Clinical trial NCT05323474: Optimized Rehabilitation After Anterior Cruciate Ligament Before Returning to Sport
Official title: Optimized Rehabilitation After Anterior Cruciate Ligament Reconstruction at the First Step of Return to Sport
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ligament Knee Injury
Anterior Cruciate Ligament Rupture
Keywords: Physiotherapy
Rehabilitation
Orthopedic surgery
Knee joint
Ligament
Anterior Cruciate Ligament Reconstruction
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2022-04-12
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Each year more than 40,000 surgical reconstructions of the anterior cruciate ligament (ACL) by ligamentoplasty are performed in France; the rupture being most often the result of sports practice. Following this surgical reconstruction of the ACL, a standardized rehabilitation protocol is carried out by a masseur-physiotherapist. A well-established rehabilitative consensus guides the first phase of the 3 months post-operative and patient compliance is generally excellent. The next phase should allow the return to sport (RTS) by following a continuum according to the objectives of the athlete patient. In this continuum, authors distinguish the return to sports activities in the axis, such as running (RTS1), preparing the return to training (RTS2), and much later will be done by the return to competition (RTS3).RTS2, which is probably the most delicate stage due to the highly variable progression from one patient to another, is generally allowed from the 6th month post-operative, after the realization and validation of a battery of tests assessing the athlete's ability to resume training.Despite this precaution, there is a major risk of new injury (20%), especially in the contralateral knee (12%) requiring new, longer, more restrictive rehabilitation care with an additional 3 to 12 months' incapacity for work or sport.. As the risk of "re-injury" of the knee seems independent of the surgical technique used and the first 3 months of rehabilitation, the rehabilitative management of this phase of 3 to 6 months post-operative appears decisive in the prevention of a new injury. The return to running (in the RTS1) therefore seems a major objective for rehabilitation and will build the necessary foundation for the resumption of the patient's favorite sport, RTS2. However, to allow the return to running, no objective criteria have been validated to date and no consensus is identifiable in the scientific literature. It is the same for his preparation and the gradual resumption of running. Thus, an optimized rehabilitation between the 3rd and 6th month, based on objective evaluations of the patient's functional abilities allowing personalized rehabilitation, including guided and individualized running training, could reduce the risk of new ACL injuries (operated or healthy knee) by better preparing the patient for RTS2: the return to his favorite sport

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

Primary outcomes:
measure: Number of patients with at least one new ACL injury
timeFrame: At 24 months post surgery
Secondary outcomes:
measure: Number of patients meeting all the criteria necessary for authorization to return to their usual sports activities
timeFrame: At 6 months post surgery
measure: Number of patients with at least one post-surgical complication
timeFrame: At 24 months post surgery
measure: Number of patients with <10% asymmetry in running biomechanical parameters
timeFrame: At 6 month post surgery
Other outcomes:
Locations:
city: Challes-les-Eaux
country: France
facility: Medipole de Savoie
city: Domont
country: France
facility: Clinique de Domont Ortholab
city: Firminy
country: France
facility: Centre Hospitalier de Firminy
city: Lyon
country: France
facility: Clinique de La Sauvegarde
city: Lyon
country: France
facility: Hopital de La Croix Rousse
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
city: Geneve
country: Switzerland
facility: Hôpital de la Tour
Study officials:
affiliation: CHU DE SAINT-ETIENNE
name: Thomas NERI, MD
role: STUDY_CHAIR
affiliation: CHU DE SAINT-ETIENNE
name: Grégory MOREL, Physio
role: PRINCIPAL_INVESTIGATOR
References: