- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03049423
MRI Appearance of Injured Ligament and Tendon of the Ankle in Different Postures
MRI Appearance of Injured Ligament and Tendon of the Ankle in Different Postures: Study Protocol for a Single-center, Diagnostic Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The ankle joint is an important part of the human lower limb. It has the function of maintaining the normal standing of the human body, supporting and bearing the body weight and conducting movements. As one of the complex joints of the human body, its surrounding ligaments and tendons not only play an important protective effect on it, but also play a fixed role in the movement of the ankle to effectively prevent excessive ankle varus/valgus. Ankle fractures account for approximately 3.9% of total body fractures, ranking the first in intra-articular fractures. An ankle injury is often accompanied by intra-articular fractures and surrounding ligament rupture. With the increasing requirements for joint functions and clinical surgery, inappropriate treatment for ankle ligament injury can result in limited movement function of the ankle, and even lead to traumatic arthritis and chronic ankle instability.
X-ray examinations are routinely preferred for the diagnosis of ankle injury, which can make an accurate diagnosis of ankle dislocation and fracture. However, X-ray plain film has a low resolution for tendon and ligament lesions, which is easy to result in missed diagnosis of mild fractures, bone contusion and occult fractures, and moreover, it is difficult to fully clear the location, type and degree of ankle injury.
MRI has high definition and resolution to implement a multi-parameter multi-directional scanning. Its histopathological findings can accurately and objectively display ankle and surrounding ligament injuries and their severity. MRI is able to display the anatomic structure and severity of ligament injury of the ankle on three anatomic planes: transverse, sagittal and coronal. Sagittal MRI is a good helper for diagnosis of Achilles tendon lesion, which can clearly show the talus, posterior tibial tendon, talocalcaneal joint, Achilles tendon, subtalar joint, articulatio talonavicularis, tibiotalar joint, and the cartilage and joint cavities. Coronal MRI can clearly show structures of the peroneal joint, tibiotalar joint, and lateral malleolus, especially the articular surface between the tibia, fibula and the ankle bone as well as between the ligament fibula and the ankle bone; and meanwhile, it can display the posterior tibial ligament, posterior talofibular ligament and posterior tibial tendon. Transverse MRI well shows the tibiofibular ligament, and anterior talofibular ligament. The ankle ligament mainly consists of three parts: the lateral collateral ligament, medial collateral ligament and tibiofibular ligament. Activities of the ankle refer to flexion and extension along the sagittal plane, including plantar flexion and dorsiflexion, to play a role of supporting and bearing, movement conduction and function as a lever.
Adverse events If expected or unexpected adverse events (such as headache and nausea) during the MRI detection, the date of occurrence, type of injury and therapeutic managements will be recorded. Severe adverse events, including a requirement for immediate surgery, damage to patient's work ability, life-threatening events or death will be reported to the project manager and the institution review board within 24 hours.
Data collection, management, analysis and open access All data will be collected on a case report form, recorded electronically and saved in a dedicated computer. Continuous variables from each record will be collected for descriptive statistical analysis, to allow real-time review and identify any potential deviation.
The validity of the data will be assessed by the censor once every 6 months through a random sampling of 10% of the database. Only the researchers participating in the study will have the right to query the database that will not be modified.
Statistical analysis will be completed by professional statisticians who will responsible for a statistical report. The statistical results will be given to the project manager, who will be responsible for writing the research report.
Anonymized trial data will be released at www.figshare.com.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Meet the diagnostic criteria for ankle ligament and tendon injury
- Age 34-78 years
- Both genders
- Sign the informed consent prior to the trial
Exclusion Criteria:
- Heart, liver, kidney and other important organ diseases
- Ankle open fracture
- Old fracture of the ankle joint
- An open tendon or ligament rupture of the ankle
- Neuropsychiatric disorders (epilepsy, depression or panic disorder)
- Pregnant or lactating women
- Participate in other clinical trials over the past 3 months
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
the trial group
30 patients with ankle ligament and tendon injury were selected in accordance with the diagnostic criteria of ankle ligament and tendon injury in the trial group.
Each participant was required to undergo MRI scans in normal position and during complete plantar flexion and complete dorsiflexion.
|
30 patients with ankle ligament and tendon injury were selected in accordance with the diagnostic criteria of ankle ligament and tendon injury in the trial group.
Each participant was required to undergo MRI scans in normal position and during complete plantar flexion and complete dorsiflexion.
|
the control group
30 patients with normal ankle joint were selected in accordance with the diagnostic criteria of ankle ligament and tendon injury in the control group.
Each participant was required to undergo MRI scans and general physical examination in normal position and during complete plantar flexion and complete dorsiflexion.
|
30 patients with normal ankle joint were selected in accordance with the diagnostic criteria of ankle ligament and tendon injury in the control group.
Each participant was required to undergo MRI scans and general physical examination in normal position and during complete plantar flexion and complete dorsiflexion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The sensitivity of MRI scan for ligament and tendon injury of the ankle
Time Frame: during the MRI scan
|
The sensitivity (true positive rate) is defined as the percentage of actual patients who are correctly diagnosed with a disease.
A higher sensitivity indicates a higher rate of correct diagnosis.
|
during the MRI scan
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The specificity of MRI scan for ligament and tendon injury of the anklethe ankle
Time Frame: during the MRI scan
|
The specificity (true negative rate) is defined as the percentage of disease-free patients who are correctly diagnosed with no disease.
A higher specificity indicates a higher rate of correct diagnosis.
|
during the MRI scan
|
Collaborators and Investigators
Investigators
- Principal Investigator: Guobin Liu, Master, The First Affiliated Hospital of Hebei Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- FirstHebei_002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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