Diagnostic Study of Lateral Ligament Complex Injury of Ankle
Comparative Study on Accuracy of Different Diagnostic Methods of Lateral Ligament Complex Injury of Ankle
1 other identifier
observational
75
1 country
1
Brief Summary
Comparative Study on Accuracy of Different Diagnostic Methods of Lateral Collateral Ligament Injury of Ankle
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
June 27, 2020
CompletedFirst Posted
Study publicly available on registry
July 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedApril 10, 2023
April 1, 2023
4.2 years
June 27, 2020
April 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
anterior talar translation and talar tilt
Assess the instability through stress X ray of the ankle
before operation
length of ATFL and CFL in relax and stress position
Assess the instability through Ultrasound of the ankle
before operation
Morphology of ATFL and CFL
Assess the ATFL and CFL through MRI of the ankle
before operation
status of ATFL and CFL
evaluation of ATFL and CFL during operation
during operation
Secondary Outcomes (2)
avulsion fracture
before operation
osteophyte
before operation
Study Arms (3)
stable
The anterior drawer test and/or talar tilt test are negative and the ankle joint is stable.
slightly instable
The anterior drawer test and/or talar tilt test are slightly positive and the ankle joint is partially instable.
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Chronic lateral ankle ligament injury due to ankle sprain in patients over 16 years of age.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Sports Medicine
Beijing, Beijing Municipality, 100000, China
Study Officials
- PRINCIPAL INVESTIGATOR
Qinwei Guo
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associated professor
Study Record Dates
First Submitted
June 27, 2020
First Posted
July 2, 2020
Study Start
November 1, 2019
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
April 10, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share