Health TrialsbyHealthPanel

Optimized Rehabilitation After Anterior Cruciate Ligament Before Returning to Sport

ConditionsLigament Knee InjuryAnterior Cruciate Ligament Rupture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Usual rehabilitation

    Other intervention

    Usual rehabilitation according to the practice of the "Haute Autorité de Santé" (HAS)

  • Rehabilitation optimized

    Other intervention

    Rehabilitation optimized according to the study protocol

Treatment groups

432 Participants
are divided into 2 treatment groups
Group A: Standard rehabilitationExperimental treatment 1 intervention
Group B: Optimized rehabilitationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with at least one new ACL injury

A re-rupture of the operated ACL or a rupture on the contralateral side, objectified by a Lachman test performed with the absence of a "firm" stop, and a difference in laxity measured with an arthrometer ( \>3 mm for the KT-1000 ™ or \>3 mm for the GNRB® or \>5 mm for the Telos™ ) and by an MRI diagnosing an ACL rupture.

Time frame
At 24 months post surgery

Secondary outcomes

1

Number of patients meeting all the criteria necessary for authorization to return to their usual sports activities

The criteria are : * Recovery of symmetry of muscle strength of the Quadriceps with a Limb Symmetry Index (LSI) \> 90% * International Knee Documentation Committee (IKDC) score \> the 15th percentile of subjects of the same age * Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) score \>56

Time frame
At 6 months post surgery
2

Number of patients with at least one post-surgical complication

Post-surgical complications are : * residual flexion (\>5°) measured by goniometric joint assessment, * knee flexion deficit (\>10°) measured by goniometric joint assessment, * Cyclops syndrome as measured by Magnetic resonance imaging (MRI), * secondary symptomatic meniscal lesions objectified by a clinical examination performed by a physician and an MRI, * Myo-aponeurotic lesions objectified by a clinical examination performed by a physician and medical imaging (MRI or ultrasound).

Time frame
At 24 months post surgery
3

Number of patients with <10% asymmetry in running biomechanical parameters

Asymmetry \<10% in biomechanical running parameters (stride length or stiffness coefficient of each lower limb)

Time frame
At 6 month post surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Saint Etienne

Lead sponsor

Ministry of Health, France

Collaborator

Source ClinicalTrials.gov
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