Fix or Replace? Patient Preferences for the Treatment of Geriatric Lower Extremity Fractures: A Discrete Choice Experiment.

Introduction: When considering treatment options for geriatric patients with lower extremity fractures, little is known about which outcomes are prioritized by patients. This study aimed to determine the patient preferences for outcomes after a geriatric lower extremity fracture. Materials and Methods: We administered a discrete choice experiment survey to 150 patients who were at least 60 years of age and treated for a lower extremity fracture at a Level I trauma center. The discrete choice experiment presented study participants with 8 sets of hypothetical outcome comparisons, including joint preservation (yes or no), risk of reoperation at 6 months and 24 months, postoperative weightbearing status, disposition, and function as measured by return to baseline walking distance. We estimated the relative importance of these potential outcomes using multinomial logit modeling. Results: The strongest patient preference was for maintained function after treatment (59%, P < .001), followed by reoperation within 6 months (12%, P < .001). Although patients generally favored joint preservation, patients were willing to change their preference in favor of joint replacement if it increased function (walking distance) by 13% (SE, 66%). Reducing the short-term reoperation risk (12%, P < .001) was more important to patients than reducing long-term reoperation risk (4%, P = .33). Disposition and weightbearing status were lesser priorities to patients (9%, P < .001 and 7%, P < .001, respectively). Discussion: After a lower extremity fracture, geriatric patients prioritized maintained walking function. Avoiding short-term reoperation was more important than avoiding long-term reoperation. Joint preservation through fracture fixation was the preferred treatment of geriatric patients unless arthroplasty or arthrodesis provides a meaningful functional benefit. Hospital disposition and postoperative weightbearing status were less important to patients than the other included outcomes. Conclusions: Geriatric patients strongly prioritize function over other outcomes after a lower extremity fracture.

Effect of Aspirin Versus Low-Molecular-Weight Heparin Thromboprophylaxis on Medication Satisfaction and Out-of-Pocket Costs: A Secondary Analysis of a Randomized Clinical Trial.

BACKGROUND: Current guidelines recommend low-molecular-weight heparin for thromboprophylaxis after orthopaedic trauma. However, recent evidence suggests that aspirin is similar in efficacy and safety. To understand patients' experiences with these medications, we compared patients' satisfaction and out-of-pocket costs after thromboprophylaxis with aspirin versus low-molecular-weight heparin. METHODS: This study was a secondary analysis of the PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT) trial, conducted at 21 trauma centers in the U.S. and Canada. We included adult patients with an operatively treated extremity fracture or a pelvic or acetabular fracture. Patients were randomly assigned to receive 30 mg of low-molecular-weight heparin (enoxaparin) twice daily or 81 mg of aspirin twice daily for thromboprophylaxis. The duration of the thromboprophylaxis, including post-discharge prescription, was based on hospital protocols. The study outcomes included patient satisfaction with and out-of-pocket costs for their thromboprophylactic medication measured on ordinal scales. RESULTS: The trial enrolled 12,211 patients (mean age and standard deviation [SD], 45 ± 18 years; 62% male), 9725 of whom completed the question regarding their satisfaction with the medication and 6723 of whom reported their out-of-pocket costs. The odds of greater satisfaction were 2.6 times higher for patients assigned to aspirin than those assigned to low-molecular-weight heparin (odds ratio [OR]: 2.59; 95% confidence interval [CI]: 2.39 to 2.80; p < 0.001). Overall, the odds of incurring any out-of-pocket costs for thromboprophylaxis medication were 51% higher for patients assigned to aspirin compared with low-molecular-weight heparin (OR: 1.51; 95% CI: 1.37 to 1.66; p < 0.001). However, patients assigned to aspirin had substantially lower odds of out-of-pocket costs of at least $25 (OR: 0.15; 95% CI: 0.12 to 0.18; p < 0.001). CONCLUSIONS: Use of aspirin substantially improved patients' satisfaction with their medication after orthopaedic trauma. While aspirin use increased the odds of incurring any out-of-pocket costs, it protected against costs of ≥$25, potentially improving health equity for thromboprophylaxis. LEVEL OF EVIDENCE: Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence.

Risk-stratified thromboprophylaxis effects of aspirin versus low-molecular-weight heparin in orthopedic trauma patients: A secondary analysis of the PREVENT CLOT trial.

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.

Does Fracture Pattern Really Predict Displacement of LC1 Sacral Fractures?

BACKGROUND: Operative management of minimally displaced lateral compression type-1 (LC1) pelvic ring injuries remains controversial. We aimed to assess the proportion of LC1 pelvic fractures that displaced following nonoperative management as a function of specific ring fracture patterns, and we quantified the magnitude of this displacement. METHODS: A retrospective review of the billing registry of a level-I trauma center was performed. Two hundred and seventy-three patients with a high-energy LC1 pelvic ring fracture and <5 mm of sacral displacement were included. The fracture pattern was characterized with use of computed tomography (CT) scans and radiographs. Absolute and interval pelvic ring displacement were quantified with use of previously described methodology. RESULTS: Thirty-five pelvic ring injuries (13%) were displaced. The rate of displacement was 31% (15 of 49) for LC1 injuries involving a complete sacral fracture and bilateral ramus fractures, 12% (7 of 58) for injuries involving a complete sacral fracture and a unilateral ramus fracture, and 10% (5 of 52) for injuries involving an incomplete sacral fracture and bilateral ramus fractures. In displaced injuries, the average interval displacement was 4.2 mm (95% confidence interval [CI], 1.8 to 6.8) and the final displacement was 9.9 mm ± 4.2 mm. CONCLUSIONS: Our study suggests that fracture characteristics can be used to predict the likelihood of displacement of LC1 fractures that are treated without surgery. To our knowledge, the present study is the first to describe the magnitude of displacement that may occur in association with LC1 pelvic ring injuries that are treated nonoperatively; however, further studies are needed to determine the clinical impact of this displacement. LEVEL OF EVIDENCE: Diagnostic Level IV . See Instructions for Authors for a complete description of levels of evidence.

Technical Factors Contributing to Nonunion in Supracondylar Distal Femur Fractures Treated With Lateral Locked Plating: A Risk-Stratified Analysis.

OBJECTIVE: To identify technical factors associated with nonunion after operative treatment with lateral locked plating. DESIGN: Retrospective cohort study. SETTING: Ten Level I trauma centers. PATIENT SELECTION CRITERIA: Adult patients with supracondylar distal femur fractures (OTA/AO type 33A or C) treated with lateral locked plating from 2010 through 2019. OUTCOME MEASURES AND COMPARISONS: Surgery for nonunion stratified by risk for nonunion. RESULTS: The cohort included 615 patients with supracondylar distal femur fractures. The median patient age was 61 years old (interquartile range: 46 -72years) and 375 (61%) were female. Observed were nonunion rates of 2% in a low risk of nonunion group (n = 129), 4% in a medium-risk group (n = 333), and 14% in a high-risk group (n = 153). Varus malreduction with an anatomic lateral distal femoral angle greater than 84 degrees, was associated with double the odds of nonunion compared to those without such varus [odds ratio, 2.1; 95% confidence interval (CI), 1.1-4.2; P = 0.03]. Malreduction by medial translation of the articular block increased the odds of nonunion, with 30% increased odds per 4 mm of medial translation (95% CI, 1.0-1.6; P = 0.03). Working length increased the odds of nonunion in the medium risk group, with an 18% increase in nonunion per 10-mm increase in working length (95% CI, 1.0-1.4; P = 0.01). Increased proximal screw density was protective against nonunion (odds ratio, 0.71; 95% CI, 0.53-0.92; P = 0.02) but yielded lower mRUST scores with each 0.1 increase in screw density associated with a 0.4-point lower mRUST (95% CI, -0.55 to -0.15; P < 0.001). Lateral plate length and type of plate material were not associated with nonunion. ( P > 0.05). CONCLUSIONS: Malreduction is a surgeon-controlled variable associated with nonunion after lateral locked plating of supracondylar distal femur fractures. Longer working lengths were associated with nonunion, suggesting that bridge plating may be less likely to succeed for longer fractures. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Patient preferences for physical therapy programs after a lower extremity fracture: a discrete choice experiment.

OBJECTIVE: To quantify patients' preferences for physical therapy programmes after a lower extremity fracture and determine patient factors associated with preference variation. DESIGN: Discrete choice experiment. SETTING: Level I trauma centre. PARTICIPANTS: One hundred fifty-one adult (≥18 years old) patients with lower extremity fractures treated operatively. INTERVENTION: Patients were given hypothetical scenarios and asked to select their preferred therapy course when comparing cost, mobility, long-term pain, session duration, and treatment setting. MAIN OUTCOME MEASURES: A multinomial logit model was used to determine the relative importance and willingness to pay for each attribute. RESULTS: Mobility was of greatest relative importance (45%, 95% CI: 40% to 49%), more than cost (23%, 95% CI: 19% to 27%), long-term pain (19%, 95% CI: 16% to 23%), therapy session duration (12%, 95% CI: 9% to 5%) or setting (1%, 95% CI: 0.2% to 2%). Patients were willing to pay US$142 more per session to return to their preinjury mobility level (95% CI: US$103 to US$182). Willingness to pay for improved mobility was higher for women, patients aged 70 years and older, those with bachelor's degrees or higher and those living in less-deprived areas. Patients were willing to pay US$72 (95% CI: US$50 to US$93) more per session to reduce pain from severe to mild. Patients were indifferent between formal and independent home therapy (willingness to pay: -US$12, 95% CI: -US$33 to US$9). CONCLUSIONS: Patients with lower extremity fractures highly value recovering mobility and are willing to pay more for postoperative physical therapy programmes that facilitate returning to their pre-injury mobility level. These patient preferences might be useful when prescribing and designing new techniques for postoperative therapy.

Local administration of vancomycin powder in orthopaedic fracture surgery: current practice and trends.

Objectives: Surgical site infections in orthopaedic trauma are a significant problem with meaningful patient and health care system-level consequences. Direct application of antibiotics to the surgical field has many potential benefits in reducing surgical site infections. However, to date, the data regarding the local administration of antibiotics have been mixed. This study reports on the variability of prophylactic vancomycin powder use in orthopaedic trauma cases across 28 centers. Methods: Intrawound topical antibiotic powder use was prospectively collected within three multicenter fracture fixation trials. Fracture location, Gustilo classification, recruiting center, and surgeon information were collected. Differences in practice patterns across recruiting center and injury characteristics were tested using chi-square statistic and logistic regression. Additional stratified analyses by recruiting center and individual surgeon were performed. Results: A total of 4941 fractures were treated, and vancomycin powder was used in 1547 patients (31%) overall. Local administration of vancomycin powder was more frequent in open fractures 38.8% (738/1901) compared with closed fractures 26.6% (809/3040) (P < 0.001). However, the severity of the open fracture type did not affect the rate at which vancomycin powder was used (P = 0.11). Vancomycin powder use varied substantially across the clinical sites (P < 0.001). At the surgeon level, 75.0% used vancomycin powder in less than one-quarter of their cases. Conclusions: Prophylactic intrawound vancomycin powder remains controversial with varied support throughout the literature. This study demonstrates wide variability in its use across institutions, fracture types, and surgeons. This study highlights the opportunity for increased practice standardization for infection prophylaxis interventions. Level of Evidence: Prognostic-III.

Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis after a Fracture.

BACKGROUND: Clinical guidelines recommend low-molecular-weight heparin for thromboprophylaxis in patients with fractures, but trials of its effectiveness as compared with aspirin are lacking. METHODS: In this pragmatic, multicenter, randomized, noninferiority trial, we enrolled patients 18 years of age or older who had a fracture of an extremity (anywhere from hip to midfoot or shoulder to wrist) that had been treated operatively or who had any pelvic or acetabular fracture. Patients were randomly assigned to receive low-molecular-weight heparin (enoxaparin) at a dose of 30 mg twice daily or aspirin at a dose of 81 mg twice daily while they were in the hospital. After hospital discharge, the patients continued to receive thromboprophylaxis according to the clinical protocols of each hospital. The primary outcome was death from any cause at 90 days. Secondary outcomes were nonfatal pulmonary embolism, deep-vein thrombosis, and bleeding complications. RESULTS: A total of 12,211 patients were randomly assigned to receive aspirin (6101 patients) or low-molecular-weight heparin (6110 patients). Patients had a mean (±SD) age of 44.6±17.8 years, 0.7% had a history of venous thromboembolism, and 2.5% had a history of cancer. Patients received a mean of 8.8±10.6 in-hospital thromboprophylaxis doses and were prescribed a median 21-day supply of thromboprophylaxis at discharge. Death occurred in 47 patients (0.78%) in the aspirin group and in 45 patients (0.73%) in the low-molecular-weight-heparin group (difference, 0.05 percentage points; 96.2% confidence interval, -0.27 to 0.38; P<0.001 for a noninferiority margin of 0.75 percentage points). Deep-vein thrombosis occurred in 2.51% of patients in the aspirin group and 1.71% in the low-molecular-weight-heparin group (difference, 0.80 percentage points; 95% CI, 0.28 to 1.31). The incidence of pulmonary embolism (1.49% in each group), bleeding complications, and other serious adverse events were similar in the two groups. CONCLUSIONS: In patients with extremity fractures that had been treated operatively or with any pelvic or acetabular fracture, thromboprophylaxis with aspirin was noninferior to low-molecular-weight heparin in preventing death and was associated with low incidences of deep-vein thrombosis and pulmonary embolism and low 90-day mortality. (Funded by the Patient-Centered Outcomes Research Institute; PREVENT CLOT ClinicalTrials.gov number, NCT02984384.).

Intraoperative assessment of bone viability through improved analysis and visualization of dynamic contrast-enhanced fluorescence imaging: technique report.

Bone devitalization is believed to be a critical determinant of complications such as infection or nonunion. However, intraoperative assessment of bone devitalization, particularly in open fractures and infections, remains highly subjective resulting in variation in treatment. Optical imaging tools, particularly dynamic contrast-enhanced fluorescence imaging, can provide real-time, intraoperative assessment of bone and soft tissue perfusion, which informs the tissues' ability to heal and fight infection. We describe a novel technique to apply indocyanine green-based fluorescence imaging, using a device that is frequently used in the operating room to assess skin or flap perfusion in plastic surgery, to assess bone and deep tissue perfusion in three pertinent cases: (1) a chronic infection/nonunion after a Gustilo type 3A tibia fracture (patient 1), (2) an acute Gustilo type 3C tibia open fracture with extensive degloving/soft tissue stripping (patient 2), and (3) an atrophic nonunion of the humerus (patient 3). In all three cases, fluorescence imaging (both time-specific fluorescence and maximum fluorescence) and derived kinetic maps of time-to-peak, ingress slope, and egress slope demonstrated clear spatial variation in perfusion that corresponded to the patient pathogenesis. The impact of this information on patient outcome will need to be evaluated in future clinical trials; however, these cases demonstrate in principle that optical imaging information has the potential to inform surgical practice, reduce the variation in treatment, and improve outcomes observed in these challenging patients.

Association of Patient-Level and Hospital-Level Factors With Timely Fracture Care by Race.

Importance: Racial disparities in treatment benchmarks have been documented among older patients with hip fractures. However, these studies were limited to patient-level evaluations. Objective: To assess whether disparities in meeting fracture care time-to-surgery benchmarks exist at the patient level or at the hospital or institutional level using high-quality multicenter prospectively collected data; the study hypothesis was that disparities at the hospital-level reflecting structural health systems issues would be detected. Design, Setting, and Participants: This cohort study was a secondary analysis of prospectively collected data in the PREP-IT (Program of Randomized trials to Evaluate Preoperative antiseptic skin solutions in orthopaedic Trauma) program from 23 sites throughout North America. The PREP-IT trials enrolled patients from 2018 to 2021, and patients were followed for 1-year. All patients with hip and femur fractures enrolled in the PREP-IT program were included in analysis. Data were analyzed April to September 2022. Exposures: Patient-level and hospital-level race, ethnicity, and insurance status. Main Outcomes and Measures: Primary outcome measure was time to surgery based on 24-hour time-to-surgery benchmarks. Multilevel multivariate regression models were used to evaluate the association of race, ethnicity, and insurance status with time to surgery. The reported odds ratios (ORs) were per 10% change in insurance coverage or racial composition at the hospital level. Results: A total of 2565 patients with a mean (SD) age of 64.5 (20.4) years (1129 [44.0%] men; mean [SD] body mass index, 27.3 [14.9]; 83 [3.2%] Asian, 343 [13.4%] Black, 2112 [82.3%] White, 28 [1.1%] other) were included in analysis. Of these patients, 834 (32.5%) were employed and 2367 (92.2%) had insurance; 1015 (39.6%) had sustained a femur fracture, with a mean (SD) injury severity score of 10.4 (5.8). Five hundred ninety-six patients (23.2%) did not meet the 24-hour time-to-operating-room benchmark. After controlling for patient-level characteristics, there was an independent association between missing the 24-hour benchmark and hospital population insurance coverage (OR, 0.94; 95% CI, 0.89-0.98; P = .005) and the interaction term between hospital population insurance coverage and racial composition (OR, 1.03; 95% CI, 1.01-1.05; P = .03). There was no association between patient race and delay beyond 24-hour benchmarks (OR, 0.96; 95% CI, 0.72-1.29; P = .79). Conclusions and Relevance: In this cohort study, patients who sought care from an institution with a greater proportion of patients with racial or ethnic minority status or who were uninsured were more likely to experience delays greater than the 24-hour benchmarks regardless of the individual patient race; institutions that treat a less diverse patient population appeared to be more resilient to the mix of insurance status in their patient population and were more likely to meet time-to-surgery benchmarks, regardless of patient insurance status or population-based insurance mix. While it is unsurprising that increased delays were associated with underfunded institutions, the association between institutional-level racial disparity and surgical delays implies structural health systems bias.

A pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solutions in open fractures (Aqueous-PREP): statistical analysis plan.

BACKGROUND: Approximately 1 in 10 patients with a surgically treated open fracture will develop a surgical site infection. The Aqueous-PREP trial will investigate the effect of 10% povidone-iodine versus 4% chlorhexidine in aqueous antiseptic solutions in reducing infections after open fracture surgery. The study protocol was published in April 2020. METHODS AND DESIGN: The Aqueous-PREP trial is a pragmatic, multicenter, open-label, randomized multiple period cluster crossover trial. Each participating cluster is randomly assigned in a 1:1 ratio to provide 1 of the 2 study interventions on all eligible patients during a study period. The intervention periods are 2 months in length. After completing a 2-month period, the participating cluster crosses over to the alternative intervention. We plan to enroll a minimum of 1540 patients at 14 sites. RESULTS: The primary outcome is surgical site infection guided by the Centers for Disease Control and Prevention's National Healthcare Safety Network reporting criteria (2017). All participants' surgical site infection surveillance period will end 30 days after definitive fracture management surgery for superficial infections and 90 days after definitive fracture management surgery for deep incisional or organ/space infections [1]. The secondary outcome is an unplanned fracture-related reoperation within 12 months of the fracture. CONCLUSION: This manuscript serves as the formal statistical analysis plan (version 1.0) for the Aqueous-PREP trial. The statistical analysis plan was completed on February 28, 2022.

Hip Fracture With Elevated Troponin: Harbinger of Mortality or Need for Accelerated Surgery?

OBJECTIVE: To determine the association of elevated troponin levels with time to surgery and the risk of mortality and other key clinical outcomes among elderly patients with hip fracture who had measured troponin levels at hospital admission. DESIGN: Retrospective cohort study. SETTING: Single academic trauma center. PATIENTS: We included 299 consecutive patients 60 years of age or older with a hip fracture and cardiac troponin levels measured at the time of hospital admission. INTERVENTION: Patients with elevated cardiac troponin levels at hospital admission (n = 43) compared with patients with normal troponin levels at admission (n = 256). MAIN OUTCOME MEASURES: Time to surgery, 90-day mortality, and major complications within 90 days of injury. RESULTS: The median age of the cohort was 80 years (interquartile range, 70-87 years), 59% were female, and 86% were living independently before their injury. Elevated troponin levels were associated with a 21-hour [95% confidence interval (CI), 12 to 32, P < 0.001] increase in the median time from admission to surgery (43 vs. 22 hours). Elevated troponin levels were also associated with a 14% (95% CI, 0% to 29%, P = 0.01) absolute increase in 90-day mortality (28% vs. 14%). Patients with elevated troponins were 15% (95% CI, -1% to 30%, P = 0.06) more likely to have a major complication (37% vs. 23%); however, the difference did not reach statistical significance. CONCLUSIONS: Among patients with a hip fracture and measured troponin levels, elevated troponin levels were associated with significant delays in surgery and increased 90-day mortality. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Does negative pressure wound therapy reduce the odds of infection and improve health-related quality of life in patients with open fractures?

AIMS: To evaluate the impact of negative pressure wound therapy (NPWT) on the odds of having deep infections and health-related quality of life (HRQoL) following open fractures. METHODS: Patients from the Fluid Lavage in Open Fracture Wounds (FLOW) trial with Gustilo-Anderson grade II or III open fractures within the lower limb were included in this secondary analysis. Using mixed effects logistic regression, we assessed the impact of NPWT on deep wound infection requiring surgical intervention within 12 months post-injury. Using multilevel model analyses, we evaluated the impact of NPWT on the Physical Component Summary (PCS) of the 12-Item Short-Form Health Survey (SF-12) at 12 months post-injury. RESULTS: After applying inverse probability treatment weighting to adjust for the influence of injury characteristics on type of dressing used, 1,322 participants were assessed. The odds of developing a deep infection requiring operative management within 12 months of initial surgery was 4.52-times higher in patients who received NPWT compared to those who received a standard wound dressing (95% confidence interval (CI) 1.84 to 11.12; p = 0.001). Overall, 1,040 participants were included in our HRQoL analysis, and those treated with NPWT had statistically significantly lower mean SF-12 PCS post-fracture (p < 0.001). These differences did not reach the minimally important difference for the SF-12 PCS. CONCLUSION: Our analysis found that patients treated with NPWT had higher odds of developing a deep infection requiring operative management within 12 months post-fracture. Due to possible residual confounding with the worst cases being treated with NPWT, we are unable to determine if NPWT has a negative effect or is simply a marker of worse injuries or poor access to early soft-tissue coverage. Regardless, our results suggest that the use of this treatment requires further evaluation. Cite this article: Bone Jt Open 2022;3(3):189-195.

Patients With Cirrhosis Who Have a Model for End-stage Liver Disease Sodium Score of 8 or Greater Are at Increased Risk of Poor Outcomes in Operatively Treated Tibia Fractures.

The purpose of this study was to compare 30-day readmission rates for cirrhotic and non-cirrhotic patients after tibia fracture fixation by retrospectively identifying all surgically managed tibial plateau, tibial shaft, and pilon fractures from 2010 through 2018 in the National Surgical Quality Improvement Program database (N=14,028). The primary outcome measure was 30-day readmission rates. Secondary outcome measures included 30-day rates of reoperation, length of stay, pulmonary embolism, deep venous thrombosis, and wound complications, including deep or superficial infection. Cirrhotic patients (n=665) and non-cirrhotic patients (n=13,363) were identified using the aspartate aminotransferase to platelet ratio index test. Cirrhotic patients were more likely to have preoperative ascites, renal failure, bleeding disorders, and preoperative transfusions. No differences were reported between the two groups in readmission rate or any of the secondary outcome measures, except that cirrhotic patients' length of stay was longer by 0.5 day. Stratification of the cirrhotic cohort demonstrated that a Model for End-stage Liver Disease sodium (MELD-Na) score of 8 or greater was associated with a 4.1-fold increase in the rate of readmission (5.9% vs 1.5%; P<.01). No other differences were identified based on MELD-Na score stratification. Patients with advanced cirrhosis (MELD-Na score ≥8) have an increased risk of 30-day readmission after tibia fracture surgery. Cirrhosis associated with a lower MELD-Na score might not significantly increase the risk of 30-day complications in patients with tibia fractures. [Orthopedics. 2022;45(2):79-85.].

Open reduction and internal fixation alone versus open reduction and internal fixation plus total hip arthroplasty for displaced acetabular fractures in patients older than 60 years: A prospective clinical trial.

INTRODUCTION: The optimal treatment of elderly patients with an acetabular fracture is unknown. We conducted a prospective clinical trial to compare functional outcomes and reoperation rates in patients older than 60 years with acetabular fracture treated with open reduction and internal fixation (ORIF) alone versus ORIF plus concomitant total hip arthroplasty (ORIF + THA). Our hypothesis was that patients who had ORIF + THA would have better patient reported outcomes and lower reoperation rates postoperatively. METHODS: Inclusion criteria were patients older than 60 years with acetabular fracture plus at least one of three fracture characteristics: dome impaction, femoral head fracture, or posterior wall component. Eligible patients were operative candidates based on fracture displacement, ambulatory status, and physiological appropriateness. Patients received either ORIF alone or ORIF + THA (accomplished at same surgery through same incision). Outcome measurements included Western Ontario and McMaster Universities Osteoarthritis Index hip score, Short Form 36, Harris Hip Score, and Patient Satisfaction Questionnaire Short Form scores. Additionally, patients were monitored for any unplanned reoperation within 2 years. RESULTS: Forty-seven of 165 eligible patients with an average age of 70.7 years were included. The mean Harris Hip Score difference favored ORIF + THA (mean difference, 12.3, [95% confidence interval (CI), -0.3 to 24.9, p = 0.07]). No clinically important differences were detected in any other validated outcome score or patient satisfaction score 1 year after surgery. ORIF + THA decreased the absolute risk of reoperation by 28% (95% CI, 13% to 44%, p < 0.01). No postoperative hip dislocation occurred in either group. CONCLUSIONS: In patients older than 60 years with an operative displaced acetabular fracture with specific fracture features (dome impaction, femoral head fracture, or posterior wall component), treatment with ORIF + THA resulted in fewer reoperations than treatment with ORIF alone. No differences in patient satisfaction and other validated outcome measures were detected.

Is a Low-Cost Drill Cover System Noninferior to Conventional Surgical Drills for Skeletal Traction Pin Placement?

SUMMARY: The Drill Cover system was developed as a low-cost alternative to conventional surgical drills with specific applicability to low- and middle-income countries. However, the system may also be useful for the sterile placement of traction pins in the emergency department of high-income country hospitals. In September 2019, a US-based Level-1 trauma center began using the Drill Cover system to apply skeletal traction pins in patients with femoral shaft fractures. With these data, we performed a retrospective interrupted time series study to determine if the Drill Cover system was noninferior to conventional surgical drills in terms of infections at the traction pin site. The study included 205 adult patients with femoral shaft fractures initially placed in skeletal traction using a conventional surgical drill (n = 150, preintervention group) or the Drill Cover system (n = 55, postintervention group). The primary outcome was an infection at the site of skeletal traction pin placement that required surgery or antibiotics, which was compared between groups using a noninferiority test with a 1-sided alpha of 0.05 and a noninferiority margin of 3%. No infections at the site of skeletal traction pin placement were found in either the preintervention or the postintervention group (difference, 0%; 95% confidence interval: 0.0%-1.4%; noninferiority P value < 0.01). The results suggest that the Drill Cover system was noninferior to conventional surgical drills regarding infections at the site of skeletal traction pins. The Drill Cover system may be a safe alternative to the more expensive surgical drills for skeletal traction pin placement in the emergency room environment.

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials.

INTRODUCTION: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. METHODS: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. RESULTS: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. DISCUSSION: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

A Prospective Clinical Trial Comparing Surgical Fixation Versus Nonoperative Management of Minimally Displaced Complete Lateral Compression Pelvis Fractures.

OBJECTIVE: To compare the early pain and functional outcomes of operative fixation versus nonoperative management for minimally displaced complete lateral compression (LC; OTA/AO 61-B1/B2) pelvic fractures. DESIGN: Prospective clinical trial. SETTING: Two academic trauma centers. PATIENTS: Forty-eight adult patients with LC pelvic ring injuries with <10 mm of displacement were treated nonoperatively and 47 with surgical fixation. Sixty percent of participants were randomized. Seventy-three percent of the fractures were displaced <5 mm, and 71% were LC-1 patterns. INTERVENTION: Operative fixation versus nonoperative management. MAIN OUTCOME MEASUREMENTS: The primary outcome was patient-reported pain using the 10-point Brief Pain Inventory. Functional outcome was measured using the Majeed pelvic score. Outcomes were analyzed using hierarchical Bayesian models to compare the average treatment effect from injury to 12 and 52 weeks postinjury. The probability of the mean treatment benefit exceeding a clinically important difference was determined. RESULTS: The 3-month average treatment effect of surgery compared with nonoperative management was a 1.2-point reduction in pain [95% credible interval (CrI): 0.4-1.9] and an 8% absolute improvement in the Majeed score (95% CrI: 3%-14%). Similar results persisted to 1 year. Patients with initial fracture displacement ≥5 mm experienced a larger reduction in pain (2.2, 95% CrI: 0.9-3.5) compared with those patients with less initial displacement (0.9, 95% CrI: 0.1-1.8). CONCLUSION: On average, surgical fixation likely provides a small improvement in pain and functional outcome for up to 12 months. Patients with ≥5 mm of posterior pelvic ring displacement are more likely to experience clinically important improvements in pain. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Association of Postoperative Infections After Fractures With Long-term Income Among Adults.

Importance: Postoperative infections after a fracture exert tremendous costs on the health care system. However, the patient economic burden associated with a postoperative infection is unclear. Objective: To evaluate the association between a postoperative infection and long-term income among patients with surgically treated fractures. Design, Setting, and Participants: A retrospective cohort study linked academic trauma center data with Maryland tax records using inverse probability of treatment weighting to estimate between-group differences among 11 673 adults who underwent surgery to treat fractures of the extremities or pelvis between January 1, 2003, and December 31, 2016. Statistical analysis was performed from November 5, 2019, to August 30, 2020. Exposure: A postoperative infection within 1 year of injury. Main Outcomes and Measures: The primary outcome was the annual household income up to 6 years after injury. Household income incorporates multiple types of income, including wage earnings, taxable Social Security benefits, workers' compensation, and disability benefits. Secondary outcomes included individual earnings, Social Security benefits, unemployment benefits, and catastrophic income loss. Results: The study included 11 673 patients (7756 male patients [66.4%]; mean [SD] age, 45.2 [19.2] years) with a mean (SD) preinjury household income of $30 505 ($89 030). A total of 403 patients (3.5%) had a postoperative infection. Postoperative infections were associated with a $6080 annual decrease (95% CI, -$12 114 to -$47; P = .048) in household income in the 6 years after injury. Postoperative infections were associated with a 6.6% increase (95% CI, 4.9%-8.3%; P < .001) in the risk of catastrophic wage loss within 2 years of the fracture and were associated with a 45% increase in the odds of receiving Social Security benefits (odds ratio, 1.45; 95% CI, 1.25-1.68; P < .001). However, incurring a postoperative infection was not associated with an increase in the value of the Social Security benefits received. Conclusions and Relevance: This study suggests that postoperative infections have significant and sustained income-associated implications for patients who experience a fracture. Current Social Security mechanisms may not offset the decreased income.

PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients.

INTRODUCTION: Patients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients. However, emerging literature in total joint arthroplasty patients suggests the potential clinical benefits of VTE prophylaxis with aspirin. The primary aim of this trial is to compare aspirin with LMWH as a thromboprophylaxis in fracture patients. METHODS AND ANALYSIS: PREVENT CLOT is a multicentre, randomised, pragmatic trial that aims to enrol 12 200 adult patients admitted to 1 of 21 participating centres with an operative extremity fracture, or any pelvis or acetabular fracture. The primary outcome is all-cause mortality. We will evaluate non-inferiority by testing whether the intention-to-treat difference in the probability of dying within 90 days of randomisation between aspirin and LMWH is less than our non-inferiority margin of 0.75%. Secondary efficacy outcomes include cause-specific mortality, non-fatal PE and deep vein thrombosis. Safety outcomes include bleeding complications, wound complications and deep surgical site infections. ETHICS AND DISSEMINATION: The PREVENT CLOT trial has been approved by the ethics board at the coordinating centre (Johns Hopkins Bloomberg School of Public Health) and all participating sites. Recruitment began in April 2017 and will continue through 2021. As both study medications are currently in clinical use for VTE prophylaxis for orthopaedic trauma patients, the findings of this trial can be easily adopted into clinical practice. The results of this large, patient-centred pragmatic trial will help guide treatment choices to prevent VTE in fracture patients. TRIAL REGISTRATION NUMBER: NCT02984384.