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

Ligament Rupture Clinical Trial

— INFO-LCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05585528
• Other study ID #: 2022-A00931-42
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: March 2026

Study information

• Verified date: January 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: David DEJOUR, MD
• Phone: 4 72 20 00 63
• Email: dejour.secretariat[@]lyon-ortho-clinic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Ligament Rupture
• Rupture

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	Clinique de la Sauvegarde	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients operated at 45 days	Rate of patients in the total population who underwent surgery 45 days after anterior cruciate ligament rupture	45 days
Secondary	Proportion of patients who persist in the choice of non-surgical	To assess the proportion of patients who persist in the choice of non-surgical management at 3, 6, 9 and 12 months (in patients who had initial non-surgical management).	12 months