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.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MRI scans | |
| 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. 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.
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)
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.
- First posted10 Feb 2017
- Study startMay 2015
- Primary completionAug 2016
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guobin Liu, The First Hospital of Hebei Medical University
- Investigators
- Guobin Liu, Master, Principal investigator, The First Affiliated Hospital of Hebei Medical University
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Appearance of Injured Ligament and Tendon of the Ankle in Different Postures: Study Protocol for a Single-center, Diagnostic Clinical Trial
- ClinicalTrials.gov ID
- NCT03049423
- Acronym / sponsor ID
- FirstHebei_002
- Conditions
- Ankle Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- May 2017 (estimated)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the trial group | – | Device: MRI scans30 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 | – | Diagnostic Test: MRI scans and general physical examination30 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. |
Who may qualify
- Ages
- 34 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- Meet the diagnostic criteria for ankle ligament and tendon injury
- Age 34-78 years
- Both genders
- Sign the informed consent prior to the trial
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scans30 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. | Device | the trial group |
| MRI scans and general physical examination30 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. | Diagnostic test | the control group |
Primary outcome
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.
1 secondary outcome
The specificity of MRI scan for ligament and tendon injury of the anklethe ankle
Time frame: during the MRI scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Ankle Injuries
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Recruiting
Investigating Auto Adjusting Dynamic AFO
Lower Limb; Fusion, Congenital, Lower Limb Fracture
Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
Enovis High Ankle Sprain Brace Testing
Athletes in Cutting Sports
Recruiting
Lateral Ankle Treatment
Avulsion Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guobin Liu, Master principal investigator
The First Affiliated Hospital of Hebei Medical University
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.