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NCT Number: NCT02542592

Effect of Methylprednisolone on Immune Signaling in Hip-arthroplasty Patients

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.

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Key information

Conditions

Osteoarthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Copenhagen University Hospital, Bispebjerg

Copenhagen NV, 2400, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

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

Other names: Solu-Medrol

isotonic sodium chloride

Drug

Placebo

Other names: Placebo

Primary outcomes

  1. 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

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

    Time frame: 14 days after surgery

  2. 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

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

    Time frame: 14 days after surgery

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

    Time frame: 28 days after surgery

  5. 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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Bispebjerg Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 7, 2015
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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