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Effect of highdose glucocorticoid on thigh muscle funktion, vesselwall function, immune system activation and blood sugar balance before total knee replacement

Effect of preoperative intravenous highdose methylprednisolone on quadriceps muscle function, endothelial function, complement activation and glucose homeostasis in patients scheduled for total knee-arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-003395-23-DK
Enrollment
Unknown
Registered
2014-12-03
Start date
2015-01-20
Completion date
Unknown
Last updated
2016-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee joint arthrosis MedDRA version: 18.1 Level: LLT Classification code 10003416 Term: Arthrosis System Organ Class: 100000004859

Interventions

Trade Name: Solu-Medrol Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Solu-Medrol Other descriptive name: METHYLPREDNISOLONE Concentration unit: mg/ml milligram(s)/m

Sponsors

Section for Surgical Pathophysiology, Rigshospitalet
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Age 55-80 years - Osteoarthrosis scheduled for primary unilateral knee-arthroplasty - Speak and understand danish Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38

Exclusion criteria

Exclusion criteria: - Allergy towards methylprednisolone - Scheduled for knee revision or bilateral surgery - Infection (local or systemic) - General anaesthesia - Current use of steroid - Insulin treated diabetes - Treatment for ulcus <3 months preoperatively - Cancer disease - Autoimmune disease - Pregnant or breast feeding women - Menopause <1 year - Menopause <1 year

Design outcomes

Primary

MeasureTime frame
Secondary Objective: To investigate the effect of intravenous highdose injection of methylprednisolone on endothelial function, complement activation and glucose homeostasis in patients undergoing total knee-arthroplasty;Primary end point(s): Change in isometric quadriceps muscle strength (Nm/kg) from baseline (before surgery) to 48 hours postoperatively;Timepoint(s) of evaluation of this end point: 48 hours;Main Objective: To investigate the effect of intravenous highdose injection of methylprednisolone on quadriceps muscle function in patients undergoing total knee-arthroplasty—

Secondary

MeasureTime frame
Secondary end point(s): A. Functional performance, knee circumference, active knee movement and pain intensity 48 hours B. Changes in endothelial markers from baseline til post-surgery 24 hours C. Changes in complement markers from baseline til post-surgery 48 hours D. Changes in blood glucose levels from baseline to post-surgery 48 hours ;Timepoint(s) of evaluation of this end point: A. 48 hours B. 24 hours C. 48 hours D. 48 hours—

Countries

Denmark

Contacts

Public ContactViktoria Oline Lindberg-Larsen

Section for Surgical Pathophysiology, Rigshospitalet

viktoria_oline@hotmail.com004528791991

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026