Abstract

Purpose

The purpose of this study was to evaluate the efficacy of intra-operative co-administration of tranexamic acid (TA) and platelet rich fibrin (PRF) using a proprietary co-delivery system on the amount of blood loss, early functional outcomes and wound complications after primary total knee arthroplasty (TKA). The intervention was compared to the standard of care (combined intravenous & topical TA) in a prospective, randomized, blinded setting.

Methods

80 patients undergoing primary cemented TKA without tourniquet were prospectively randomized into control (combined intravenous and topical TA) and PRF (intra-venous TA and co-delivery of topical PRF and TA) groups after informed consent. Total blood loss, drainage blood loss, knee range of motion, VAS pain scores, length of stay and wound complications were analysed. Data collection was performed in a double blind manner on days 1, 3 and 21.

Results

There was no statistically significant difference in drainage blood loss (550 ml vs. 525 ml, p = 0.643), calculated total blood loss on day 1 (401 ml vs. 407 ml, p = 0.722), day 3 (467 ml vs 471 ml, p = 0.471) and day 21 (265 ml vs. 219 ml, p = 0.082) between the PRF and control groups respectively. The PRF group had a small but statistically significant increase in median knee extension in the early post-operative period, however this difference evened out at 3 weeks. No significant difference could be demonstrated between the PRF and control groups in length of stay, VAS pain scores, narcotic usage, wound complications and knee flexion at all time points.

Conclusions

The topical co-delivery of PRF and TA does not significantly decrease blood loss in primary TKA compared to the standard of care. Slightly better active knee extension in the first 3 postoperative days can be achieved, however this benefit is not clinically relevant.

Level of evidence

I, Therapeutic study.

中文翻译：

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与常规护理标准相比，局部共同递送富含血小板的纤维蛋白和氨甲环酸不会降低初次全膝关节置换术的失血量：一项前瞻性，随机，对照试验

摘要

目的

这项研究的目的是评估使用专有的共输送系统对氨甲环酸（TA）和富含血小板的纤维蛋白（PRF）术中共同给药的失血量，早期功能结局和伤口并发症的疗效初次全膝关节置换术后（TKA）。在前瞻性，随机，盲法条件下，将干预措施与护理标准（静脉内和局部TA联合治疗）进行比较。

方法

经知情同意后，将80例接受无止血带的初次骨水泥化TKA的患者随机分为对照组（静脉和局部TA联合）和PRF（静脉TA和局部PRF与TA共同给药）组。分析了总失血量，引流失血量，膝关节活动范围，VAS疼痛评分，住院时间和伤口并发症。在第1、3和21天以双盲方式进行数据收集。

结果

 第3天（第3天467 ml和471 ml）的引流失血量（550 ml vs. 525 ml，p  = 0.643），计算的总失血量无统​​计学意义的显着差异（401 ml vs. 407 ml，p = 0.722）。 PRF组和对照组之间分别为30毫升，p  = 0.471）和第21天（265毫升vs. 219毫升，p = 0.082）。PRF组在术后早期膝关节中位伸直的增加很小，但有统计学意义，但是这种差异在3周后趋于平稳。在所有时间点，PRF和对照组在住院时间，VAS疼痛评分，麻醉药使用，伤口并发症和膝关节屈曲方面均无明显差异。

结论

与标准治疗相比，PRF和TA的局部联合分娩并不能显着降低原发性TKA的失血量。术后前3天可略微改善活动性膝关节伸展，但是这种益处在临床上并不重要。

证据水平

我，治疗研究。