patients, vi) obesity, vii) previous VTE ≥ 6 months, viii) isolated upper extremity fracture, ix) isolated lower extremity fracture, x) isolated pelvic or acetabular fracture, and xi) geriatric femur fracture. OUTCOME MEASURES AND COMPARISONS:The primary outcome was 90-day all-cause mortality. Secondary outcomes included non-fatal pulmonary embolism, proximal deep vein thrombosis (DVT), distal DVT, and bleeding events. Outcomes were assessed using Kaplan-Meier estimators and Cox proportional hazards models comparing 81 mg of aspirin versus 30 mg of LMWH twice daily. The threshold for statistical significance was a Bonferroni-corrected alpha of 0.001 to account for multiple comparisons. RESULTS:The largest subpopulations were isolated lower extremity fractures (n=6,289), obesity (n=4,234), and polytrauma with Injury Severity Score (ISS) >16 (n=1,596). No comparison of aspirin vs LMWH within the 11 subpopulations for the 5 outcomes reached the corrected threshold for statistical significance of P < 0.001. However, 5 comparisons of aspirin vs LMWH were less than the conventional P-value of 0.05. Specifically, the aspirin group demonstrated lower mortality in patients with a head injury (difference, -3.2%; 95% CI -6.1% to -0.3%; P = 0.03) or a spine injury (difference, -6.0%; 95% CI -11.7% to -0.3%; P = 0.04) than the LMWH group. The LMWH group demonstrated a lower rate of distal DVTs for patients with a head injury (difference, 4.4%; 95% CI, 0.8% to 8.1%; P = 0.03), thoracic injury (difference, 1.5%; 95% CI, 0.0% to 2.9%; P=0.034) or with ISS >16 (difference, 1.7%; 95% CI, 0.2% to 3.3; P = 0.03) than the aspirin group. CONCLUSIONS:Within 11 high-risk or fracture location-specific subpopulations, there were no statistically significant differences between aspirin or LMWH in the 90-day rates of all-cause mortality, non-fatal PE, proximal DVT, distal DVT, or bleeding complications at a threshold corrected for multiple comparisons (P < 0.001). LEVEL OF EVIDENCE:Therapeutic Level I.

BACKGROUND:A preoperative chlorhexidine gluconate (CHG) bath is used to reduce the risk of surgical site infection (SSI) in elective surgery, but its efficacy in the trauma setting is unknown. We compared the incidence of SSI between patients who did versus did not receive a CHG bath before operative fixation of extremity and/or pelvic fractures. METHODS:We conducted a secondary analysis of the PREP-IT cluster-randomized crossover trials that enrolled patients undergoing operative treatment for open or closed extremity or pelvic fractures. Preoperative CHG bathing (yes or no) was recorded for each patient per study protocol. The association between CHG bathing and SSI within 90 days after definitive fracture surgery was assessed. We performed multivariable regression to adjust for prognostic variables. We also conducted a separate instrumental variable analysis to compare SSI rates between study sites that used CHG bathing for >90% of participants and those that used CHG bathing for <1% of participants. RESULTS:Of the 10,103 participants (mean age, 51 ± 20 years; 47% female; 77% White; 17% Black; 4% Asian; 7% Hispanic) included in the analysis, 2,674 (26%) had a documented preoperative CHG bath and 7,429 (74%) did not. CHG bathing was not associated with a significant reduction in the odds of 90-day SSI in the multivariable (odds ratio [OR], 1.07; 95% confidence interval [CI], 0.86 to 1.32; p = 0.56) or instrumental variable (OR, 0.88; 95% CI, 0.62 to 1.25; p = 0.48) analyses. CONCLUSIONS:Among adult patients who underwent extremity or pelvic fracture surgery, preoperative CHG bathing was not associated with a significant reduction in SSI. LEVEL OF EVIDENCE:Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

BACKGROUND:We evaluated antimicrobial resistance (AMR) patterns following local antibiotic use in a large cohort of patients with fractures from the PREP-IT (A Program of Randomized Trials to Evaluate Preoperative Antiseptic Skin Solutions in Orthopaedic Trauma) study. We hypothesized that, among patients with extremity fractures who developed fracture-related infection (FRI), there would be no difference in AMR rates between those who had or had not received local antibiotic therapy with surgical fixation. METHODS:This was a secondary analysis of all patients in the PREP-IT trial who developed FRI. Patient demographics, injury and fracture characteristics, and the primary outcome of the presence of an antimicrobial-resistant FRI were evaluated on the basis of whether the patient had or had not received local antibiotics in the operating room prior to, or at, definitive fixation. RESULTS:A total of 555 FRIs in 546 patients (mean age, 50 years; 39% female; and 82% White) were included. A total of 268 fractures (264 patients) received local antibiotics. The Injury Severity Score and the proportion of open fractures were higher among patients and fractures that received local antibiotics, respectively. There were more Gustilo-Anderson type-IIIB or IIIC fractures in the local antibiotic group, but the rate did not differ significantly from that in the group with no local antibiotics (20% versus 14%; p = 0.14). Other baseline and fracture characteristics were similar between the groups, with the exception of age (lower in the group with local antibiotics). When examining FRIs with gram-positive organisms, we found that 3 (1.7%) of the FRIs in fractures that had been treated with local vancomycin had organisms resistant to vancomycin compared with 2 (0.9%) of the FRIs in fractures for which local vancomycin had not been used (p = 0.67). When examining FRIs with gram-negative organisms, the number of FRIs with aminoglycoside-resistant organisms was 8 (11.6%) among fractures that received local aminoglycosides and 10 (6.2%) among fractures that did not receive local aminoglycosides (p = 0.26). CONCLUSIONS:Among extremity fractures that developed FRI, we were unable to detect differences in the rates of AMR between fractures treated with or without local antibiotic prophylactic strategies in our analysis of a randomized trial of various skin preparation solutions for extremity trauma surgery. These findings provide cautious reassurance regarding the safety of local antibiotics but underscore the need for further prospective analysis. LEVEL OF EVIDENCE:Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

OBJECTIVES: Isolated femoral shaft fractures can be treated preoperatively with skeletal traction (TXN) or maintenance of a position of comfort (COMF). The goal of this retrospective review was to determine if preoperative opioid consumption differs significantly between these forms of treatment. METHODS: Design: Case-control retrospective study Setting: Two academic level 1 trauma centers Patient Selection Criteria: Patients presenting to the emergency department with isolated OTA/AO 32A-C femoral shaft fractures from 2017-2020. Outcome Measures and Comparisons: The primary outcome was preoperative opioid consumption (morphine milligram equivalents (MME)) comparing patients treated with application of skeletal traction (TXN) or placed in a position of comfort (COMF). RESULTS: Two hundred and twenty patients were studied (COMF n=167, TXN n=53). Multivariate regression analysis revealed significantly greater preoperative opioid consumption in the Emergency Department (ED) for the TXN group compared to COMF (2.6 more MME [CI 0.23,4.96], p=0.031)). There was no difference in preoperative opioid consumption between groups on the hospital floor (p=0.811) nor during the entire preoperative course (p=0.486). The total preoperative rate of opioid consumption (MME/hour) did not differ (p=0.825). CONCLUSIONS: Patients with isolated femoral shaft fractures treated preoperatively with skeletal traction consumed more opioids in the ED compared to patients treated in a position of comfort but no difference in opioid consumption was observed between groups for the entire preoperative course. A position of comfort may be considered as an acceptable alternative to skeletal traction for patients with isolated femur fractures. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

OBJECTIVE:To quantify work impairment and economic losses due to lost employment, lost work time (absenteeism), and lost productivity while working (presenteeism) after a lateral compression pelvic ring fracture. Secondarily, productivity loss of patients treated with surgical fixation versus nonoperative management was compared. METHODS: DESIGN:Secondary analysis of a prospective, multicenter trial. SETTING:Two level I academic trauma centers. PATIENT SELECTION CRITERIA:Adult patients with a lateral compression pelvic fracture (OTA/AO 61-B1/B2) with a complete posterior pelvic ring fracture and less than 10 mm of initial displacement. Excluded were patients who were not working or non-ambulatory before their pelvis fracture or who had a concomitant spinal cord injury. OUTCOME MEASURES AND COMPARISONS:Work impairment, including hours lost to unemployment, absenteeism, and presenteeism, measured by Work Productivity and Activity Impairment assessments in the year after injury. Results after non-operative and operative treatment were compared. RESULTS:Of the 64 included patients, forty-seven percent (30/64) were treated with surgical fixation, and 53% (30/64) with nonoperative management. 63% returned to work within 1 year of injury. Workers lost an average of 67% of a 2080-hour average work year, corresponding with $56,276 in lost economic productivity. Of the 1395 total hours lost, 87% was due to unemployment, 3% to absenteeism, and 10% to presenteeism. Surgical fixation was associated with 27% fewer lost hours (1155 vs. 1583, P = 0.005) and prevented $17,266 in average lost economic productivity per patient compared with nonoperative management. CONCLUSIONS:Lateral compression pelvic fractures are associated with a substantial economic impact on patients and society. Surgical fixation reduces work impairment and the corresponding economic burden. LEVEL OF EVIDENCE:Economic Level IV. See Instructions for Authors for a complete description of levels of evidence.

OBJECTIVES: To determine whether the timing of acetabular fracture fixation through an anterior approach influences estimated and calculated perioperative blood loss. METHODS: Design: Retrospective cohort study. Setting: Level 1 trauma center from 2013 to 2021. Patient Selection Criteria: Patients age >18 treated with acetabular fracture fixation through an anterior-based approach. Outcome Measures and Comparisons: The primary outcome was calculated blood loss (CBL). Secondary outcomes were estimated blood loss (EBL) reported by surgeon and anesthesia, and blood transfusion requirements. Comparisons of blood loss were made at discrete post-injury time thresholds (24, 36, and 48 hours) and on a continuous basis. RESULTS: 108 patients were studied. The mean age was 65 and 73% of patients were male. Earlier fixation of acetabular fractures resulted in greater CBL and EBL (surgeon and anesthesia) compared to later fixation when analyzed on a continuum and at specific time points (24, 36, and 48 hours). Mean CBL in patients treated earlier (< 48hrs, 2539 ml +/-1194) was significantly greater than those treated later (>48 hrs, 1625 ml +/-909; p<0.001). Fracture repair before 48 hours post-injury was associated with a 3 times greater risk of >2000 ml of CBL (p=0.006). This did not result in differences in transfusion rates between groups at 24 hours (p=0.518), 36 hours (p=1.000) or 48 hours (p=0.779). CONCLUSIONS: Delaying fixation of acetabular fractures treated through an anterior approach for 48 hours post-injury may significantly reduce perioperative blood loss. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

OBJECTIVE: To determine whether intrawound vancomycin changes the bacteriology of surgical site infection pathogens and investigate the emergence of antibiotic-resistant pathogens. METHODS: Design: Secondary analysis of phase III, prospective, randomized clinical trial. Setting: Thirty-six US trauma centers. Patient Selection Criteria: Patients who became infected after fixation of tibial plateau or pilon fracture. Outcome Measures and Comparisons: Pathogen types and bacterial susceptibilities as determined from routine clinical culture in the operating room. RESULTS: 74 patients were studied that were 67.5% male with a mean age of 48.6 years. A lower proportion of gram-positive cocci was observed in the vancomycin powder compared to the standard of care group (3.7% vs. 8.0%, p =0.01). Methicillin-resistant Staphylococcus aureus (MRSA) infection incidence was comparable in both the vancomycin powder and standard of care groups, but rates of methicillin-susceptible Staphylococcus aureus (MSSA) infections were lower in the treatment group (1.4% vs. 4.8%, p =0.01). The incidence of coagulase-negative Staphylococci (CoNS) and gram-negative rod infections were similar in both groups. There was no significant difference in susceptibilities between groups in rates of vancomycin-resistant enterococcus. CONCLUSION: Topical vancomycin powder decreases the likelihood of gram-positive infections consistent with the biologic activity of vancomycin. Fewer MSSA and CoNS infections were observed in the group treated with vancomycin powder. An effect of vancomycin powder on MRSA infection risk was not detected given the low incidence in both the intrawound vancomycin and standard of care groups. There was no emergence of gram-negative rod infections or increased resistance patterns observed. Use of topical vancomycin powder does not appear to produce infections in these patients with greater antibiotic resistance than would have occurred without its use.

Venous thromboembolism (VTE) is a notable contributor to the morbidity and mortality of patients with orthopaedic trauma. Several associations have published guidelines on VTE prophylaxis, with a strong predilection toward low-molecular-weight heparin for chemoprophylaxis. However, previous recommendations may be revisited because recent high-level evidence demonstrated aspirin to be noninferior to low-molecular-weight heparin in preventing serious complications of VTE. Direct oral anticoagulants are emerging as safe alternatives to injectable medication and may offer improved patient compliance. There is no consensus on postinjury duration of chemoprophylaxis as an outpatient. Mechanical prophylaxis remains an important adjunctive VTE preventive measure for inpatients with pelvis and extremity fractures. Proteomics and novel laboratory measurements may be able to predict high-risk patients and detect early thrombus formation. Despite high-quality prospective research over the past decade, we still have much to learn about patient- and injury-specific risk factors.

The immune system plays an integral role in the regulation of cellular processes responsible for fracture healing. Local and systemic influences on fracture healing correlate in many ways with fracture-related outcomes, including soft tissue healing quality and fracture union rates. Impaired soft tissue healing, restricted perfusion of a fracture site, and infection also in turn affect the immune response to fracture injury. Modern techniques used to investigate the relationship between immune system function and fracture healing include precision medicine, using vast quantities of data to interpret broad patterns of inflammatory response. Early data from the PRECISE trial have demonstrated distinct patterns of inflammatory response in polytrauma patients, which thereby directly and indirectly regulate the fracture healing response. The clearly demonstrated linkage between immune function and fracture healing suggests that modulation of immune function has significant potential as a therapeutic target that can be used to enhance fracture healing.

Intramedullary nailing (IMN) of periarticular distal tibia fractures may offer advantages compared to plating. This study aims to report on the outcomes of select periarticular distal tibia fractures treated with IMN. Patients over 17 years of age that underwent IMN for extraarticular distal tibia fractures (Osteosynthesefragen/Orthopaedic Trauma Association [AO/OTA] 43-A), partial articular with associated segmental shaft component (43-B), and simple intraarticular (43-C1/2) at a Level I trauma center were included. The primary outcome was physical function (PF) and pain interference (PI) assessed via Patient-Reported Outcomes Measurement Information System (PROMIS). Secondary outcomes included reoperation, nonunion, infection, and malalignment. Eighty-four patients with > 12 months follow up were included. Mean PROMIS PI and PF scores were 55.5 and 45.0, respectively. The rate of nonunion and deep infection each were 8%. Eighty-four percent of patients achieved normal alignment. There were no differences detected in clinical outcomes between patients with intraarticular injuries compared with those with extraarticular fractures. Satisfactory clinical, radiographic, and patient-reported outcomes can be expected following treatment of extraarticular and simple intraarticular distal tibia fractures with IMN. (Journal of Surgical Orthopaedic Advances 32(4):246-251, 2023).

Abstract. Objectives:. Patient engagement in the design and implementation of clinical trials is necessary to ensure that the research is relevant and responsive to patients. The PREP-IT trials, which include 2 pragmatic trials that evaluate different surgical preparation solutions in orthopaedic trauma patients, followed the patient-centered outcomes research (PCOR) methodology throughout the design, implementation, and conduct. We conducted a substudy within the PREP-IT trials to explore participants' experiences with trial participation. Methods:. At the final follow-up visit (12 months after their fracture), patients participating in the PREP-IT trials were invited to participate in the substudy. After providing informed consent, participants completed a questionnaire that asked about their experience and satisfaction with participating in the PREP-IT trials. Descriptive statistics are used to report the findings. Results:. Four hundred two participants participated in the substudy. Most participants (394 [98%]) reported a positive experience, and 376 (94%) participants felt their contributions were appreciated. The primary reasons for participation were helping future patients with fracture (279 [69%]) and to contribute to science (223 [56%]). Two hundred seventeen (46%) participants indicated that their decision to participate was influenced by the minimal time commitment. Conclusions:. Most participants reported a positive experience with participating in the PREP-IT trials. Altruism was the largest motivator for participating in this research. Approximately half of the participants indicated that the pragmatic, low-participant burden design of the trial influenced their decision to participate. Meaningful patient engagement, a pragmatic, and low-burden protocol led to high levels of participant satisfaction.

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.

BACKGROUND:The PREVENT CLOT trial concluded that thromboprophylaxis with aspirin was noninferior to low-molecular-weight heparin (LMWH) in preventing death after orthopedic trauma. However, it was unclear if these results applied to patients at highest risk of thrombosis. Therefore, we assessed if the effect of aspirin versus LMWH differed based on patients' baseline risk of venous thromboembolism (VTE). METHODS:The PREVENT CLOT trial enrolled 12,211 adult patients with fractures. This secondary analysis stratified the study population into VTE risk quartiles: low (<1%) to high (>10%) using the Caprini score. We assessed stratum-specific treatment effects using the win ratio method, in which each patient assigned to aspirin was paired with each assigned to LMWH. In each pair, we compared outcomes hierarchically, starting with death, then pulmonary embolism, deep vein thrombosis, and bleeding. The secondary outcome added patients' medication satisfaction as a fifth composite component. RESULTS:In the high-risk quartile (n = 3052), 80% had femur fracture, pelvic, or acetabular fractures. Thoracic (47%) and head (37%) injuries were also common. In the low risk quartile (n = 3053), most patients had a tibia fracture (67%), 5% had a thoracic injury, and less than 1% had head or spinal injuries. Among high risk patients, thromboembolic events did not differ statistically between aspirin and LMWH (win ratio, 0.94; 95% confidence interval [CI], 0.82-1.08, p = 0.42). This result was consistent in the low (win ratio, 1.15; 95% CI, 0.90-1.47, p = 0.27), low-medium (win ratio, 1.05; 95% CI, 0.85-1.29, p = 0.68), and medium-high risk quartiles (win ratio, 0.94; 95% CI, 0.80-1.11, p = 0.48). When medication satisfaction was considered, favorable outcomes were 68% more likely with aspirin (win ratio, 1.68; 95% CI, 1.60-1.77; p < 0.001). CONCLUSION:Thromboembolic outcomes were similar with aspirin or LMWH, even among patients at highest risk of VTE. Aspirin was favored if medication satisfaction was also considered. LEVEL OF EVIDENCE:Therapeutic/Care Management; Level II.

Background: At the initiation of the COVID-19 pandemic, restrictions forced researchers to decide whether to continue their ongoing clinical trials. The PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities) trial is a pragmatic cluster-randomized crossover trial in patients with open and closed fractures. PREPARE was enrolling over 200 participants per month at the initiation of the pandemic. We aim to describe how the COVID-19 research restrictions affected participant enrollment. Methods: The PREPARE protocol permitted telephone consent, however, sites were obtaining consent in-person. To continue enrollment after the initiation of the restrictions participating sites obtained ethics approval for telephone consent scripts and the waiver of a signature on the consent form. We recorded the number of sites that switched to telephone consent, paused enrollment, and the length of the pause. We used t-tests to compare the differences in monthly enrollment between July 2019 and November 2020.Results: All 19 sites quickly implement telephone consent. Fourteen out of nineteen (73.6%) sites paused enrollment due to COVID-19 restrictions. The median length of enrollment pause was 46.5 days (range, 7-121 days; interquartile range, 61 days). The months immediately following the implementation of restrictions had significantly lower enrollment.Conclusion: A pragmatic design allowed sites to quickly adapt their procedures for obtaining informed consent via telephone and allowed for minimal interruptions to enrollment during the pandemic.

Background:With a rising number of periprosthetic femur fractures (PPFFs) each year, the primary objective of our study was to quantify risk factors that predict complications following operative treatment of PPFFs.Methods:A retrospective cohort study of 231 patients with a periprosthetic femur fracture was conducted at an Academic, Level 1 Trauma Center. The main outcome measurement of interest was complications, as defined by the ACS-NSQIP, within 30 days of surgery.Results:56 patients had 96 complications. Bivariate analyses revealed ASA score, preoperative ambulatory status, length of stay, discharge disposition, time from admission to surgery, length of surgery, perioperative change in hemoglobin, Charlson comorbidity index, cerebral vascular accident/transient ischemic attack, chronic obstructive pulmonary disease, diabetes mellitus, and receipt of a blood transfusion were associated with development of a complication (p < 0.1). Multivariate logistic regression showed length of stay (OR 1.11, 95% CI 1.03-1.19; p = 0.006), receipt of a blood transfusion (OR 2.48, 95% CI 1.14-5.42; p = 0.02), and diabetes mellitus (OR 2.17, 95% CI 1.03-4.56; p = 0.04) remained independently predictive of complication.Conclusions:Length of stay, receipt of a blood transfusion, and diabetes were associated with increased perioperative risk for developing a complication following operative treatment of periprosthetic femur fractures. Methods to decrease length of stay or transfusion rates may mitigate complication risk in these patients.Level of Evidence:Prognostic, Level III.

Background: Modern external ring fixation has been hypothesized to reduce complications requiring hospital readmission compared with internal fixation when treating patients with high-energy open tibial shaft fractures. In this study, the 1-year probability of a major limb complication was compared between external and internal fixation of severe open tibial fractures. Methods: This multicenter randomized clinical trial included patients 18 to 64 years of age with severe open tibial shaft fractures randomly assigned to either modern external ring fixation (n = 127) or internal fixation (n = 133). The primary outcome was a major limb complication within 365 days after randomization; these complications included amputation, infection, a soft-tissue problem, nonunion, malunion, and a loss of reduction/implant failure. Results: Of 260 randomized patients, 254 were included in the final analysis. Their mean age (standard deviation) was 39 (13) years; 214 (84%) were men. The probability of at least 1 major limb complication was higher for external fixation (62.1% [95% confidence interval (CI): 53.4% to 70.8%]) than internal fixation (43.7% [95% CI: 35.5% to 52.9%]), with a risk difference of 18.4% (95% CI: 5.8% to 30.4%); p = 0.005). The most notable difference was in loss of reduction/implant failure, the rate of which was higher for external fixation (risk difference: 14.4% [95% CI: 7.0% to 21.6%]; p = 0.002). There was no appreciable difference in the probability of deep infection between external fixation (26.1%) and internal fixation (29.7%) (risk difference: -3.5% [95% CI: -14.8% to 7.8%]; p = 0.54). There were also no appreciable differences in the probabilities of amputation, nonunion, soft-tissue problems, malunion, or fracture healing between the groups. Conclusions: These results argue against routine use of modern external ring fixation for the treatment of these severe open tibial fractures.