Safety and Effectiveness of Expandable Intravertebral Implant Use for Thoracolumbar Burst Fractures.

PURPOSE: To determine the safety and effectiveness of an expandable intravertebral implant (Spinejack; Stryker, Kalamazoo, Michigan) as a treatment option for patients with thoracolumbar spine burst fractures without fracture-related neurologic deficit. MATERIALS AND METHODS: Imaging studies before and after expandable intravertebral implantation and medical records of 33 patients, 11 (33.3%) men and 22 (66.6%) women with an overall mean age of 71.7 years ± 8.3, were reviewed for 60 thoracolumbar Magerl Type A3 injuries secondary to osteoporosis, trauma, or malignancy. The mean follow-up time was 299 days. RESULTS: Implantation of an expandable intravertebral device resulted in a statistically significant reduction in bone fragment retropulsion (mean ± SD, 0.64 mm ± 16.4; P < .001), reduction in the extent of canal compromise (mean, 5.5%; P < .001), increased central canal diameter (mean ± SD, 0.71 mm ± 1.3; P < .001), and restoration of vertebral body height, with a mean increase of 5.0 mm (P < .001). However, the implantation did not result in a statistically significant kyphosis reduction (mean, 1.38°; P = .10). All patients except for 1 reported improvement in pain after surgery, with a mean improvement of 1.54 on a 4-point pain scale (P < .001). No clinically significant adverse events were reported. CONCLUSIONS: This study suggests that expandable intravertebral device implantation is a safe and effective treatment for thoracolumbar vertebral burst fractures in patients without fracture-related neurologic deficit. Although implantation did not result in a statistically significant reduction in kyphotic angle, it offered significant improvement in pain, vertebral body height, fracture fragment retropulsion, and central canal diameter compromise.

A randomized controlled trial to evaluate outcomes with Aggrenox in patients with SARS-CoV-2 infection.

BACKGROUND: Coronavirus disease 2019 (COVID-19) is an immunoinflammatory and hypercoagulable state that contributes to respiratory distress, multi-organ dysfunction, and mortality. Dipyridamole, by increasing extracellular adenosine, has been postulated to be protective for COVID-19 patients through its immunosuppressive, anti-inflammatory, anti-coagulant, vasodilatory, and anti-viral actions. Likewise, low-dose aspirin has also demonstrated protective effects for COVID-19 patients. This study evaluated the effect of these two drugs formulated together as Aggrenox in hospitalized COVID-19 patients. METHODS: In an open-label, single site randomized controlled trial (RCT), hospitalized COVID-19 patients were assigned to adjunctive Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally) with standard of care treatment compared to standard of care treatment alone. Primary endpoint was illness severity according to changes on the eight-point COVID ordinal scale, with levels of 1 to 8 where higher scores represent worse illness. Secondary endpoints included all-cause mortality and respiratory failure. Outcomes were measured through days 14, 28, and/or hospital discharge. RESULTS: From October 1, 2020 to April 30, 2021, a total of 98 patients, who had a median [IQR] age of 57 [47, 62] years and were 53.1% (n = 52) female, were randomized equally between study groups (n = 49 Aggrenox plus standard of care versus n = 49 standard of care alone). No clinically significant differences were found between those who received adjunctive Aggrenox and the control group in terms of illness severity (COVID ordinal scale) at days 14 and 28. The overall mortality through day 28 was 6.1% (3 patients, n = 49) in the Aggrenox group and 10.2% (5 patients, n = 49) in the control group (OR [95% CI]: 0.40 [0.04, 4.01], p = 0.44). Respiratory failure through day 28 occurred in 4 (8.3%, n = 48) patients in the Aggrenox group and 7 (14.6%, n = 48) patients in the standard of care group (OR [95% CI]: 0.21 [0.02, 2.56], p = 0.22). A larger decrease in the platelet count and blood glucose levels, and larger increase in creatinine and sodium levels within the first 7 days of hospital admission were each independent predictors of 28-day mortality (p < 0.05). CONCLUSION: In this study of hospitalized patients with COVID-19, while the outcomes of COVID illness severity, odds of mortality, and chance of respiratory failure were better in the Aggrenox group compared to standard of care alone, the data did not reach statistical significance to support the standard use of adjuvant Aggrenox in such patients.

The Pathogenesis of Chronic Subdural Hematomas: A Study on the Formation of Chronic Subdural Hematomas and Analysis of Computed Tomography Findings.

BACKGROUND: The origin of chronic subdural hematomas (CSDH) and the pathophysiology of its enlargement remain unknown. The chemical fluid composition of CSDH, the contribution of cerebrospinal fluid (CSF) to its enlargement, and the relationship to its appearance on computed tomography (CT) also are not entirely clear. METHODS: In this prospective study, 58 samples in 41 patients treated surgically for CSDH were analyzed. CSDHs were evaluated for the presence of CSF via ß-2 transferrin and substances related to cell breakdown and hemolysis. These were compared with normal value of those substances in the serum and the CT appearances of the CSDH. RESULTS: In this study, 24% of the samples contained ß-2 transferrin, which was statistically significant. Total protein, lactate dehydrogenase, total bilirubin, and red blood cells also were statistically different when compared with their normal serum concentration, indicating an active process of rebleeding and hemolysis rather than plasma ultrafiltration; however, their concentrations did not correlate with specific CT scan appearance. The absence of CSF in CSDH in 76% of cases did not support the theory that most CSDHs originate from subdural hygromas. The presence of hemolysis and cell breakdown, byproducts supports the hypothesis that the primary enlargement of CSDH develops through neomembrane and neovascular formation, rebleeding, and inhibition of the blood coagulation process. Our study did not test for serum transudation as a component of the enlargement of CSDH. CONCLUSIONS: Our study confirms that the origin and enlargement of CSDH is multifactorial, but the contribution of individual factors and condition under which it occurs still remains unclear. CT scan findings do not correlate with the chemical composition or the presence of CSF in the CSDH.