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

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

Tranexamic Acid and Holding Venous Thromboembolism Prophylaxis Morning of Surgery Do Not Decrease Transfusion Requirements in Patients Undergoing Anterior Intrapelvic Approach for Acetabular Open Reduction and Internal Fixation.

INTRODUCTION: The objective of this study was to determine factors that may affect transfusion rates for patients requiring an anterior intrapelvic (AIP) approach for an acetabulum fracture. METHODS: This was a multicenter retrospective comparison study (3 trauma centers at two urban academic centers). Patients who had an AIP approach for an acetabulum fracture without other notable same-day procedures (irrigation and débridement and/or external fixation were only other allowed procedures) were included. One hundred ninety-five adult (18 and older) patients had adequate records to complete analysis with no preexisting coagulopathy. The main outcome evaluated was the number of units transfused at the time of surgery and up to 7 days after surgery. RESULTS: Factors that were found to affect intraoperative transfusion rates were older age, lower preoperative hematocrit, longer surgery duration, and requiring increased intraoperative intravenous fluids. Factors that did not affect transfusion rate included sex, body mass index, hip dislocation at the time of injury, fracture pattern, AIP approach alone or with lateral window ± distal extension, Injury Severity Score, preoperative platelet count, use of tranexamic acid, and venous thromboembolism prophylaxis received morning of surgery. When followed out through the remainder of a week after surgery, the results for any factor did not change. DISCUSSION: In this large multicenter retrospective study of patients requiring an AIP approach, tranexamic acid and use of venous thromboembolism prophylaxis (or holding it the morning of surgery) did not affect transfusion rates either during surgery or up to a week after surgery. Older age, lower preoperative hematocrit level, longer surgery time, and increased intraoperative intravenous fluids were associated with higher transfusion rates. DATA AVAILABILITY AND TRIAL REGISTRATION NUMBERS: Data are available on request. LEVEL OF EVIDENCE: Level 3, retrospective case-control study.

Early Results of Orthopaedic Trauma and Anemia: Conservative Versus Liberal Transfusion Strategy.

INTRODUCTION: The purpose of this study was to determine whether it is safe to use a conservative packed red blood cell transfusion hemoglobin threshold (5.5 g/dL) compared with a liberal transfusion threshold (7.0 g/dL) for asymptomatic patients with musculoskeletal-injured trauma out of the initial resuscitative period. METHODS: This was a multicenter, prospective, nonblinded, randomized study done at three level 1 trauma centers. One hundred patients were enrolled. One patient was inappropriately enrolled, withdrawn from the study, and excluded from analysis leaving 99 patients (49 liberal and 50 conservative) with 30-day follow-up. After initial resuscitation, patients were enrolled and randomized to either a liberal or a conservative transfusion strategy. This strategy was followed throughout the index hospitalization. The primary outcome of the study was infection. Superficial infection was defined as clinical diagnosis of cellulitis or other superficial infection treated with oral antibiotics only. Deep infection was defined as clinical diagnosis of fracture-related infection requiring IV antibiotics and/or surgical débridement. RESULTS: Ninety-nine patients were successfully followed for 30 days with 100% follow-up during this time. Seven infections (14%) occurred in the liberal group and none in the conservative group ( P < 0.01). Five deep infections (10%) occurred in the liberal group and none in the conservative group ( P = 0.03). Three superficial infections (6%) occurred in the liberal and none in the conservative group, which was not a significant difference ( P = 0.1). No difference was observed in length of stay between groups. DISCUSSION: Transfusing young healthy asymptomatic patients with orthopaedic trauma for hemoglobin <7.0 g/dL increases the risk of infection. No increased risk of anemia-related complications was identified with a conservative transfusion threshold of 5.5 g/dL. DATA AVAILABILITY AND TRIAL REGISTRATION NUMBERS: Data are available on request. IRB protocol number is 1402557771. This study was registered with Clinicaltrials.gov identifier NCT02972593. LEVEL OF EVIDENCE: Level 2, unblinded prospective randomized multicenter study.

Early Treatment of Acetabular Fractures Using an Anterior Approach Increases Blood Loss but not Packed Red Blood Cell Transfusion.

OBJECTIVE: The objective of this study was to determine whether time from hospital admission to surgery for acetabular fractures using an anterior intrapelvic (AIP) approach affected blood loss. DESIGN: Retrospective review. SETTING: Three level 1 trauma centers at 2 academic institutions. PATIENT SELECTION CRITERIA: Adult (18 years or older) patients with no pre-existing coagulopathy treated for an acetabular fracture via an AIP approach. Excluded were those with other significant same day procedures (irrigation and debridement and external fixation were the only other allowed procedures). OUTCOME MEASURES AND COMPARISONS: Multiple methods for evaluating blood loss were investigated, including estimated blood loss (EBL), calculated blood loss (CBL) by Gross and Hgb balance methods, and packed red blood cell (PRBC) transfusion requirement. Outcomes were evaluated based on time to surgery. RESULTS: 195 patients were studied. On continuous linear analysis, increasing time from admission to surgery was significantly associated with decreasing CBL at 24 hours (-1.45 mL per hour by Gross method, P = 0.003; -0.440 g of Hgb per hour by Hgb balance method, P = 0.003) and 3 days (-1.69 mL per hour by Gross method, P = 0.013; -0.497 g of Hgb per hour by Hgb balance method, P = 0.010) postoperative, but not EBL or PRBC transfusion. Using 48 hours from admission to surgery to define early versus delayed surgery, CBL was significantly greater in the early group compared to the delayed group (453 [IQR 277-733] mL early versus 364 [IQR 160-661] delayed by Gross method, P = 0.017; 165 [IQR 99-249] g of Hgb early versus 143 [IQR 55-238] g Hgb delayed by Hgb balance method, P = 0.035), but not EBL or PRBC transfusion. In addition, in multivariate linear regression, neither giving tranexamic acid nor administering prophylactic anticoagulation for venous thromboembolism on the morning of surgery affected blood loss at 24 hours or 3 days postoperative ( P > 0.05). CONCLUSION: There was higher blood loss with early surgery using an AIP approach, but early surgery did not affect PRBC transfusion and may not be clinically relevant. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Orthopaedic Trauma and Anemia: Conservative versus Liberal Transfusion Strategy: A Prospective Randomized Study.

OBJECTIVES: To determine whether it is safe to use a conservative packed red blood cell transfusion hemoglobin (Hgb) threshold (5.5 g/dL) compared with a liberal transfusion threshold (7.0 g/dL) for asymptomatic musculoskeletal injured trauma patients who are no longer in the initial resuscitative period. METHODS: Design: Prospective, randomized, multicenter trial. SETTING: Three level 1 trauma centers. PATIENT SELECTION CRITERIA: Patients aged 18-50 with an associated musculoskeletal injury with Hgb less than 9 g/dL or expected drop below 9 g/dL with planned surgery who were stable and no longer being actively resuscitated were randomized once their Hgb dropped below 7 g/dL to a conservative transfusion threshold of 5.5 g/dL versus a liberal threshold of 7.0 g/dL. OUTCOME MEASURES AND COMPARISONS: Postoperative infection, other post-operative complications and Musculoskeletal Functional Assessment scores obtained at baseline, 6 months, and 1 year were compared for liberal and conservative transfusion thresholds. RESULTS: Sixty-five patients completed 1 year follow-up. There was a significant association between a liberal transfusion strategy and higher rate of infection (P = 0.01), with no difference in functional outcomes at 6 months or 1 year. This study was adequately powered at 92% to detect a difference in superficial infection (7% for liberal group, 0% for conservative, P < 0.01) but underpowered to detect a difference for deep infection (14% for liberal group, 6% for conservative group, P = 0.2). CONCLUSIONS: A conservative transfusion threshold of 5.5 g/dL in an asymptomatic young trauma patient with associated musculoskeletal injuries leads to a lower infection rate without an increase in adverse outcomes and no difference in functional outcomes at 6 months or 1 year. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.