NCT00968903

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

September 29, 2011

Status Verified

September 1, 2011

Enrollment Period

9 months

First QC Date

August 28, 2009

Last Update Submit

September 28, 2011

Conditions

LOSPostoperative PainPostoperative Nausea and VomitingSleeping QualityFatigueInflammatory Response

Keywords

Hip arthroplastyMethylprednisolonePost-operative pain

Outcome Measures

Primary Outcomes (1)

  • Time to fulfill discharge criteria

    At discharge (mean 1-2 days)

Secondary Outcomes (8)

  • Hand muscle strength

    24 hours

  • Sleeping quality on the visual analog scale

    up to four days

  • Inflammatory response measured as CRP in blood sample

    24 hours postoperatively

  • Fatigue measured on a 10 point numeric range scale

    up to four days

  • Additional analgetics, antinausea agents and sleeping medicine.

    up to four days

  • +3 more secondary outcomes

Study Arms (2)

Methylprednisolone

ACTIVE COMPARATOR

Methylprednisolone 125 mg iv pre-operatively

Drug: Methylprednisolone

Saline

PLACEBO COMPARATOR

Saline iv pre-operatively in equivalent volume (placebo)

Drug: Methylprednisolone

Interventions

MethylprednisoloneDRUG

Methylprednisolone 125 mg iv pre-operatively

MethylprednisoloneSaline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective total hip arthroplasty
  • Able to speak and understand danish
  • Able to give informed consent

You may not qualify if:

  • Alcohol or medical abuse
  • Allergies to local anesthetics or methylprednisolone
  • Age \< 18 years
  • Daily use of opioids or glucocorticoids
  • Pregnancy or breastfeeding (fertile women)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and VomitingFatigue

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomiting

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

April 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

September 29, 2011

Record last verified: 2011-09

Locations

DK(1)