Tranexamic Acid Use in Open Reduction and Internal Fixation of Fractures of the Pelvis, Acetabulum, and Proximal Femur: A Randomized Controlled Trial Objective: To assess the safety and efficacy of tranexamic acid (TXA) use in fractures of the pelvic ring, acetabulum, and proximal femur. Design: Prospective, randomized controlled trial. Setting: Single Level 1 trauma center. Patients: Forty-seven patients were randomized to the study group, and 46 patients comprised the control group. Intervention: The study group received 15 mg/kg IV TXA before incision and a second identical dose 3 hours after the initial dose. Main Outcome Measurements: Transfusion rates and total blood loss (TBL) [via hemoglobin-dilution method and rates of venous thromboembolic events (VTEs)]. Results: TBL was significantly higher in the control group (TXA = 952 mL, no TXA = 1325 mL, P = 0.028). The total transfusion rates between the TXA and control groups were not significantly different (TXA 1.51, no TXA = 1.17, P = 0.41). There were no significant differences between the TXA and control groups in inpatient VTE events (P = 0.57). Conclusion: The use of TXA in high-energy fractures of the pelvis, acetabulum, and femur significantly decreased calculated TBL but did not decrease overall transfusion rates. TXA did not increase the rate of VTE. Further study is warranted before making broad recommendations for the use of TXA in these fractures. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Validation of PROMIS Physical Function Instruments in Patients With an Orthopaedic Trauma to a Lower Extremity Objectives: To evaluate the reliability, convergent validity, known-groups validity, and responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS) Mobility Computer Adaptive Test (CAT) and PROMIS Physical Function 8a Short Form. Design: Prospective cohort study. Setting: Two Level-I trauma centers. Patients: Eligible adults with an isolated lower extremity trauma injury receiving treatment were approached consecutively (n = 402 consented at time 1, median = 80 days after treatment). After 6 months, 122 (30.3%) completed another assessment. Intervention: Cross-sectional and longitudinal monitoring of patients. Main Outcome Measurements: Floor and ceiling effects, reliability (marginal reliability and Cronbach's alpha), convergent validity, known-groups discriminant validity (weight-bearing status and fracture severity), and responsiveness (Cohen's d effect size) were evaluated for the PROMIS Mobility CAT, PROMIS Physical Function 8a Short Form, and 5 other measures of physical function. Results: PROMIS PFSF8a and Foot and Ankle Ability Measure Activities of Daily Living Index had ceiling effects. Both PROMIS measures demonstrated excellent internal consistency reliability (mean marginal reliability 0.94 and 0.96; Cronbach's alpha = 0.96). Convergent validity was supported by high correlations with other measures of physical function (r = 0.70–0.87). Known-groups validity by weight-bearing status and fracture severity was supported as was responsiveness (Mobility CAT effect size = 0.81; Physical Function Short Form 8a = 0.88). Conclusions: The PROMIS Mobility CAT and Physical Function 8a Short Form demonstrated reliability, convergent and known-groups discriminant validity, and responsiveness in a sample of patients with a lower extremity orthopaedic trauma injury.

A Randomized Controlled Trial Comparing rhBMP-2/Absorbable Collagen Sponge Versus Autograft for the Treatment of Tibia Fractures With Critical Size Defects Objectives: To compare radiographic union of tibia fractures with bone defects treated with recombinant bone morphogenetic protein‐2 (rhBMP‐2) with allograft to autogenous iliac crest bone graft (ICBG). Design: FDA-regulated multicenter randomized trial. Setting: Sixteen US trauma centers. Patients/Participants: Thirty patients (18–65 years of age) with Type II, IIIA, or IIIB open tibia fracture and bone defect treated with an intramedullary nail. Intervention: rhBMP-2 (n = 16) versus ICBG (n = 14). Main Outcome Measurements: Radiographic union within 52 weeks. Secondary outcomes included clinical healing, patient-reported function, major complications, and treatment cost. Equivalence was evaluated by testing whether a 90% two‐sided confidence interval for the difference in the probability of radiographic union between rhBMP‐2 or ICBG is contained with the interval [220% to +20%]. A post hoc Bayesian analysis, using data from a previous trial, was also conducted. Results: Twenty-three patients had union data at 52 weeks: 7/12 (58.3%) rhBMP-2 were radiographically united compared with 9/11 (81.8%) ICBG, resulting in a treatment difference of −0.23 (90% CI: −0.55 to 0.10). Patients treated with rhBMP-2 had lower rates of clinical healing at 52 weeks (27% vs. 54%), higher mean Short Musculoskeletal Function Assessment scores (dysfunction: 33.3 vs. 23.7; bother score: 32.8 vs. 21.4) and experienced more complications (5 vs. 3). Mean treatment cost for rhBMP-2 was estimated at $14,155 versus $9086 for ICBG. Conclusions: These data do not provide sufficient evidence to conclude that ICBG and rhBMP-2 are equivalent regarding radiographic union. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Extreme Nailing: Is It Safe to Allow Immediate Weightbearing After Intramedullary Nail Fixation of Extra-articular Distal Tibial Fractures (OTA/AO 43-A)? Objectives: To determine whether immediate weightbearing after intramedullary (IM) fixation of extra-articular distal tibial fractures (OTA/AO 43-A) results in a change in alignment before healing. Design: Retrospective review. Setting: Level 1 trauma center. Intervention: IM nailing of distal tibial fractures. Patients/Participants: Fifty-three patients with 54 fractures, all of whom could bear weight as tolerated postoperatively. Eighteen fractures were OTA/AO 43-A1, 20 OTA/AO 43-A2, and 16 OTA/AO 43-A3; 20 fractures were open. Main Outcome Measurements: Change in fracture alignment or loss of position. Results: Average change from initial angulation at final follow-up was 0.52 ± 1.49 degrees of valgus and 0.48 ± 3.14 degrees of extension. Final alignment was excellent in 14, acceptable in 28, and poor in 12; 2 fractures went from acceptable initial alignment to poor final alignment; and 2 fractures went from excellent to acceptable alignment. Seven fractures had an improvement in alignment over time. Two fractures required free-flap coverage and 4 required staged grafting because of bone loss. Ten fractures had an unplanned return to the operating room (5 for infected nonunion requiring implant exchange, 3 for infection requiring debridement without implant revision, and 2 for aseptic nonunion). No patient had revision for implant failure. Conclusions: Immediate weightbearing after IM fixation of extra-articular distal tibial fractures (OTA/AO 43-A) led to minimal change in alignment and seems to be safe for most patients. Complications were consistent with those reported in previous non-weightbearing cohorts. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Importance of Syndesmotic Reduction on Clinical Outcome After Syndesmosis Injuries Objectives: To evaluate the relationship between syndesmosis reduction and outcome. Design: Retrospective cohort study. Setting: One Level 1 and 1 Level 3 Trauma Center. Patients: Ninety-seven patients with syndesmosis injury. Intervention: Stabilization of syndesmosis injury. Open reduction and internal fixation of malleolar fracture, if present. Main Outcome Measurements: Anterior, central, and posterior measures of syndesmosis width on computed tomography scans, Olerud–Molander Ankle score, American Orthopaedic Foot and American Orthopaedic Foot and Ankle Society Ankle-Hindfoot score, and range of motion measurements. Results: Eighty-seven patients completed 2 years of follow-up. The difference in anterior tibiofibular distance (aTFD) between the injured and noninjured ankle postoperatively had a significant effect on the Olerud-Molander Ankle score after 6 weeks [b = −2.6, 95% confidence interval (CI), −4.8 to −0.4; P = 0.02], 1 year (b = −2.7, 95% CI, −4.7 to −0.8; P < 0.001), and 2 years (b = −2.6, 95% CI, −4.6 to −0.6; P = 0.009) and on American Orthopaedic Foot and Ankle Society Ankle-Hindfoot score after 6 weeks (b = −2.2, 95% CI, −3.7 to −0.7; P = 0.004), 1 year (b = −1.7, 95% CI, −3.0 to −0.4; P = 0.04), and 2 years (b = −1.9, 95% CI, −3.2 to −0.5; P = 0.006). The effect of computed tomography measurements on range of motion was inconsistent. Receiver operating characteristic (ROC) curves demonstrated that aTFD had adequate discriminatory performance (area under the ROC curve ≥ 0.7) 1 and 2 years after surgery and the central measurement at only 2 years after surgery. ROC analyses indicate a cutoff value for syndesmosis malreduction of 2 mm. The postoperative rate of malreduction was 32%. Conclusions: The aTFD correlated with clinical outcome. A 2-mm difference in aTFD seems to predict poorer clinical outcome. Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Quantification of Postoperative Posterior Malleolar Fragment Reduction Using 3-Dimensional Computed Tomography (Q3DCT) Determines Outcome in a Prospective Pilot Study of Patients With Rotational Type Ankle Fractures Objective: To correlate Q3DCT measurements of residual step-off, gap, and 3D multidirectional displacement of postoperative posterior malleolar fracture fragment reduction in patients with rotational type ankle fractures, with patients' clinical outcome using standardized patient- and physician-based outcome measures. Design: Prospective cohort study. Setting: Level-I Trauma Center. Patients: Thirty-one patients with ankle fractures including a posterior malleolar fracture (OTA/AO type 44) were included. Intervention: All patients underwent open reduction internal fixation of their ankle fracture, of which 18 patients (58%) had direct fixation of the posterior malleolar fragment. Decision of (direct) fixation of the posterior malleolar fragment was not standardized and guided by surgeons' preference. Main Outcome Measurements: Quality of postoperative reduction was quantified using Q3DCT: posterior fragment size (% of joint surface), residual step-off (mm), postoperative gaps (mm2), and overall multidirectional displacement were quantified. Foot and Ankle Outcome Score pain and symptoms subscales and quality of life (Short Form-36) at 1 year postoperatively were included as the main outcome measures. Results: Step-off (mean 0.6 mm, range 0.0–2.7, SD 0.8) showed a significant correlation with worse Foot and Ankle Outcome Score pain and symptoms subscales. Residual fracture gap (mean 12.6 mm2, range 0.0–68.8, SD 19.5) and 3D multidirectional displacement (mean 0.96 mm, range 0.0–2.8, SD 0.8) showed no correlation. Conclusions: In patients with rotational type ankle fractures involving a posterior malleolar fracture, contemporary Q3DCT measurements of posterior fragment size and residual intra-articular step-off—but not gap—show significant correlation with patient-reported pain and symptoms. Level of Evidence: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Biomechanical Analysis of Instability in Rotational Distal Fibula Fractures (OTA/AO 44-B1) With an Intact Deltoid Ligament Objectives: To biomechanically analyze instability in supination external rotation (SER) II/III patterns. Methods: Nineteen cadaver legs were tested in a mechanical jig. One, 2, 3, and 4 Nm of external rotation were applied to intact ankles, SER II injuries, and SER III injuries. The talar position relative to the tibia was recorded using 3D motion tracking. Change from the unloaded state in each condition and the torque level was calculated. Results were analyzed using analysis of variance with post hoc paired t tests. Results: SER II showed statistically significant differences from the intact state with coronal translation (2, 3, and 4 Nm), sagittal translation (1 and 2 Nm), axial rotation (1, 2, 3, and 4 Nm), and coronal rotation (3 and 4 Nm). SER III showed statistically significant differences from the intact state with coronal translation (2, 3, and 4 Nm), sagittal translation (1, 2, and 3 Nm), axial rotation (1, 2, 3, and 4 Nm), and coronal rotation (3 and 4 Nm). SER II and SER III differed significantly from each other with coronal translation (1, 2, and 3 Nm), axial rotation (2, 3, and 4 Nm), and coronal rotation (1, 3, and 4 Nm). Conclusion: Instability in SER injuries has only been described with coronal translation and suggests that deltoid rupture is necessary. Our data demonstrate instability in SER II/III in sagittal translation and axial rotation as well as subtle instability in coronal translation. The clinical impact is unclear, but better understanding of long-term sequelae of this instability is needed.

Hook Plate Fixation for Acute Unstable Distal Clavicle Fracture: A Systematic Review and Meta-analysis Objectives: To compare the outcome of hook plate fixation with other techniques in surgical fixation of acute unstable distal clavicle fractures. Data Sources: In July 2018, a systematic search of electronic databases (PubMed, Medline, Embase, and Cochrane databases for systematic reviews) was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. Articles were limited to English language. Study Selection: Studies were included if they compared the results of hook plate fixation of acute unstable distal clavicle fracture in adults with other surgical techniques. Data Extraction: Data on the study setting, functional outcome, union, and complication rates were extracted. A quality assessment was performed using the Newcastle–Ottawa Scale. Data Synthesis: Eleven studies were found that met the inclusion criteria. Six hundred thirty-four patients were pooled using a random effects model. There were 397 male and 237 female patients. Primary outcome measure was functional result, and the secondary outcome measures were union and complication rates. There was no significant difference between the functional outcome and union rate between hook plate fixation, coracoclavicular (CC) stabilization, and locking plate fixation. Hook plate fixation resulted in a higher Constant–Murley score compared with tension band wiring (TBW) [odds ratio (OR), 3.52; 95% confidence interval (CI), 0.79–6.26]. It was also associated with a higher complication rate compared with CC stabilization (OR, 3.68; 95% CI, 1.19–11.33) and the locking plate (OR, 5.19; 95% CI, 1.58–17.06). Compared with TBW, hook plate fixation was associated with a lower complication rate (OR, 0.28; 95% CI, 0.10–0.77). Conclusions: Hook plate fixation achieves a similar functional outcome and union rate compared with CC stabilization and locking plate fixation. However, it has a superior functional result compared with TBW. The complication rate is higher compared with CC stabilization and locking plate fixation and is lower compared with TBW. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Treatment Discrepancy for Pelvic Fracture Patients With Urethral Injuries: A Survey of Orthopaedic and Urologic Surgeons Objectives: In patients with traumatic pelvic fracture urethral injuries (PFUI), the interaction between urethral management and orthopaedic decision making remains unknown. We aimed to survey orthopaedic and urologic surgeons to assess interdisciplinary interactions in the management of PFUI. Methods: An anonymous cross-sectional survey of members of the Orthopaedic Trauma Association (OTA) and the Society of Genitourinary Reconstructive Surgeons (GURS) was conducted between September 2017 and August 2018. Participants were queried regarding the impact of urethral injuries and their management on orthopaedic operative decision making. Results: Fifty-three GURS and 64 OTA members responded (17% response rate). For urethral injury management, 73% of OTA respondents preferred that suprapubic tubes (SPTs) were not placed for urethral injury management, whereas 43% of GURS respondents preferred SPTs (P = 0.08). Ninety-two percent of OTA respondents stated that SPTs increase hardware infection risks in patients undergoing pelvic open reduction with internal fixation (ORIF), whereas only 8% of GURS respondents agreed (P < 0.01). Although 66% of GURS respondents reported not considering the operative plans of orthopaedics when determining urethral management, 75% of OTA respondents reported that they were less inclined to proceed with ORIF, and 70% would perform external fixation in the setting of an SPT, despite 78% believing that this resulted in an inferior outcome for the patient. Conclusions: There is discordance between urologists and orthopaedists as to the optimal management of PFUI patients, with significant disagreement regarding the infectious risks of SPT in the setting of ORIF. Improved data and interdisciplinary dialogue are required to maximize patient outcomes. Level of Evidence: Therapeutic Level V. See Instructions for Authors for a complete description of levels of evidence.

Delaying Surgery in Type III Supracondylar Humerus Fractures Does Not Lead to Longer Surgical Times or More Difficult Reduction Objective: To determine if delay in surgical treatment of type III supracondylar humerus fracture would affect the length of operative time. Design: Retrospective cohort study. Setting: Level 1 trauma center. Patients/Participants: This is a series of 309 modified Gartland type III supracondylar fractures treated operatively from 2011 to 2013. Intervention: Fifteen hours was defined as the cutoff between early and delayed treatment. A total of 53.7% (166/309) fractures were treated early, and 46.4% (143/309) were delayed. Main Outcome Measurements: Surgical time was defined as “incision start” to “incision close.” Fluoroscopy time was used as a surrogate for difficulty of reduction. Results: Time from injury to operating room was shorter for high-energy fractures (fractures with soft-tissue or neurovascular injury) versus low-energy fractures (12.9 vs. 15.3 hours, P < 0.0001); however, surgical time (37.3 vs. 31.8 minutes, P = 0.004) and fluoroscopy time (54.6 vs. 48.6 seconds, P = 0.027) were longer in high-energy fractures versus low-energy fractures. Among low-energy fractures, no significant difference was detected in the surgical time between the early and delayed treatment groups or in the fluoroscopy time. In addition, there was no statistically significant difference found in the surgical or fluoroscopy time with the presence of a surgical assistant. Conclusions: Delay in surgery did not result in a longer surgical time or more difficult reduction for type III supracondylar humerus fracture. Patients with low-energy fractures still underwent a shorter operative time even with delay from injury to surgery. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.