Effect of Methylprednisolone on Immune Signaling in Hip-arthroplasty Patients

Rigshospitalet

Status and phase: Completed; Phase 3; Phase 2

Conditions: Osteoarthrosis

Treatments: Drug: Methylprednisolone; Drug: Isotonic Sodium Chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02542592

2015-000102-19 (EudraCT Number)

HK_VL_08_2015a

Details and patient eligibility

About

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.

Full description

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

Enrollment: 64 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

64 participants in 2 patient groups, including a placebo group

Methylprednisolone

Active Comparator group

Description:

Preoperative single high dose of Solu-Medrol 125 mg iv.

Treatment:

Drug: Methylprednisolone

Placebo

Placebo Comparator group

Description:

Preoperative single dose of isotonic Sodium Chloride

Treatment:

Drug: Isotonic Sodium Chloride