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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915223
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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

Condition or disease Intervention/treatment Phase
Leg Injuries Fracture Edema Drug: Solumedrol (steroidal anti-inflammatory drug) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Solumedrol (steroidal anti-inflammatory drug) injection
Masking: Double (Participant, Investigator)
Masking Description: double blinded
Primary Purpose: Treatment
Official Title: Interest of Preoperative Corticosteroid Therapy for Surgical Fractures of the Lower Limb
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : May 10, 2021
Estimated Study Completion Date : May 10, 2022


Arm Intervention/treatment
Experimental: Arm "Injection corticosteroids"
Single dose of Solumedrol 2 mg/kg
Drug: Solumedrol (steroidal anti-inflammatory drug)
Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug)

Placebo Comparator: Arm " injection physiological serum"
Single dose of physilogical serum
Drug: Solumedrol (steroidal anti-inflammatory drug)
Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug)




Primary Outcome Measures :
  1. leg perimeter [ Time Frame: 15 days ]
    measure of leg perimeter at the fractured area compared to the contralateral side


Secondary Outcome Measures :
  1. leg perimeter [ Time Frame: 2 days ]
    measure of leg perimeter at the fractured area compared to the contralateral side

  2. leg perimeter [ Time Frame: 7 days ]
    measure of leg perimeter at the fractured area compared to the contralateral side

  3. pain leg [ Time Frame: preoperative ]
    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)

  4. pain leg [ Time Frame: 2 days ]
    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)

  5. pain leg [ Time Frame: 7 days ]
    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. pain leg [ Time Frame: 15 days ]
    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. pain leg [ Time Frame: 45 days ]
    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)

  8. pain leg [ Time Frame: 3 months ]
    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)

  9. pain leg [ Time Frame: 6 months ]
    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)

  10. State cutaneous [ Time Frame: 7 days ]
    index form of follow-up the state cutaneous of the wound

  11. State cutaneous [ Time Frame: 15 days ]
    index form of follow-up the state cutaneous of the wound

  12. Lower limb functional scale (EFMI) [ Time Frame: 6 months ]
    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

  13. Complications [ Time Frame: 6 months ]
    list of the complications : Phlyctenes, scar disunity, cutaneous necrosis, infection, phlebitis, compartment syndrome, complex regional pain syndrome, delay of bone consolidation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915223


Contacts
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Contact: lise Laclautre +334.73.754.963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63000
Contact: Lise laclautre       promo_interne_drci@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Stéphane Boisgard University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03915223    
Other Study ID Numbers: RBHP 2018 BOISGARD
2018-003565-33 ( Other Identifier: 2018-003565-33 )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
preoperative procedure
leg fractures
osteosynthesis
corticosteroids
Additional relevant MeSH terms:
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Fractures, Bone
Leg Injuries
Wounds and Injuries
Anti-Inflammatory Agents
Methylprednisolone Hemisuccinate
Methylprednisolone Acetate
Methylprednisolone
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents