Chronic Ankle Instability Return to Sport (NCT04726566) | Clinical Trial Compass
CompletedNot Applicable
Chronic Ankle Instability Return to Sport
France204 participantsStarted 2021-01-19
Plain-language summary
Real-life, observational, monocentric, prospective, longitudinal study, carried out at the European Center for Sports Rehabilitation (CERS), France.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 15 years;
* Patient treated at the European Sports Rehabilitation Center after a first arthroscopic surgery on the external lateral ligament of the ankle for chronic instability by anatomical reconstruction:
* With tendon graft;
* By suture with biological reinforcement;
* Non-opposition of the patient and his/her parents (if minor) to the collection of his/her personal data.
Exclusion Criteria:
\- Minor patient (age \<18 years) not accompanied by one of his/her parents or legal representative during the inclusion visit;
* History of surgery on the same ankle;
* Associated complex osteochondral or internal ligament damage, syndesmosis, fracture;
* Non-anatomical reconstruction;
* Inability of the patient to understand the study protocol;
* Vulnerable person whose inclusion is not justified by the purposes of the research: pregnant woman, person undergoing psychiatric care, or adult person subject to legal protection.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of return to main sport at the expected level in both groups
Timeframe: 10 months
Trial details
NCT IDNCT04726566
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche