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Effects of Methylprednisolone After Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00968578
Recruitment Status : Completed
First Posted : August 31, 2009
Last Update Posted : September 26, 2012
Lundbeck Foundation
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Postoperative Pain Postoperative Nausea and Vomiting Sleeping Quality Fatigue Inflammatory Response Drug: Methylprednisolone Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : August 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

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)

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00968578

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Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Lundbeck Foundation
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Troels Haxholdt Lunn, MD, Hvidovre University Hospital Identifier: NCT00968578    
Other Study ID Numbers: H-C-2008-134
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012
Keywords provided by Troels Haxholdt Lunn, Hvidovre University Hospital:
Knee arthroplasty
Post-operative pain
Additional relevant MeSH terms:
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Postoperative Nausea and Vomiting
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Signs and Symptoms, Digestive
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
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
Antineoplastic Agents, Hormonal
Antineoplastic Agents