Effects of Methylprednisolone After Total Knee Arthroplasty | NCT00968578

Studies
Effects of Methylprednisolone After Total Knee Arthroplasty

NCT00968578

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Sep 26, 2012Estimated

Enrollment

48Actual

Phase

Phase 4

Conditions

Postoperative Pain
Postoperative Nausea and Vomiting
Sleeping Quality
Fatigue
Inflammatory Response

Interventions

Methylprednisolone
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-41-3786

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Aug 28, 2009

First Submission Date that Met QC Criteria

Aug 28, 2009

First Posted Date

Aug 31, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2012

Last Update Posted Date

Sep 26, 2012Estimated

Name	Class
Lundbeck Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Methylprednisolone	Active Comparator	Methylprednisolone 125 mg iv pre-operatively	Drug: Methylprednisolone
Saline	Placebo Comparator	Saline iv pre-operatively in equivalent volume (placebo)	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methylprednisolone	Drug	Methylprednisolone 125 mg iv pre-operatively	Methylprednisolone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative pain		48 hours + follow up

Secondary Outcomes

Measure	Description	Time Frame
Postoperative nausea and vomiting (PONV)		48 hours + follow up
Sleeping quality		48 hours + follow up
Inflammatory response

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre University Hospital		Copenhagen	Hvidovre	2650	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21131371	Derived	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.

ID	Term
D010149	Pain, Postoperative
D020250	Postoperative Nausea and Vomiting
D005221	Fatigue

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

ID	Term
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes