Leg InjuriesICOMINCT03915223
Soft Part Management for Surgical Fractures of the Lower Limb
A study testing leg fracture in people with Leg Injuries and Fracture, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Injuries, Fracture, Edema
- What is being tested?
- leg fracture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2019to 6 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 14Show fewer
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Leg Injuries, Fracture, Edema
- Being tested
- leg fracture
- Keywords
- preoperative procedure, leg fractures, osteosynthesis, corticosteroids
- Medical subject headings
- Leg Injuries, Fractures, Bone, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leg fractureProcedure or surgery
Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug) or physiological serum
| Study group | Role | What they receive |
|---|---|---|
| Arm "Injection corticosteroids" | Experimental | Single dose of Solumedrol 2 mg/kg Receives: Procedure: leg fracture |
| Arm " injection physiological serum" | Placebo comparator | Single dose of physilogical serum Receives: Procedure: leg fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
leg perimeter
measure of leg perimeter at the fractured area compared to the contralateral side
Measured: 2 days
Secondary outcomes (13)
leg perimeter
measure of leg perimeter at the fractured area compared to the contralateral side
Measured: 15 days
leg perimeter
measure of leg perimeter at the fractured area compared to the contralateral side
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 6 months
State cutaneous
index form of follow-up the state cutaneous of the wound
Measured: 7 days
State cutaneous
index form of follow-up the state cutaneous of the wound
Measured: 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
Measured: 6 months
Complications
list of the complications : Phlyctenes, scar disunity, cutaneous necrosis, infection, phlebitis, compartment syndrome, complex regional pain syndrome, delay of bone consolidation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start10 May 2019
- Primary completion25 Dec 2023
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leg InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Solumedrol (steroidal anti-inflammatory drug) injection
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Boisgard, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915223
- Sponsor's protocol ID
- RBHP 2018 BOISGARD
- Other IDs
- 2018-003565-33, 2018
- Acronym
- ICOMI
- Status last verified
- Aug 2026
- First submitted
- 4 Apr 2019
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fassot G, Villatte G, Descamps S, Monadjemi S, Galvin M, Pereira B, Boisgard S, Erivan R. The influence of preoperative methylprednisolone bolus on edema in lower leg fractures: A prospective randomized controlled trial. Orthop Traumatol Surg Res. 2025 Nov;111(7):104304. doi: 10.1016/j.otsr.2025.104304. Epub 2025 May 23.
PubMed 40414492
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Preoperative Corticosteroid Therapy for Surgical Fractures of the Lower Limb
- ClinicalTrials.gov ID
- NCT03915223
- Acronym / sponsor ID
- ICOMI / RBHP 2018 BOISGARD
- Conditions
- Leg Injuries, Fracture, Edema
- Keywords
- preoperative procedure, leg fractures, osteosynthesis, corticosteroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Solumedrol (steroidal anti-inflammatory drug) injection
| Arm | Type | Receives |
|---|---|---|
| Arm "Injection corticosteroids" | Experimental | Procedure: leg fractureSingle dose of Solumedrol 2 mg/kg |
| Arm " injection physiological serum" | Placebo comparator | Procedure: leg fractureSingle dose of physilogical serum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| leg fractureSurgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug) or physiological serum | Procedure or surgery | Arm " injection physiological serum", Arm "Injection corticosteroids" |
Primary outcome
leg perimeter
Time frame: 2 days
measure of leg perimeter at the fractured area compared to the contralateral side
13 secondary outcomes
leg perimeter
Time frame: 15 days
leg perimeter
Time frame: 7 days
pain leg
Time frame: preoperative
pain leg
Time frame: 2 days
pain leg
Time frame: 7 days
pain leg
Time frame: 15 days
pain leg
Time frame: 45 days
pain leg
Time frame: 3 months
pain leg
Time frame: 6 months
State cutaneous
Time frame: 7 days
State cutaneous
Time frame: 15 days
Lower limb functional scale (EFMI)
Time frame: 6 months
Complications
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Results publication: PubMed 40414492Fassot G, Villatte G, Descamps S, Monadjemi S, Galvin M, Pereira B, Boisgard S, Erivan R. The influence of preoperative methylprednisolone bolus on edema in lower leg fractures: A prospective randomized controlled trial. Orthop Traumatol Surg Res. 2025 Nov;111(7):104304. doi: 10.1016/j.otsr.2025.104304. Epub 2025 May 23.
Related trials for Leg Injuries
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Boisgard principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing leg fracture in people with Leg Injuries and Fracture, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
leg perimeter (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03915223, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.