Effect of highdose glucocorticoid on thigh muscle funktion, vesselwall function, immune system activation and blood sugar balance before total knee replacement
- Conditions
- MedDRA version: 18.1Level: LLTClassification code 10003416Term: ArthrosisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Knee joint arthrosis
- Registration Number
- EUCTR2014-003395-23-DK
- Lead Sponsor
- Section for Surgical Pathophysiology, Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): A. Functional performance, knee circumference, active knee movement and pain intensity 48 hours<br>B. Changes in endothelial markers from baseline til post-surgery 24 hours<br>C. Changes in complement markers from baseline til post-surgery 48 hours<br>D. Changes in blood glucose levels from baseline to post-surgery 48 hours<br>;Timepoint(s) of evaluation of this end point: A. 48 hours<br>B. 24 hours<br>C. 48 hours<br>D. 48 hours