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NCT Number: NCT02332616

Effect of Methylprednisolone on Complement Activation in Patients Undergoing 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.

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Key information

Conditions

Osteoarthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bispebjerg Hospital

Copenhagen NV, 2400, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

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

Other names: Solu-Medrol

isotonic sodium chloride

Drug

Placebo

Primary outcomes

  1. Change in plasma and serum Pentraxin-3 concentrations from baseline (before surgery) to 48 hours after surgery

    Time frame: baseline to 48 hours

Secondary outcomes

  1. Change in plasma and serum Complement Component 3 concentrations from baseline (before surgery) to 48 hours after surgery

    Time frame: baseline to 48 hours

  2. Change in plasma and serum Complement Component 4 concentrations from baseline (before surgery) to 48 hours after surgery

    Time frame: baseline to 48 hours

  3. Change in plasma and serum Mannose-binding lectin concentrations from baseline (before surgery) to 48 hours after surgery

    Time frame: baseline to 48 hours

  4. Change in plasma and serum Ficolin-1, -2 and -3 concentrations from baseline (before surgery) to 48 hours after surgery

    Time frame: baseline to 48 hours

  5. Change in plasma and serum Terminal Complement Complex concentrations from baseline (before surgery) to 48 hours after surgery

    Time frame: baseline to 48 hours

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Bispebjerg Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 7, 2015
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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