An observational study in Avulsion Fracture of Lateral Ankle Ligament, sponsored by Peking University Third Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by Peking University Third Hospital · Observational
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.
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.
16 studies on the registry are indexed under Fractures, Avulsion; 4 are open to participants now.
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Patients with chronic lateral ankle instability with or without lateral ankle avulsion fracture meeting surgical indications.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
f. Patients with to MRI g. Hemophiliacs h. Patients with systemic conditions that cannot tolerate surgery
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
rupture of lateral ankle ligament
Procedure: lateral ankle ligament repair or reconstruction
avulsion fracture of lateral ankle ligament
Procedure: lateral ankle ligament repair or reconstruction
repair or reconstruction procedure for lateral ankle ligament
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
Time frame: 2 weeks, 3 months, 6 months, 1 year, and 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks, 3 months, 6 months, 1 year, and 2 years
Plan to share: Undecided
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This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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