E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Arthrosis in the hip joint |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003416 |
E.1.2 | Term | Arthrosis |
E.1.2 | System Organ Class | 100000004859 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the effect of intravenous highdose injection of methylprednisolone on orthostatic intolerance in patients undergoing total hip-arthroplasty |
|
E.2.2 | Secondary objectives of the trial |
To investigate the effect of intravenous highdose injection of methylprednisolone on heart rate variability, sleeping pattern, glucose homeostasis and immune signaling in patients undergoing total hip-arthroplasty |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age 55-80 years
- Osteoarthrosis scheduled for primary unilateral hip-arthroplasty
- Speak and understand Danish |
|
E.4 | Principal exclusion criteria |
- Allergy towards methylprednisolone
- Scheduled for hip revision or bilateral surgery
- Infection (local or systemic)
- General anaesthesia
- Current use of steroids
- Insulin treated diabetes
- Atrial fibrillation
- Neurological disease incl. Parkinsons
- Daily use of hypnotics and sedativas
- Treatment for ulcus <3 months preoperatively
- Cancer disease
- Alcohol abuse (>35 units per week)
- Autoimmune disease
- Pregnant or breast feeding women
- Menopause <1 year |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in the systolic arterial bloodpressure from baseline (before surgery) to 6 hours postoperatively |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
A. Change in blood pressure, cardiac output, stroke volume and systemic vascular resistance and incidence of orthostatic intolerance form baseline to 6 and 24 hours postoperatively
B. Change in heart rate variability (HRV) from baseline to 24 hours postoperatively
C. Change in sleeping pattern and sleeping quality from baseline to the 1st morning postoperatively
D. Change in blood glucose levels from baseline to 48 hours postoperatively
E. Change in immune cell signaling from baseline to 14 days postoperatively |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
A+B+C. 24 hours postoperatively
D. 48 hours postoperatively
E. 14 days postoperatively |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |