Soft Part Management for Surgical Fractures of the Lower Limb

Fracture Clinical Trial

— ICOMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03915223
• Other study ID #: RBHP 2018 BOISGARD
• Secondary ID: 2018-003565-33
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: May 6, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: May 6, 2024
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Edema
• Fracture
• Fractures, Bone
• Leg Injuries

Intervention

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

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	leg perimeter	measure of leg perimeter at the fractured area compared to the contralateral side	2 days
Secondary	leg perimeter	measure of leg perimeter at the fractured area compared to the contralateral side	15 days
Secondary	leg perimeter	measure of leg perimeter at the fractured area compared to the contralateral side	7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	State cutaneous	index form of follow-up the state cutaneous of the wound	7 days
Secondary	State cutaneous	index form of follow-up the state cutaneous of the wound	15 days
Secondary	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
Secondary	Complications	list of the complications : Phlyctenes, scar disunity, cutaneous necrosis, infection, phlebitis, compartment syndrome, complex regional pain syndrome, delay of bone consolidation	6 months