Lisfranc InjuryNCT04182308
Anatomic Characteristics of Lisfranc Ligament in Vietnamese Adult
An observational study of Lisfranc Injury, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
Goal: the aim of this study is to determine the anatomic characteristic of lisfranc ligament Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lisfranc Injury
- What is being tested?
- dissection
- How many people
- 30 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Nov 2019to 30 Jul 2021
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: above ankle amputation samples at Cho Ray hospital, HCM city, Vietnam
Who may be able to join
- above ankle amputation samples at Cho Ray hospital, HCM city, Vietnam
Who cannot join
- foot injuries
- foot infection
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Cho Ray hospital
Ho Chi Minh City, Ho Chi Minh
Hung P Do, professor, +30123413
About this study
Goal: the aim of this study is to determine the anatomic characteristic of lisfranc ligament
Read the detailed description
Goal: the aim of this study is to determine the anatomic characteristic of lisfranc ligament, including components, thickness, height, and width, origins as well as relationship of center point of origin with neighbor structures in Vietnamese adults
- Conditions
- Lisfranc Injury
- Being tested
- dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dissectionOther
Dissection of lisfranc ligament from 30 aldult Vietnamese cadavers's foot
What is being measured
The primary outcome is the main question the study is designed to answer.
Some anatomic characteristic of lisfranc ligament
lenght, width
Measured: 2 years
Secondary outcomes (1)
relative position with neighbor structures
cm
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start1 Nov 2019
- Primary completion30 May 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lisfranc InjuryStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Phu Chan, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Hung P Do, professor, Study director, Cho Ray Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182308
- Sponsor's protocol ID
- IRB00010195
- Status last verified
- Nov 2019
- First submitted
- 24 Nov 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet
Publications
Johnson A, Hill K, Ward J, Ficke J. Anatomy of the lisfranc ligament. Foot Ankle Spec. 2008 Feb;1(1):19-23. doi: 10.1177/1938640007312300..
PubMed 19825687
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomic Characteristics of Lisfranc Ligament in Vietnamese Adult
- ClinicalTrials.gov ID
- NCT04182308
- Acronym / sponsor ID
- IRB00010195
- Conditions
- Lisfranc Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 2 Dec 2019 (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.
Goal: the aim of this study is to determine the anatomic characteristic of lisfranc ligament
Detailed description
Goal: the aim of this study is to determine the anatomic characteristic of lisfranc ligament, including components, thickness, height, and width, origins as well as relationship of center point of origin with neighbor structures in Vietnamese adults
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- above ankle amputation samples at Cho Ray hospital, HCM city, Vietnam
Key inclusion criteria (1 listed)
- above ankle amputation samples at Cho Ray hospital, HCM city, Vietnam
Key exclusion criteria (2 listed)
- foot injuries
- foot infection
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 |
|---|---|---|
| dissectionDissection of lisfranc ligament from 30 aldult Vietnamese cadavers's foot | Other | – |
Primary outcome
Some anatomic characteristic of lisfranc ligament
Time frame: 2 years
lenght, width
1 secondary outcome
relative position with neighbor structures
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Results publication: PubMed 19825687Johnson A, Hill K, Ward J, Ficke J. Anatomy of the lisfranc ligament. Foot Ankle Spec. 2008 Feb;1(1):19-23. doi: 10.1177/1938640007312300..
- Individual participant dataSharing planned: Undecided. not yet
Related trials for Lisfranc Injury
Recruiting
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Medial Malleolus Fracture, Lisfranc Injury
Active, not recruiting
Stability and Outcomes of Non-displaced Lisfranc Injuries
Lisfranc Injury, Sprain of Foot
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.
Hung P Do, professor study director
Cho Ray 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 Lisfranc Injury, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 2 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 2 Dec 2019. 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 Vietnam. 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 Chan P Nguyen, doctor (+84396722467, nguyenphuchan1993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Some anatomic characteristic of lisfranc ligament (time frame: 2 years). 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 NCT04182308, which also lists 1 linked publication.
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 2 Dec 2019.