Informing the Patient on the Type of Management, Surgical or Functional, After Rupture of the Anterior Cruciate Ligament (INFO-LCA)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Enrolling

Conditions: Ligament Rupture

Treatments: Procedure: Functional or surgical management in 1st intention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05585528

2022-A00931-42

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

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

Other group

Description:

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

Treatment:

Procedure: Functional or surgical management in 1st intention