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

NCT05528432 | Unknown DMC

• 1 other identifier: CE-21-02-21
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fractures Bone

Keywords

Fracture ankle; Fracture foot; Frature metatarsus; Ultrasound; X-ray

Outcome Measures

Primary Outcomes (1)

• Negative predictive value

  Negative predictive value of ultrasound compared to standard radiography in the detection of long bone fractures

  at inclusion

Secondary Outcomes (2)

• Sensitivity

  at inclusion

• Specificity

  at inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any adult patient presenting to the emergency services of the CHU Saint Pierre

You may qualify if:

• 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.

You may not qualify if:

• 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, … )

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

FREZALS Laeticia Vaiana

Brussels, 1000, Belgium

RECRUITING

Related Publications (2)

• 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.

  PMID: 30191190 RESULT

• 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.

  PMID: 39953135 DERIVED

Related Links

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

MeSH Terms

Conditions

Fractures, Bone; Ankle Fractures

Condition Hierarchy (Ancestors)

Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Officials

• Laeticia Vaiana FL Frezals, Médecin

  Centre Hospitalier Universitaire Saint Pierre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laeticia Vaiana FL Frezals, Médecin

CONTACT

0493481204; laeticia.frezals@gmail.com

Alain PA Plumacker, Médecin

CONTACT

alain.plumacker@stpierre-bru.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 6, 2022
• Study Start: February 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-08

Locations

BE (1)