ARTHROPLASTY
Comparison of oral versus intra-articular tranexamic acid in enhanced-recovery primary total knee arthroplasty without tourniquet application: a randomized controlled trial
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2022;10(10):7 BMC Musculoskelet Disord. 2018 Mar 15;19(1):85150 patients scheduled for total knee arthroplasty were randomized to either perioperative oral tranexamic acid or intraarticular tranexamic acid. Patients were assessed perioperatively for total blood loss, intraoperative blood loss, the incidence of transfusion, number of transfused units, and postoperative complications. At the 1-month and 3-month follow-ups, patients were also assessed for knee circumference, health-related quality of life, mortality, and readmission. No significant differences were observed between groups in the perioperative measures, including total blood loss, intraoperative blood loss, transfusion rate, and complication rate. Additionally, there were no significant differences between groups in outcomes at follow-up.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
4/4
Randomization
4/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/5
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Tranexamic acid has been the subject of investigation for reducing blood loss in total knee arthroplasty. Early studies have focused on the intravenous and intra-articular application of tranexamic acid in these procedures. More recently, interest has grown in the application of oral tranexamic acid. While results from placebo-controlled trials have demonstrated efficacy, comparisons to other forms of tranexamic acid are needed.
主な研究課題は何ですか？
In total knee arthroplasty, is there a significant difference in total blood loss between oral tranexamic acid administration and intraarticular tranexamic acid administration?
重要な知見は？
- Total blood loss did not significantly differ between the oral TXA group (788.8+/-349.1mL) and the IA TXA group (872.4+/-393.1mL) (p=0.21).
- Intraoperative blood loss and transfusion rate did not significantly differ between the oral TXA group and the IA TXA group (p=0.58 and 0.73, respectively).
- Hemoglobin and hematocrit level at 72 hours post-operation did not significantly differ between the oral TXA group and the IA TXA group (p=0.22 and 0.20, respectively).
- The incidence of complications did not significantly differ between the oral TXA group (2/74) and the IA TXA group (1/73). Complications included one case of DVT in the oral TXA group, one case of wound secretion in the oral TXA group, and one case of hematoma in the IA TXA group.
- QoR-40, knee range of motion, and pain scores did not significantly differ between the oral TXA group and the IA TXA at 1 month or 3 months postoperatively.
- No case of all cause 30-day mortality was observed in either group.
- No case of all cause 90-day readmission was observed in either group.
最も覚えておくべきことは？
In total knee arthroplasty, oral tranexamic acid and intraarticular tranexamic acid demonstrated no significant differences in total blood loss, transfusion rate, incidence of postoperative complications, or postoperative clinical and functional outcomes up to 3 months postoperatively.
それが私の患者ケアにどのように影響するか？
The results of this study suggest that oral tranexamic acid may offer similar effects to intraarticular tranexamic acid on blood loss, transfusion rate, postoperative outcomes, and complications following total knee arthroplasty.
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