Soft Part Management for Surgical Fractures of the Lower Limb (ICOMI)

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Edema; Leg Injuries; Fracture

Treatments: Procedure: leg fracture

Study type: Interventional

Funder types: Other

Identifiers

NCT03915223

RBHP 2018 BOISGARD

2018-003565-33 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 2 patient groups, including a placebo group

Arm "Injection corticosteroids"

Experimental group

Description:

Single dose of Solumedrol 2 mg/kg

Treatment:

Procedure: leg fracture

Arm " injection physiological serum"

Placebo Comparator group

Description:

Single dose of physilogical serum

Treatment:

Procedure: leg fracture