Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-02-03 @ 1:52 AM
Study NCT ID:
NCT03621150
Status:
UNKNOWN
Last Update Posted:
2018-08-08
First Post:
2018-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Ultrasound in Evaluation of Tendo-ligamentous Ankle Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052256', 'term': 'Tendinopathy'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-08-07', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of ankle tendi-ligamentous injury by dynamic ultrasound and MRI', 'timeFrame': '1 month', 'description': 'Approximately 85%of anke tendo-ligamentous injuries are due to inversion forces and, therefore involve the lateral collateral ligamentous complex.\n\n* Grade I sprain is a mild injury limited to microtears and stretching of the ligaments.\n* Grade II sprains are partial macroscopic tears\n* Grade III sprains the ligament has ruptured completely.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mri', 'musculoskeletal ultrasound', 'tendinopathy'], 'conditions': ['Tendinoligamentous Injury of the Ankle']}, 'referencesModule': {'references': [{'pmid': '16247724', 'type': 'BACKGROUND', 'citation': 'Bianchi S, Martinoli C, Gaignot C, De Gautard R, Meyer JM. Ultrasound of the ankle: anatomy of the tendons, bursae, and ligaments. Semin Musculoskelet Radiol. 2005 Sep;9(3):243-59. doi: 10.1055/s-2005-921943.'}, {'pmid': '18095247', 'type': 'BACKGROUND', 'citation': 'Khoury V, Guillin R, Dhanju J, Cardinal E. Ultrasound of ankle and foot: overuse and sports injuries. Semin Musculoskelet Radiol. 2007 Jun;11(2):149-61. doi: 10.1055/s-2007-1001880.'}]}, 'descriptionModule': {'briefSummary': 'Several imaging modalities, such as computed tomography, magnetic resonance imaging, and ultrasound (US) can be used to evaluate the ankle. However, US has several benefits for the evaluation of the tendons and ligaments of the ankle, such as its suitability to be integrated with a dynamic assessment and a stress test, its ability to provide real-time analysis, its avoidance of the risk of radiation exposure, and its cost-effectiveness. US is especially powerful when used to evaluate a tear, subluxation, or dislocation in a dynamic examination and when performing a comparison with the contralateral extremity. Dynamic imaging with muscle contraction or passive movement is often helpful. Additionally, Doppler imaging may be used to distinguish small intrasubstance tears from blood vessels that can occur in a tendinopathic tendon.', 'detailedDescription': 'Ankle injuries account for approximately 14% of sports-related orthopedic emergency visits. Various pathological conditions can affect the ankle, including trauma, overuse disorders, and inflammatory conditions.\n\nSeveral imaging modalities, such as computed tomography, magnetic resonance imaging, and ultrasound (US) can be used to evaluate the ankle. However, US has several benefits for the evaluation of the tendons and ligaments of the ankle, such as its suitability to be integrated with a dynamic assessment and a stress test, its ability to provide real-time analysis, its avoidance of the risk of radiation exposure, and its cost-effectiveness. US is especially powerful when used to evaluate a tear, subluxation, or dislocation in a dynamic examination and when performing a comparison with the contralateral extremity. Dynamic imaging with muscle contraction or passive movement is often helpful. Additionally, Doppler imaging may be used to distinguish small intrasubstance tears from blood vessels that can occur in a tendinopathic tendon.\n\nApproximately 85%of them are due to inversion forces and, therefore, involve the lateral collateral ligamentous complex. A Grade I sprain is a mild injury limited to microtears and stretching of the ligaments. Grade II sprains are partial macroscopic tears and in Grade III sprains the ligament has ruptured completely. There is general agreement that the overwhelming majority of Grade I and II sprains heal uneventfully with conservative care. Treatment of Grade III sprains is more controversial: some practitioners prefer operative repair, at least for high-performance athletes and others prefer a regimen of casting and physical therapy, which is the case in our institution. The proper role of imaging in the diagnosis of ankle sprains includes first of all conventional radiographs to ensure a fracture is not overlooked. Ultrasound is will be used to evaluate disorders of the musculoskeletal system, and because of their size and superficial location the ankle tendons can be well evaluated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'no gender based Age 15-60 -y-old Complaining from unilateral ankle pain or instability', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients complaining of unilateral ankle joint pain (acute or chronic).\n\nExclusion Criteria:\n\n* previous ankle surgery, interventional Intra-articular procedures (previous arthroscope, injections),\n* Systemic inflammatory disorders (collagen diseases),\n* Diagnosed osseous lesions.'}, 'identificationModule': {'nctId': 'NCT03621150', 'briefTitle': 'Dynamic Ultrasound in Evaluation of Tendo-ligamentous Ankle Injury', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparative Study Between Dynamic Ultrasound and MRI in Evaluation of Tendino-ligamentous Injuries Around the Ankle Joint', 'orgStudyIdInfo': {'id': 'Dynamic ankle ultrasound'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients complaining of ankle pain, swelling or dysfunction underwent ultrasound examination and then MRI as a reference to compare the diagnostic accuracy of ultrasonography in the assessment of tendino-ligamentous injuries around the ankle joint'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mostafa S Shehata, MD', 'role': 'CONTACT', 'email': 'shakrovish4447@yahoo.com', 'phone': '01006904447'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mostafa Shaker Abolela Shehata', 'investigatorAffiliation': 'Assiut University'}}}}