Avulsion Fracture of Lateral Ankle LigamentNCT06277544
Analysis of Prognosis and Risk Factors of LAL Reconstruction Procedure for Patients With AF of the LAL: a Prospective Cohort Study
An observational study of Avulsion Fracture of Lateral Ankle Ligament, run by Peking University Third Hospital at 1 site in China.
Trial summary
To compare the clinical outcomes of CAI patients with and without lateral ankle avulsion fracture after ligament repair/reconstruction, and to analyze the risk factors associated with the outcome. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Avulsion Fracture of Lateral Ankle Ligament
- What is being tested?
- lateral ankle ligament repair or reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 27 Jan 2024to 30 Jun 2026
- How long will I take part?
- 2 Years
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with chronic lateral ankle instability with or without lateral ankle avulsion fracture meeting surgical indications.
Who may be able to join
- Age 18-60 years old
- Chronic pain or instability in the ankle, injury to the lateral collateral ligament of the ankle determined by MRI examination of the ankle, and distal avulsion fracture of the fibula indicated by CT examination.
- Patients with poor results after more than 3 months of conservative treatment with rest/topical/oral non-steroidal anti-inflammatory drugs
- Patients voluntarily participate in clinical trials, sign informed consent, and can cooperate with clinical follow-up
Who cannot join
- Persons who have participated in clinical trials of other drugs or medical devices within the last 6 months
- Malalignment of ankle joint force (varus or valgus \>5 degrees)
- Chronic specific synovitis (rheumatoid, pigmented villonodular synovitis, etc.)
- Patients with joint fibrosis, joint stiffness, and obvious limited movemente. Moderate to severe osteoarthritis (Takakura stage III or IV)
- Patients with contraindications to MRI g. Hemophiliacs h. Patients with systemic conditions that cannot tolerate surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Prognosis and Risk Factors of Lateral Ankle Ligament Reconstruction Procedure for Patients With Avulsion Fracture of the Lateral Ankle Ligament: a Prospective Cohort Study
To compare the clinical outcomes of CAI patients with and without lateral ankle avulsion fracture after ligament repair/reconstruction, and to analyze the risk factors associated with the outcome.
Read the detailed description
80 patients with external ankle ligament injury without avulsion fracture and 40 patients with external ankle ligament injury combined with avulsion fracture were treated by surgery in our department. The outcomes included Karlsson score, VAS, AOFAS and Tegner score. The outcomes were compared between the two groups, and the risk factors were analyzed.
- Being tested
- lateral ankle ligament repair or reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral ankle ligament repair or reconstructionProcedure or surgery
repair or reconstruction procedure for lateral ankle ligament
| Study group | Role | What they receive |
|---|---|---|
| rupture group | rupture of lateral ankle ligament Receives: Procedure: lateral ankle ligament repair or reconstruction | |
| fracture group | avulsion fracture of lateral ankle ligament Receives: Procedure: lateral ankle ligament repair or reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Karlsson score
The Karlsson score consists of seven questions covering ankle pain, swelling, levels of daily activity and exercise .et al,provided by the patient with objective scores. The minimum and maximum values of Karlsson are 0 and 100, respectively. And higher scores mean a better outcome
Measured: 2 weeks, 3 months, 6 months, 1 year, and 2 years
Secondary outcomes (3)
Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain they experienced. This gives them the greatest freedom to choose their pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. The minimum and maximum values of VAS are 10 and 0, respectively. And higher scores mean a worse outcome.
Measured: 2 weeks, 3 months, 6 months, 1 year, and 2 years
American Orthopaedic Foot and Ankle Society (AOFAS)
The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability and alignment of the ankle-hindfoot). The scale includes nine items that can be divided into three subscales (pain, function and alignment). The minimum and maximum values of AOFAS are 100 and 0, respectively. And higher scores mean a better outcome.
Measured: 2 weeks, 3 months, 6 months, 1 year, and 2 years
Tegner Scale
The Tegner Scale is a tool commonly used to assess the degree of sports injury and the degree of functional recovery, which is graded according to the level of motor activity a participant participates in and the gradual increase in requirements. It is graded on a scale of 0 to 10, with the specific meanings.
Measured: 2 weeks, 3 months, 6 months, 1 year, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start27 Jan 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avulsion Fracture of Lateral Ankle LigamentStudies 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
- 120 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guo Qinwei, MD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277544
- Sponsor's protocol ID
- M2024087
- Status last verified
- Jan 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Prognosis and Risk Factors of Lateral Ankle Ligament Reconstruction Procedure for Patients With Avulsion Fracture of the Lateral Ankle Ligament: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06277544
- Acronym / sponsor ID
- M2024087
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 27 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Feb 2024 (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.
To compare the clinical outcomes of CAI patients with and without lateral ankle avulsion fracture after ligament repair/reconstruction, and to analyze the risk factors associated with the outcome.
Detailed description
80 patients with external ankle ligament injury without avulsion fracture and 40 patients with external ankle ligament injury combined with avulsion fracture were treated by surgery in our department. The outcomes included Karlsson score, VAS, AOFAS and Tegner score. The outcomes were compared between the two groups, and the risk factors were analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rupture group | – | Procedure: lateral ankle ligament repair or reconstructionrupture of lateral ankle ligament |
| fracture group | – | Procedure: lateral ankle ligament repair or reconstructionavulsion fracture of lateral ankle ligament |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with chronic lateral ankle instability with or without lateral ankle avulsion fracture meeting surgical indications.
Key inclusion criteria (4 listed)
- Age 18-60 years old
- Chronic pain or instability in the ankle, injury to the lateral collateral ligament of the ankle determined by MRI examination of the ankle, and distal avulsion fracture of the fibula indicated by CT examination.
- Patients with poor results after more than 3 months of conservative treatment with rest/topical/oral non-steroidal anti-inflammatory drugs
- Patients voluntarily participate in clinical trials, sign informed consent, and can cooperate with clinical follow-up
Key exclusion criteria (5 listed)
- Persons who have participated in clinical trials of other drugs or medical devices within the last 6 months
- Malalignment of ankle joint force (varus or valgus \>5 degrees)
- Chronic specific synovitis (rheumatoid, pigmented villonodular synovitis, etc.)
- Patients with joint fibrosis, joint stiffness, and obvious limited movemente. Moderate to severe osteoarthritis (Takakura stage III or IV)
- Patients with contraindications to MRI g. Hemophiliacs h. Patients with systemic conditions that cannot tolerate surgery
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 |
|---|---|---|
| lateral ankle ligament repair or reconstructionrepair or reconstruction procedure for lateral ankle ligament | Procedure or surgery | fracture group, rupture group |
Primary outcome
Karlsson score
Time frame: 2 weeks, 3 months, 6 months, 1 year, and 2 years
The Karlsson score consists of seven questions covering ankle pain, swelling, levels of daily activity and exercise .et al,provided by the patient with objective scores. The minimum and maximum values of Karlsson are 0 and 100, respectively. And higher scores mean a better outcome
3 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: 2 weeks, 3 months, 6 months, 1 year, and 2 years
American Orthopaedic Foot and Ankle Society (AOFAS)
Time frame: 2 weeks, 3 months, 6 months, 1 year, and 2 years
Tegner Scale
Time frame: 2 weeks, 3 months, 6 months, 1 year, and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: Undecided
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.
Guo Qinwei, MD study director
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 Avulsion Fracture of Lateral Ankle Ligament, 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 4 inclusion and 5 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 26 Feb 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Karlsson score (time frame: 2 weeks, 3 months, 6 months, 1 year, and 2 years). 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 26 Feb 2024.