Soft Part Management for Surgical Fractures of the Lower Limb

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Interest of Preoperative Corticosteroid Therapy for Surgical Fractures of the Lower Limb

Conditions
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Fracture, Leg Injuries, Edema

Intervention / Treatment
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* Procedure: leg fracture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient over the age of 18, hospitalized in the Orthopedics Department for a leg fracture (ankle, tibia: proximal, diaphysis, distal) requiring surgery within 72 hours of the trauma Patient covered by the social security system Patient giving informed consent Exclusion Criteria: Open fracture with infectious risks cauchoix 2 and 3 Multiple trauma, Pathological fracture on primary or secondary lesions, Pre-existing bone disease (excluding osteoporosis) of the operated limb, Diabetes, Pre-existing trophic disorders on one of the 2 lower limbs, Long-term corticotherapy, Pathology of the pituitary-adrenal axis, Any other contraindication to glucocorticoids: any infectious condition, some developing viral diseases (including hepatitis, herpes, chicken pox, shingles), hypersensitivity to one of the constituents Hypernatremia and hypochloremia Pre-existing severe cardiac injury Contraindication to TegadermTM Patient placed under guardianship, tutorship or safeguard of justice, Pregnant or lactating women,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Solumedrol (steroidal anti-inflammatory drug) injection
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm Injection corticosteroids<br>Single dose of Solumedrol 2 mg/kg | Procedure: leg fracture<br>* Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug) or physiological serum<br>|
| Placebo Comparator: Arm  injection physiological serum<br>Single dose of physilogical serum | Procedure: leg fracture<br>* Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug) or physiological serum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| leg perimeter | measure of leg perimeter at the fractured area compared to the contralateral side | 2 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preoperative procedure, leg fractures, osteosynthesis, corticosteroids