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

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

Study Overview

• Status: Recruiting
• Conditions: Fractures Bone

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Laeticia Vaiana FL Frezals, Médecin; Phone Number: 0032 0493481204; Email: laeticia.frezals@gmail.com
• Study Contact Backup: Name: Alain PA Plumacker, Médecin; Email: alain.plumacker@stpierre-bru.be

Study Locations

• Belgium
  • Bruxelles, Belgium, 1000
    • Recruiting
    • FREZALS Laeticia Vaiana
    • Contact: Alain PA Plumacker, Médecin; Email: alain.plumacker@stpierre-bru.be
    • Contact: Laeticia Vaiana FL Frezals, Médecin; Phone Number: 0032 02493481204; Email: laeticia.frezals@gmail.com
    • Principal Investigator: Laeticia FL Frezals, Médecin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative predictive value	Negative predictive value of ultrasound compared to standard radiography in the detection of long bone fractures	at inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	of ultrasound compared to standard radiography in the detection of long bone fractures	at inclusion
Specificity	of ultrasound compared to standard radiography in the detection of long bone fractures	at inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Saint Pierre
• Investigators: Principal Investigator: Laeticia Vaiana FL Frezals, Médecin, Centre Hospitalier Universitaire Saint Pierre

Publications and helpful links

General Publications

• 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.

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasound; X-ray; Fracture ankle; Fracture foot; Frature metatarsus
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: CE-21-02-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No