ARTHROPLASTY
Peri-articular tranexamic acid injection in total knee arthroplasty: a randomized controlled trial
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(20):5 BMC Musculoskelet Disord. 2016 Jul 26;17:313.60 patients scheduled for unilateral total knee arthroplasty were randomized to be administered either periarticular or intravenous tranexamic acid (TXA). The purpose of this study was to compare blood loss and adverse events throughout the first 48-hours post-surgery. The results from this trial demonstrated non-significant differences between groups for postoperative blood loss volume, hematocrit levels, hemoglobin concentration, the number of patients requiring transfusion, VAS pain scores, and thigh/leg circumference when evaluated at 24- or 48-hours postoperatively.
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。
1/4
Randomização
2/4
Medidas de resultado
4/4
Inclusão/Exclusão
4/4
Descrição do tratamento
4/4
Estatística
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？
Intravenous tranexamic acid remains a popular mode of reducing postoperative blood loss after total knee arthroplasty. Despite its well-established anti-fibrinolytic efficacy, potential drawbacks such as thrombus formation and venous thromboembolism (VTE) still remain major concerns with the intravenous administration method. As a result, it has been suggested that other methods of application, such as topical administration or periarticular injection, may offer similar outcomes while reducing the risk of developing these complications.
主な研究課題は何ですか？
In patients undergoing unilateral total knee arthroplasty, did the periarticular injection of tranexamic acid (TXA) produce comparable results to conventional intravenous TXA in terms of postoperative blood loss, hemoglobin concentration, and the need for blood transfusion during the first 48 hours post-surgery?
重要な知見は？
- The volume of blood present in Hemovac drain (postoperative blood loss) was not significantly different between periarticular and intravenous groups when compared at the 24-hour follow-up (300+/-128 vs. 334+/-124mL, respectively; p=0.279) or 24-48 hour follow-up (145+/-92 vs. 186+/-106mL, respectively; p=0.094).
- Hematocrit levels for periarticular and intravenous groups were not significantly different when compared at 24 hours (29.7 vs 30.4; p=0.550) and 48 hours (31.0 vs. 31.8; p=0.352) postoperatively.
- Hemoglobin concentrations were not significantly different between periarticular and intravenous groups when compared at 24 hours (9.60 vs 10.09; p=0.215) and 48 hours (10.16 vs 10.40; p=0.693) postoperatively.
- The number of patients requiring blood transfusion was not significantly different between periarticular and intravenous groups (9 vs. 7, p=0.928).
- Differences between periarticular and intravenous groups for thigh and leg circumference were not significant at 48 hours (p=0.398 and 0.052 respectively).
- VAS pain scores measured at 24 hours (p=0.889) and 48 hours (p=0.724), Knee flexion at time of hospital discharge(p=0.087), and total length of hospital stay ( p=0.276) were comparable between periarticular and intravenous groups.
最も覚えておくべきことは？
For patients undergoing total knee arthroplasty, periarticular and intravenous administration of tranexamic acid (TXA) resulted in comparable postoperative blood loss volume, hematocrit levels, hemoglobin concentration, the number of patients requiring transfusion, VAS pain scores, and thigh/leg circumference throughout a 48-hour postoperative period.
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 demonstrated comparable effects of either periarticular or intravenous tranexamic acid on postoperative blood loss and clinical outcomes for patients undergoing unilateral TKA. Further investigation with dose-response analyses, a control group, and larger patient populations is recommended to both determine optimal dosing of either periarticular or intravenous TXA dosing and to determine if differences in safety outcomes exist.
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