Osteoarthrosis Clinical Trial
Official title:
Effect of Preoperative Intravenous High Dose Methylprednisolone on Complement Activation in Patients Scheduled for Total Knee-arthroplasty
This study evaluates the pathophysiological effects of a single dose of methylprednisolone
administered prior to total knee-arthroplasty surgery. The investigators examine the effect
on complement activation.
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
beneficial inhibition of the undesirable parts of the complement activation.
The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on
postoperative pain, postoperative nausea and vomiting are well-documented.
Anaesthesia and surgery are associated with a dramatic increase in the inflammatory
response. The complement system participates in the disposal of products due to inflammatory
damage. The complement activation generates proinflammatory mediators which amplifies the
tissue damage and the inflammation.
Glucocorticoid administration prior to surgery is thought to effectively reduce the
inflammatory response and the activation of the complement system. The effect of
glucocorticoids on specific complement markers 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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