Ankle InjuriesNCT03695965
Magnetic Resonance Imaging Evaluation of Lateral Ankle Instability
An observational study of Ankle Injuries, run by Assiut University.
Trial summary
Lateral ankle instability may be acute or chronic. Acute instability usually occurs due to extreme rear foot supination with planter-flexion trauma leads to injury of lateral collateral ligament complex especially the anterior talofibular ligament. Most ankle ligamentous injuries are treated conservatively. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- magnetic resonance imaging.
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with history of ankle trauma or chronic lateral ankle pain that will be evaluated using magnetic resonance imaging.
Who may be able to join
- Patients with any sex, age, complaining of chronic lateral ankle pain.
Who cannot join
- Tumors at ankle region.
- Postoperative status around the ankle.
- Rheumatoid arthritis.
- Comminuted fracture at the ankle.
- Congenital anomalies of the ankle.
About this study
Lateral ankle instability may be acute or chronic. Acute instability usually occurs due to extreme rear foot supination with planter-flexion trauma leads to injury of lateral collateral ligament complex especially the anterior talofibular ligament. Most ankle ligamentous injuries are treated conservatively. However, 20% to 40% of patients complain of chronic instability and persistent discomfort. Structural instability, loss of proprioceptive capabilities, and the weakness of peroneal muscles seem to induce chronic instability
- Conditions
- Ankle Injuries
- Being tested
- magnetic resonance imaging.
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imaging.Procedure or surgery
Also called MRI.
1.5 Tesla magnet system is going to be utilized for ankle imaging. A dedicated extremity surface coil (Foot/Ankle 16-Channel Coil; Siemens Medical Solution) is used to enhance spatial resolution.
| Study group | Role | What they receive |
|---|---|---|
| study group | patients with history of ankle trauma or chronic lateral ankle pain Receives: Procedure: magnetic resonance imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with ankle or ligaments abnormalities by examination
Magnetic resonance imaging examination will be the method for diagnosis
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study startDec 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695965
- Sponsor's protocol ID
- MRILAI
- Status last verified
- Oct 2018
- First submitted
- 3 Oct 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging Evaluation of Lateral Ankle Instability
- ClinicalTrials.gov ID
- NCT03695965
- Acronym / sponsor ID
- MRILAI
- Conditions
- Ankle Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Oct 2018 (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.
Lateral ankle instability may be acute or chronic. Acute instability usually occurs due to extreme rear foot supination with planter-flexion trauma leads to injury of lateral collateral ligament complex especially the anterior talofibular ligament. Most ankle ligamentous injuries are treated conservatively. However, 20% to 40% of patients complain of chronic instability and persistent discomfort. Structural instability, loss of proprioceptive capabilities, and the weakness of peroneal muscles seem to induce chronic instability
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Procedure: magnetic resonance imaging.patients with history of ankle trauma or chronic lateral ankle pain |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with history of ankle trauma or chronic lateral ankle pain that will be evaluated using magnetic resonance imaging.
Key inclusion criteria (1 listed)
- Patients with any sex, age, complaining of chronic lateral ankle pain.
Key exclusion criteria (5 listed)
- Tumors at ankle region.
- Postoperative status around the ankle.
- Rheumatoid arthritis.
- Comminuted fracture at the ankle.
- Congenital anomalies of the ankle.
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 |
|---|---|---|
| magnetic resonance imaging.Also: MRI.1.5 Tesla magnet system is going to be utilized for ankle imaging. A dedicated extremity surface coil (Foot/Ankle 16-Channel Coil; Siemens Medical Solution) is used to enhance spatial resolution. | Procedure or surgery | study group |
Primary outcome
The percentage of patients with ankle or ligaments abnormalities by examination
Time frame: 30 minutes
Magnetic resonance imaging examination will be the method for diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Injuries, run by Assiut 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 1 inclusion and 5 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 4 Oct 2018. 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 percentage of patients with ankle or ligaments abnormalities by examination (time frame: 30 minutes). 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 4 Oct 2018.