Effect of Methylprednisolone on Complement Activation in Patients Undergoing Total Knee-arthroplasty

• Register: ClinicalTrials.gov
• Last refreshed on: 18 April 2016
• Main ID: NCT02332616
• Date of registration: 05/01/2015
• Prospective Registration: No
• Primary sponsor: Rigshospitalet, Denmark
• Public title: Effect of Methylprednisolone on Complement Activation in Patients Undergoing Total Knee-arthroplasty
• Scientific title: Effect of Preoperative Intravenous High Dose Methylprednisolone on Complement Activation in Patients Scheduled for Total Knee-arthroplasty
• Date of first enrolment: January 2015
• Target sample size: 70
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02332616
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
• Phase: Phase 3

Countries of recruitment

Denmark

Contacts

• Name: Viktoria Lindberg-Larsen, MD
• Affiliation: Section for Surgical Pathophysiology, Rigshospitalet

Key inclusion & exclusion criteria

Inclusion Criteria:

- Osteoarthrosis

- Undergoing total unilateral knee-arthroplasty surgery

- Speak and understand Danish

- Have given informed consent

Exclusion Criteria:

- Revision, bilateral or uni chamber knee-arthroplasty surgery

- General anaesthesia

- Allergy or intolerance towards Methylprednisolone

- Local or systemic infection

- Permanent systemic treatment with steroids within 30 days preoperatively

- Insulin-dependent diabetes

- Active treatment of ulcer within 3 months preoperatively

- Cancer disease

- Autoimmune disease incl. rheumatoid arthritis

- Pregnant or breast feeding women

- Menopause <1 year



Age minimum: 55 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Osteoarthrosis

Intervention(s)

Drug: Methylprednisolone

Drug: Isotonic Sodium Chloride

Primary Outcome(s)

Change in plasma and serum Pentraxin-3 concentrations from baseline (before surgery) to 48 hours after surgery [Time Frame: baseline to 48 hours]

Secondary Outcome(s)

Change in plasma and serum Terminal Complement Complex concentrations from baseline (before surgery) to 48 hours after surgery [Time Frame: baseline to 48 hours]

Change in plasma and serum Complement Component 4 concentrations from baseline (before surgery) to 48 hours after surgery [Time Frame: baseline to 48 hours]

Change in plasma and serum Ficolin-1, -2 and -3 concentrations from baseline (before surgery) to 48 hours after surgery [Time Frame: baseline to 48 hours]

Change in plasma and serum Complement Component 3 concentrations from baseline (before surgery) to 48 hours after surgery [Time Frame: baseline to 48 hours]

Change in plasma and serum Mannose-binding lectin concentrations from baseline (before surgery) to 48 hours after surgery [Time Frame: baseline to 48 hours]

Secondary ID(s)

HK_VL_08_2014b

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bispebjerg Hospital