NCT03915223 - Soft Part Management for Surgical Fractures of the Lower Limb | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

104

Conditions

Leg Injuries Fracture Edema

Interventions

leg fracturePROCEDURE

Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug) or physiological serum

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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,

Locations (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Outcomes

Primary Outcomes

leg perimeter

measure of leg perimeter at the fractured area compared to the contralateral side

Time frame: 2 days

Secondary Outcomes

leg perimeter

measure of leg perimeter at the fractured area compared to the contralateral side

Time frame: 15 days

leg perimeter

measure of leg perimeter at the fractured area compared to the contralateral side

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)