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

Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)
Overall Status
Recruiting
CT.gov ID
NCT05585528
Collaborator
(none)
200
1
1
21.4
9.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Functional or surgical management in 1st intention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, longitudinal, open, non-comparative (single arm), monocentric study.Prospective, longitudinal, open, non-comparative (single arm), monocentric study.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effect of Informing the Patient on the Type of Management, Surgical or Functional, After Rupture of the Anterior Cruciate Ligament : INFO-LCA
Actual Study Start Date :
Dec 20, 2022
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients operated at 45 days [45 days]

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

Secondary Outcome Measures

  1. Proportion of patients who persist in the choice of non-surgical [12 months]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique de la Sauvegarde Lyon France 69009

Sponsors and Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GCS Ramsay Santé pour l'Enseignement et la Recherche
ClinicalTrials.gov Identifier:
NCT05585528
Other Study ID Numbers:
  • 2022-A00931-42
First Posted:
Oct 18, 2022
Last Update Posted:
Jan 13, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2023