Effects of Methylprednisolone After Total Hip Arthroplasty

This study has been completed.

Sponsor:

Collaborator:

Lundbeck Foundation

Information provided by (Responsible Party):

Troels Haxholdt Lunn, Hvidovre University Hospital

ClinicalTrials.gov Identifier:

NCT00968903

First received: August 28, 2009

Last updated: September 28, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	August 28, 2009
Last Updated Date	September 28, 2011
Start Date ^ICMJE	April 2010
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 21, 2010)	Time to fulfill discharge criteria [ Time Frame: At discharge (mean 1-2 days) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: August 28, 2009)	Postoperative pain [ Time Frame: 48 hours + follow up ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00968903 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 21, 2010)	Hand muscle strength [ Time Frame: 24 hours ] [ Designated as safety issue: No ] Sleeping quality on the visual analog scale [ Time Frame: up to four days ] [ Designated as safety issue: No ] Inflammatory response measured as CRP in blood sample [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ] Fatigue measured on a 10 point numeric range scale [ Time Frame: up to four days ] [ Designated as safety issue: No ] Additional analgetics, antinausea agents and sleeping medicine. [ Time Frame: up to four days ] [ Designated as safety issue: No ] Measures as mg (analgetics) and daily use (yes or no)(antinausea agents and sleeping medicine). Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ] Postoperative pain scores on the visual analog scale [ Time Frame: up 30 days ] [ Designated as safety issue: No ] Postoperative nausea and vomiting (PONV) on 4 point numeric range scale [ Time Frame: up to 4 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: August 28, 2009)	Postoperative nausea and vomiting (PONV) [ Time Frame: 48 hours + follow up ] [ Designated as safety issue: No ] Sleeping quality [ Time Frame: 48 hours + follow up ] [ Designated as safety issue: No ] Inflammatory response [ Time Frame: 48 hours + follow up ] [ Designated as safety issue: No ] Fatigue [ Time Frame: 48 hours + follow up ] [ Designated as safety issue: No ] Additional analgetics, antinausea agents and sleeping medicine [ Time Frame: 48 hours + follow up ] [ Designated as safety issue: No ] Time in hospital [ Time Frame: Until discharge ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of Methylprednisolone After Total Hip Arthroplasty
Official Title ^ICMJE	Effects of Pre-operative Methylprednisolone (125mg iv) After Total Hip Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail
Brief Summary	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	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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Condition ^ICMJE	LOS Postoperative Pain Postoperative Nausea and Vomiting Sleeping Quality Fatigue Inflammatory Response
Intervention ^ICMJE	Drug: Methylprednisolone Methylprednisolone 125 mg iv pre-operatively
Study Arm (s)	Active Comparator: Methylprednisolone Methylprednisolone 125 mg iv pre-operatively Intervention: Drug: Methylprednisolone Placebo Comparator: Saline Saline iv pre-operatively in equivalent volume (placebo) Intervention: Drug: Methylprednisolone
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	48
Completion Date	January 2011
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT00968903
Other Study ID Numbers ^ICMJE	H-A-2008-030, 2009-41-3784, 2612-3916, EudraCT: 2008-006528-67
Has Data Monitoring Committee	No
Responsible Party	Troels Haxholdt Lunn, Hvidovre University Hospital
Study Sponsor ^ICMJE	Hvidovre University Hospital
Collaborators ^ICMJE	Lundbeck Foundation
Investigators ^ICMJE	Not Provided
Information Provided By	Hvidovre University Hospital
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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