Optimized Rehabilitation After Anterior Cruciate Ligament Before Returning to Sport (ORACL-Run)

Optimized Rehabilitation After Anterior Cruciate Ligament Reconstruction at the First Step of Return to Sport

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Rupture; Ligament Knee Injury
• Intervention / Treatment: Other: Usual rehabilitation; Other: Rehabilitation optimized

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

• Study Type: Interventional
• Enrollment (Estimated): 432
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas NERI, MD; Phone Number: +33 (0)4 77 12 08 26; Email: thomas.neri@chu-st-etienne.fr
• Study Contact Backup: Name: GREGORY MOREL, physio; Phone Number: +33 (0)4 77 12 94 55; Email: gregory.morel@chu-st-etienne.fr

Study Locations

• France
  • Challes-les-Eaux, France, 73000
    • Recruiting
    • Médipôle de Savoie
    • Principal Investigator: Claire Coulondre, physio
  • Domont, France, 95330
    • Not yet recruiting
    • Clinique de Domont Ortholab
    • Contact: Email: florian.forelli.mk@gmail.com
    • Principal Investigator: Florian FORELLI, Physio
  • Firminy, France
    • Not yet recruiting
    • Centre Hospitalier de Firminy
    • Principal Investigator: Jacques Gaetan, physio
  • Lyon, France, 69000
    • Not yet recruiting
    • Clinique de la Sauvegarde
    • Principal Investigator: Benoit Pairot de Fontenay, Physio
  • Lyon, France, 69000
    • Not yet recruiting
    • Hopital de la Croix Rousse
    • Principal Investigator: CLEMENT CHOMMY, PHYSIO
  • Saint-Étienne, France, 42055
    • Recruiting
    • CHU de SAINT-ETIENNE
    • Sub-Investigator: Hugo MORON, Physio
    • Principal Investigator: Grégory MOREL, Physio
• Switzerland
  • Geneve, Switzerland
    • Not yet recruiting
    • Hôpital de La Tour
    • Principal Investigator: François FOURCHET, Physio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard rehabilitation; Classical rehabilitation carried out by a physiotherapist with an evaluation at 6 months post-surgery to authorize the return to sport.	Other: Usual rehabilitation; Usual rehabilitation according to the practice of the "Haute Autorité de Santé" (HAS)
Active Comparator: Optimized rehabilitation; Classical rehabilitation carried out by a physiotherapist + expert physiotherapist performing monthly clinical and functional assessments with recommendations for exercises and running program sent to the physiotherapist.	Other: Rehabilitation optimized; Rehabilitation optimized according to the study protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 24 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At 6 months post surgery
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).	At 24 months post surgery
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)	At 6 month post surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Ministry of Health, France
• Investigators: Study Chair: Thomas NERI, MD, CHU de SAINT-ETIENNE; Study Chair: ALEXANDRE RAMBAUD, Physio, CHU de SAINT-ETIENNE; Principal Investigator: Grégory MOREL, Physio, CHU de SAINT-ETIENNE

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Anterior Cruciate Ligament Reconstruction; Ligament; Physiotherapy; Orthopedic surgery; Knee joint
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Rupture; Knee Injuries
• Other Study ID Numbers: 20PH282; 2022-A00287-36 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No