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Evaluation of the Benefits of Ultrasound in Improving the Diagnosis and Management of Injuries the Child's Ankle (ANKLE)

U

University Hospital, Lille

Status

Terminated

Conditions

Ankle Trauma

Treatments

Radiation: Member MRI
Radiation: ankle ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT03507972
2015-A01127-42 (Other Identifier)
2014_35

Details and patient eligibility

About

Evaluate ankle's ultrasound contribution in the accuracy of ankle's diagnosis of traumatic injuries (objectivated by reference's examination : ankle's MRI)

Enrollment

97 patients

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 5 years and < 18 years
  • Isolated's trauma from one or both ankles
  • First-line consultation for pediatrics emergencies at the University Hospital of Lille
  • Informed and written consent of the holders of parental authority

Exclusion criteria

  • Age < 5 years and ≥ 18 years
  • History of trauma of the same ankle dating from less than 3 month
  • History of surgery of this same ankle
  • Constitutional or acquired bone disease
  • Associated trauma affecting another anatomical region than the ankle or midfoot
  • Polytrauma (presence of several traumas including at least one endangers vital functions)
  • Associated wound requiring surgical exploration
  • initial management of this trauma in another center
  • Non affiliation to a social security scheme

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

97 participants in 1 patient group

Ankle ultrasound & ankle MRI
Other group
Description:
Ankle ultrasound performed on the day of emergency consultation member MRI (without injection of contrast products) performed within 7 days following the trauma
Treatment:
Radiation: ankle ultrasound
Radiation: Member MRI

Trial contacts and locations

1

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Central trial contact

François Dubos, MD

Data sourced from clinicaltrials.gov

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