Osteoarthrosis Clinical Trial
Official title:
Effect of Preoperative Intravenous High Dose Methylprednisolone on Glucose Homeostasis in Patients Scheduled for Total Hip- and Knee-arthroplasty
Verified date | January 2017 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the pathophysiological effects of a single dose of Methylprednisolone
administered prior to total hip- and knee-arthroplasty surgery. The investigators examine
the effect on blood glucose homeostasis.
Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will
receive placebo.
The investigators hypothesize that the glucose homeostasis remains equally stable in the
group receiving Methylprednisolone as in the group receiving placebo.
Status | Completed |
Enrollment | 134 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Osteoarthrosis - Undergoing total unilateral hip- or knee arthroplasty surgery - Speak and understand Danish - Have given informed consent Exclusion Criteria: - Revision or bilateral hip- or 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 |
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. — 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. — 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. — 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 | Changes in plasma blood glucose from baseline (before surgery) to 48 hours after surgery | baseline to 48 hours | ||
Secondary | Changes in plasma C-peptide from baseline (before surgery) to 48 hours after surgery | baseline to 48 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02542592 -
Effect of Methylprednisolone on Immune Signaling in Hip-arthroplasty Patients
|
Phase 2/Phase 3 | |
Completed |
NCT02445898 -
Effect of Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Hip-arthroplasty Patients
|
Phase 2/Phase 3 | |
Completed |
NCT02910830 -
Osteoarthritis Relationships and Tobacco " Ancillary Study Khoala "
|
N/A | |
Completed |
NCT01443975 -
Clinical Evaluation on the Use of the X-pander Device
|
N/A | |
Completed |
NCT01603017 -
Nuclear Magnetic Resonance Therapy in Knee Osteoarthrosis
|
N/A | |
Completed |
NCT02222740 -
A Safety, Tolerability and Pharmacokinetic Dose Escalation Study of HC-ER in Patients With Osteoarthritis Pain
|
Phase 2 | |
Completed |
NCT00860873 -
Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis
|
Phase 3 | |
Recruiting |
NCT02923310 -
Evaluation of Two Types of PRP in Knee Osteoarthritis
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT02518269 -
A 3-Arm Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty
|
N/A | |
Completed |
NCT03093038 -
Early Stability of the Delta-TT Cup With Polyethylene Insert Versus a Ceramic Insert. A RSA Study.
|
N/A | |
Completed |
NCT02967874 -
Autologous Adipose-Derived Stromal Vascular Fraction Cells for Osteoarthritis Treatment
|
Phase 1/Phase 2 | |
Withdrawn |
NCT02341079 -
Intraoperative Liposomal Bupivacaine Injection in Primary Total Knee Arthroplasty
|
Phase 2/Phase 3 | |
Completed |
NCT00291499 -
Efficacy Study of Condrosulf in the Treatment of Symptomatic OA of the Hand
|
Phase 3 | |
Recruiting |
NCT05882227 -
Nursing Intervention for the Reduction of Anxiety During the Process of Primary Total Hip Arthroplasty Within the Optimized Recovery Program.
|
N/A | |
Completed |
NCT05697952 -
E1K Intra Articular(IA) Treatment for Knee Osteoarthritis
|
Phase 2 | |
Completed |
NCT01940692 -
Topical and Intravenous Administration of TXA Are Equally Effective in DAA THA
|
Phase 2 | |
Completed |
NCT02071745 -
Navigated Total Knee Arthroplasty, the Correlation to CT Scans and Clinical Results
|
N/A | |
Completed |
NCT02332616 -
Effect of Methylprednisolone on Complement Activation in Patients Undergoing Total Knee-arthroplasty
|
Phase 3 | |
Completed |
NCT02332629 -
Effect of Methylprednisolone on Endothelial Function in Patients Undergoing Total Knee-arthroplasty
|
Phase 3 | |
Completed |
NCT02319343 -
Effect of Methylprednisolone on Quadriceps Muscle Function in Patients Undergoing Total Knee-arthroplasty
|
Phase 3 |