Clinical trial NCT03915223: Soft Part Management for Surgical Fractures of the Lower Limb
Official title: Interest of Preoperative Corticosteroid Therapy for Surgical Fractures of the Lower Limb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Injuries
Fracture
Edema
Keywords: preoperative procedure
leg fractures
osteosynthesis
corticosteroids
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Solumedrol (steroidal anti-inflammatory drug) injection
Primary purpose: TREATMENT

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.

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,

Primary outcomes:
measure: leg perimeter
timeFrame: 2 days
Secondary outcomes:
measure: leg perimeter
timeFrame: 15 days
measure: leg perimeter
timeFrame: 7 days
measure: pain leg
timeFrame: preoperative
measure: pain leg
timeFrame: 2 days
measure: pain leg
timeFrame: 7 days
measure: pain leg
timeFrame: 15 days
measure: pain leg
timeFrame: 45 days
measure: pain leg
timeFrame: 3 months
measure: pain leg
timeFrame: 6 months
measure: State cutaneous
timeFrame: 7 days
measure: State cutaneous
timeFrame: 15 days
measure: Lower limb functional scale (EFMI)
timeFrame: 6 months
measure: Complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Stéphane Boisgard
role: PRINCIPAL_INVESTIGATOR
References: