Overview

Effect of Methylprednisolone on Immune Signaling in Hip-arthroplasty Patients

Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rigshospitalet, Denmark
Collaborator:
Bispebjerg Hospital
Treatments:
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
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