Optimized Rehabilitation After Anterior Cruciate Ligament Before Returning to Sport

NCT05323474 | Recruiting

• 2 other identifiers: 20PH2822022-A00287-36
• Study Type: interventional
• Target: 432
• Locations: 2 countries
• Sites: 8

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.

Conditions

Ligament Knee Injury; Anterior Cruciate Ligament Rupture

Keywords

Physiotherapy; Rehabilitation; Orthopedic surgery; Knee joint; Ligament; Anterior Cruciate Ligament Reconstruction

Outcome Measures

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.

  At 24 months post surgery

Secondary Outcomes (3)

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

  At 6 months post surgery

• Number of patients with at least one post-surgical complication

  At 24 months post surgery

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

  At 6 month post surgery

Study Arms (2)

Standard rehabilitation

EXPERIMENTAL

Classical rehabilitation carried out by a physiotherapist with an evaluation at 6 months post-surgery to authorize the return to sport.

Other: Usual rehabilitation

Optimized rehabilitation

ACTIVE COMPARATOR

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

Interventions

Usual rehabilitation OTHER

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

Standard rehabilitation

Rehabilitation optimized OTHER

Rehabilitation optimized according to the study protocol

Optimized rehabilitation

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Ministry of Health, France: collaborator

Study Sites (8)

Medipole de Savoie

Challes-les-Eaux, 73000, France

RECRUITING

Clinique de Domont Ortholab

Domont, 95330, France

NOT YET RECRUITING

Centre Hospitalier de Firminy

Firminy, France

NOT YET RECRUITING

Clinique de La Sauvegarde

Lyon, 69000, France

RECRUITING

Hopital de La Croix Rousse

Lyon, 69000, France

NOT YET RECRUITING

Hôpital Lyon Sud

Lyon, 69495, France

NOT YET RECRUITING

CHU de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

Hôpital de la Tour

Geneva, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Thomas NERI, MD

  CHU DE SAINT-ETIENNE

  STUDY CHAIR

• Grégory MOREL, Physio

  CHU DE SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GREGORY MOREL, physio

CONTACT

(0)4 77 12 94 55; gregory.morel@chu-st-etienne.fr

Thomas NERI, MD

CONTACT

(0)4 77 12 08 26; thomas.neri@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 12, 2022
• Study Start: November 14, 2022
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7); CH (1)