Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-24 @ 1:33 PM
Study NCT ID:
NCT05528432
Status:
UNKNOWN
Last Update Posted:
2022-09-08
First Post:
2022-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D064386', 'term': 'Ankle Fractures'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-05', 'studyFirstSubmitDate': '2022-08-30', 'studyFirstSubmitQcDate': '2022-08-31', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Negative predictive value', 'timeFrame': 'at inclusion', 'description': 'Negative predictive value of ultrasound compared to standard radiography in the detection of long bone fractures'}], 'secondaryOutcomes': [{'measure': 'Sensitivity', 'timeFrame': 'at inclusion', 'description': 'of ultrasound compared to standard radiography in the detection of long bone fractures'}, {'measure': 'Specificity', 'timeFrame': 'at inclusion', 'description': 'of ultrasound compared to standard radiography in the detection of long bone fractures'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fracture ankle', 'Fracture foot', 'Frature metatarsus', 'Ultrasound', 'X-ray'], 'conditions': ['Fractures Bone']}, 'referencesModule': {'references': [{'pmid': '30191190', 'type': 'RESULT', 'citation': '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': '39953135', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1007/s00068-018-01069-y', 'label': '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)'}, {'url': 'https://doi.org/10.1007/s40279-013-0102-5', 'label': '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)'}, {'url': 'https://doi.org/10.1186/s12873-019-0226-5', 'label': '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'}, {'url': 'https://doi.org/10.1186/s12873-019-0226-5', 'label': 'Nelson BP, Chason K. Use of ultrasound by emergency medical services: a review. International Journal of Emergency Medicine 2008 12;1(4):253-259'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nCare 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any adult patient presenting to the emergency services of the CHU Saint Pierre', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAny adult patient with acute ankle trauma\n\n\\+ one or more criteria of the Ottawa ankle rules :\n\n* Inability to walk 4 steps immediately after the trauma or in the emergency room,\n* pain at the level of the internal or external malleolus (the distal 6 cm) or the base of the 5th metatarsal bone.\n\nExclusion Criteria:\n\n* Any patient under the age of 18 years\n* Any patient unable to sign the informed consent\n* Skin lesions contraindicating sonography (e.g. open fracture wound, … )\n* An unstable patient whose inclusion in the study would delay vital treatment'}, 'identificationModule': {'nctId': 'NCT05528432', 'briefTitle': 'ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Saint Pierre'}, 'officialTitle': 'ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures', 'orgStudyIdInfo': {'id': 'CE-21-02-21'}}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Laeticia Vaiana FL Frezals, Médecin', 'role': 'CONTACT', 'email': 'laeticia.frezals@gmail.com', 'phone': '02493481204', 'phoneExt': '0032'}, {'name': 'Alain PA Plumacker, Médecin', 'role': 'CONTACT', 'email': 'alain.plumacker@stpierre-bru.be'}, {'name': 'Laeticia FL Frezals, Médecin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'FREZALS Laeticia Vaiana', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Laeticia Vaiana FL Frezals, Médecin', 'role': 'CONTACT', 'email': 'laeticia.frezals@gmail.com', 'phone': '0493481204', 'phoneExt': '0032'}, {'name': 'Alain PA Plumacker, Médecin', 'role': 'CONTACT', 'email': 'alain.plumacker@stpierre-bru.be'}], 'overallOfficials': [{'name': 'Laeticia Vaiana FL Frezals, Médecin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Saint Pierre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Saint Pierre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}