Tendinoligamentous Injury of the AnkleNCT03621150
Dynamic Ultrasound in Evaluation of Tendo-ligamentous Ankle Injury
An observational study of Tendinoligamentous Injury of the Ankle, run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Tendinoligamentous Injury of the Ankle
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Oct 2020
- How long will I take part?
- 2 Months
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: no gender based Age 15-60 -y-old Complaining from unilateral ankle pain or instability
Who may be able to join
- patients complaining of unilateral ankle joint pain (acute or chronic).
Who cannot join
- previous ankle surgery, interventional Intra-articular procedures (previous arthroscope, injections),
- Systemic inflammatory disorders (collagen diseases),
- Diagnosed osseous lesions.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Dynamic Ultrasound and MRI in Evaluation of Tendino-ligamentous Injuries Around the Ankle Joint
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.
Read the 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
- Conditions
- Tendinoligamentous Injury of the Ankle
- Keywords
- mri, musculoskeletal ultrasound, tendinopathy
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of ankle tendi-ligamentous injury by dynamic ultrasound and MRI
Approximately 85%of anke tendo-ligamentous injuries are due to inversion forces and, therefore involve the lateral collateral ligamentous complex.
- Grade I sprain is a mild injury limited to microtears and stretching of the ligaments.
- Grade II sprains are partial macroscopic tears
- Grade III sprains the ligament has ruptured completely.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tendinoligamentous Injury of the AnkleStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Shaker Abolela Shehata, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621150
- Sponsor's protocol ID
- Dynamic ankle ultrasound
- Status last verified
- Aug 2018
- First submitted
- 2 Aug 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 16247724Khoury 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.
PubMed 18095247
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Dynamic Ultrasound and MRI in Evaluation of Tendino-ligamentous Injuries Around the Ankle Joint
- ClinicalTrials.gov ID
- NCT03621150
- Acronym / sponsor ID
- Dynamic ankle ultrasound
- Conditions
- Tendinoligamentous Injury of the Ankle
- Keywords
- mri, musculoskeletal ultrasound, tendinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 8 Aug 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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- no gender based Age 15-60 -y-old Complaining from unilateral ankle pain or instability
Key inclusion criteria (1 listed)
- patients complaining of unilateral ankle joint pain (acute or chronic).
Key exclusion criteria (3 listed)
- previous ankle surgery, interventional Intra-articular procedures (previous arthroscope, injections),
- Systemic inflammatory disorders (collagen diseases),
- Diagnosed osseous lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of ankle tendi-ligamentous injury by dynamic ultrasound and MRI
Time frame: 1 month
Approximately 85%of anke tendo-ligamentous injuries are due to inversion forces and, therefore involve the lateral collateral ligamentous complex. * Grade I sprain is a mild injury limited to microtears and stretching of the ligaments. * Grade II sprains are partial macroscopic tears * Grade III sprains the ligament has ruptured completely.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Background: PubMed 16247724Bianchi 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.
- Background: PubMed 18095247Khoury 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.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Tendinoligamentous Injury of the Ankle, 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 3 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 8 Aug 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?
Contact Mostafa S Shehata, MD (01006904447, shakrovish4447@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of ankle tendi-ligamentous injury by dynamic ultrasound and MRI (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621150, which also lists 2 linked publications.
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 8 Aug 2018.