Effects of Methylprednisolone After Total Knee Arthroplasty

September 25, 2012 updated by: Troels Haxholdt Lunn, Hvidovre University Hospital

Effects of Pre-operative Methylprednisolone (125mg iv) After Total Knee Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail

The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after knee arthroplasty.

The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce pain and improve outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total knee arthroplasty is still associated with postoperative pain and delayed rehabilitation. We therefore decided to evaluate the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome in a well defined fast-track setup after knee arthroplasty.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

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
    • Hvidovre
      • Copenhagen, Hvidovre, Denmark, 2650
        • Hvidovre University 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective total knee arthroplasty
  • Able to speak and understand danish
  • Able to give informed consent

Exclusion Criteria:

  • Alcohol or medical abuse
  • Allergies to local anesthetics or methylprednisolone
  • Age < 18 years
  • Daily use of opioids or glucocorticoids
  • Pregnancy or breastfeeding (fertile women)

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Methylprednisolone
Methylprednisolone 125 mg iv pre-operatively
Drug: Methylprednisolone
Methylprednisolone 125 mg iv pre-operatively
Placebo Comparator: Saline
Saline iv pre-operatively in equivalent volume (placebo)
Drug: Placebo
Saline iv pre-operatively in equivalent volume (placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative pain
Time Frame: 48 hours + follow up
48 hours + follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative nausea and vomiting (PONV)
Time Frame: 48 hours + follow up
48 hours + follow up
Sleeping quality
Time Frame: 48 hours + follow up
48 hours + follow up
Inflammatory response
Time Frame: 48 hours + follow up
48 hours + follow up
Additional analgetics, antinausea agents and sleeping medicine
Time Frame: 48 hours + follow up
48 hours + follow up
Time in hospital
Time Frame: Until discharge
Until discharge
Fatigue
Time Frame: 48 hours + follow up
48 hours + follow up

Collaborators and Investigators

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

Sponsor

Hvidovre University Hospital

Collaborators

Lundbeck Foundation

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

August 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

August 28, 2009

First Submitted That Met QC Criteria

August 28, 2009

First Posted (Estimate)

August 31, 2009

Study Record Updates

Last Update Posted (Estimate)

September 26, 2012

Last Update Submitted That Met QC Criteria

September 25, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-C-2008-134
  • 2009-41-3786

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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