Chronic Instability of Ankle JointNCT04455386
Diagnostic Study of Lateral Ligament Complex Injury of Ankle
An observational study of Chronic Instability of Ankle Joint and Lateral Ligament Complex Injury of Ankle, run by Peking University Third Hospital at 1 site in China.
Trial summary
Comparative Study on Accuracy of Different Diagnostic Methods of Lateral Collateral Ligament Injury of Ankle Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Instability of Ankle Joint, Lateral Ligament Complex Injury of Ankle
- What is being tested?
- Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,Arthroscopy
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 31 Dec 2023
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic lateral ligament complex injury of the ankle were divided into 3 groups and each group with 25 cases, according to the anterior drawer test and talar tilt test.
Who may be able to join
- Chronic lateral ankle ligament injury due to ankle sprain in patients over 16 years of age.
Who cannot join
- Acute and subacute injury of the lateral ligament complex of the ankle joint (less than 3 months), malalignment of ankle (more than 5 degrees), osteoarthritis (stage IV).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Sports Medicine
Beijing, Beijing Municipality, 100000
Qinwei Guo, MD, 86+18601129252, guoqinwei@vip.sina.com
About this study
Official title: Comparative Study on Accuracy of Different Diagnostic Methods of Lateral Ligament Complex Injury of Ankle
Comparative Study on Accuracy of Different Diagnostic Methods of Lateral Collateral Ligament Injury of Ankle
Read the detailed description
Background: The lateral ligament complex of ankle joint consisting of the anterior talofibular ligament (ATFL), the calcaneofibular ligament (CFL), and the posterior talofibular ligament (PTFL), is often injured by an ankle sprain. Improper diagnosis and treatment of lateral ligament complex injury are not only prone to recurrent sprain, pain, swelling and other symptoms, but also can lead to chronic lateral ankle instability, and osteoarthritis, which could seriously affect the joint motor function.
Method and objective: This study is a prospective diagnostic test. By comparing the sensitivity and specificity of stress X-ray, B-ultrasound, Computed tomography (CT), and Magnetic resonance imaging (MRI), and analyzing the imaging manifestations and characteristics of different diagnostic methods of lateral chronic ankle instability, We aim to propose the criteria of the imaging diagnosis of lateral ankle ligament injury.
- Being tested
- Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,Arthroscopy
- Keywords
- Lateral Ligament complex, Ankle, Diagnostic Methods, Chronic Lateral Instability of Ankle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,ArthroscopyDiagnostic test
All patients suspected chronic ankle instability, will perform an anterior drawer test, stress ultrasound, computed tomography, magnetic resonance imaging of ankle. Patients with chronic ankle instability will be recommended to perform an arthroscopic repair if non-operative treatment failed.
| Study group | Role | What they receive |
|---|---|---|
| stable | The anterior drawer test and/or talar tilt test are negative and the ankle joint is stable. Receives: Diagnostic Test: Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,Arthroscopy | |
| slightly instable | The anterior drawer test and/or talar tilt test are slightly positive and the ankle joint is partially instable. Receives: Diagnostic Test: Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,Arthroscopy | |
| obviously instable | The anterior drawer test and/or talar tilt test is significantly positive, with significantly instable. The ankle joint is completely instable and can featured with dimple sign. Receives: Diagnostic Test: Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,Arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
anterior talar translation and talar tilt
Assess the instability through stress X ray of the ankle
Measured: before operation
length of ATFL and CFL in relax and stress position
Assess the instability through Ultrasound of the ankle
Measured: before operation
Morphology of ATFL and CFL
Assess the ATFL and CFL through MRI of the ankle
Measured: before operation
status of ATFL and CFL
evaluation of ATFL and CFL during operation
Measured: during operation
Secondary outcomes (2)
avulsion fracture
avulsion fracture found by X ray, Ultrasound, CT or MRI
Measured: before operation
osteophyte
osteophyte found by X ray, Ultrasound, CT or MRI
Measured: before operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Nov 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Instability of Ankle JointStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo Qinwei, Peking University Third Hospital
- Investigators
- Qinwei Guo, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455386
- Sponsor's protocol ID
- PKU-GUO-02
- Status last verified
- Apr 2023
- First submitted
- 27 Jun 2020
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on Accuracy of Different Diagnostic Methods of Lateral Ligament Complex Injury of Ankle
- ClinicalTrials.gov ID
- NCT04455386
- Acronym / sponsor ID
- PKU-GUO-02
- Keywords
- Lateral Ligament complex, Ankle, Diagnostic Methods, Chronic Lateral Instability of Ankle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Jul 2020 (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.
Comparative Study on Accuracy of Different Diagnostic Methods of Lateral Collateral Ligament Injury of Ankle
Detailed description
Background: The lateral ligament complex of ankle joint consisting of the anterior talofibular ligament (ATFL), the calcaneofibular ligament (CFL), and the posterior talofibular ligament (PTFL), is often injured by an ankle sprain. Improper diagnosis and treatment of lateral ligament complex injury are not only prone to recurrent sprain, pain, swelling and other symptoms, but also can lead to chronic lateral ankle instability, and osteoarthritis, which could seriously affect the joint motor function.
Method and objective: This study is a prospective diagnostic test. By comparing the sensitivity and specificity of stress X-ray, B-ultrasound, Computed tomography (CT), and Magnetic resonance imaging (MRI), and analyzing the imaging manifestations and characteristics of different diagnostic methods of lateral chronic ankle instability, We aim to propose the criteria of the imaging diagnosis of lateral ankle ligament injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| stable | – | Diagnostic Test: Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,ArthroscopyThe anterior drawer test and/or talar tilt test are negative and the ankle joint is stable. |
| slightly instable | – | Diagnostic Test: Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,ArthroscopyThe anterior drawer test and/or talar tilt test are slightly positive and the ankle joint is partially instable. |
| obviously instable | – | Diagnostic Test: Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,ArthroscopyThe anterior drawer test and/or talar tilt test is significantly positive, with significantly instable. The ankle joint is completely instable and can featured with dimple sign. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic lateral ligament complex injury of the ankle were divided into 3 groups and each group with 25 cases, according to the anterior drawer test and talar tilt test.
Key inclusion criteria (1 listed)
- Chronic lateral ankle ligament injury due to ankle sprain in patients over 16 years of age.
Key exclusion criteria (1 listed)
- Acute and subacute injury of the lateral ligament complex of the ankle joint (less than 3 months), malalignment of ankle (more than 5 degrees), osteoarthritis (stage IV).
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 |
|---|---|---|
| Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,ArthroscopyAll patients suspected chronic ankle instability, will perform an anterior drawer test, stress ultrasound, computed tomography, magnetic resonance imaging of ankle. Patients with chronic ankle instability will be recommended to perform an arthroscopic repair if non-operative treatment failed. | Diagnostic test | obviously instable, slightly instable, stable |
Primary outcome
anterior talar translation and talar tilt
Time frame: before operation
Assess the instability through stress X ray of the ankle
length of ATFL and CFL in relax and stress position
Time frame: before operation
Assess the instability through Ultrasound of the ankle
Morphology of ATFL and CFL
Time frame: before operation
Assess the ATFL and CFL through MRI of the ankle
status of ATFL and CFL
Time frame: during operation
evaluation of ATFL and CFL during operation
2 secondary outcomes
avulsion fracture
Time frame: before operation
osteophyte
Time frame: before operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Chronic Instability of Ankle Joint
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
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.
Qinwei Guo principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Instability of Ankle Joint and Lateral Ligament Complex Injury of Ankle, run by Peking University Third Hospital at 1 site in China.
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 1 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 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Qinwei Guo (18601129252, guoqinwei@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anterior talar translation and talar tilt (time frame: before operation). The study lists 4 primary outcomes in all. 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 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.