Effect of Methylprednisolone on Immune Signaling in Hip-arthroplasty Patients

Rigshospitalet, Denmark64 enrolled

Overview

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.

The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on postoperative pain, postoperative nausea and vomiting are well-documented. Hip-arthroplasty surgery and the inflammatory stress response in general affect the potential of recovery. The basic physiological mechanisms behind restoration of recovery after surgery are still unresolved. The many different immune cells involved in the complex signal response enables wound healing and recovery, and the individual immune signal pattern might be able to predict recovery. The effects of glucocorticoids on this immune signal pattern is unknown and calls for further investigation. The study is to be considered as exploratory. This study is embedded in a primary study registrated as: NCT02445898 For further details please view the EudraCT registration: EudraCT nr.: 2015-000102-19

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Osteoarthrosis

Interventions

MethylprednisoloneDRUG

Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo)

Isotonic Sodium ChlorideDRUG

Placebo

Eligibility

Sex: ALLMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Copenhagen University Hospital, Bispebjerg

Copenhagen NV, Denmark

Outcomes

Primary Outcomes

Change in concentration of plasma-STAT3 (Signal transducer and activator of transcription) from baseline to 48 hours after surgery

Time frame: 48 hours after surgery

Secondary Outcomes

Change in concentration of plasma-STAT3 from baseline to 14 days after surgery

Time frame: 14 days after surgery

Change in concentration of plasma-CREB (Adenosine 3',5'-monophosphate response element-binding protein) from baseline to 14 days after surgery

Time frame: 14 days after surgery

Change in concentration of plasma-NF-kB (Nuclear factor kB) from baseline to 14 days after surgery

Time frame: 14 days after surgery

Change in Surgical Recovery Scale score from baseline to 28 days after surgery

Time frame: 28 days after surgery

Change in modified WOMAC (Western Ontario and McMaster Universities Arthritis Index) score from baseline to 28 days after surgery

Time frame: 28 days after surgery

Data from ClinicalTrials.gov

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