MedDataX Logo

Effects of Methylprednisolone After Total Hip Arthroplasty

NCT ID: NCT00968903

Last Updated: 2011-09-29

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

2010-04-30

Study Completion Date

2011-01-31

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 hip arthroplasty.

The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce time to fulfill discharge criteria.

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 hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. The investigators 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 hip arthroplasty.

Conditions

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

LOS Postoperative Pain Postoperative Nausea and Vomiting Sleeping Quality Fatigue Inflammatory Response

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

Methylprednisolone

Intervention Type DRUG

Methylprednisolone 125 mg iv pre-operatively

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

Eligibility Criteria

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

Inclusion Criteria

* Elective total hip 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

Other Identifiers

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

2009-41-3784

Identifier Type: -

Identifier Source: secondary_id

2612-3916

Identifier Type: -

Identifier Source: secondary_id

EudraCT: 2008-006528-67

Identifier Type: -

Identifier Source: secondary_id

H-A-2008-030

Identifier Type: -

Identifier Source: org_study_id