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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-41-3784 | |||
| 2612-3916 | |||
| EudraCT: 2008-006528-67 |
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| Name | Class |
|---|---|
| Lundbeck Foundation | OTHER |
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The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after hip arthroplasty.
The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce time to fulfill discharge criteria.
In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. The investigators therefore decided to evaluate the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome in a well defined fast-track setup after hip arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone | Active Comparator | Methylprednisolone 125 mg iv pre-operatively |
|
| Saline | Placebo Comparator | Saline iv pre-operatively in equivalent volume (placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | Methylprednisolone 125 mg iv pre-operatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to fulfill discharge criteria | At discharge (mean 1-2 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Hand muscle strength | 24 hours | |
| Sleeping quality on the visual analog scale | up to four days | |
| Inflammatory response measured as CRP in blood sample |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre University Hospital | Copenhagen | Hvidovre | 2650 | Denmark |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| 24 hours postoperatively |
| Fatigue measured on a 10 point numeric range scale | up to four days |
| Additional analgetics, antinausea agents and sleeping medicine. | Measures as mg (analgetics) and daily use (yes or no)(antinausea agents and sleeping medicine). | up to four days |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | up to 30 days |
| Postoperative pain scores on the visual analog scale | up 30 days |
| Postoperative nausea and vomiting (PONV) on 4 point numeric range scale | up to 4 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |