ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures

NCT ID: NCT05528432

Last Updated: 2022-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-09-30

Brief Summary

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To investigate the diagnostic value of ultrasound performed by a lay experimenter compared to standard radiographic imaging (or standard x-ray) in the detection of fractures in patients with closed acute ankle trauma and positive Ottawa ankle rules

Detailed Description

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Selection of patients is according to the criteria detailed below. If the patient is deemed eligible for the study, he will be asked to read and sign the informed consent. Besides standard history taking, physical examination and radiographic imaging, a standardized ultrasound examination of the ankle joint will be performed by a lay experimenter.

Care will be provided by the attending physician and, according to "standard of care", treatment decisions will be based on history taking, physical examination and conventional ankle x-ray series. Sonographic results will not be used for this purpose. All ankle x-ray series will be reviewed by a senior resident radiologist.

Conditions

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Fractures Bone

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Any adult patient with acute ankle trauma

\+ one or more criteria of the Ottawa ankle rules :

* Inability to walk 4 steps immediately after the trauma or in the emergency room,
* pain at the level of the internal or external malleolus (the distal 6 cm) or the base of the 5th metatarsal bone.

Exclusion Criteria

* Any patient under the age of 18 years
* Any patient unable to sign the informed consent
* Skin lesions contraindicating sonography (e.g. open fracture wound, … )
* An unstable patient whose inclusion in the study would delay vital treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laeticia Vaiana FL Frezals, Médecin

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Saint Pierre

Locations

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FREZALS Laeticia Vaiana

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Laeticia Vaiana FL Frezals, Médecin

Role: CONTACT

0493481204 ext. 0032

Alain PA Plumacker, Médecin

Role: CONTACT

Facility Contacts

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Laeticia Vaiana FL Frezals, Médecin

Role: primary

02493481204 ext. 0032

Alain PA Plumacker, Médecin

Role: backup

References

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Bozkurt O, Ersel M, Karbek Akarca F, Yalcinli S, Midik S, Kucuk L. The diagnostic accuracy of ultrasonography in determining the reduction success of distal radius fractures. Turk J Emerg Med. 2018 Aug 10;18(3):111-118. doi: 10.1016/j.tjem.2018.04.001. eCollection 2018 Sep.

Reference Type RESULT
PMID: 30191190 (View on PubMed)

Frezals LV, Delafontaine A, Scoubeau H, Sontou R, Moorthamers S, Plumacker A, Plumacker A. Diagnostic value of FAST ankle ultrasound compared to standard radiography for fracture detection in the emergency department by non-radiologist physicians: a monocentric prospective diagnostic cohort study. Eur J Trauma Emerg Surg. 2025 Feb 14;51(1):107. doi: 10.1007/s00068-025-02772-3.

Reference Type DERIVED
PMID: 39953135 (View on PubMed)

Related Links

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https://doi.org/10.1007/s00068-018-01069-y

Ferràs-Tarragó, J., Antequera-Cano, J.M., Català-de-las-Marinas, J. et al. Ankle torque-related fractures and its echo-fast diagnosis protocol. Eur J Trauma Emerg Surg 46, 801-805 (2020)

https://doi.org/10.1007/s40279-013-0102-5

Doherty, C., Delahunt, E., Caulfield, B. et al. The Incidence and Prevalence of Ankle Sprain Injury: A Systematic Review and Meta-Analysis of Prospective Epidemiological Studies. Sports Med 44, 123-140 (2014)

https://doi.org/10.1186/s12873-019-0226-5

Champagne N, Eadie L, Regan L, Wilson P. The effectiveness of ultrasound in the detection of fractures in adults with suspected upper or lower limb injury: a systematic review and subgroup meta-analysis. BMC Emergency Medicine 2019;19

https://doi.org/10.1186/s12873-019-0226-5

Nelson BP, Chason K. Use of ultrasound by emergency medical services: a review. International Journal of Emergency Medicine 2008 12;1(4):253-259

Other Identifiers

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CE-21-02-21

Identifier Type: -

Identifier Source: org_study_id

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