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Effect of Methylprednisolone on Endothelial Function in Patients Undergoing Total Knee-arthroplasty

NCT02332629 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-04-08

No results posted yet for this study

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.

Conditions

  • Osteoarthrosis

Interventions

DRUG

Methylprednisolone

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

DRUG

Isotonic Sodium Chloride

Placebo

Sponsors & Collaborators

  • Bispebjerg Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Viktoria Lindberg-Larsen, MD · Section for Surgical Pathophysiology, Rigshospitalet

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Denmark

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02332629 on ClinicalTrials.gov