Effects of Methylprednisolone After Total Hip Arthroplasty

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00968903

Collaborator

Lundbeck Foundation (Other)

Enrollment

Location

Arms

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg

versus placebo on postoperative outcome after hip arthroplasty.

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

Condition or Disease	Intervention/Treatment	Phase
LOS Postoperative Pain Postoperative Nausea and Vomiting Sleeping Quality Fatigue Inflammatory Response	Drug: Methylprednisolone	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Methylprednisolone Methylprednisolone 125 mg iv pre-operatively	Drug: Methylprednisolone Methylprednisolone 125 mg iv pre-operatively
Placebo Comparator: Saline Saline iv pre-operatively in equivalent volume (placebo)	Drug: Methylprednisolone Methylprednisolone 125 mg iv pre-operatively

Arm

Intervention/Treatment

Active Comparator: Methylprednisolone

Methylprednisolone 125 mg iv pre-operatively

Drug: Methylprednisolone

Methylprednisolone 125 mg iv pre-operatively

Placebo Comparator: Saline

Saline iv pre-operatively in equivalent volume (placebo)

Drug: Methylprednisolone

Methylprednisolone 125 mg iv pre-operatively

Outcome Measures

Primary Outcome Measures

Time to fulfill discharge criteria [At discharge (mean 1-2 days)]

Secondary Outcome Measures

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]
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 [up to 30 days]
Postoperative pain scores on the visual analog scale [up 30 days]
Postoperative nausea and vomiting (PONV) on 4 point numeric range scale [up to 4 days]