ArticleJB & JS open access
Femoral-Canal Administration of Tranexamic Acid in Tourniquet-Assisted Total Knee Arthroplasty: A Prospective Randomized Trial.
Article in JB & JS open access. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
8 authors.
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Abstract
Background: This study compared femoral-canal administration of tranexamic acid (TXA), which is a modified intraosseous regional administration (IORA) technique, with intravenous (IV) TXA and combined IORA+IV-TXA across prosthesis designs in tourniquet-assisted, manual total knee arthroplasty (TKA). Methods: This single-center study comprised 2 consecutive prospective, randomized, placebo-controlled, triple-blind cohorts: a previously reported cruciate-retaining (CR) cohort followed by a posterior-stabilized (PS) cohort. Within each cohort, patients undergoing primary, unilateral, manual TKA were randomized to IORA-TXA, IV-TXA, or IORA+IV-TXA. The primary outcome was total blood loss (TBL). Secondary outcomes included transfusion, inflammatory and coagulation markers, pain, knee function, and complications. Pooled and prosthesis-stratified analyses were performed, including treatment-by-prosthesis interaction testing. Results: Among 202 randomized participants (mean age, 69.1 years [SD, 6.5]; 162 women [80%]; CR, 97; PS, 105), TBL differed significantly among groups. Compared with IV-TXA (578.7 ± ±277.4 mL), TBL was lower with IORA-TXA (429.2 ± 293.9 mL, p = 0.010) and IORA+IV-TXA (354.3 ± 252.1 mL, p < 0.001). The treatment-by-prosthesis interaction for TBL was not significant (p = 0.289). Transfusion occurred in 1 participant in the IV-TXA group and none in the IORA-TXA or IORA+IV groups. Statistically significant differences were observed in the selected early inflammatory and clinical outcomes, primarily involving the combined regimen; however, these differences did not translate into clinically meaningful differences in pain scores, range of motion, or KOOS-JR scores by 90 days. No statistically detectable differences in complications were observed. Conclusions: In tourniquet-assisted manual TKA, femoral-canal IORA-TXA reduced TBL compared with IV-TXA, and IORA+IV-TXA showed the lowest mean TBL. These findings should be interpreted within the pre-tourniquet-release IV-TXA protocol; evidence was insufficient to establish corresponding reductions in transfusion or clinically meaningful functional benefits by 90 days. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
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