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AzTrials

Ligament Knee InjuryORACL-RunNCT05323474

Optimized Rehabilitation After Anterior Cruciate Ligament Before Returning to Sport

A study testing Usual rehabilitation and Rehabilitation optimized in people with Ligament Knee Injury and Anterior Cruciate Ligament Rupture, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 25 years
What is being tested?
Usual rehabilitation and Rehabilitation optimized
Could I receive a placebo?
No, everyone receives an active treatment
How many people
432 participants
Where
8 sitesin 2 countries
Study dates
14 Nov 2022to Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

GREGORY MOREL, physio contact

(0)4 77 12 94 55 ext. +33

gregory.morel@chu-st-etienne.fr

Thomas NERI, MD contact

(0)4 77 12 08 26 ext. +33

thomas.neri@chu-st-etienne.fr

8 sites in 2 countries

France7 sites, 7 recruiting

  • Medipole de Savoie

    Challes-les-Eaux, 73000

    Claire Coulondre, physio

    Recruiting

  • Clinique de Domont Ortholab

    Domont, 95330

    JEAN MAZEAS, PHYSIO

    AYRTON MOIROUX-SARAHOUI, PHYSIO

    Not yet recruiting

  • Centre Hospitalier de Firminy

    Firminy

    Jacques Gaetan, physio

    Not yet recruiting

  • Clinique de La Sauvegarde

    Lyon, 69000

    Benoit Pairot de Fontenay, Physio

    Recruiting

  • Hopital de La Croix Rousse

    Lyon, 69000

    CLEMENT CHOMMY, PHYSIO

    Not yet recruiting

  • Hôpital Lyon Sud

    Lyon, 69495

    Sébastien MATEO, PHYSIO

    Not yet recruiting

  • CHU de Saint-Etienne

    Saint-Etienne, 42055

    Hugo MORON, Physio

    Grégory MOREL, Physio

    Recruiting

Other trials in France

Switzerland1 site, 1 recruiting

  • Hôpital de la Tour

    Geneva

    François FOURCHET, Physio

    Not yet recruiting

Other trials in Switzerland

About this study

Official title: 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.

Read the 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

Being tested
Usual rehabilitation, Rehabilitation optimized
Keywords
Physiotherapy, Rehabilitation, Orthopedic surgery, Knee joint, Ligament, Anterior Cruciate Ligament Reconstruction
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual rehabilitationOther

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

  • Rehabilitation optimizedOther

    Rehabilitation optimized according to the study protocol

Study groups in NCT05323474
Study groupRoleWhat they receive
Standard rehabilitationExperimentalClassical rehabilitation carried out by a physiotherapist with an evaluation at 6 months post-surgery to authorize the return to sport.
Receives: Other: Usual rehabilitation
Optimized rehabilitationActive comparatorClassical 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.
Receives: Other: Rehabilitation optimized

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 24 months post surgery

Secondary outcomes (3)

  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

    Measured: 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).

    Measured: 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)

    Measured: At 6 month post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start14 Nov 2022
  3. Primary completionMar 2028 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
432 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05323474
Sponsor's protocol ID
20PH282
Other IDs
2022-A00287-36
Acronym
ORACL-Run
Status last verified
Apr 2026
First submitted
5 Apr 2022
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Usual rehabilitation and Rehabilitation optimized in people with Ligament Knee Injury and Anterior Cruciate Ligament Rupture, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact GREGORY MOREL, physio ((0)4 77 12 94 55 ext. +33, gregory.morel@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with at least one new ACL injury (time frame: At 24 months post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05323474.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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