Effect of Methylprednisolone on Immune Signaling in Hip-arthroplasty Patients

Osteoarthrosis Clinical Trial

Official title:

Effect of Preoperative Intravenous High Dose Methylprednisolone on Immune Signaling in Patients Scheduled for Total Hip-arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542592
• Other study ID #: HK_VL_08_2015a
• Secondary ID: 2015-000102-19
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 3, 2015
• Last updated: January 17, 2017
• Start date: September 2015
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Joint Diseases
• Osteoarthritis
• Osteoarthrosis

Intervention

Drug:
• Methylprednisolone
Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo)
• Isotonic Sodium Chloride
Placebo

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Bispebjerg	Copenhagen NV

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (5)

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

Outcome

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