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

Primary Purpose

Ligament Knee Injury, Anterior Cruciate Ligament Rupture

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Usual rehabilitation
Rehabilitation optimized
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ligament Knee Injury focused on measuring Physiotherapy, Rehabilitation, Orthopedic surgery, Knee joint, Ligament, Anterior Cruciate Ligament Reconstruction

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medipole de Savoie
  • Clinique de Domont Ortholab
  • Centre Hospitalier de Firminy
  • Clinique de La Sauvegarde
  • Hopital de La Croix Rousse
  • CHU de Saint-EtienneRecruiting
  • Hôpital de la Tour

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Standard rehabilitation

Optimized rehabilitation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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).
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)

Full Information

First Posted
April 5, 2022
Last Updated
October 13, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT05323474
Brief Title
Optimized Rehabilitation After Anterior Cruciate Ligament Before Returning to Sport
Acronym
ORACL-Run
Official Title
Optimized Rehabilitation After Anterior Cruciate Ligament Reconstruction at the First Step of Return to Sport
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ligament Knee Injury, Anterior Cruciate Ligament Rupture
Keywords
Physiotherapy, Rehabilitation, Orthopedic surgery, Knee joint, Ligament, Anterior Cruciate Ligament Reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
432 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard rehabilitation
Arm Type
Experimental
Arm Description
Classical rehabilitation carried out by a physiotherapist with an evaluation at 6 months post-surgery to authorize the return to sport.
Arm Title
Optimized rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Usual rehabilitation
Intervention Description
Usual rehabilitation according to the practice of the "Haute Autorité de Santé" (HAS)
Intervention Type
Other
Intervention Name(s)
Rehabilitation optimized
Intervention Description
Rehabilitation optimized according to the study protocol
Primary Outcome Measure Information:
Title
Number of patients with at least one new ACL injury
Description
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 Outcome Measure Information:
Title
Number of patients meeting all the criteria necessary for authorization to return to their usual sports activities
Description
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
Title
Number of patients with at least one post-surgical complication
Description
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
Title
Number of patients with <10% asymmetry in running biomechanical parameters
Description
Asymmetry <10% in biomechanical running parameters (stride length or stiffness coefficient of each lower limb)
Time Frame
At 6 month post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ALEXANDRE RAMBAUD, physio
Phone
(0)4 77 30 76 55
Ext
+33
Email
alexandre.rambaud.kine@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas NERI, MD
Phone
(0)4 77 12 08 26
Ext
+33
Email
thomas.neri@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALEXANDRE RAMBAUD, Physio
Organizational Affiliation
CHU DE SAINT-ETIENNE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas NERI, MD
Organizational Affiliation
CHU DE SAINT-ETIENNE
Official's Role
Study Chair
Facility Information:
Facility Name
Medipole de Savoie
City
Challes-les-Eaux
ZIP/Postal Code
73000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Coulondre, physio
Facility Name
Clinique de Domont Ortholab
City
Domont
ZIP/Postal Code
95330
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Email
florian.forelli.mk@gmail.com
First Name & Middle Initial & Last Name & Degree
Florian FORELLI, Physio
Facility Name
Centre Hospitalier de Firminy
City
Firminy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Gaetan, physio
Facility Name
Clinique de La Sauvegarde
City
Lyon
ZIP/Postal Code
69000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit Pairot de Fontenay, Physio
Facility Name
Hopital de La Croix Rousse
City
Lyon
ZIP/Postal Code
69000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CLEMENT CHOMMY, PHYSIO
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre RAMBAUD, Physio
Facility Name
Hôpital de la Tour
City
Geneve
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François FOURCHET, Physio

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimized Rehabilitation After Anterior Cruciate Ligament Before Returning to Sport

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