Interest of Preoperative Corticosteroid Therapy for Surgical Fractures of the Lower Limb
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- leg perimeter
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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,
研究组 & 干预措施
Arm "Injection corticosteroids"
Single dose of Solumedrol 2 mg/kg
干预措施: leg fracture (Procedure)
Arm " injection physiological serum"
Single dose of physilogical serum
干预措施: leg fracture (Procedure)
结局指标
主要结局
leg perimeter
时间窗: 2 days
measure of leg perimeter at the fractured area compared to the contralateral side
次要结局
- Lower limb functional scale (EFMI)(6 months)
- leg perimeter(7 days)
- pain leg(6 months)
- State cutaneous(15 days)
- Complications(6 months)