Informing the Patient on the Type of Management, Surgical or Functional, After Rupture of the Anterior Cruciate Ligament

NCT ID: NCT05585528

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-20
• Study Completion Date: 2026-03-31

Brief Summary

The purpose of the study is to evaluate the proportion of patients after rupture of the anterior cruciate ligament (ACL) of the knee, who will have functional or surgical management (PEC) in 1st intention, after having received appropriate information.

Detailed Description

As part of this study, patients will be followed for 1 year with regular functional and quality of life assessments (45 days after inclusion, 3, 6, 9 and 12 months after the start of surgical or non-surgical management). Patients who, during follow-up, will have been redirected towards surgery by the doctor (in the event of functional instability) or who will have chosen to finally move towards surgical PEC, will also be followed.

Conditions

Ligament Rupture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Type of management, surgical or functional, after rupture of the anterior cruciate ligament

Patients will choose the type of management, surgical or functional, after rupture of the anterior cruciate ligament.

Group Type: OTHER

Functional or surgical management in 1st intention

Intervention Type: PROCEDURE

Proportion of patients after rupture of the anterior cruciate ligament of the knee, who will have functional or surgical management in 1st intention

Interventions

Functional or surgical management in 1st intention

Proportion of patients after rupture of the anterior cruciate ligament of the knee, who will have functional or surgical management in 1st intention

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Rupture, partial or complete, of the anterior cruciate ligament less than 3 months old (confirmed by magnetic resonance imaging);
• Patient with no contraindication to surgery or functional management, according to the medical team;
• Patient able to understand the information related to the study, to read the information leaflet and having consented to participate in the study
• Patient benefiting from a social security scheme;

Exclusion Criteria

• Grade 3 associated ligament injury on the fibular collateral ligament and/or the tibial collateral ligament;
• Symptomatic meniscal lesion;
• Practice of sport in national or international competition ;
• Recurrence of rupture of the same anterior cruciate ligament;
• Patient with a neurological (motor and/or sensory), vestibular or rheumatic pathology;
• Pregnant woman ;
• Protected adult patient (under guardianship, or under a regime of deprivation of liberty).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Euraxi Pharma

INDUSTRY

Sponsor Role: collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique de la Sauvegarde

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

David DEJOUR, MD

Role: CONTACT

dejour.secretariat@lyon-ortho-clinic.com

4 72 20 00 63 ext. +33

Facility Contacts

David DEJOUR, MD

Role: primary

Other Identifiers

2022-A00931-42

Identifier Type: -

Identifier Source: org_study_id