Osteoarthrosis Clinical Trial
Official title:
Effect of Preoperative Intravenous High Dose Methylprednisolone on Quadriceps Muscle Function 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 Methylprednisolone
administered prior to total knee-arthroplasty (TKA). The investigators examine the effect on
thigh muscle function to evaluate the efficacy of Methylprednisolone on knee-extension
strength at discharge after TKA.
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
smaller loss of knee-extension strength compared to the placebo-group, early after TKA.
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,
Bandholm T, Kehlet H. Physiotherapy exercise after fast-track total hip and knee arthroplasty: time for reconsideration? Arch Phys Med Rehabil. 2012 Jul;93(7):1292-4. doi: 10.1016/j.apmr.2012.02.014. Epub 2012 Feb 27. — View Citation
Geborek P, Månsson B, Wollheim FA, Moritz U. Intraarticular corticosteroid injection into rheumatoid arthritis knees improves extensor muscles strength. Rheumatol Int. 1990;9(6):265-70. — View Citation
Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010 Nov;91(11):1770-6. doi: 10.1016/j.apmr.2010.07.229. — View Citation
Holte K, Kehlet H. Perioperative single-dose glucocorticoid administration: pathophysiologic effects and clinical implications. J Am Coll Surg. 2002 Nov;195(5):694-712. Review. — 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
Lunn TH, Kristensen BB, Andersen LØ, Husted H, Otte KS, Gaarn-Larsen L, Kehlet H. Effect of high-dose preoperative methylprednisolone on pain and recovery after total knee arthroplasty: a randomized, placebo-controlled trial. Br J Anaesth. 2011 Feb;106(2):230-8. doi: 10.1093/bja/aeq333. Epub 2010 Dec 3. — 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
Rice DA, McNair PJ. Quadriceps arthrogenic muscle inhibition: neural mechanisms and treatment perspectives. Semin Arthritis Rheum. 2010 Dec;40(3):250-66. doi: 10.1016/j.semarthrit.2009.10.001. Epub 2009 Dec 2. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in isometric knee extension strength measured as Nm/kg from baseline to 48 hours after surgery | two days after surgery | No | |
Secondary | Change in Timed Up & Go (sec.) from baseline (before surgery) to 48 hours after surgery | two days after surgery | No | |
Secondary | Change in knee circumference (cm) from baseline (before surgery) to 48 hours after surgery | two days after surgery | No | |
Secondary | Change in pain intensity from baseline (before surgery) to 48 hours after surgery | two days after surgery | No | |
Secondary | Change in concentration of C-reactive Protein from baseline (before surgery) to 48 hours after surgery | two days after suregry | No |
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