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Effects of Methylprednisolone After Total Knee Arthroplasty

This study has been completed.
Lundbeck Foundation
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital Identifier:
First received: August 28, 2009
Last updated: September 25, 2012
Last verified: September 2012

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.

Condition Intervention Phase
Postoperative Pain
Postoperative Nausea and Vomiting
Sleeping Quality
Inflammatory Response
Drug: Methylprednisolone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Pre-operative Methylprednisolone (125mg iv) After Total Knee Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail

Resource links provided by NLM:

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: 48 hours + follow up ]

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

Enrollment: 48
Study Start Date: August 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00968578

Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Lundbeck Foundation
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Troels Haxholdt Lunn, MD, Hvidovre University Hospital Identifier: NCT00968578     History of Changes
Other Study ID Numbers: H-C-2008-134
Study First Received: August 28, 2009
Last Updated: September 25, 2012

Keywords provided by Hvidovre University Hospital:
Knee arthroplasty
Post-operative pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Nausea and Vomiting
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms, Digestive
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents processed this record on April 28, 2017