Effect of Methylprednisolone on Complement Activation in Patients Undergoing Total Knee-arthroplasty

Rigshospitalet

Status and phase: Completed; Phase 3

Conditions: Osteoarthrosis

Treatments: Drug: Isotonic Sodium Chloride; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT02332616

HK_VL_08_2014b

Details and patient eligibility

About

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.

Full 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

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 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

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