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

NCT05585528 | Recruiting

• 1 other identifier: 2022-A00931-42
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Ligament Rupture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of patients who persist in the choice of non-surgical

  12 months

Study Arms (1)

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

OTHER

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

Interventions

Functional or surgical management in 1st intention PROCEDURE

Proportion of patients after rupture of the anterior cruciate ligament of the knee, who will have functional or surgical management in 1st intention

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Clinique de la Sauvegarde

Lyon, 69009, France

RECRUITING

MeSH Terms

Interventions

Functional Status

Intervention Hierarchy (Ancestors)

Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

David DEJOUR, MD

CONTACT

4 72 20 00 63; dejour.secretariat@lyon-ortho-clinic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, longitudinal, open, non-comparative (single arm), monocentric study.

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 18, 2022
• Study Start: December 20, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)