Edema, Fracture, Leg Injuries
Conditions
Keywords
preoperative procedure, leg fractures, osteosynthesis, corticosteroids
Brief summary
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
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.
Interventions
PROCEDUREleg fracture
Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug) or physiological serum
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double blinded
Intervention model description
Solumedrol (steroidal anti-inflammatory drug) injection
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| leg perimeter | 2 days | measure of leg perimeter at the fractured area compared to the contralateral side |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| leg perimeter | 15 days | measure of leg perimeter at the fractured area compared to the contralateral side |
| pain leg | preoperative | 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) |
| State cutaneous | 7 days | index form of follow-up the state cutaneous of the wound |
| Lower limb functional scale (EFMI) | 6 months | 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 |
| Complications | 6 months | list of the complications : Phlyctenes, scar disunity, cutaneous necrosis, infection, phlebitis, compartment syndrome, complex regional pain syndrome, delay of bone consolidation |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORStéphane Boisgard
University Hospital, Clermont-Ferrand
Outcome results
None listed