Osteoarthrosis
Conditions
Keywords
Glucocorticoid, Complement activation, Knee arthroplasty, total
Brief summary
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.
Detailed description
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
Interventions
DRUGMethylprednisolone
Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride
Placebo
Sponsors
Bispebjerg Hospital
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Osteoarthrosis * Undergoing total unilateral knee-arthroplasty surgery * Speak and understand Danish * Have given informed consent
Exclusion criteria
* Revision, bilateral or uni chamber knee-arthroplasty surgery * General anaesthesia * Allergy or intolerance towards Methylprednisolone * Local or systemic infection * Permanent systemic treatment with steroids within 30 days preoperatively * Insulin-dependent diabetes * Active treatment of ulcer within 3 months preoperatively * Cancer disease * Autoimmune disease incl. rheumatoid arthritis * Pregnant or breast feeding women * Menopause \<1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in plasma and serum Pentraxin-3 concentrations from baseline (before surgery) to 48 hours after surgery | baseline to 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| Change in plasma and serum Complement Component 3 concentrations from baseline (before surgery) to 48 hours after surgery | baseline to 48 hours |
| Change in plasma and serum Complement Component 4 concentrations from baseline (before surgery) to 48 hours after surgery | baseline to 48 hours |
| Change in plasma and serum Mannose-binding lectin concentrations from baseline (before surgery) to 48 hours after surgery | baseline to 48 hours |
| Change in plasma and serum Ficolin-1, -2 and -3 concentrations from baseline (before surgery) to 48 hours after surgery | baseline to 48 hours |
| Change in plasma and serum Terminal Complement Complex concentrations from baseline (before surgery) to 48 hours after surgery | baseline to 48 hours |
Countries
Denmark
Outcome results
None listed