Effect of Sequential Intravenous and Oral Tranexamic Acid on Hemoglobin Drop After Total Knee Arthroplasty: A Randomized Controlled Trial.

BACKGROUND: Tranexamic acid (TXA) is typically discontinued on the day of total knee arthroplasty (TKA). However, bleeding may persist for several days. We sought to determine whether sequential administration of intravenous (IV) and oral TXA could reduce hemoglobin (Hb) drop more than IV TXA alone. We also wanted to determine whether the use of additional oral TXA increased the rate of complications of deep vein thrombosis (DVT) or symptomatic pulmonary embolism (PE). METHODS: This prospective, randomized controlled trial included 141 patients. We compared the Hb drop, estimated blood loss (EBL), and transfusion rate of patients receiving IV TXA alone (group IV, n = 48) to those of patients who received IV TXA followed by oral TXA for 2 days (group 2D, n = 46) or 5 days (group 5D, n = 47). IV TXA was administered 10 minutes prior to the tourniquet release and 3 hours after the first IV TXA administration. Computed tomography (CT) was performed on postoperative day 6 to identify radiographic evidence of DVT. We also assessed the prevalence of symptomatic DVT and PE. RESULTS: There were no differences in maximal Hb drop, Hb drops measured at each time point, EBL, or transfusion rate among the 3 groups. The mean maximal Hb drop was 3.5 g/dL in group IV, 3.2 g/dL in group 2D, and 3.4 g/dL in group 5D. The mean EBL was 999.9 mL in group IV, 886.4 mL in group 2D, and 972.5 mL in group 5D. One patient in each group required a transfusion. There were no differences in the prevalence of radiographic evidence of DVT or symptomatic DVT. Symptomatic DVT occurred in 3 patients in group IV and 2 patients in group 5D. One patient in group IV developed a symptomatic PE. CONCLUSIONS: Although there was no increase in the complication rate, the sequential administration of oral TXA for up to 5 days after IV TXA did not decrease Hb drop. Therefore, our findings suggest that sequential use of oral and IV TXA is not recommended. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Efficacy and safety of short-term use of a pelubiprofen CR and aceclofenac in patients with symptomatic knee osteoarthritis: A double-blinded, randomized, multicenter, active drug comparative, parallel-group, phase IV, non-inferiority clinical trial.

INTRODUCTION: At present, information about clinical efficacy and adverse events of controlled release (CR) form of pelubiprofen, a prodrug of 2-arylopropionic acid with relatively selective effects on cyclooxygenase-2 activity, remains scarce. In this study, we sought to determine non-inferiority of pelubiprofen CR 90 mg/day compared to aceclofenac 200 mg/day regarding clinical efficacy and adverse events after a 4-week course of medication in the patients with symptomatic knee osteoarthritis. MATERIALS AND METHODS: A total of 191 patients were randomly assigned to take either pelubiprofen CR 90 mg (n = 95) or aceclofenac 200 mg (n = 96). The primary outcome variable was non-inferiority of pain reduction between baseline and week 4 when assessed using a 100 mm pain visual analogue scale (VAS). Pelubiprofen was considered non-inferior to aceclofenac if the upper limit of the one-sided 97.5% confidence interval for the difference in terms of pain VAS was above 15 mm (the average change of pain VAS in the pelubiprofen group-pain VAS reduction in the aceclofenac group). Secondary outcome variables were the changes in 100 mm pain VAS at week 2 versus baseline, K-Western Ontario, and McMaster University Arthritis Index (K-WOMAC) changes at weeks 2 and 4 as compared to baseline, patient global assessment at weeks 2 and 4. The frequency and amount of rescue medicine usage at weeks 2 and 4 were also evaluated as the secondary outcome variable. For safety analysis, adverse events, clinical laboratory tests, vital signs, and physical examinations were assessed and conducted at each follow-up visit. RESULTS: At week 4, the pain VAS values were significantly reduced in both groups receiving either pelubiprofen CR 90 mg or aceclofenac 200 mg as compared to the baseline. However, the pelubiprofen group and the aceclofenac group respectively showed the pain VAS changes of -22 and -21.9 in the pre-protocol set and -20.8 and -21.7 in the full analysis set, confirming non-inferiority. The pelubiprofen CR 90 mg showed a reduced incidence of adverse events compared to the aceclofenac 200 mg (p = 0.005). CONCLUSIONS: Pelubiprofen CR 90 mg is as effective as aceclofenac 200 mg with reduced adverse events for the treatment of symptomatic knee osteoarthritis.

Relationship Between Coronal Alignment and Rotational Profile of Lower Extremity in Patients With Knee Osteoarthritis.

BACKGROUND: We aimed at determining whether the coronal alignment of lower extremity was related to rotational geometry of distal femur, femoral anteversion, and tibial torsion in patients with knee osteoarthritis. METHODS: A total of 422 lower extremities were divided into 3 groups according to the coronal alignment: valgus (n = 31), neutral (n = 78), and varus group (n = 313). Condylar twisting angle was measured to determine rotational geometry of distal femur as the angle between the clinical transepicondylar axis and the posterior condylar line. Femoral anteversion was assessed using the angle between a line intersecting the femoral neck and the posterior condylar line (pFeAV) and the angle between the same line and transepicondylar axis that is not affected by posterior condylar variations (tFeAV). Tibial torsion was evaluated by measuring the angle between the posterior condyles of the proximal tibia and the transmalleolar axis. RESULTS: As the coronal alignment changed from varus to valgus, the condylar twisting angle increased (r = 0.253, P < .001; 6.6° in varus, 7.4° in neutral, and 10.2° in valgus group). Although the pFeAV also increased (r = 0.145, P = .003), the tFeAV did not change significantly (P = .218). Mean tFeAV was 4.3° in varus, 4.7° in neutral, and 6.5° in valgus group. In contrast, as the coronal alignment changed from varus to valgus, the external tibial torsion increased (r = 0.374, P < .001; 22.6° in varus, 26.3° in neutral, and 32.6° in valgus group). CONCLUSION: The change patterns of the rotational profiles of the lower extremity according to the coronal alignment should be considered in order to obtain satisfactory rotational alignment after TKA.

Accuracy and Reproducibility of the Femoral Tunnel With Different Viewing Techniques in the ACL Reconstruction.

The purpose of this study was to compare the accuracy and reproducibility of the femoral tunnel location among 3 different viewing techniques used during outside-in anterior cruciate ligament (ACL) reconstruction with 3- dimensional (3-D) computed tomography (CT): (1) an anterolateral (AL) or anteromedial (AM) portal with a 30° arthroscope (A group) vs (2) a posterolateral (PL) portal with a 70° arthroscope (PL group) vs (3) a trans-septal (TS) portal with a 30° arthroscope (TS group). A total of 106 patients undergoing outside-in ACL reconstruction were recruited. Patients were divided into 3 groups according to viewing technique (A group=36 patients; PL group=35 patients; TS group=35 patients). Femoral tunnel locations were evaluated with the quadrant method and the anatomic coordinate axes measurement (ACAM) method in the medial wall of the lateral femoral condyle using 3-D reconstructed CT. The accuracy and reproducibility of the femoral tunnel locations were compared among the 3 techniques. The accuracy of the tunnel location was higher in the TS group by the quadrant method as well as the ACAM method. The reproducibility of the femoral tunnel position in the TS group was the highest, and the femoral tunnel locations of the TS group were more compactly distributed compared with those of the A and PL groups. The accuracy and reproducibility of the femoral tunnel location could be improved with a TS portal viewed using a 30° arthroscope. Anteromedial/anterolateral and PL portals viewed using a 70° arthroscope showed no difference. [Orthopedics. 2016; 39(6):e1085-e1091.].