Optimized Rehabilitation After Anterior Cruciate Ligament Before Returning to Sport (NCT05323474) | Clinical Trial Compass
RecruitingNot Applicable
Optimized Rehabilitation After Anterior Cruciate Ligament Before Returning to Sport
France, Switzerland432 participantsStarted 2022-11-14
Plain-language summary
Following reconstruction of the anterior cruciate ligament (ACL), a standardized rehabilitation protocol is carried out by a physiotherapist. In France, a well-established rehabilitation consensus guides the first phase of 3 months postoperatively and patient compliance is generally excellent. The next phase should allow a return to sport (RTS) following a continuum depending on the objectives of the sport's patient, starting with a return to running activities (RTR) and a preparatory phase for a RTS which may be authorized at 6 months post-op.
This multicentre randomized control trial aims to evaluate the effectiveness of an individualized and optimized rehabilitation program guided by monthly assessments carried out by physiotherapists from the 3rd to the 6th month postoperatively to reduce the risk of new ACL injuries (operated or healthy knee), compared to standard management.
Who can participate
Age range
18 Years – 25 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:
* Affiliation to the French Social Security system
* Patient who has had an ACL reconstruction regardless of the standard surgical technique used
* Patient with a sports activity, pivot and/or contact (e.g. soccer, basketball, handball, rugby, judo...) and practiced in competition (Tegner sports activity scores \>7 and Marx scores \>11 before the accident.
* Patient wishing to return to competitive sport
* Consent signed by the patient
Exclusion Criteria:
* Contralateral or bilateral involvement or operated on for a re-injury of the ACL
* Patients with a medical contraindication to the performance of one of the tests
* Patients suffering from a neurological (motor and/or sensitive), vestibular or rheumatic pathology
* Patient performing rehabilitation with a physiotherapist who does not wish to participate in the study.
* Pregnant or breastfeeding woman
* Patient under guardianship or curators
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
Number of patients with at least one new ACL injury
Timeframe: At 24 months post surgery
Trial details
NCT IDNCT05323474
SponsorCentre Hospitalier Universitaire de Saint Etienne