Osteoarthrosis Clinical Trial
Official title:
Effect of Preoperative Intravenous High Dose Methylprednisolone on Endothelial Function in Patients Scheduled for Total Knee-arthroplasty
This study evaluates the pathophysiological effects of a single dose methylprednisolone
administered prior to total knee-arthroplasty surgery (TKA). The investigators examine the
effect on the endothelial glycocalyx shedding due to surgical trauma.
Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will
receive placebo.
The investigators hypothesize that the group receiving methylprednisolone will experience
reduction in glycocalyx degradation compared to the placebo-group, early after TKA.
The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on
postoperative pain, postoperative nausea and vomiting are well-documented.
Postoperatively, activation and / or dysregulation of the inflammatory system influence on
the endothelial glycocalyx. Damage of the vascular endothelia increases the risk of
cardiovascular and thromboembolic complications.
In animal studies glucocorticoids have been found to preserve the endothelial glycocalyx and
the vascular barrier.
The effect of glucocorticoids on human endothelial glycocalyx after surgery is unknown and
calls for further investigation.
This study is embedded in a primary study registrated as: NCT02319343
For further details please view the EudraCT registration:
EudraCT nr.: 2014-003395-23
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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