CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 70 enrolled
Drug / intervention
Methylprednisolone +1 moredrug
Likely dose
Methylprednisolone 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02332629
NCT02332629Phase 3Completed
CompareCT.gov

Effect of Preoperative Intravenous High Dose Methylprednisolone on Endothelial Function in Patients Scheduled for Total Knee-arthroplasty

Rigshospitalet, Denmark·interventional·Posted Jan 7, 2015·Updated Apr 8, 2016

In Brief

A Phase 3 clinical trial evaluating Methylprednisolone and Isotonic Sodium Chloride for Osteoarthrosis. Completed, enrolled 70 participants across 1 site.

Detailed Summary

This study evaluates the pathophysiological effects of a single dose methylprednisolone administered prior to total knee-arthroplasty surgery (TKA). The investigators examine the effect on the endothelial glycocalyx shedding due to surgical trauma. Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will receive placebo. The investigators hypothesize that the group receiving methylprednisolone will experience reduction in glycocalyx degradation compared to the placebo-group, early after TKA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthrosis
CountriesDenmark
CollaboratorsBispebjerg Hospital

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 7, 2015
Enrollment StartJan 1, 2015
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.5 years ago

Interventions

Methylprednisolonedrug

Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride

Isotonic Sodium Chloridedrug

Placebo