Kunze Kyle N, Madjarova Sophia, Olsen Reena, Smolarsky Ryan, Menta Samarth, Baldwin Robert, Ranawat Anil S, Nawabi Danyal H, Kelly Bryan T, Nwachukwu Benedict U
Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York, U.S.A..
Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, New York, U.S.A.
Arthroscopy. 2025 Aug;41(8):2865-2873. doi: 10.1016/j.arthro.2025.01.008. Epub 2025 Jan 23.
To determine the effectiveness of administering intravenous (IV) tranexamic acid (TXA) on altering visual field clarity (VFC) during arthroscopic hip preservation surgery for patients with femoroacetabular impingement syndrome (FAIS).
This randomized, double-blind, parallel-design trial was conducted over a 7-month period between October 2023 and May 2024 at a single tertiary musculoskeletal hospital. The inclusion criteria were consecutive patients who received a diagnosis of FAIS through clinical history, physical examination, and advanced imaging and was indicated for hip arthroscopy after failure of conservative management. This trial prospectively randomized 78 participants (39 assigned to receive 1,000 mg of TXA in a 100-mL/0.9% normal saline solution bolus and 39 assigned to receive a 100-mL/0.9% normal saline solution bolus only). Treatment intervention was administered within 15 minutes of incision. The primary outcome was arthroscopic VFC assessed on a Likert-style numeric rating scale and graded by the surgeon at 15-minute intervals as follows: 1, poor visibility (active bleeding to the degree that vision was too poor to perform the operation); 2, fair visibility (mild bleeding that interfered with vision, but the operation could still be performed); or 3, good visibility (clear vision without obvious blood). The percentage of good VFC ratings (i.e., the percentage of surgeon ratings equal to 3 on the numeric rating scale throughout the procedure) was quantified for each patient. No minimum follow-up was required because the primary endpoint was intraoperative.
The baseline characteristics of the TXA cohort (mean age, 37.3 years; 61.5% male sex; 76.9% white) were not significantly different from those of the placebo group (mean age, 33.6 years; 59% male sex; 86.8% white) (P > .05 for all). TXA was not associated with improved VFC compared with placebo at any intraoperative time point or when considering composite overall VFC scores (2.51 ± 0.41 in TXA group vs 2.64 ± 0.42 in placebo group, P = .16). Furthermore, no significant difference was observed in the percentage of good VFC ratings between treatment groups (56.4% in TXA group vs 66.4% in placebo group, P = .17). Multivariate regression analysis adjusted for demographic and intraoperative covariates did not show an association between TXA and VFC ratings (β = -0.14, P = .14) or percentage of good VFC ratings (β = -11.6, P = .15). No medical or intraoperative complications related to the treatment intervention were observed in either treatment arm.
Among patients with FAIS undergoing arthroscopic hip preservation surgery, administration of TXA did not improve arthroscopic VFC when compared with placebo. Therefore, the results of this randomized trial do not support the routine use of TXA in arthroscopic hip preservation surgery for improvement in arthroscopic visualization.
Level I, prospective randomized controlled trial.
确定在股骨髋臼撞击综合征（FAIS）患者的关节镜下髋关节保留手术中静脉注射氨甲环酸（TXA）对改变视野清晰度（VFC）的有效性。
这项随机、双盲、平行设计试验于2023年10月至2024年5月在一家三级肌肉骨骼专科医院进行，为期7个月。纳入标准为通过临床病史、体格检查和高级影像学检查确诊为FAIS且保守治疗失败后适合髋关节镜检查的连续患者。该试验前瞻性地将78名参与者随机分组（39名被分配接受1000毫克TXA溶于100毫升0.9%生理盐水的大剂量注射，39名被分配仅接受100毫升0.9%生理盐水的大剂量注射）。治疗干预在切开后15分钟内进行。主要结局是通过李克特式数字评分量表评估并由外科医生每隔15分钟分级的关节镜下VFC，分级如下：1，视野不佳（出血严重以至于视野太差无法进行手术）；2，视野尚可（轻度出血干扰视野，但手术仍可进行）；或3，视野良好（视野清晰无明显出血）。为每位患者量化良好VFC评分的百分比（即整个手术过程中数字评分量表上等于3的外科医生评分的百分比）。由于主要终点是术中情况，因此无需进行最低随访。
TXA组（平均年龄37.3岁；男性占61.5%；白人占76.9%）的基线特征与安慰剂组（平均年龄33.6岁；男性占59%；白人占86.8%）无显著差异（所有P值均>.05）。与安慰剂相比，在任何术中时间点或考虑综合总体VFC评分时，TXA均未改善VFC（TXA组为2.51±0.41，安慰剂组为2.64±0.42，P = 0.16）。此外,治疗组之间良好VFC评分的百分比无显著差异（TXA组为56.4%，安慰剂组为66.4%，P = 0.17）。对人口统计学和术中协变量进行调整的多变量回归分析未显示TXA与VFC评分（β = -0.14，P = 0.14）或良好VFC评分的百分比（β = -11.6，P = 0.15）之间存在关联。在任何一个治疗组中均未观察到与治疗干预相关的医疗或术中并发症。
在接受关节镜下髋关节保留手术的FAIS患者中，与安慰剂相比，TXA并未改善关节镜下VFC。因此，这项随机试验的结果不支持在关节镜下髋关节保留手术中常规使用TXA来改善关节镜视野。
I级，前瞻性随机对照试验。
