Pharmacological Thromboprophylaxis Effectiveness in Low-Risk Patients Underwent Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial

Abstract

Purpose: This study aims to evaluate the effectiveness and safety of Aspirin and LMWH in an arthroscopic anterior cruciate ligament (ACL) reconstruction of low-risk patients. Material and Methods: We conduct a single-center, assessor-blind, simple randomized clinical trial from March 2019- May 2020. 18 to 45 years old patients with ACL rupture without concomitant injury, diagnosed by magnetic resonance imaging, enrolled in the study. Selected subjects were allocated between three parallel arms of the study, with 46 participants. Three parallels are 8o mg aspirin bid for 14 days, LMWH subcutaneous injection for 14 days, and no treatment parallel. Effectiveness outcomes were estimated by the DVT rate and PE rate, and safety was checked out by bleeding or hemarthrosis. Orthopedists assessed knee effusion with stroke score and ask patients for any symptoms during weekly clinic visits. The radiologist performed ultrasonography of lower extremities, searching for a sign of DVT. Results: Mean age of participants was 31.4 + 5.6, and 93 individuals (67%) were male and 23% were female. No DVT and PE were observed. Three cases in the LMWH and one case in aspirin groups had minor surgical site bleeding. One case of hemarthrosis with normal ultrasonography occurred in the LMWH group. Regarding safety and effectiveness, there was no statistically significant difference between the parallels. Conclusion: Use of LMWH or Aspirin after simple arthroscopic ACL reconstruction in low-risk patients have no different effectiveness. Hence routine use of thromboprophylaxis in this setting is questionable, although adverse events are rare.

Keywords

• Venous thromboembolism; Arthroplasty; Randomized Controlled Trial; Heparin
• Low-Molecular-Weight; Aspirin