Osteoarthrosis Clinical Trial
Official title:
Effect of Preoperative Intravenous High Dose Methylprednisolone on Complement Activation in Patients Scheduled for Total Knee-arthroplasty
Verified date | April 2016 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Health and Medicines Authority |
Study type | Interventional |
This study evaluates the pathophysiological effects of a single dose of methylprednisolone
administered prior to total knee-arthroplasty surgery. The investigators examine the effect
on complement activation.
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
beneficial inhibition of the undesirable parts of the complement activation.
Status | Completed |
Enrollment | 70 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 55 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Denmark | Bispebjerg Hospital | Copenhagen NV |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Bispebjerg Hospital |
Denmark,
Abdelmalak BB, Bonilla AM, Yang D, Chowdary HT, Gottlieb A, Lyden SP, Sessler DI. The hyperglycemic response to major noncardiac surgery and the added effect of steroid administration in patients with and without diabetes. Anesth Analg. 2013 May;116(5):1116-22. doi: 10.1213/ANE.0b013e318288416d. Epub 2013 Apr 4. — View Citation
de la Motte L, Kehlet H, Vogt K, Nielsen CH, Groenvall JB, Nielsen HB, Andersen A, Schroeder TV, Lönn L. Preoperative methylprednisolone enhances recovery after endovascular aortic repair: a randomized, double-blind, placebo-controlled clinical trial. Ann Surg. 2014 Sep;260(3):540-8; discussion 548-9. doi: 10.1097/SLA.0000000000000895. — View Citation
Dieleman JM, Nierich AP, Rosseel PM, van der Maaten JM, Hofland J, Diephuis JC, Schepp RM, Boer C, Moons KG, van Herwerden LA, Tijssen JG, Numan SC, Kalkman CJ, van Dijk D; Dexamethasone for Cardiac Surgery (DECS) Study Group. Intraoperative high-dose dexamethasone for cardiac surgery: a randomized controlled trial. JAMA. 2012 Nov 7;308(17):1761-7. doi: 10.1001/jama.2012.14144. — View Citation
Husted H. Fast-track hip and knee arthroplasty: clinical and organizational aspects. Acta Orthop Suppl. 2012 Oct;83(346):1-39. doi: 10.3109/17453674.2012.700593. Review. — View Citation
Kehlet H. Fast-track hip and knee arthroplasty. Lancet. 2013 May 11;381(9878):1600-2. doi: 10.1016/S0140-6736(13)61003-X. — View Citation
Khan SK, Malviya A, Muller SD, Carluke I, Partington PF, Emmerson KP, Reed MR. Reduced short-term complications and mortality following Enhanced Recovery primary hip and knee arthroplasty: results from 6,000 consecutive procedures. Acta Orthop. 2014 Feb;85(1):26-31. doi: 10.3109/17453674.2013.874925. Epub 2013 Dec 20. — View Citation
Malviya A, Martin K, Harper I, Muller SD, Emmerson KP, Partington PF, Reed MR. Enhanced recovery program for hip and knee replacement reduces death rate. Acta Orthop. 2011 Oct;82(5):577-81. doi: 10.3109/17453674.2011.618911. Epub 2011 Sep 6. — View Citation
Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear T, Vender JS, Gray J, Landry E. The effect of single low-dose dexamethasone on blood glucose concentrations in the perioperative period: a randomized, placebo-controlled investigation in gynecologic surgical patients. Anesth Analg. 2014 Jun;118(6):1204-12. doi: 10.1213/ANE.0b013e3182a53981. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in plasma and serum Pentraxin-3 concentrations from baseline (before surgery) to 48 hours after surgery | baseline to 48 hours | No | |
Secondary | Change in plasma and serum Complement Component 3 concentrations from baseline (before surgery) to 48 hours after surgery | baseline to 48 hours | No | |
Secondary | Change in plasma and serum Complement Component 4 concentrations from baseline (before surgery) to 48 hours after surgery | baseline to 48 hours | No | |
Secondary | Change in plasma and serum Mannose-binding lectin concentrations from baseline (before surgery) to 48 hours after surgery | baseline to 48 hours | No | |
Secondary | Change in plasma and serum Ficolin-1, -2 and -3 concentrations from baseline (before surgery) to 48 hours after surgery | baseline to 48 hours | No | |
Secondary | Change in plasma and serum Terminal Complement Complex concentrations from baseline (before surgery) to 48 hours after surgery | baseline to 48 hours | No |
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