Osteoarthrosis Clinical Trial
Official title:
Effect of Preoperative Intravenous High Dose Methylprednisolone on Endothelial Function in Patients Scheduled for Total Knee-arthroplasty
This study evaluates the pathophysiological effects of a single dose methylprednisolone
administered prior to total knee-arthroplasty surgery (TKA). The investigators examine the
effect on the endothelial glycocalyx shedding due to surgical trauma.
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
reduction in glycocalyx degradation compared to the placebo-group, early after TKA.
The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on
postoperative pain, postoperative nausea and vomiting are well-documented.
Postoperatively, activation and / or dysregulation of the inflammatory system influence on
the endothelial glycocalyx. Damage of the vascular endothelia increases the risk of
cardiovascular and thromboembolic complications.
In animal studies glucocorticoids have been found to preserve the endothelial glycocalyx and
the vascular barrier.
The effect of glucocorticoids on human endothelial glycocalyx after surgery is unknown and
calls for further investigation.
This study is embedded in a primary study registrated as: NCT02319343
For further details please view the EudraCT registration:
EudraCT nr.: 2014-003395-23
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02445898 -
Effect of Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Hip-arthroplasty Patients
|
Phase 2/Phase 3 | |
| Completed |
NCT02542592 -
Effect of Methylprednisolone on Immune Signaling 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 |
NCT02319343 -
Effect of Methylprednisolone on Quadriceps Muscle Function in Patients Undergoing Total Knee-arthroplasty
|
Phase 3 | |
| Completed |
NCT02332616 -
Effect of Methylprednisolone on Complement Activation in Patients Undergoing Total Knee-arthroplasty
|
Phase 3 | |
| Completed |
NCT02332603 -
Effect of Methylprednisolone on Glucose Homeostasis in Patients Undergoing Total Hip- and Knee-arthroplasty
|
Phase 3 |