Tranexamic Acid and Heterotopic Ossification Formation Following Elbow Surgery: A Prospective Randomized Controlled Trial.

Objectives: 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.

Methods:

Design: Prospective, randomized clinical trial.

Setting: Hand and Upper Extremity Surgery Unit.

Patient selection criteria: 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.

Outcome measures and comparisons: 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.

Results: 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.

Conclusions: 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.

Level of evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.