Dataset Information

Comparison of Effects of a Thrombin-Based Hemostatic Agent and Topical Tranexamic Acid on Blood Loss in Patients with Preexisting Thromboembolic Risk Undergoing a Minimally Invasive Total Knee Arthroplasty. A Prospective Randomized Controlled Trial.

ABSTRACT:

Background

The efficacy of a thrombin-based hemostatic agent (Floseal®) on reducing postoperative blood loss after total knee arthroplasty (TKA) was still unclear. The aim of our study was to conduct a prospective randomized controlled study to compare the blood conservation effects of Floseal® and topical TXA in patients with preexisting thromboembolic risk undergoing primary minimally invasive TKA.

Methods

Our power analysis of this study was based upon the following description, to obtain a statistical power of 0.90 and an alpha error of 0.05, 30 patients were required in each group. Therefore, we enrolled a total of 103 patients with at least one of the risk factors for thromboembolism who underwent unilateral primary minimally invasive TKA, and the participants were randomly divided into the topical TXA group (n = 34), receiving intra-articular injection of 3?g of TXA in 100?mL saline after TKA, the topical Floseal® group (n = 34), receiving 10?mL of Floseal® intra-articularily during surgery, and the placebo group (n = 35), receiving an intra-articular saline injection only. The total blood loss (TBL) and hemoglobin (Hb) drop were compared among the 3 groups.

Results

The TXA group had a lower TBL of 645?mL (227 to 1090) in comparison with 1145?mL (535 to 1942) in the Floseal® group and 1103?mL (424 to 1711) in the placebo (p < 0.001, respectively). The TBL was similar between the Floseal® group and the placebo group (p = 0.819). No patients in any group had symptoms of venous thromboemblism.

Conclusion

Our prospective randomized controlled study showed that intra-articular application of TXA was superior to hemostatic matrix (Floseal®) in terms of blood conservation in patients with preexisting thromboembolic risk undergoing minimally invasive TKA. This trial is registered with Clinicaltrials.gov (NCT02865174) on 08/09/2016.

SUBMITTER: Yen SH

PROVIDER: S-EPMC7822658 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Comparison of Effects of a Thrombin-Based Hemostatic Agent and Topical Tranexamic Acid on Blood Loss in Patients with Preexisting Thromboembolic Risk Undergoing a Minimally Invasive Total Knee Arthroplasty. A Prospective Randomized Controlled Trial.

Yen Shih-Hsiang SH Lin Po-Chun PC Wu Cheng-Ta CT Wang Jun-Wen JW

BioMed research international 20210114

<h4>Background</h4>The efficacy of a thrombin-based hemostatic agent (Floseal®) on reducing postoperative blood loss after total knee arthroplasty (TKA) was still unclear. The aim of our study was to conduct a prospective randomized controlled study to compare the blood conservation effects of Floseal® and topical TXA in patients with preexisting thromboembolic risk undergoing primary minimally invasive TKA.<h4>Methods</h4>Our power analysis of this study was based upon the following description ...[more]

PMID: 33511201

Similar Datasets

Project description:ObjectiveTo explore the outcome and surgical technique of minimally invasive unicompartmental knee arthroplasty (UKA) for spontaneous osteonecrosis of the knee.MethodsTwenty-seven patients with medial compartmental spontaneous osteonecrosis treated by minimally invasive Oxford phase 3 UKA from January 2009 to June 2013 were reviewed retrospectively. Twelve subjects were men and 15 women, with an average age of 64.6 ± 8.6 years (52-82 years). At the time of diagnosis, 11 patients had with grade III necrosis and 16 grade IV according to Mont's classification. Pain, range of motion (ROM) and Hospital for Special Surgery (HSS) knee scores were evaluated before and after UKA. Pre-and postoperative alignment of the lower limbs was measured and compared. Postoperative radiographic assessments were made according to the guidelines proposed by the Oxford group at the final follow-up.ResultsAll patients were followed for a mean time of 27.8 ± 15.9 months (6-59 months). There were no serious adverse events, such as infection, bearing dislocation, aseptic loosening, pulmonary embolism, deep venous thrombosis, cardio-cerebral vascular incident or psychological problems. One revision was required for unrelated causes (fracture of tibia plateau) 3 years after arthroplasty. One femoral component was tilted with a postoperative radiographic angle >10°. One radiolucent line was observed in a patient with spontaneous osteonecrosis of the knee. The two patients with implant failure had no symptoms at last follow-up. Visual analogue scale scores decreased from 6.9 ± 0.9 to 2.0 ± 1.1 (t = 19.27, P = 0.00). Pain was relieved in 96.3% of subjects (26/27). The mean post-operative ROM and femorotibial angle were 125.7° ± 9.6° and 177.7° ± 3.1°, respectively. HSS scores increased from 61.3 ± 9.7 to 93.0 ± 4.8 (t = 14.46, P = 0.00). Of the 27 patients, 26 (96.3%) were satisfied with the outcome of this surgical procedure.ConclusionMinimally invasive UKA is an effective means of managing spontaneous osteonecrosis of the knee. The short-term outcome of UKA is encouraging.

Dataset Information

Comparison of Effects of a Thrombin-Based Hemostatic Agent and Topical Tranexamic Acid on Blood Loss in Patients with Preexisting Thromboembolic Risk Undergoing a Minimally Invasive Total Knee Arthroplasty. A Prospective Randomized Controlled Trial.

Background

Methods

Results

Conclusion

Publications

Comparison of Effects of a Thrombin-Based Hemostatic Agent and Topical Tranexamic Acid on Blood Loss in Patients with Preexisting Thromboembolic Risk Undergoing a Minimally Invasive Total Knee Arthroplasty. A Prospective Randomized Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets