Ghaffar Shokouhi, Arad Iranmehr, Peyman Gholipour, Mohammad Reza Fattahi, Seyed Taher Mousavi, Mohammad Ali Bitaraf, Mohammad Kazem Sarpoolaki,
Volume 37, Issue 1 (2-2023)
Abstract
Background: There is still no standard of care to manage thoracolumbar burst fractures. With all the recent advances, posterior approaches are still one of the mainstays of treatment. On the other hand, while spinal canal decompression in neurological impaired patients is an important goal of treatment, its technique remains controversial.
This study compared the effects of direct laminectomy decompression against ligamentotaxis/indirect canal decompression on neurological and radiographic improvements.
Methods: A prospective double-blind randomized clinical trial was conducted on 60 thoracolumbar burst-fracture patients meeting our inclusion and exclusion criteria. They were randomized into 2 treatment arms: (1) direct decompression using laminectomy and (2) indirect decompression using ligamentotaxis/distraction. Each patient was observed for 6 months, and their neurological and radiographical data were collected prospectively. Statistical analysis was done by the Student t test, Friedman test, Mann Whitney-U test, Wilcoxon ranked test, and 1-way analysis of variance.
Results: Among 60 patients enrolled in our study, each treatment arm had an improvement in Frankel scores but there was no difference between the groups at any given time. After 6 months of surgery, local sagittal kyphosis improved in both groups (from 32.2 to 7.43 and 29.93 to 8.77 for the indirect and direct groups, respectively), as well as anterior vertebral height ratio (from 57.73 to 70.7 and 62.17 to 66.27 for the indirect and direct group, respectively) and posterior vertebral height ratio (from 61.17 to 74.87 and 64 to 67.5 for the indirect and direct group, respectively). For between-group comparisons after 6 months, there was a significant difference only for posterior vertebral height ratio (P = 0.040).
Conclusion: Posterior approaches with ligamentotaxis have shown to be safe and may present the same outcome as direct decompression techniques using wide laminectomy.
Samira Kafan, Mohammad Reza Fattahi, Mahsa Akhbari Shojaie, Aida Hossein Nezhad, Mahshid Imankhan, Davoud Jahansouz, Mahnaz Montazeri, Azar Hadadi, Sara Fattahi, Arad Iranmehr, Marzieh Pazoki, Hormat Rahimzadeh,
Volume 37, Issue 1 (2-2023)
Abstract
Background: Coronavirus disease 2019 (COVID-19) has been associated with a hypercoagulopathy state; however, the efficacy of different anticoagulant regimens in preventing thrombotic events is not clear. We aimed to compare therapeutic versus prophylactic enoxaparin therapy in severe COVID-19 patients.
Methods: In this single-center, open-label, randomized controlled trial, adult patients with severe COVID-19 presentations and an increased D-dimer level of more than 4 times the normal upper limit were randomly assigned to receive either prophylactic or therapeutic dose of enoxaparin. All patients were observed for at least 4 months regarding the overall survival as the primary outcome. Hospitalization duration, the need for intensive care unit (ICU) admission, the need for mechanical ventilation, and major adverse events (MAEs) were also analyzed as the secondary outcomes. Survival analysis was done via Kaplan-Meier curves and the Log-rank test. Cox regression was used, adjusting for baseline variables.
Results: Overall, 237 patients (152 men and 85 women) were randomized to either arm (121 to prophylactic and 116 to therapeutic groups). The mortality rate was 27 (22.3%) and 52 (44.8%) in prophylactic and therapeutic arms, respectively. Prophylactic enoxaparin was associated with better survival in the log-rank test (P < 0.001; HR, 0.42). Additionally, a significantly lower rate of ICU admission, a lower rate of MAEs, and shorter hospitalization were observed in the prophylactic arm (P < 0.001, P = 0.009, and P = 0.028, respectively).
Conclusion: The results of the current study were in favor of anticoagulant treatment with prophylactic doses of enoxaparin. Still, due to the limitations of this paper, we suggest that these findings be treated cautiously.
