Effects of Methylprednisolone After Total Knee Arthroplasty

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00968578

Collaborator

Lundbeck Foundation (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg

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.

Study Design

Study Type:

Interventional

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 :

Aug 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Postoperative pain [48 hours + follow up]

Secondary Outcome Measures

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