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

Rigshospitalet

Status and phase: Completed; Phase 3

Conditions: Osteoarthrosis

Treatments: Drug: Methylprednisolone; Drug: Isotonic Sodium Chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02332629

HK_VL_08_2014a

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No 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

Trial design

70 participants in 2 patient groups, including a placebo group

Methylprednisolone

Active Comparator group

Description:

Preoperative single high dose of Solu-Medrol 125 mg iv.

Treatment:

Drug: Methylprednisolone

Isotonic Sodium Chloride

Placebo Comparator group

Description:

Preoperative single dose of isotonic Sodium Chloride

Treatment:

Drug: Isotonic Sodium Chloride