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

April 7, 2016 updated by: Viktoria Oline Lindberg-Larsen, Rigshospitalet, Denmark

Effect of Preoperative Intravenous High Dose Methylprednisolone on Complement Activation in Patients Scheduled for 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen NV, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

53 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Methylprednisolone
Preoperative single high dose of Solu-Medrol 125 mg iv.
Drug: Methylprednisolone
Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride
Other Names:
  • Solu-Medrol
Placebo Comparator: Isotonic Sodium Chloride
Preoperative single dose of isotonic Sodium Chloride
Drug: Isotonic Sodium Chloride
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in plasma and serum Pentraxin-3 concentrations from baseline (before surgery) to 48 hours after surgery
Time Frame: baseline to 48 hours
baseline to 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in plasma and serum Complement Component 3 concentrations from baseline (before surgery) to 48 hours after surgery
Time Frame: baseline to 48 hours
baseline to 48 hours
Change in plasma and serum Complement Component 4 concentrations from baseline (before surgery) to 48 hours after surgery
Time Frame: baseline to 48 hours
baseline to 48 hours
Change in plasma and serum Mannose-binding lectin concentrations from baseline (before surgery) to 48 hours after surgery
Time Frame: baseline to 48 hours
baseline to 48 hours
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
baseline to 48 hours
Change in plasma and serum Terminal Complement Complex concentrations from baseline (before surgery) to 48 hours after surgery
Time Frame: baseline to 48 hours
baseline to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Bispebjerg Hospital

Investigators

  • Principal Investigator: Viktoria Lindberg-Larsen, MD, Section for Surgical Pathophysiology, Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

January 6, 2015

First Posted (Estimate)

January 7, 2015

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

April 7, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HK_VL_08_2014b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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