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Status unknownNCT04455386Updated Apr 10, 2023

Diagnostic Study of Lateral Ligament Complex Injury of Ankle

An observational study in Chronic Instability of Ankle Joint and Lateral Ligament Complex Injury of Ankle, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2023-04-10.

Sponsored by Peking University Third Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
75
Ages
16 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Instability of Ankle Joint
  • Lateral Ligament Complex Injury of Ankle

Keywords

  • Lateral Ligament complex
  • Ankle
  • Diagnostic Methods
  • Chronic Lateral Instability of Ankle
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's planned enrollment of 75 is below the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • Chronic lateral ankle ligament injury due to ankle sprain in patients over 16 years of age.

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
75 participants (estimated)
Patient registry
No

Groups and cohorts

  • stable

    The anterior drawer test and/or talar tilt test are negative and the ankle joint is stable.

    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.

    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.

    Diagnostic Test: Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,Arthroscopy

Interventions

  • Diagnostic testStress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,Arthroscopy

    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.

06

What researchers measure

Primary outcomes

  1. anterior talar translation and talar tilt

    Assess the instability through stress X ray of the ankle

    Time frame: before operation

  2. length of ATFL and CFL in relax and stress position

    Assess the instability through Ultrasound of the ankle

    Time frame: before operation

  3. Morphology of ATFL and CFL

    Assess the ATFL and CFL through MRI of the ankle

    Time frame: before operation

  4. status of ATFL and CFL

    evaluation of ATFL and CFL during operation

    Time frame: during operation

Secondary outcomes

  1. avulsion fracture

    avulsion fracture found by X ray, Ultrasound, CT or MRI

    Time frame: before operation

  2. osteophyte

    osteophyte found by X ray, Ultrasound, CT or MRI

    Time frame: before operation

07

Study locations

1 of 1 sites recruiting
  • Institute of Sports Medicine
    Beijing, Beijing 100000, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04455386
Lead sponsor
Peking University Third Hospital
Responsible party
Guo Qinwei (associated professor, Peking University Third Hospital) — Principal investigator
First posted
Jul 2, 2020
Start date
Nov 1, 2019
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Apr 10, 2023

Study contacts

Qinwei Guo
Contact
guoqinwei@vip.sina.com
18601129252
Anhong Wang
Contact
wah1995@pku.edu.cn
18501325799
Qinwei Guo
principal investigator · Peking University Third Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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