Effect of Methylprednisolone on Endothelial Function in Patients Undergoing Total Knee-arthroplasty

Effect of Preoperative Intravenous High Dose Methylprednisolone on Endothelial Function in Patients Scheduled for Total Knee-arthroplasty

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02332629

Enrollment

Registered

2015-01-07

Start date

2015-01-31

Completion date

2016-04-30

Last updated

2016-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthrosis

Keywords

Glucocorticoid, Endothelial barrier, Glycocalyx, Knee arthroplasty, total

Brief summary

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.

Detailed description

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

Interventions

DRUGMethylprednisolone

Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride

DRUGIsotonic Sodium Chloride

Placebo

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

Inclusion criteria

* Osteoarthrosis * Undergoing total unilateral knee-arthroplasty surgery * Speak and understand Danish * Have given informed consent

Exclusion criteria

* Revision, bilateral og 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 Syndecan-1 from baseline (before surgery) to 24 hours after surgery	baseline to 24 hours

Secondary

Measure	Time frame
Change in plasma soluble Thrombomodulin from baseline (before surgery) to 24 hours after surgery	baseline to 24 hours
Change in plasma SE-Selectin from baseline (before surgery) to 24 hours after surgery	One day after surgery
Change in plasma VE-Cadherin from baseline (before surgery) to 24 hours after surgery	baseline to 24 hours

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026