Xin Zheng1,2, Dong-Ya Li1, Yufan Wangyang3, Xing-Chen Zhang1, Kai-Jin Guo1, Feng-Chao Zhao1, Yong Pang1, Yi-Xin Chen4. 1. Department of Orthopaedics, The Affiliated Hospital of Xuzhou Medical College, Xuzhou, China. 2. Department of Orthopaedics, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China. 3. Department of Orthopaedics, The Central Hospital of Xuzhou City, Xuzhou, China. 4. Department of Orthopaedics, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China chenyixin11d@163.com.
Abstract
BACKGROUND:Venous thromboembolism (VTE) is a well-documented complication in patients with lower limb fractures, but management guidelines for its prevention in isolated foot and ankle fracture patients are conflicting. The aim of this study was to conduct a multicenter, prospective cohort study to define the prevalence of VTE in patients with isolated foot and ankle fractures and determine whether routine prophylaxis is necessary in these patients. METHODS: In a double-blind, placebo-controlled study, consecutive patients in 3 hospitals who met our criteria were enrolled. After randomization, patients received either thromboprophylaxis with low-molecular-weight heparin units (LMWH group) or placebo (placebo group) for a period of 2 weeks. All patients underwent routine ultrasonography 1 day preoperatively, 1 week postoperatively, and 1 month postoperatively. Demographic parameters were then collected and compared. RESULTS: Of the 814 patients who met our criteria, 19 patients (2.3%, 95% confidence interval [CI], 0%-31.9%) were found to have objectively confirmed VTE, but none of the patients were symptomatic. Of the 411 patients in theLMWH group, 2 developed VTEs preoperatively and 4 postoperatively; of the 403 patients in the placebo group, 5 developed VTEs preoperatively and 8 postoperatively. The overall incidence of asymptomatic postoperative deep vein thrombosis (DVT) was 0.98% (95% CI 0%-20.3%) in the LMWH group and 2.01% (95% CI 0%-29.5%) in the placebo group without significant difference. Advanced age (odds ratio [OR] 1.050, 95% CI 1.014-1.088, P = .007) and high body mass index (OR 1.201, 95% CI 1.034-1.395, P = .016) were identified as risk factors in predicting occurrence of DVT. No fatal pulmonary emboli or major bleeding complication occurred in either group. CONCLUSION: Routine anticoagulant prophylaxis was not found to be necessary for patients with foot and ankle fractures, although further investigation with a properly powered study design is required to definitively determine which foot and ankle patients are best served by anticoagulation and which ones are not. LEVEL OF EVIDENCE: Level II, prospective comparative study.
RCT Entities:
BACKGROUND:Venous thromboembolism (VTE) is a well-documented complication in patients with lower limb fractures, but management guidelines for its prevention in isolated foot and ankle fracturepatients are conflicting. The aim of this study was to conduct a multicenter, prospective cohort study to define the prevalence of VTE in patients with isolated foot and ankle fractures and determine whether routine prophylaxis is necessary in these patients. METHODS: In a double-blind, placebo-controlled study, consecutive patients in 3 hospitals who met our criteria were enrolled. After randomization, patients received either thromboprophylaxis with low-molecular-weight heparin units (LMWH group) or placebo (placebo group) for a period of 2 weeks. All patients underwent routine ultrasonography 1 day preoperatively, 1 week postoperatively, and 1 month postoperatively. Demographic parameters were then collected and compared. RESULTS: Of the 814 patients who met our criteria, 19 patients (2.3%, 95% confidence interval [CI], 0%-31.9%) were found to have objectively confirmed VTE, but none of the patients were symptomatic. Of the 411 patients in the LMWH group, 2 developed VTEs preoperatively and 4 postoperatively; of the 403 patients in the placebo group, 5 developed VTEs preoperatively and 8 postoperatively. The overall incidence of asymptomatic postoperative deep vein thrombosis (DVT) was 0.98% (95% CI 0%-20.3%) in the LMWH group and 2.01% (95% CI 0%-29.5%) in the placebo group without significant difference. Advanced age (odds ratio [OR] 1.050, 95% CI 1.014-1.088, P = .007) and high body mass index (OR 1.201, 95% CI 1.034-1.395, P = .016) were identified as risk factors in predicting occurrence of DVT. No fatal pulmonary emboli or major bleeding complication occurred in either group. CONCLUSION: Routine anticoagulant prophylaxis was not found to be necessary for patients with foot and ankle fractures, although further investigation with a properly powered study design is required to definitively determine which foot and ankle patients are best served by anticoagulation and which ones are not. LEVEL OF EVIDENCE: Level II, prospective comparative study.
Authors: Abdullah Pandor; Daniel Horner; Sarah Davis; Steve Goodacre; John W Stevens; Mark Clowes; Beverley J Hunt; Tim Nokes; Jonathan Keenan; Kerstin de Wit Journal: Health Technol Assess Date: 2019-12 Impact factor: 4.014
Authors: Daniel Horner; Steve Goodacre; Abdullah Pandor; Timothy Nokes; Jonathan Keenan; Beverley Hunt; Sarah Davis; John W Stevens; Kerstin Hogg Journal: Emerg Med J Date: 2019-11-06 Impact factor: 2.740
Authors: Daniel Horner; John W Stevens; Abdullah Pandor; Tim Nokes; Jonathan Keenan; Kerstin de Wit; Steve Goodacre Journal: J Thromb Haemost Date: 2019-12-01 Impact factor: 5.824