Soft Part Management for Surgical Fractures of the Lower Limb
ICOMI
Interest of Preoperative Corticosteroid Therapy for Surgical Fractures of the Lower Limb
2 other identifiers
interventional
104
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedStudy Start
First participant enrolled
May 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2024
CompletedMay 8, 2024
May 1, 2024
4.6 years
April 4, 2019
May 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
leg perimeter
measure of leg perimeter at the fractured area compared to the contralateral side
2 days
Secondary Outcomes (13)
leg perimeter
15 days
leg perimeter
7 days
pain leg
preoperative
pain leg
2 days
pain leg
7 days
- +8 more secondary outcomes
Study Arms (2)
Arm "Injection corticosteroids"
EXPERIMENTALSingle dose of Solumedrol 2 mg/kg
Arm " injection physiological serum"
PLACEBO COMPARATORSingle dose of physilogical serum
Interventions
Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug) or physiological serum
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stéphane Boisgard
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- double blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2019
First Posted
April 16, 2019
Study Start
May 10, 2019
Primary Completion
December 25, 2023
Study Completion
May 6, 2024
Last Updated
May 8, 2024
Record last verified: 2024-05