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

Primary Purpose

Ligament Rupture

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Functional or surgical management in 1st intention
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ligament Rupture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Clinique de la SauvegardeRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of patients operated at 45 days
Rate of patients in the total population who underwent surgery 45 days after anterior cruciate ligament rupture

Secondary Outcome Measures

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).

Full Information

First Posted
October 14, 2022
Last Updated
January 12, 2023
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
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1. Study Identification

Unique Protocol Identification Number
NCT05585528
Brief Title
Informing the Patient on the Type of Management, Surgical or Functional, After Rupture of the Anterior Cruciate Ligament
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ligament Rupture

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, longitudinal, open, non-comparative (single arm), monocentric study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Type of management, surgical or functional, after rupture of the anterior cruciate ligament
Arm Type
Other
Arm Description
Patients will choose the type of management, surgical or functional, after rupture of the anterior cruciate ligament.
Intervention Type
Procedure
Intervention Name(s)
Functional or surgical management in 1st intention
Intervention Description
Proportion of patients after rupture of the anterior cruciate ligament of the knee, who will have functional or surgical management in 1st intention
Primary Outcome Measure Information:
Title
Proportion of patients operated at 45 days
Description
Rate of patients in the total population who underwent surgery 45 days after anterior cruciate ligament rupture
Time Frame
45 days
Secondary Outcome Measure Information:
Title
Proportion of patients who persist in the choice of non-surgical
Description
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).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David DEJOUR, MD
Phone
4 72 20 00 63
Ext
+33
Email
dejour.secretariat@lyon-ortho-clinic.com
Facility Information:
Facility Name
Clinique de la Sauvegarde
City
Lyon
ZIP/Postal Code
69009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David DEJOUR, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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