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

Interest of Preoperative Corticosteroid Therapy for Surgical Fractures of the Lower Limb

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

Study Overview

• Status: Completed
• Conditions: Leg Injuries; Edema; Fracture
• Intervention / Treatment: Procedure: leg fracture

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm "Injection corticosteroids"; Single dose of Solumedrol 2 mg/kg	Procedure: leg fracture; Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug) or physiological serum
Placebo Comparator: Arm " injection physiological serum"; Single dose of physilogical serum	Procedure: leg fracture; Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug) or physiological serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
leg perimeter	measure of leg perimeter at the fractured area compared to the contralateral side	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
leg perimeter	measure of leg perimeter at the fractured area compared to the contralateral side	15 days
leg perimeter	measure of leg perimeter at the fractured area compared to the contralateral side	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)	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)	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)	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)	15 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)	45 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)	3 months
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)	6 months
State cutaneous	index form of follow-up the state cutaneous of the wound	7 days
State cutaneous	index form of follow-up the state cutaneous of the wound	15 days
Lower limb functional scale (EFMI)	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	6 months
Complications	list of the complications : Phlyctenes, scar disunity, cutaneous necrosis, infection, phlebitis, compartment syndrome, complex regional pain syndrome, delay of bone consolidation	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Stéphane Boisgard, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Actual): December 25, 2023
• Study Completion (Actual): May 6, 2024

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: corticosteroids; osteosynthesis; preoperative procedure; leg fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Leg Injuries
• Other Study ID Numbers: RBHP 2018 BOISGARD; 2018-003565-33 (Other Identifier: 2018-003565-33)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No