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

Primary Purpose

Leg Injuries, Fracture, Edema

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
leg fracture
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Injuries focused on measuring preoperative procedure, leg fractures, osteosynthesis, corticosteroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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,

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm "Injection corticosteroids"

Arm " injection physiological serum"

Arm Description

Single dose of Solumedrol 2 mg/kg

Single dose of physilogical serum

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

leg perimeter
measure of leg perimeter at the fractured area compared to the contralateral side
leg perimeter
measure of leg perimeter at the fractured area compared to the contralateral side
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)
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)
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)
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)
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)
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)
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)
State cutaneous
index form of follow-up the state cutaneous of the wound
State cutaneous
index form of follow-up the state cutaneous of the wound
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
Complications
list of the complications : Phlyctenes, scar disunity, cutaneous necrosis, infection, phlebitis, compartment syndrome, complex regional pain syndrome, delay of bone consolidation

Full Information

First Posted
April 4, 2019
Last Updated
May 10, 2022
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03915223
Brief Title
Soft Part Management for Surgical Fractures of the Lower Limb
Acronym
ICOMI
Official Title
Interest of Preoperative Corticosteroid Therapy for Surgical Fractures of the Lower Limb
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Injuries, Fracture, Edema
Keywords
preoperative procedure, leg fractures, osteosynthesis, corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Solumedrol (steroidal anti-inflammatory drug) injection
Masking
ParticipantInvestigator
Masking Description
double blinded
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm "Injection corticosteroids"
Arm Type
Experimental
Arm Description
Single dose of Solumedrol 2 mg/kg
Arm Title
Arm " injection physiological serum"
Arm Type
Placebo Comparator
Arm Description
Single dose of physilogical serum
Intervention Type
Procedure
Intervention Name(s)
leg fracture
Intervention Description
Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug) or physiological serum
Primary Outcome Measure Information:
Title
leg perimeter
Description
measure of leg perimeter at the fractured area compared to the contralateral side
Time Frame
2 days
Secondary Outcome Measure Information:
Title
leg perimeter
Description
measure of leg perimeter at the fractured area compared to the contralateral side
Time Frame
15 days
Title
leg perimeter
Description
measure of leg perimeter at the fractured area compared to the contralateral side
Time Frame
7 days
Title
pain leg
Description
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
Title
pain leg
Description
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
Title
pain leg
Description
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
Title
pain leg
Description
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
15 days
Title
pain leg
Description
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
45 days
Title
pain leg
Description
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
3 months
Title
pain leg
Description
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
6 months
Title
State cutaneous
Description
index form of follow-up the state cutaneous of the wound
Time Frame
7 days
Title
State cutaneous
Description
index form of follow-up the state cutaneous of the wound
Time Frame
15 days
Title
Lower limb functional scale (EFMI)
Description
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
Time Frame
6 months
Title
Complications
Description
list of the complications : Phlyctenes, scar disunity, cutaneous necrosis, infection, phlebitis, compartment syndrome, complex regional pain syndrome, delay of bone consolidation
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lise Laclautre
Phone
+334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Boisgard
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise laclautre
Email
promo_interne_drci@chu-clermontferrand.fr

12. IPD Sharing Statement

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Soft Part Management for Surgical Fractures of the Lower Limb

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