Soft Part Management for Surgical Fractures of the Lower Limb

Not Applicable

Completed

• Conditions: Fracture; Edema; Leg Injuries
• Interventions: Procedure: leg fracture

• Registration Number: NCT03915223
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-16
• Study Start: 2019-05-10
• Primary Completion: 2023-12-25
• Status Verified: 2024-05
• Study Completion: 2024-05-06
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm " injection physiological serum"	leg fracture	Single dose of physilogical serum
Arm "Injection corticosteroids"	leg fracture	Single dose of Solumedrol 2 mg/kg

Primary Outcome Measures

Name	Time	Method
leg perimeter	2 days	measure of leg perimeter at the fractured area compared to the contralateral side

Secondary Outcome Measures

Name	Time	Method
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
leg perimeter	7 days	measure of leg perimeter at the fractured area compared to the contralateral side
pain leg	6 months	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	15 days	index form of follow-up the state cutaneous of the wound
Complications	6 months	list of the complications : Phlyctenes, scar disunity, cutaneous necrosis, infection, phlebitis, compartment syndrome, complex regional pain syndrome, delay of bone consolidation

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France