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Ankle InjuriesNCT03049423

MRI Appearance of Injured Ligament and Tendon of the Ankle in Different Postures

An observational study of Ankle Injuries, run by The First Hospital of Hebei Medical University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To compare the results of multi-position MRI scans for ankle ligaments and tendons to clarify how to obtain imaging data of different ankle ligaments and define severity of injuries to calculate the rate of correct diagnosis, thereby developing a reasonable surgical treatment in clinical practice. Read more about this study

Who is it for?
Ages 34 to 78 yearsHealthy volunteers can take part
Conditions the study is for
Ankle Injuries
What is being tested?
MRI scans and MRI scans and general physical examination
Type of treatment
Medical device
How many people
60 participants
Where
No sites listed yet
Study dates
May 2015to May 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 34 to 78 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Six participants from the First Affiliated Hospital of Hebei Medical University were recruitment through newspapers, public communication, hospital and public institution websites. The participants gave written informed consent prior to participation in the trial.

Who may be able to join

  • Meet the diagnostic criteria for ankle ligament and tendon injury
  • Age 34-78 years
  • Both genders
  • Sign the informed consent prior to the trial

Who cannot join

  • 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

About this study

Official title: MRI Appearance of Injured Ligament and Tendon of the Ankle in Different Postures: Study Protocol for a Single-center, Diagnostic Clinical Trial

To compare the results of multi-position MRI scans for ankle ligaments and tendons to clarify how to obtain imaging data of different ankle ligaments and define severity of injuries to calculate the rate of correct diagnosis, thereby developing a reasonable surgical treatment in clinical practice.

Read the 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.

Conditions
Ankle Injuries
Being tested
MRI scans, MRI scans and general physical examination
Medical subject headings
Ankle Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI scansDevice

    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.

  • MRI scans and general physical examinationDiagnostic test

    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.

Study groups in NCT03049423
Study groupRoleWhat they receive
the trial group30 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.
Receives: Device: MRI scans
the control group30 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.
Receives: Diagnostic Test: MRI scans and general physical examination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The sensitivity of MRI scan for ligament and tendon injury of the ankle

    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.

    Measured: during the MRI scan

Secondary outcomes (1)
  1. The specificity of MRI scan for ligament and tendon injury of the anklethe ankle

    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.

    Measured: during the MRI scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2017
  2. Study startMay 2015
  3. Primary completionAug 2016
  4. Study completionMay 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03049423
Sponsor's protocol ID
FirstHebei_002
Status last verified
Feb 2017
First submitted
8 Feb 2017
Last updated
10 Feb 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Ankle Injuries, run by The First Hospital of Hebei Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The sensitivity of MRI scan for ligament and tendon injury of the ankle (time frame: during the MRI scan). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.

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