Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003565-33 | Other Identifier | 2018-003565-33 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The assessment consists in comparing corticoids injection versus placebo in surgery of lower limb fractures The aim of study is to assess (state cutaneous, efficacy, safety) corticoids injection on a prospective, randomized analysis
One of the major problems of below-knee fractures is edema (delaying surgery time and post-operative complications for healing).
The effect corticosteroids (anti-edema and anti-inflammatory) is used in neurosurgery and maxillofacial surgery.
So, it seemed judicious to evaluate the effectiveness of corticosteroids in bolus preoperatively in order to limit the importance of the edema before intervention to prevent adverse effect of the edema on the cicatrization.
This study will aim to confirm this indication or not on the contrary to change current practices.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm "Injection corticosteroids" | Experimental | Single dose of Solumedrol 2 mg/kg |
|
| Arm " injection physiological serum" | Placebo Comparator | Single dose of physilogical serum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| leg fracture | Procedure | Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug) or physiological serum |
|
| Measure | Description | Time Frame |
|---|---|---|
| leg perimeter | measure of leg perimeter at the fractured area compared to the contralateral side | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| leg perimeter | measure of leg perimeter at the fractured area compared to the contralateral side | 15 days |
| leg perimeter | measure of leg perimeter at the fractured area compared to the contralateral side |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stéphane Boisgard | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63000 | France |
Not provided
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D050723 | Fractures, Bone |
| D004487 | Edema |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Solumedrol (steroidal anti-inflammatory drug) injection
Not provided
Not provided
double blinded
| 7 days |
| pain leg | THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10) | preoperative |
| pain leg | THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10) | 2 days |
| pain leg | THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10) | 7 days |
| pain leg | THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10) | 15 days |
| pain leg | THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10) | 45 days |
| pain leg | THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10) | 3 months |
| pain leg | THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10) | 6 months |
| State cutaneous | index form of follow-up the state cutaneous of the wound | 7 days |
| State cutaneous | index form of follow-up the state cutaneous of the wound | 15 days |
| Lower limb functional scale (EFMI) | The Lower limb functional scale grading system uses 100 points to assess pain, function and mobility of the leg. The score varies between 0 and 100, more the value is better brought up is the score | 6 months |
| Complications | list of the complications : Phlyctenes, scar disunity, cutaneous necrosis, infection, phlebitis, compartment syndrome, complex regional pain syndrome, delay of bone consolidation | 6 months |