Osteoarthrosis Clinical Trial
Official title:
Effect of Preoperative Intravenous High Dose Methylprednisolone on Immune Signaling in Patients Scheduled for Total Hip-arthroplasty
Verified date | January 2017 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study evaluates the pathophysiological effects of a single dose Methylprednisolone
administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the
effect on immune signaling and recovery after surgery.
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 a
positive modulation of the immune response and an enhanced recovery.
Status | Completed |
Enrollment | 64 |
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-arthroplasty surgery - Speak and understand Danish - Have given informed content Exclusion Criteria: - Revision or bilateral hip-arthroplasty surgery - General anaesthesia - Allergy or intolerance towards Methylprednisolone - Local or systemic infection - Permanent systemic treatment with steroids within 30 days peroperatively - Insulin-dependent diabetes - Atrial fibrillation - Neurological disease incl. Parkinsons - Daily use of hypnotics or sedatives - Alcohol abuse >35 units per week - 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 | Copenhagen University Hospital, Bispebjerg | Copenhagen NV |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Bispebjerg Hospital |
Denmark,
Baigrie RJ, Lamont PM, Kwiatkowski D, Dallman MJ, Morris PJ. Systemic cytokine response after major surgery. Br J Surg. 1992 Aug;79(8):757-60. — View Citation
Gaudillière B, Fragiadakis GK, Bruggner RV, Nicolau M, Finck R, Tingle M, Silva J, Ganio EA, Yeh CG, Maloney WJ, Huddleston JI, Goodman SB, Davis MM, Bendall SC, Fantl WJ, Angst MS, Nolan GP. Clinical recovery from surgery correlates with single-cell immu — View Citation
Giannoudis PV, Smith RM, Perry SL, Windsor AJ, Dickson RA, Bellamy MC. Immediate IL-10 expression following major orthopaedic trauma: relationship to anti-inflammatory response and subsequent development of sepsis. Intensive Care Med. 2000 Aug;26(8):1076-81. — View Citation
Stoecklein VM, Osuka A, Lederer JA. Trauma equals danger--damage control by the immune system. J Leukoc Biol. 2012 Sep;92(3):539-51. doi: 10.1189/jlb.0212072. Review. — View Citation
Wilmore DW. From Cuthbertson to fast-track surgery: 70 years of progress in reducing stress in surgical patients. Ann Surg. 2002 Nov;236(5):643-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in concentration of plasma-STAT3 (Signal transducer and activator of transcription) from baseline to 48 hours after surgery | 48 hours after surgery | ||
Secondary | Change in concentration of plasma-STAT3 from baseline to 14 days after surgery | 14 days after surgery | ||
Secondary | Change in concentration of plasma-CREB (Adenosine 3',5'-monophosphate response element-binding protein) from baseline to 14 days after surgery | 14 days after surgery | ||
Secondary | Change in concentration of plasma-NF-kB (Nuclear factor kB) from baseline to 14 days after surgery | 14 days after surgery | ||
Secondary | Change in Surgical Recovery Scale score from baseline to 28 days after surgery | 28 days after surgery | ||
Secondary | Change in modified WOMAC (Western Ontario and McMaster Universities Arthritis Index) score from baseline to 28 days after surgery | 28 days after surgery |
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 |
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 | |
Completed |
NCT02332603 -
Effect of Methylprednisolone on Glucose Homeostasis in Patients Undergoing Total Hip- and Knee-arthroplasty
|
Phase 3 |