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Effects of Methylprednisolone After Total Hip Arthroplasty

Information source: Hvidovre University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: LOS; Postoperative Pain; Postoperative Nausea and Vomiting; Sleeping Quality; Fatigue; Inflammatory Response

Intervention: Methylprednisolone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hvidovre University Hospital


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.

Clinical Details

Official title: Effects of Pre-operative Methylprednisolone (125mg iv) After Total Hip Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Time to fulfill discharge criteria

Secondary outcome:

Hand muscle strength

Sleeping quality on the visual analog scale

Inflammatory response measured as CRP in blood sample

Fatigue measured on a 10 point numeric range scale

Additional analgetics, antinausea agents and sleeping medicine.

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Postoperative pain scores on the visual analog scale

Postoperative nausea and vomiting (PONV) on 4 point numeric range scale

Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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)

Locations and Contacts

Hvidovre University Hospital, Copenhagen, Hvidovre 2650, Denmark
Additional Information

Starting date: April 2010
Last updated: September 28, 2011

Page last updated: August 23, 2015

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