- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03621150
Dynamic Ultrasound in Evaluation of Tendo-ligamentous Ankle Injury
Comparative Study Between Dynamic Ultrasound and MRI in Evaluation of Tendino-ligamentous Injuries Around the Ankle Joint
Study Overview
Status
Conditions
Detailed Description
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.
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.
Approximately 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
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients complaining of unilateral ankle joint pain (acute or chronic).
Exclusion Criteria:
- previous ankle surgery, interventional Intra-articular procedures (previous arthroscope, injections),
- Systemic inflammatory disorders (collagen diseases),
- Diagnosed osseous lesions.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cases
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of ankle tendi-ligamentous injury by dynamic ultrasound and MRI
Time Frame: 1 month
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Approximately 85%of anke tendo-ligamentous injuries are due to inversion forces and, therefore involve the lateral collateral ligamentous complex.
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1 month
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dynamic ankle ultrasound
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tendinoligamentous Injury of the Ankle
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Sykehuset Asker og BaerumOslo University HospitalCompletedSyndesmotic Injury of the AnkleNorway
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Peking University Third HospitalRecruitingChronic Instability of Ankle Joint | Lateral Ligament Complex Injury of AnkleChina
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Pharmanutra S.p.a.NEA Clinical S.r.l.Active, not recruitingAnkle Injury or Chronic Trauma to the AnkleGeorgia, Italy
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Paragon 28CompletedAnkle Injuries | Achilles Tendon Rupture | Ankle Sprains | Syndesmotic Injuries | Ankle Inversion Sprain | Flexor Digitorum Longus on the Right | Flexor Digitorum Longus on the Left | Deltoid Ankle Sprain | Flexor Hallucis Longus on the Left | Flexor Hallucis Longus on the RightUnited States
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Paragon 28CompletedAnkle Injuries | Achilles Tendon Rupture | Ankle Sprains | Syndesmotic Injuries | Ankle Inversion Sprain | Flexor Digitorum Longus on the Right | Flexor Digitorum Longus on the Left | Deltoid Ankle Sprain | Flexor Hallucis Longus on the Left | Flexor Hallucis Longus on the RightUnited States
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Hospital Universitario Infanta LeonorRecruitingPrimary Disease or Condition Being Studied in the Trial or the Focus of the Study Mild Ankle SprainSpain
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University Medical Centre LjubljanaUnknownInstability; Ankle (Ligaments) (Old Injury) | Ankle Arthritis | Osteochondral Lesion of Talus | Impingement Syndrome of AnkleSlovenia
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Cairo UniversityCompletedAnkle Sprain | Ankle Pain | TECAR Therapy | Ankle Proprioception | TECAR Therapy Efficacy in the Treatment of Ankle Sprain | Ankle Dynamic BalanceEgypt
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Second Affiliated Hospital, School of Medicine,...RecruitingAnkle Ligament Injury,Chronic Ankle Instability,Ankle ArthroscopyChina
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Second Affiliated Hospital, School of Medicine,...Not yet recruitingChronic Ankle Instability | Ankle Ligament Injury | Ankle Arthroscopy