MedDataX Logo

Effects of Methylprednisolone After Total Knee Arthroplasty

NCT ID: NCT00968578

Last Updated: 2012-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain Postoperative Nausea and Vomiting Sleeping Quality Fatigue Inflammatory Response

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Knee arthroplasty Methylprednisolone Post-operative pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Methylprednisolone

Methylprednisolone 125 mg iv pre-operatively

Group Type ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type DRUG

Methylprednisolone 125 mg iv pre-operatively

Saline

Saline iv pre-operatively in equivalent volume (placebo)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline iv pre-operatively in equivalent volume (placebo)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Methylprednisolone

Methylprednisolone 125 mg iv pre-operatively

Intervention Type DRUG

Placebo

Saline iv pre-operatively in equivalent volume (placebo)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lundbeck Foundation

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Troels Haxholdt Lunn

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hvidovre University Hospital

Copenhagen, Hvidovre, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

Lunn TH, Kristensen BB, Andersen LO, Husted H, Otte KS, Gaarn-Larsen L, Kehlet H. Effect of high-dose preoperative methylprednisolone on pain and recovery after total knee arthroplasty: a randomized, placebo-controlled trial. Br J Anaesth. 2011 Feb;106(2):230-8. doi: 10.1093/bja/aeq333. Epub 2010 Dec 3.

Reference Type DERIVED
PMID: 21131371 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-41-3786

Identifier Type: -

Identifier Source: secondary_id

H-C-2008-134

Identifier Type: -

Identifier Source: org_study_id