NCT05323474 Optimized Rehabilitation After Anterior Cruciate Ligament Before Returning to Sport
| NCT ID | NCT05323474 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Ligament Knee Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 432 participants |
| Start Date | 2022-11-14 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 432 participants in total. It began in 2022-11-14 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Thomas NERI, MD
STUDY CHAIR
CHU DE SAINT-ETIENNE
Frequently Asked Questions
Who can join the NCT05323474 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 25 Years, studying Ligament Knee Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05323474 currently recruiting?
Yes, NCT05323474 is actively recruiting participants. Contact the research team at gregory.morel@chu-st-etienne.fr for enrollment information.
Where is the NCT05323474 trial being conducted?
This trial is being conducted at Challes-les-Eaux, France, Domont, France, Firminy, France, Lyon, France and 4 additional locations.
Who is sponsoring the NCT05323474 clinical trial?
NCT05323474 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The principal investigator is Thomas NERI, MD at CHU DE SAINT-ETIENNE. The trial plans to enroll 432 participants.