Interest of Preoperative Corticosteroid Therapy for Surgical Fractures of the Lower Limb
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Leg Injuries
- Sponsor
- University Hospital, Clermont-Ferrand
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- leg perimeter
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
leg perimeter
Time Frame: 2 days
measure of leg perimeter at the fractured area compared to the contralateral side
Secondary Outcomes
- Lower limb functional scale (EFMI)(6 months)
- leg perimeter(7 days)
- pain leg(6 months)
- State cutaneous(15 days)
- Complications(6 months)