Avisar Erez, Essa Ahmad, Paul Ryan, Kachko Eric, Rabau Oded, Mattan Rom, Persitz Jonathan
The Hand and Upper Extremity Surgery Unit, Department of Orthopaedic Surgery, Yitzhak Shamir Medical Center affiliated with the Sackler Faculty of Medicine, Tel Aviv University, Tzrifin, Israel.
Department of Orthopaedic Surgery, Yitzhak Shamir Medical Center affiliated with the Sackler Faculty of Medicine, Tel Aviv University, Tzrifin, Israel ; and.
J Orthop Trauma. 2025 May 1;39(5):261-268. doi: 10.1097/BOT.0000000000002963.
This study investigates whether the intraoperative administration of intravenous tranexamic acid (TXA), known for its hemostatic and potential anti-inflammatory properties, affects the incidence of heterotopic ossification (HO) following surgery for elbow fracture dislocations.
Prospective, randomized clinical trial.
Hand and Upper Extremity Surgery Unit.
Patients aged 18-75 years with acute traumatic elbow fracture dislocations requiring surgical management from June 1, 2016, to October 31, 2022, were eligible. Inclusion criteria included traumatic nonpathological elbow fracture dislocations. Patients were randomized 1:1 to receive either intraoperative TXA or no additional treatment.
The primary outcome was the occurrence of HO, defined by new bone formation observed in radiographic exams during postoperative follow-ups. Secondary outcomes included the presence of clinically relevant HO, reoperation rate due to symptomatic HO, and time to HO reoperation. Compared were patients who received TXA with controls.
Out of 47 patients with elbow fracture dislocations who completed the follow-up, 23 (49%) received TXA prophylaxis while 24 (51%) were controls. The average age was 51.2 years (range, 18-77 years) with a mean follow-up of 12.9 months (range, 6.11-34.2). In the TXA group, 11 (47.8%) were men and 12 (52.2%) were women, while in the control group, 14 (58.3%) were men and 10 (41.7%) were women. HO was observed in 30% of patients, primarily around the radial head (71%). In this study, 43.5% of patients in the TXA group developed HO compared with 16.7% in the control group. The differences in HO formation suggest a potentially higher risk in the TXA group (relative risk = 2.6, 95% 1.0 to 8.5, P = 0.06). Clinically relevant HO led to reoperation in 2 of 10 (20%) patients in the TXA group, while none of the patients in the control group required reoperation, resulting in an overall reoperation rate of 14.3% in the study cohort.
This prospective trial identified a possible increased risk of HO formation in patients receiving TXA, however, with the sample size available a statistically significant difference was unable to be detected. These findings highlight the need for further research emphasizing larger prospective comparative studies to assess TXA's impact on HO. A deeper understanding of this relationship will enable clinicians to balance TXA's potential risks and benefits more effectively, optimizing outcomes in orthopedic surgery.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
本研究旨在调查术中静脉注射氨甲环酸（TXA），因其止血和潜在的抗炎特性而闻名，是否会影响肘部骨折脱位手术后异位骨化（HO）的发生率。
前瞻性随机临床试验。
手与上肢外科单元。
2016年6月1日至2022年10月31日期间，年龄在18 - 75岁，因急性创伤性肘部骨折脱位需要手术治疗的患者符合条件。纳入标准包括创伤性非病理性肘部骨折脱位。患者按1:1随机分组，分别接受术中TXA治疗或不接受额外治疗。
主要结果是HO的发生，通过术后随访期间影像学检查中观察到的新骨形成来定义。次要结果包括临床相关HO的存在、因症状性HO导致的再次手术率以及HO再次手术的时间。将接受TXA的患者与对照组进行比较。
在47例完成随访的肘部骨折脱位患者中，23例（49%）接受了TXA预防，24例（51%）为对照组。平均年龄为51.2岁（范围18 - 77岁），平均随访时间为12.9个月（范围6.11 - 34.2个月）。TXA组中，男性11例（47.8%），女性12例（52.2%）；对照组中，男性14例（58.3%），女性10例（41.7%）。30%的患者观察到HO，主要在桡骨头周围（71%）。在本研究中，TXA组43.5%的患者发生HO，而对照组为16.7%。HO形成的差异表明TXA组可能风险更高（相对风险 = 2.6，95%置信区间1.0至8.5，P = 0.06）。临床相关HO导致TXA组10例患者中的2例（20%）再次手术，而对照组无患者需要再次手术，研究队列的总体再次手术率为14.3%。
这项前瞻性试验发现接受TXA的患者可能有增加的HO形成风险，然而，鉴于可用的样本量，未能检测到统计学上的显著差异。这些发现强调需要进一步研究，重点是更大规模的前瞻性比较研究，以评估TXA对HO的影响。对这种关系的更深入理解将使临床医生能够更有效地平衡TXA的潜在风险和益处，优化骨科手术的结果。
治疗性I级。有关证据水平的完整描述，请参阅作者指南。
