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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ligament Rupture
• Intervention / Treatment: Procedure: Functional or surgical management in 1st intention

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David DEJOUR, MD; Phone Number: +33 4 72 20 00 63; Email: dejour.secretariat@lyon-ortho-clinic.com

Study Locations

• France
  • Lyon, France, 69009
    • Recruiting
    • Clinique de la Sauvegarde
    • Contact: David DEJOUR, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: 2022-A00931-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No